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Service Manual - Strumedical.com

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1. 48 Technical Specifications s s s s s m nn eee HR DEEDES ee Se ee 51 Electromagnetic Compatibility EN 60601 1 2 22 2 u u eee ee 55 DECLARATION OF CONFORMITY AE erooline EG KONFORMITATSERKLARUNG DECLARATION OF CONFORMITY 0123 Wir We ergoline GmbH Lindenstr 5 72475 Bitz Germany erkl ren in alleiniger Verantwortung dass ergoselect 100 das Medizinprodukt ergoselect 200 declare on our own responsibility that the ergoselect 50 medical device Optibike Modelle Models 1611010 ergoselect 100 P 1611020 ergoselect 100 P m BD 1611050 ergoselect 100 K 1611060 ergoselect 100 K m BD 1612010 ergoselect 200 P 1612020 ergoselect 200 P m BD 1612050 ergoselect 200 K 1612060 ergoselect 200 K m BD 1612090 ergoselect 150 P 1612100 ergoselect 150 P m BD 161109 Optibike K 161110 Optibike K Med 161051 ergoselect 50 P 1613010 ergoselect 100 K Reha 1613020 ergoselect 100 K Reha m SA 1613030 ergoselect 100 K Reha m BD 1613050 ergoselect 100 K Reha m 5A m BD 1613170 ergoselect 100 K Reha m Polar 1613180 ergoselect 100 K Reha m SA m Polar 1613190 ergoselect 100 K Reha m BD m Polar 1613200 ergoselect 100 K Reha m SA m BD m Polar 1613090 ergoselect 200 K Reha 1613100 ergoselect 200 K Reha m SA 1613110 ergoselect 200 K Reha m BD 1613130 ergoselect 200 K Reha m SA m BD 1613210 ergoselect 200 K Reha m Polar 1613220 ergoselect 200 K Reha m
2. continuous operation 100 240V 50 60Hz 60VA max specification power cord US SJT 2xAWG16 125V 10A hospital or hospital grade specification internal backup battery IEC CR 2032 3V 230 mAh computer controlled eddy current brake with torque measurement Speed independent to DIN VDE 0750 0238 6 999 watts speed independent see diagrams 30 to 130 RPM to DIN VDE 0750 0238 user programmable Control Terminal P e 5 fixed incremental exercise test protocols e g WHO e 10 user programmable protocols e manual load control Control Terminal K e 5 fixed incremental exercise test protocols e g WHO e 10 user programmable protocols e manual load control e 4 fixed test protocols e g PWC e 10 user programmable training protocols 160 kg continuous for patients between 120 cm and 210 cm ergoselect 100 manual adjustment of saddle height ergoselect 200 electrical adjustment of saddle height with digital readout for patient heights between 120 cm and 210 cm continuous handlebar adjustment over 360 ergoselect 100 rigid steering column ergoselect 200 height adjustable steering column 170 mm cranks with adjustable length are optional accessories Displays Interfaces Dimensions Weight Safety Standards Protection Class Degree of Protection MDD Classification RF Emission Environment BLooD PRESSURE MODULE Measuring Method Measuring Range Measurement Error I
3. gt 95 dip in UT for 5s Power frequency 50 60 Hz magnetic field to EN 61000 4 8 Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power should be that of a typical commer cial or hospital environment Mains power should be that of a typical commer cial or hospital environment Mains power should be that of a typical com mercial or hospital environment If the user of the ergoselect ergometer requires continued operation during power mains interruptions it is recom mended that the ergoselect ergometer be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment The ergoselect ergometer has no components suscep tible to magnetic fields NOTE UT is the a c mains voltage prior to application of the test level E GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The ergoselect ergometer is intended for use in the electromagnetic environment specified below It is the responsibil ity of the customer or user to ensure that the ergoselect ergometer is used in such an environment ImmunityTest IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communi
4. 0 0 00 0 Ve _ mmHg i min min sec Watt 1 min Training No 1 Pulse Saddle 7 12 Saddle Select Make settings INITIAL SCREEN OF THE TRAINING SESSION N 1 min min sec_ _1 min J mnta No 1 Pulse 25 Watt Basic Load Warmup 2 min Training time 20 min 20 Watt Recovery Time 3 Watt 8 Watt min 100 P min 80 Watt Select protocol Recovery Load Load increment Training pulse Select Maximum load SELECTING THE TRAINING PROTOCOL 722 1 min 0 5 Training running DISPLAY DURING EXERCISE TEST 1 most recent BP value systolic diastolic pressures or cuff pressure during inflation heart rate BPM duration of exercise test minutes seconds current load in watts pedal speed RPM mM A GW N ADJUSTMENTS DURING THE TRAINING SESSION Press the key to display the configuration menu This is what you can do during the training session e end the training session and advance to the recovery phase e directly terminate the training session e change the display mode see PC Mode TRAINING WITH CHIP CARD As an alternative to the training protocols saved in the ergometer it is possible to load training protocols from the chip card The training protocols are saved to the chip card by means of a PC program ergoline opticare professional or ergo line opticare basic Upon completion of the training session the entire proce dure incl load and heart rate waveforms i
5. Cuff Deflation Method pulse dependent deflation rate approx 3 mmHg beat or approx 3 mmHg s Calibration calibration with external pressure meter Artifact Rejection automatic artifact rejection and comparison of the rest ing BP readings from both methods for plausibility EXERCISE TEST PROTOCOLS Protocol initial load time in stage load recovery load recovery time W min increment W min W 1 WHO 25 2 25 25 99 2 BAL 50 3 50 25 99 3 Hollmann 30 3 40 25 99 4 STD France 30 3 30 25 99 5 Standard 20 1 25 25 99 6 15 user programmable 25 2 25 25 99 Adjustment Range 20 100 1 30 1 400 20 100 1 99 With Control Terminal P the recovery load is fixed at 25 W Test Protocots ControL TERMINAL K ONLY Protocol initial load duration load time in stage recovery load recovery time W sec increment sec W min W ramping protocol 0 120 25 10 0 99 PWC 130 25 120 25 120 25 99 PWC 150 50 120 50 120 25 99 PWC 170 75 120 50 120 25 99 The program advances to the recovery phase as soon as the target heart rate 130 150 170 is reached ee FAMILY OF CHARACTERISTICS OF THE BRAKING TORQUE CONTROL RANGE rpm min 130 120 110 100 90 80 70 60 50 40 30 20 10 50 5 6 aso 3954 6 25 100 200 300 400 500 600 700 800 900 1000 Watt Load black speed independent range to DIN VDE 0750 0238 black grey speed independent range of the ergoselect ergometer FAMILY OF CHARACTERI
6. MDD 93142IEEC Annex clause 13 6 c 10 SETUP AND Mains CONNECTION CONTROLS AND INDICATORS 1 Control terminal model P or model K 2 Blood pressure cuff connection option 3 Adjustment of the handlebar angle 4 Blood pressure cuff 5 Adjustment of the handlebar height ergoselect 200 only 6 Castors 7 Speed display RPM for patient 8 Adjustment of the saddle height ergoselect 100 only 9 Digital saddle height indication ergoselect 200 only 10 Power switch green button 11 Sockets for power cord and connection cables underside of ergometer 12 Levelling devices to adjust the ergometer to uneven floors 11 ERGOSELECT 100 CONTROLS CONNECTIONS AND INDICATORS ERGOSELECT 200 CONTROLS CONNECTIONS AND INDICATORS TRANSPORT For short distances the ergoselect can be lifted at the Caution saddle and rolled away on its castors e Equipment Damage To cover greater distances however we recommend the following method Avoid strong vibrations of the ergoselect during transport e Disconnect the power cord from the wall outlet e Rotate the handlebar towards the front Tighten the clamping lever e Stand in front of the ergoselect grasp the handlebar and tilt the ergoselect towards you until it is standing on the castors only and Is balanced e t is now possible to transport the ergoselect e When you have reached the new location lower the ergoselect very carefully to avoi
7. SA m Polar 1613230 ergoselect 200 K Reha m BD m Polar 1613240 ergoselect 200 K Reha m SA m BD m Polar 1613730 ergoselect 150 K Reha 1613740 ergoselect 150 K Reha m SA 1613750 ergoselect 150 K Reha m BD 1613760 ergoselect 150 K Reha m SA m BD und das Zubeh r and the accessories 705300 Kippsicherung f r ergoselect 100 200 705306 Klemmpb gel Stellfu f r ergoselect 705308 Satteladapter mit Schnellspanner 705295 Elektrodengurt Polar 705348 Elektrodengurt Polar Gr e L 705084 Sattelbefestigung Horizontal kpl 471107 Rennsattel Nr 18 PU schwarz 705308 Satteladapter mit Schnellspanner 705085 Verstellbarer Kurbelsatz li und re 705087 Triathlon Lenker ergoselect 200 kpl 705080 Sattelbefestigung Kindersattel kpl 471110 Kindersattel schwarz 705088 Blutdruck Manschette mit Schlauch 130cm Standard 705089 Blutdruck Manschette mit Schlauch 200cm Standard 705090 Blutdruck Manschette mit Schlauch 130cm lange Ausf hrung 705091 Blutdruck Manschette mit Schlauch 200cm lange Ausf hrung 705092 Blutdruck Manschette mit Schlauch 130cm Kinder 305320 Elektrodenleitung 1 3m System 2002 PHG 705082 Elektrodensatz 2002 Reha PHG 3x1 3m 705081 Elektrodensatz Druckknopf PHG 3x1 5m 705093 Verbindungskabel RS232 ergoselect zu PC 5m lang 705094 Verbindungskabel RS232 ergoselect zu PC 12m lang 705095 Verbindungskabel RS232 ergoselect zu PC 17m lang 705305 Adapterkabel USB RS232 9 polig mit den Anfor
8. Before each use visually inspect the device for signs of damage If you detect damages or impaired functions which may result in a hazard to the patient or the operator the device must be repaired before it can be used again TECHNICAL SAFETY INSPECTIONS AND TECHNICAL INSPECTIONS OF THE MEASURING SYSTEM The technical safety inspections and the inspections of the measuring system must be completed every two years according to the rules of the art by a Service Engineer authorized by ergoline Similarly the automatic sohygmomanometer in the control terminal must be checked and calibrated by an authorized Specialist every two years to fulfill legal requirements The date of the next inspection is indicated on the inspection sticker attached next to the type plate on the ergometer DISPOSAL The product described in this operator manual must not be disposed as unsorted municipal waste and must be col lected separately Please contact an authorized representative of the manu facturer for information concerning the decommissioning of your equipment 50 TECHNICAL SPECIFICATIONS ERGOMETER Model Operating Mode Power Braking Principle Load Range Speed Range Deviation of Measured Load Load Increments Internal Protocols Permitted Patient Weight Saddle Height Adjustment Handlebar Adjustment Crank Length eo ee modular ergometer system ergoselect models ergoselect 100 P K ergoselect 200P K
9. Por K 2 22 0 0 o 13 Connecting the Power Cord AA III 13 Connecting the Blood Pressure CUM s a se a m ee bow RB oe Soe eke ee eRe ESE EHS 16 MANSPOTE 62 ac ono aa eee en ee cae aka tae ae aee ee ou Gos 16 Preparing the Patient awa a aca kn Geechee Hee GRRE wee 17 Adjusting the Saddle and The Handlebar u 2 u dee ec a ek ee we 17 Preparing the Patient for Blood Pressure Measurements s 222222000 18 Eneckima the CUM TUDNO 22 ue oe ee ae ee ow ee ee a ew 19 OPEN Aa ke Oech eee eee ea ee ewes wee ees ee amp oS 21 Control terminal Pe s sms Gee ee eee eee Re Ree eR EH DR 21 Turning the System UN ur s ann en a RRA a a A ee 21 Operating Modes with Control TerminalP aoaaa e 22 A III 23 o Ys a ota ae home ee ee we A ee ee 24 DVIS wen 2 nue ds ae Se ee AAA A 26 Settings with Control Terminal P s se sss carenar nn een aw ad 27 Control Terminal K aa noaoo eae ae bee e hee ee kee eG ke we 32 Turning CAG gt SCENE e ac ae en ok ee om a ec a a A Se a2 Operating Modes with Control lerminal K 4 2 a ee oe ew ana nenn 33 SECTION a fe eeu as AAA AA ea ee ARS ee 33 CO NOUE sereno a ee ee ele we he wee ee et 34 ETOOMEL eds a tare eae Re ee AAA 35 MARIA o oca nad Pete Sed we eee we Soke eee ss 37 MAMI a in aoa ee are As ce ee AA 38 kanng Wit CMP CId bar Ree oo aaa CORRES Ges 39 SELLINGS for Control Terminals K so sa s is A AA A AA A ee a a 41 Cleaning Maintenance Disposal a 2 2200 m 0 nn
10. Select EKG Type Choose function CONFIGURATION MENU Protocols 1 WHO 2 BAL 3 Hollmann A STD France 5 Standard 7 25W 2min 25W 8 25W 2min 25W 9 25W 2min 25W 10 25W 2min 25W Choose function SELECTING THE EXERCISE TEST PROTOCOL TO EDIT Use the softkeys T to select the parameter to edit Protocol 25 Watt Stage Time 2 min Load Stage 25 Watt NIBP Lead Time 60 sec Recovery Load 25 Watt Recovery Time 2 min Select Choose function SELECTING THE PARAMETER TO EDIT When confirmed with SELECT the corresponding value ap pears in reverse video and can be changed with the arrow Protocol keys Basic Load 25 Watt Stage Time 2 min Pressing SELECT will save the new value Load Stage 25 Watt NIBP Lead Time 60 sec Recovery Load 25 Watt Recovery Time 2 min Select All other parameters are edited in the same way You exit the configuration with ei Choose function EDITING THE PARAMETER VALUE CONTRAST The display contrast is adjustable in the range from Contrast O to 100 l Select Choose function EDITING THE PARAMETER VALUE 42 LOAD CHANGE Here you determine the increments for each load change Depending on your choice each key press will change the load by 1 5 10 und 20 watts LANGUAGE The texts can be displayed in different languages BEEP The audio signal emitted during blood pressure measure ments can be turned on and
11. added leakage currents do not present a hazard In case of questions please contact your ERGOLINE dealer or the ergoline GmbH Service Department For use the ergometer must always be connected to electric installations that fulfill the local requirements e Patient Hazard The German Medical Device Operator Ordinance MPBetreibV 5 demands that users e must be trained in the use of the ergometer e must be familiar with the routines for handling and assembly of the ergometer e must be familiar with and observe the safety rules and regulations for operation of this type of equipment e must be informed about any other pertinent rules and regu lations e g safety features e must be informed about the potential hazards arising from the use of this type of equipment Hint Removing the power cord results in complete disconnection from mains all poles Danger Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards e g IEC 60950 for data processing equipment Furthermore all configurations shall comply with the re quirements for medical electrical systems see IEC 60601 1 1 or clause 16 of the 3Ed of IEC 60601 1 respectively Anybody connecting additional equipment to medical electrical equipment config ures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems Attention is drawn
12. at any time with the END key located in the middle The load will immediately drop to O watt There is no recovery phase in the manual mode 37 lt Watt _1 min Saddle 1 12 Saddle Ergometry Waiting for start SCREEN DISPLAY IN MANUAL MODE TRAINING Cardiologic training sessions can be performed with er goselect ergometers equipped with control terminal K For a detailed description of the protocols please refer to the Appendix Pressing the Training key will display the training proto col used last Press the Start key to re start the protocol or press the Select key to display the protocol parameters or to switch to another training protocol All training protocols 1 10 are user configurable see Settings for Control Terminals K Use the arrow keys to display the protocol to use and the corresponding parameters Confirm the selection with the Select key You initiate the training session with the Start key The display changes to the training session screen where load and heart rate are represented both by numeric values and by waveforms When the basic load appears on the display after approx 15 seconds or upon termination of the blood pressure measurement and the patient s RPM indicator blinks the patient should start pedalling The internal protocol will now control the entire training session the display always indicates the current values 38 AE
13. clothing paper etc Apply the cuff approx 2 em above the bend of the elbow The cuff should be tight but it should not constrict blood vessels The cuff may not move during the exercise test CORRECT CUFF SIZE WRONG CUFF SIZE CORRECT MICROPHONE POSITION MICROPHONE PLACEMENT ON THE ARTERY lt 18 When you close the Velcro strap check that the metal clasp a is inside the marked index range b and not outside The cuff tab must be located below the metal clasp see illustration at right CHECKING THE CUFF TUBING Check that the cuff tubing does not knock against the patient s knee when the patient is pedalling and the hand is on the handlebar Secure the cuff tubing with the Velcro tape attached to the handlebar Instruct your patient to move as little as possible during a blood pressure measurement and in particular to avoid excessive contractions of the muscles in the upper arm DISTANCE BETWEEN KNEE AND TUBING Caution e Patient Hazard Apply the cuff directly on the skin Make sure that rolled up sleeves do not impede blood circulation in the upper arm Loose cuffs will cause erroneous measurements overtight cuffs may constrict blood vessels or cause skin lesions and hemato mas Warning e Patient Hazard e Incorrect Measurements If by accident an excessive pressure builds up inside the cuff either remove the cuff immediately from the arm or disconnect A loose cuff would degr
14. e Using the supplied strain relief attach the cable to the metal frame CONNECTION PANEL a Power input b Lock POWER CORD WITH INSTALLED STRAIN RELIEF Hint e disconnection Removing the power cord results in complete disconnection from mains all poles Danger e Patient Hazard To insure a safe connection to the protective ground system power cords of type hospital only or hospital grade have to be used 14 Connecting the ECG Cable ergoselect ergometers can be connected to electrocardio graphs and PC based ECG systems of most manufacturers Different connection cables are available to support differ ent communication modes digital analog remote start etc The appropriate cable is plugged into the corresponding socket on the connection panel Port 1 USB and secured with the strain relief 15 EKG PC CONNECTION USB PC connection via USB virtual COM PORT 1 Digital connection RS232 remote control by PC or ECG recorder Hint e connecting cables Only use connecting cables released by ergoline To use the integrated USB connector a special driver is required contact ergoline CONNECTING THE BLOOD PRESSURE CUFF e Connect the microphone at 1 e Slip the cuff tubing onto the fitting 2 and engage To disconnect push back the connector s knurled sleeve Artifacts that may be caused by patient movements during the exercise test must be avoided
15. easy very very easy ENTERING THE BORG VALUE Training finished Writing card WRITING TO THE CHIP CARD SETTINGS FOR CONTROL TERMINALS K Some of the device settings are configurable to meet spe cific requirements The settings will be saved and remain stored even when the ergometer is switched off Select SETTINGS to display the configuration menu When all changes have been made you can exit the con figuration menu with the key Use the softkeys f to position the bar cursor on the pa rameter to change and confirm the selection with SELECT DEFAULT MODE In this menu you choose the default mode activated when the ergometer is turned on When first turned on the ergometer will display this menu Use the softkeys f to position the bar cursor on your preferred default mode and save the selection with SELECT PROTOCOLS Protocols 6 15 are user programmable protocols 1 5 are fixed see Appendix for protocol parameter details Standard values for the following parameters can be entered initial load stage time load increment load increase with each stage NIBP lead time blood pressure measurement recovery load recovery time Use the softkeys f to position the bar cursor on the protocol to change No 6 15 and confirm the selection with SELECT Settings Default Mode Protocols Contrast Load Change Language Beep Software Version Date Time Training
16. its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions to EN 55011 The ergoselect ergometer is suitable for use in all establishments including domestic and those directly Harmonic emissions to EN 61000 3 2 Class A connected to the public low voltage power supply network that supplies buildings used for domestic Voltage fluctuations flicker emissions Complies purposes to EN 61000 3 3 55 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The ergoselect ergometer is intended for use in the electromagnetic environment specified below It is the responsibil ity of the customer or user to ensure that the ergoselect ergometer is used in such an environment ImmunityTest IEC 60601 Test Level Compliance Level Electrostatic discharge ESD 6 kV contact 6kV to EN 61000 4 2 8 kV air 8 kV Electrical fast transient burst 2 kV for power supply 2 kV passed to EN 61000 4 4 lines 1 kV for input and output lines Surge to EN 61000 4 5 1 kV differential mode 1 kV 2 kV 2 kV common mode Voltage dips short interrup lt 5 UT lt 5 UT tions and voltage variations gt 95 dip in UT on power supply input lines to for 0 5 cycles EN 61000 4 11 40 UT 40 UT 60 dip in UT for 5 cycles 70 UT 70 UT 30 dip in UT for 25 cycles lt 5 UT lt 5 UT
17. off SOFTWARE VERSION Select this option to view the ergometer s installed soft ware version 43 Load Change 1 Watt 5 Watt 10 Watt 25 Watt l Select SELECTING THE INCREMENT FOR MANUAL LOAD CHANGES Language Deutsch English Francais IBP Espanol Italiano TT Te am Choose function LANGUAGE MENU Date Time To begin with you select DATE or TIME and confirm the selection Then the value displayed in reverse video can be edited with the keys and saved with SELECT The time is set in the same way You exit the configuration with ei TRAINING Ten training protocols consisting of warmup training and recovery phase are user configurable Depending on the selected training mode pulse constant interval there will be different parameters to define for the training phase First of all you select and confirm the protocol you wish to configure Then you select the parameters with the arrow keys as usual and edit them 44 Date Time 22 08 2007 Time 17 33 51 l Select Choose function SETTING THE DATE Date Time Date 22 2007 Time 17 33 51 l Select Choose function CHANGING THE DATE Training 2 Constant 3 Interval 4 Interval 5 Pulse 6 Pulse 7 Pulse 8 Pulse 9 Pulse Select 10 Pulse Choose function SELECTING THE EXERCISE TEST PROTOCOL TO EDIT For all training modes pulse constant load
18. to the fact that local laws take priority over the above mentioned requirements If in doubt consult your local representative or the technical service department e EC 60601 1 Al A2 1995 6 8 2 c 19 2 6 19 2 c e EC 606011 2005 7 9 2 5 8 1 16 20 e MDD 93142IlEEC Annex clause 13 6 c SAFETY INFORMATION FOR Non INvasive BLOOD PRESSURE MEASUREMENT Warning e Patient Hazard Do not take blood pressure measurements with a cuff on patients suffering from sickle cell anemia or where skin lesions are likely to occur The cuff may cause hematomas in patients with severe blood coagulation disease In these instances the user must take a decision for or against automatic blood pressure measure ments Caution e Compromised Measuring Accuracy Arrhythmias occurring frequently during a measurement may compromise the accuracy of the measurement In certain cases a valid measurement will not be possible Electromagnetic fields are also capable of impairing the mea suring accuracy Note The blood pressure module and the approved accessories are defibrillation proof and may remain attached to the patient during defibrillation If the cuff pressure exceeds the maximum value of 300 mmHg during inflation the inflation procedure will be aborted and the cuff deflated As a redundant safety precaution the cuff is immediately deflated when the cuff pressure exceeds 320 mmHg You can check the proper functioning of th
19. with SELECT Using the arrow keys change the value and save the new value with SELECT Note e The limits selected in this menu only apply to the load range between 6 and 150 watts At higher loads the RPM limits automatically adapt to the respective loads Load watts Green RPM range 1 min 6 150 54 64 adjustable 151 250 58 65 251 350 68 75 351 450 78 85 451 550 88 95 551 650 98 105 651 750 108 115 751 850 118 125 851 950 125 951 999 130 Purse DISPLAY The pulse readout on the display can be turned off 31 SETTING THE RPM LIMIT VALUES CONTROL TERMINAL K TURNING THE SYSTEM ON You turn the ergometer on by pressing the power switch the green indicator in the switch lights up The ergometer runs a self test Subsequently the main menu displays Note e Instruct the patient not to pedal while the ergometer is being turned on and during the self test e Apply the blood pressure cuff to the patient AFTER the ergometer has been turned on and the self test been completed e The device may be configured to default to one of the operating modes If this option is selected the initial screen of the selected operating mode e g Ergometry will be displayed instead of the main menu With the key you can display the main menu e Ifan error message e g E 01 appears immediately after the self test please refer to the Troubleshooting section for advice The e
20. 0 118 125 851 950 25 951 999 2190 Purse DISPLAY The pulse readout on the display can be turned off 47 CLEANING MAINTENANCE DISPOSAL GENERAL CLEANING Wipe the device surface down with a cloth moistened with Soap water or a disinfectant The cloth should not be dripping wet do not allow liquids to enter the device Recommendeddisinfectants are for example Fugaten spray Lysoform or Promanum N CLEANING THE SADDLE Clean the saddle with a soft and dry or moist cloth Disinfectants used should not contain any alcohol CLEANING THE UPHOLSTERY E G COUCH ERGOMETER Wipe the upholstery down with a soft cloth moistened with soap water The cloth should only be moist and not dripping wet If the cleaning agents and disinfectants used are caustic or contain alcohol they may damage and or discolor the upholstery Only the following disinfectants are approved Helipur Octenisept Neo Kodan Cutasept F Wofasept Incidur spray Strictly observe the manufacturer s instructions for use 48 Warning e Shock Hazard e Disconnect the device from the power line before clean ing e Equipment Damage Do not allow liquids to enter the equipment Devices into which liquids have entered must be immedi ately cleaned and checked by a service technician before they can be reused Do not use acids alkaline solutions household cleaners or caustic disinfecta
21. ENTS DURING THE EXERCISE TEST Press the key to display the configuration menu This is what you can do during the test SIR e increase or decrease the current load in increments mmHg i min min sec Watt t min adjustable between 1 watt and 25 watts Load Recovery phase e hold the current load e end the exercise phase and advance to the recovery oY To ie End phase e terminate the test Load const Previous Make settings CONFIGURATION MENU Pressing Gi again displays another menu where you co A can change the saddle height and the display mode see D O 0 00 0 0o 3 PC Mode __ mmHg ji min min sec _ Watt 1 min Saddle 12 Saddle Previous Display Make settings CONFIGURATION MENU II TERMINATING THE TEST Once the full protocol has been completed the test will be terminated However it is possible at any time to manually terminate the test or switch to the recovery phase see above lt 36 MANUAL In this operating mode the user controls the entire exercise test by selecting the loads stage times and by initiating blood pressure measurements The exercise test is started with the Start key afterwards the load can be set and changed with the Load and Load keys in increments of 1 W up to 25 W as config ured Blood pressure measurements can be initiated with ED TERMINATING AN EXERCISE TEST The exercise test can be terminated manually
22. EXERCISE TEST PROTOCOL TO EDIT Use the right and left softkeys to select the parameter to edit When confirmed with SELECT the corresponding value ap pears in reverse video and can be changed with the arrow keys J Pressing SELECT will save the new value All other parameters are edited in the same way You exit the configuration with Gi CONTRAST The display contrast is adjustable in the range from O to 100 LOAD CHANGE Here you determine the increments for each load change Depending on your choice each key press will change the load by 1 5 10 und 20 Watts SELECTING THE PARAMETER TO EDIT EDITING THE PARAMETER VALUE ADJUSTING THE DISPLAY CONTRAST 28 SELECTING THE INCREMENT FOR MANUAL LOAD CHANGES LANGUAGE The texts can be displayed in different languages LANGUAGE MENU BEEP The audio signal emitted during blood pressure measure ments can be turned on and off BEEP DURING BP MEASUREMENTS SOFTWARE VERSION Select this option to view the installed software version Date Time To begin with you select DATE or TIME and confirm the selection Then the value displayed in reverse video can be edited with the keys and saved with SELECT The time is adjusted in the same way You exit the configuration with ei SETTING THE DATE SETTING THE DAY 29 EKG Type The selected EKG Type determines the communication met
23. STICS OF LOAD DURATION DUE TO IEC 60601 1 600 900 400 350 300 0 20 40 60 80 100 120 140 160 180 200 220 240 min Under permanent load conditions the shown load and pause times white have to be observed lt 54 ELECTROMAGNETIC COMPATIBILITY Warning e RF INTERFERENCE e EN 60601 1 2 e Use of portable telephones or other radio frequency RF Changes or modifications to this system not expressly emitting equipment near the system may cause unexpect approved by ergoline could cause EMC issues with this or ed or adverse operation other equipment This system is designed to comply with applicable regula tions regarding EMC Its compliance with these requirements has been verified Caution It needs to be installed and put into service according to e Equipment Malfunction the EMC information stated as follows e The equipment or system should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the equipment or system should be tested to verify normal operation in the configuration in which it is being used GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The ergoselect ergometer is intended for use in the electromagnetic environment specified below It is the responsibil ity of the customer or user to ensure that the ergoselect ergometer is used in such an environment RF emissions to EN 55011 Group 1 The ergoselect ergometer uses RF energy only for
24. Y DURING THE TEST 26 SETTINGS WITH CONTROL TERMINAL P Some of the device settings are configurable to meet spe cific requirements The settings will be saved and remain stored even when the ergometer is switched off Use the softkeys on the right and left 1 to position the bar cursor on SETTINGS and confirm the selection with SELECT The configuration menu displays When all changes have been made you can exit the con figuration menu with the key Use the softkeys on the right and left 1 to position the bar cursor on the parameter to change and confirm the selection with SELECT DEFAULT MODE In this menu you choose the default mode activated when the ergometer is turned on When first turned on the ergometer will display this menu Use the softkeys on the right and left 1 to position the bar cursor on your preferred default mode and save the selection with SELECT PROTOCOLS Protocols 6 15 are user programmable protocols 1 5 are fixed see Appendix for protocol parameter details Standard values for the following parameters can be entered Initial load stage time load increment load increase with each stage Use the softkeys on the right and left 1 to position the bar cursor on the protocol to change No 6 15 and confirm the selection with SELECT MAIN MENU Default Mode CONFIGURATION MENU SELECTING THE DEFAULT MODE 27 SELECTING THE
25. ade the accuracy of the measurement the cuff tubing from the control terminal Therefore the computer aborts the measurement if a mini The same measures are recommended if the cuff does not mum pressure is not attained within a few seconds deflate correctly 19 20 OPERATION The ergometers of the ergoselect series are available with two versions of the control terminal whose functionalities differ The following sections describe the control and configura tion of the ergometer CONTROL TERMINAL P TURNING THE SYSTEM ON You turn the ergometer on by pressing the power switch the green indicator in the switch lights up The ergometer runs a self test Subsequently the main menu displays Note e Instruct the patient not to pedal while the ergometer is being turned on and during the self test e Apply the blood pressure cuff to the patient AFTER the er gometer has been turned on and the self test completed e The device can be configured to default to one of the operating modes If this option is selected the initial screen of the selected operating mode e g Ergometry will be displayed instead of the main menu With the key you can display the main menu e Ifan error message e g E 01 appears immediately after the self test please refer to the Troubleshooting section for advice The ergometer software is controlled with 5 keys With this key you display the main menu or return to the previous m
26. and interval the warmup phase the duration of the training session and the recovery phase are defined first Depending on the selected training mode you can edit the corresponding parameters afterwards e Pulse controlled training Training pulse 40 250 1 min Maximum load 1 999 Watt e Constant load Training load 1 999 Watt e nterval training Load Stage 1 1 999 Watt Stage Time 1 10 300 sec Load Stage 2 1 999 Watt Stage Time 2 10 300 sec 45 Training Select NOS E Moy To 20 Watt Warmup 2 min Training time 20 min Recovery Load 20 Watt Recovery Time 3 min Load increment 8 W min Training pulse 100 1 min Maximum load 50 Watt Choose function EDITING THE TRAINING PROTOCOL Select EKG Type The selected EKG Type determines the communication method with the ECG recorder PC based ECG system etc To prevent an accidental change of this setting the menu is protected with a password Using the arrow keys enter 003 and confirm the entry with SELECT Select Choose function ENTERING THE EKG TYPE PASSWORD All ergoselect ergometers support the following communi cation modes e Analog with pulse Remote start mode prior the each load change the ergometer generates a control pulse and sends the corresponding data via the interface e Analog Digital An analog voltage controls the load blood pressure measurements can be initiated with digital commands e Digita
27. cations equip ment should be used no closer to any part of the ergoselect ergometer including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 12 xP d 1 2 vP for 80 MHz to 800 MHz d 2 3 VP for 800 MHz to 2 5 GHz Conducted RF to 3 Vrms EN 61000 4 6 150 kHz to 80 MHz where P is the rated output power rating of the transmitter in watts W according to the trans mitter manufacturer and d is the recommended Radiated RF to 3 V m separation distance in meters m EN 61000 4 3 80 MHz to 2 5 GHz Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol a NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF trans mitters an electromagnetic site survey should be considered If the
28. col or press the Select key to display the protocol parameters or to switch Saddle l to another test protocol There are five fixed protocols protocols 1 5 see Select Appendix whereas protocols 6 15 are user program mable NECESITES INITIAL SCREEN OF AN EXERCISE TEST With the arrow keys you can display the test protocol o y With Select you confirm the selection mmHg ft min _ The selected exercise test is started with the Start key a Protocol WHO eee pressure measurement at rest may precede the test le nn see Settings Stage Time 2 min The display changes to the exercise test screen where load Poa ae en and heart rate are represented both by numeric values and DE waveforms Recovery Time 10 min NIBP Lead Time 60 sec When the basic load appears on the display after approx Select 15 seconds or upon termination of the blood pressure measurement and the patient s RPM indicator blinks the patient should start pedalling SELECTING THE TEST PROTOCOL Select protocol 1 2 3 4 5 The internal protocol will now control the entire exercise test the display always indicates the current values App min 5 10 15 20 Exercise test running DisPLAY DURING EXERCISE TEST 1 most recent BP value systolic diastolic pressures or cuff pressure during inflation heart rate BPM duration of exercise test minutes seconds current load in watts pedal speed RPM mM NR 0 N 95 a ADJUSTM
29. d damage TRANSPORTING THE ERGOSELECT SETUP Place the ergoselect on a level floor The ergoselect must be set up in a secure and stable posi tion the two levelling feet at the back make for easy adjustment to uneven floor surfaces Extend the foot concerned until the ergoselect no longer wobbles In case of delicate flooring it is recommended to place a mat under the ergometer to protect the flooring from damage by the feet LEVELLING FEET OF THE ERGOSELECT ERGOMETER Ll MOUNTING THE ConTROL TERMINAL P or K The control terminal can be installed with the display either facing the patient or the operator It is recommended to install the terminal with the display and control keys towards the operator and the speed display towards the patient CONNECTING THE POWER CORD Set the handlebar to the front upper position and secure Tilt the ergoselect carefully towards you until it rests on the handlebar DIFFERENT ORIENTATIONS OF THE CONTROL TERMINAL ASSEMBLY POSITION OF THE ERGOSELECT ERGOMETER Caution e Equipment Damage Before connecting the ergometer to the power line check that the line voltage corresponds to the ratings on the type plate The type plate is located on the back of the ergometer at the bottom 13 2 The connection panel is located on the underside of the ergometer e Plug the power cord into socket a and use the sup plied lock b to secure it against disconnection
30. derungen der Richtlinie bereinstimmt is in conformity with the Directive UMDNS Code UMDNS Code Benannte Stelle Notified Body Konformit tsbewertungsverfahren Conformity assessment procedure Klassifizierung nach Classification according to Beginn der G ltigkeit Begin of the validity Datum Date 28 05 2003 Ort City Bitz den 09 03 2010 93 42 EWG und 2007 47 EG 93 42 EEC and 2007 47 EC 10383 TUV SUD Product Service GmbH Ridlerstr 65 80339 M nchen Germany Anhang I V appendix V Anhang IX Regel 10 appendix IX rule 10 Axel Bodmer erqoline GENERAL INFORMATION The product ergoselect bears the CE marking CE 0123 Notified Body TUV indicating its compliance with the provisions of the Council Directive 93 42 EEC about medical devices and fulfills the essential requirements of Annex of this directive The CE marking covers only the accessories listed in the Order Information chapter The ergometer is an MDD class Ila product The device fulfills the requirements of standard EN 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety as well as the interference protection requirements of standard EN 60601 1 2 Electromagnetic Compatibility Medical Electrical Devices The radio interference emitted by this product is within the limits specified in EN 55011 class B This manual is an integral part of the equipment It Should be available to the equ
31. ent function press and the arrow keys will again be displayed Additional blood pressure measurements can be initiated with ED Changing the display mode Instead of the waveforms the individual parameter values can be displayed at a large scale With the key you display the menu with the key at the bottom right you select the DISPLAY The blood pressure values will now be displayed with large digits With each subsequent activation of the key at the bottom right you scroll through the following values heart rate test duration load Watt RPM graphic display 34 0 00 in sec S 0 y mmHi 1 min m Watt 1 min Saddle 12 Saddle PC Mode Waiting for start INITIAL SCREEN IN PC MODE 712 2 1 min 0 5 10 15 Exercise test running 20 DISPLAY DURING EXERCISE TEST 1 most recent BP value systolic diastolic pressures or cuff pressure during inflation heart rate BPM duration of exercise test minutes seconds current load in watts pedal speed RPM 1 min min sec Watt 1 min S 1 6 F mmHg mM A 0 N 167 D 91 mmH D 91 am BP DISPLAYED WITH LARGE DIGITS Exercise test running ERGOMETRY The ergometer is controlled by an internally stored proto ER col Y 0 m l nin s Watt _ min Pressing the Ergometry key will display the test protocol used last Saddle 12 Press the Start key to re start the proto
32. enu level ED With this key you initiate a blood pressure mea surement A measurement in progress can be aborted with the same key 2 a o The functions of these three softkeys change with the displayed menu the key label describing the function is shown on the display Control terminal P Control terminal K SELF TEST SCREEN MAIN MENU Keypan P M1 OPERATING MODES WITH CONTROL TERMINAL P An ergoselect ergometer with a control terminal P sup ports the following operating modes PC MODE An external device e g stand alone electrocardio graph PC based ECG system controls the ergometer no intervention at all is required at the ergometer ERGOMETRY The ergometer runs an automatic exercise test some of the corresponding test protocols are user configu rable and stored in the system see chapter Settings MANUAL The ergometer is controlled manually i e the user performs all load changes via the keypad SETTINGS Used to configure the ergometer SPEED READOUT At the top of the control terminal there is a speed readout for the patient as well as three LEDs that inform the patient of the speed too slow too fast or correct The ranges for the respective speed ratings depend on the selected load see Technical Specifications SPEED READOUT 1 speed low patient should pedal faster 2 correct speed 3 speed high patient should pedal slower Note e If during an exercise te
33. ercoline ergoselect II 100 200 Bicycle Ergometer Operator s Manual 2010000134000 e Version 03 2010 English This manual was written with the utmost care Should you still find details that do not correspond with the system please let us know and we will correct the issue as soon as possible We reserve the right to modify the design and technical features of the device and are not bound by the information and illustrations provided in this manual All trademarks appearing in this document are trademarks of their respective owners Their protection is acknowledged No part of this manual may be reprinted translated or reproduced without the manufacturer s written permission This manual is not subject to any change order service Please contact the manufacturer for the latest document revision ergoline GmbH LindenstraBe 5 72475 Bitz Germany Tel 49 0 7431 98 94 0 Fax 49 0 7431 98 94 128 e mail info ergoline com http www ergoline com C 4 0123 Printed in Germany CONTENTS Declaration of Conformity 4 ek GRA eR a ERD REE RS BD 5 General Information a s s s e eee ee ee ae a ed A 7 Safety Information ss sasas Bee ee ee ee ee ee em 8 INTEMACO USE sa ss ee hae ee eae ew ee ss 9 Setup and Mains Connection a o o o 11 Controls ana INAICATONS do de hn a AAA A 11 Iran DO 3 ver ea a a A ee A A AA A A 12 SED ee De een 12 Mounting the Control Terminal
34. es an imminent hazard If not avoided the hazard will result in death or serious injury Warning indicates a hazard If not avoided the hazard may result in minor injury and or product property damage Caution indicates a potential hazard If not avoided the hazard may result in minor injury and or product property damage e To ensure patient safety the specified measuring ac curacy and interference free operation we recom mend using only original ERGOLINE accessories The user is responsible if non ERGOLINE accessories are used e ERGOLINE is responsible for the safety reliability and performance of the equipment only if modifications and repair are carried out by ergoline GmbH or by an organization expressly authorized by ergoline GmbH the equipment is used in accordance with the instructions given in this operator s manual ergoline GmbH Lindenstrasse 5 72475 Bitz Germany Phone 49 0 7431 9894 0 Fax 49 0 7431 9894 128 e mail info ergoline com http www ergoline com www ergoline eu SAFETY INFORMATION Danger e Explosion Hazard The device is not designed for use in areas where an explosion hazard may occur Explosion hazards may result from the use of flammable anes thetics skin cleansing agents or disinfectants Warning e Patient Hazard Equipment Damage Do not expose the ergoselect to direct sunlight to prevent sys tem components from reaching inadmissible high tem
35. he top of the control terminal there is a speed readout for the patient as well as three LEDs that inform the patient of the speed too slow too fast or correct The ranges for the respective speed ratings depend on the selected load see Technical Specifications SPEED READOUT 1 speed low patient should pedal faster 2 correct speed 3 speed high patient should pedal slower Note If during an exercise test the speed drops below 30 RPM the load readout starts blinking on the display To reactivate the saddle height adjustment function press and the arrow keys will again be displayed Additional blood pressure measurements can be initiated with ED a PC Mope When the PC Mode key has been pressed the screen appears as shown at right The ergometer Is waiting for commands from the external ECG unit With the arrrow keys the saddle height can be electrically adjusted on the ergoselect 200 on the ergoselect 400 these key adjust the height of the drive unit As soon as the ergometer receives commands from the controlling ECG unit or PC the exercise test will start and the corresponding values will be displayed The exercise test can only be terminated with the corre sponding command from the controlling ECG unit Note All functions are locked while the ergometer is operating in PC mode except for the saddle height adjustment and the blood pressure key To reactivate the saddle height adjustm
36. hod with the ECG recorder PC based ECG system etc To prevent an accidental change of this setting the menu is protected with a password Using the arrow keys enter 003 and confirm the entry with SELECT ENTERING THE EKG Type PASSWORD All ergoselect ergometers support the following communi cation modes e Analog with pulse Remote start mode prior the each load change the ergometer generates a control pulse and sends the corresponding data via the interface e Analog Digital An analog voltage controls the load blood pressure measurements can be initiated with digital commands e Digital default The communication with the ergometer is entirely controlled with digital commands The entire communication load control and BP mea Analog with pulse surements is controlled with analog signals No digital data will be sent Select the communication mode and confirm with SELECT SELECTING THE ERGOMETER COMMUNICATION MODE Note e The EKG Type needs to be selected only when the ergom eter is connected to an ECG unit The selection is part of the installation procedure e The Analog Digital and Digital communication is only possible when PC Mode is selected from the main menu or when this is the default mode 30 RPM Here you determine the RPM limits When these limits are exceeded the LEDs for high or low speed RPM will illuminate Select the value to change Min or Max and confirm
37. if possible while the BLOOD PRESSURE CUFF CONNECTIONS blood pressure is being taken 1 Microphone connection Therefore do not forget to attach the cuff tubing to the 2 Cuff tubing handlebar with the supplied Velcro tape e Open the large Velcro tape and wrap around handlebar e Secure the cuff tubing with the small Velcro tape but do not exert pressure on the tubing VELCRO TAPE TO SECURE THE CUFF TUBING TRANSPORT e Disconnect the power cord and the connection cables e Stand in front of the ergometer grasp the handlebar and tilt the ergometer towards you until it is standing on the castors only and balanced e When you have reached the new location lower the ergometer very carefully to avoid damage Caution e Equipment Damage Avoid strong vibrations of the ergometer during transport 16 PREPARING THE PATIENT ADJUSTING THE SADDLE AND THE HANDLEBAR On the ergoselect 100 you adjust the saddle height manu ally with a clamping lever On the ergoselect 200 the saddle height is electrically adjusted with the correspond ing keys on the control terminal the display below the saddle indicates the saddle height With the pedal in the bottom position the angle between the axis formed by the upper body and the thigh should be approximately 10 Set the handlebar to a position where the patient sitting upright on the saddle can reach It easily To do so open clamping lever 1 and set the handlebar to a Sui
38. in contact with the patient during the intended use fulfill the biocompatibility requirements of the applicable standards if applied as intended If you have questions in this matter please contact ERGOLINE or a representative APPLICABLE LAWS REGULATIONS AND DIRECTIVES 93 42 EEC Medical Device Directive of the EU 89 336 EEC Electromagnetic Compatibility Directive of the EU EN 1060 1 Non invasive sohygmomanometers Part 1 General requirements EN 1060 3 Non invasive sohygmomanometers Part 3 Supplementary requirements for electro mechanical blood pressure measuring systems Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards e g IEC 60950 for data processing equipment Furthermore all configurations shall comply with the re quirements for medical electrical systems see IEC 60601 1 1 or clause 16 of the 3Ed of IEC 60601 1 respectively Anybody connecting additional equipment to medical electrical equipment config ures a medical system and Is therefore responsi ble that the system complies with the requirements for medical electrical systems Attention is drawn to the fact that local laws take priority over the above mentioned requirements If in doubt consult your local representative or the technical service department Standard directive references IEC 60601 1 Al A2 1995 6 8 2 c 19 2 6 19 2 c IEC 60601 1 2005 7 9 2 5 8 1 16 2 d
39. ipment operator at all times Close observance of the information given in the manual is a prerequisite for proper device perfor mance and correct operation and ensures patient and operator safety Please note that information pertinent to several chapters is given only once Therefore read the manual once carefully in its entirety The symbols A BA mean Consult accompanying documents It indicates points which are of particular importance in the operation of the device Observance of the safety information protects from injuries and prevents inappropriate use of the device All equipment users and persons responsible for assembly maintenance Inspection and repair of the device must read and understand the content of this manual before using or work on it Paragraphs with special symbols are of particular importance If unauthorized individuals open the control terminal damaging the calibration sticker any warranty claim Shall become void This manual reflects the equipment specifications and applicable safety standards valid at the time of printing All rights are reserved for devices circuits techniques software programs and names appearing in this manual On request ERGOLINE will provide a Field Service Manual e The ERGOLINE quality management system complies with the standards ISO 9001 2000 and EN ISO 13485 2003 e he safety information given in this manual is classi fied as follows Danger indicat
40. is safety precau tion by abruptly bending your arm while the cuff is being inflated causing a brief overpressure in the cuff The cuff must deflate immediately Measurements that did not yield a valid measurement will not be repeated during the exercise test If the inflation phase takes longer than 40 seconds or if an adequate pressure does not build up in the cuff within a reasonable period of time the measurement will be aborted and the cuff deflated If a valid measurement cannot be completed within 120 seconds the measurement will be aborted and the cuff deflated If the cuff pressure remains constant for some time the measurement will also be aborted and the cuff deflated INTENDED USE The ergoselect is a computer controlled medical ergometer At pedal speeds between 30 and 130 RPM and loads between 6 and 999 watt the ergometer operates indepen dent of the pedal speed The speed independent range is shown in the Appendix Technical Specifications The ergoselect ergometer may only be used in exercise testing as well as for rehabilitation of cardiac and cardio vascular patients according to the instructions given in this manual If the ergometer is used for other purposes the manufacturer cannot be held liable for personal inju ries or property damage resulting from the unintended use of the equipment BIOCOMPATIBILITY The parts of the product described in this manual includ ing all accessories that come
41. l default EKG Type The communication with the ergometer is entirely controlled with digital commands Analog with pulse e Analog IN OUT Analog Digital The entire communication load control and BP mea Digital surements is controlled with analog signals Analog IN OUT No digital data will be sent Select Select the communication mode and confirm with SELECT SELECTING THE ERGOMETER COMMUNICATION MODE Note e The EKG Type needs to be selected only when the ergom eter is connected to an ECG unit The selection is part of the installation procedure e The Analog Digital and Digital communication is only possible when PC Mode is selected from the main menu or when this is the default mode 46 RPM Here you determine the RPM limits When these limits are exceeded the LEDs for high or low speed RPM will illuminate Select the value to change Min or Max and confirm with SELECT Using the arrow keys change the corresponding value and Save the new value with SELECT Choose function SETTING THE RPM LIMIT VALUES Note e The limits selected in this menu only apply to the load range between 6 and 150 watts At higher loads the RPM limits automatically adapt to the respective loads Load watts Green RPM range 1 min 6 150 54 64 adjustable 151 250 58 65 251 350 68 75 351 450 78 85 451 550 88 95 551 650 98 105 651 750 108 115 751 85
42. measured field strength in the location in which the ergoselect ergometer is used exceeds the applicable RF compliance level above the ergoselect ergometer should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the ergoselect ergometer b Over the frequency range from 150 kHz to 80 MHz field strengths should be less than 3 V m y q RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE ERGOSELECT ERGOMETER The ergoselect ergometer is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ergoselect ergometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ergoselect ergometer as recommended below according to the maximum output power of the communications equipment Rated Maximum Separation Distance According to Frequency of Transmitter Output Power of m Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 vP d 1 2 vP d 2 3 vP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the t
43. nflation Pressure Inflation Rate 59 LCD 68 x 34 mm 128 x 64 pixels Control Terminal P 115 x 88 mm 320 x 240 pixels Control Terminal K additional LED display for speed RPM PORT 1 DSUB 9 pole digital remote control RS232 by PC or ECG recorder remote start of ECG recorder optional USB digital remote control by PC driver required length 900 mm width 460 mm width of handlebar approx 575 mm height 900 mm to 1350 mm weight approx 64 kg ergoselect 100 approx 68 kg ergoselect 200 DIN EN 60601 1 DIN EN 60601 1 2 DIN VDE 0750 238 I B to DIN EN 60601 1 class lla to 93 42 EEC class B to DIN EN 55011 5 0 DIN EN 60601 1 2 operation temperature 10 to 40 C 50 to 104 F rel humidity 30 to 75 no condensation atmospheric pressure 700 to 1060 hPa transport and storage temperature 40 to 70 C 40 to 158 F rel humidity 10 to 90 no condensation atmospheric pressure 500 to 1060 hPa auscultatory method oscillometric for resting BP the results from both measurements are compared for plausibility systolic pressure 40 to 280 mmHg diastolic pressure 40 to 280 mmHg pulse rate 35 to 230 P min pressure readout error 3 mmHg readout resolution 1 mmHg 300 mmHg max during inflation the inflation pressure automatically adapts to patients BP between approx 6 seconds to 140 mmHg and approx 18 seconds to 300 mmHg Max Cuff Pressure 300 mmHg
44. nts CLEANING THE BLOOD PRESSURE CUFF REMOVING THE MICROPHONE Pull the end of the cuff through the metal clasp and fold out the cuff Pull on the short Velcro tab to open the microphone pocket and carefully remove the microphone CLEANING DISINFECTION Clean the cuff and tubing with a moist cloth You can use a dishwashing liquid or mild soap water Clean the microphone with a cloth moistened with alcohol or soap water Allow the microphone to dry before reinserting it in its pocket For disinfection spray a disinfectant sparingly on the cuff the tubing and the microphone After the contact time indicated by the manufacturer wipe all components dry INSERTING THE MICROPHONE Slip the microphone into the pocket the metal side facing the arm Guide the microphone cable out of the pocket and to the right of the Velcro tab Then close the tab Fold the end of the cuff over and introduce it into the metal clasp REMOVING THE MICROPHONE Warning e Equipment Damage Cuff microphone and tubing may not under any circum stances be immersed in liquids be cleaned ina water bath or in running water Note Approved cleaning agents common dishwashing liquids mild soap water moist cloth Approved ingredients of disinfectants tenside glycol propanol and ethanol Approved disinfectants Fugaten spray Promanum N 49 INSERTING THE MICROPHONE MAINTENANCE CHECKS BEFORE EACH USE
45. of exercise test min heart rate at the time of the BP measurement BPM pedal speed RPM I ERGOMETRY Use the softkeys on the right and left f to position the bar cursor on ERGOMETRY and confirm the selection with SELECT The stored test protocols available for selection will be displayed There are five fixed protocols protocols 1 to 5 see Appendix whereas protocols 6 to 15 are user pro grammable The protocol menu provides an overview of the test phases eo 50W 2min 25W means initial basic load 50 watts stage time 2 minutes load increment 25 watts Use the softkeys on the right and left f to position the bar cursor on one of the protocols and confirm the selec tion with SELECT The exercise test Is started with the Start key a blood pressure measurement at rest may precede the test see Settings When the basic load appears on the display after approx 15 seconds or upon termination of the blood pressure measurement and the patient s RPM indicator blinks the patient should start pedalling The internal protocol will now control the entire exercise test the display always indicates the current values With the 5 W and 5 W keys the current load can be changed at any time in increments of 1 W up to 25 W as configured Ergometry MAIN MENU SELECTING AN EXERCISE TEST PROTOCOL INITIAL EXERCISE TEST SCREEN 94 SCREEN DISPLAY DURING THE TEST No
46. peratures Do NOT use the ergoselect outdoors medical device Further more the device has no additional protection against the ingress of humidity Humidity inside the device may cause equipment malfunctions and increases the risk of an electric shock Additionally the device should not be operated in the vicinity of electric power plants because they may impair equipment functions The ergoselect ergometer may only be used in combination with accessories approved by ergoline GmbH e Risk to Persons Before using the ergometer the operator must ascertain that it is in correct working order and operating condition The cables and connectors in particular must be checked for signs of damage Damaged parts must be replaced immediately before use e Equipment Malfunction Only the special shielded cables supplied by ERGOLINE may be used to connect the device to other pieces of equipment e Equipment Malfunction Cellular teleohones may not be used in the immediate vicinity of the ergometer because they might interfere with the proper functioning of the ergometer Electromagnetic interference most probably exists when the watt reading is unstable If the displayed value changes fre quently even though the speed is above 30 RPM this may be due to electromagnetic interference Warning e Shock Hazard When the ergometer is connected to other equipment or if a medical system is created it must be ensured that the
47. ransmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 58 ercoline ergoline GmbH LindenstraBe 5 72475 Bitz Germany Tel 49 0 7431 98 94 0 Fax 49 0 7431 98 94 128 e mail info ergoline com http www ergoline com
48. rgometer software is controlled with 8 keys With this key you display the main menu or return to the previous menu level EB With this key you initiate a blood pressure mea surement A measurement in progress can be aborted with the same key The functions of these six softkeys change with the displayed menu the key label describing the function is shown on the display SELF TEST SCREEN 3932 MAIN MENU Keypan K OPERATING MODES WITH CONTROL TERMINAL K An ergoselect ergometer with a control terminal K sup ports the following operating modes training sessions PC MODE TEST An external device e g stand alone electrocardio Integrated test protocols steep ramping test PWC graph PC based ECG system controls the ergometer tests allow an assessment of the physical fitness no intervention at all is required at the ergometer ERGOMETRY MANUAL The ergometer runs an automatic exercise test some The ergometer is controlled manually i e the user of the corresponding test protocols are user configu performs all load changes via the keypad rable and stored in the system see chapter Settings TRAINING SETTINGS Ten different training protocols with warm up exer Used to configure the ergometer cise and recovery phases can be custom configured see chapter Settings A POLAR receiver is integrated in the ergometer and provides the relevant data for heart rate controlled SPEED READOUT At t
49. s saved to the chip card and can be reviewed and analyzed at the PC STARTING THE CHIP CARD TRAINING SESSION Select the Training mode and insert the chip card into the card reader on the side of the control terminal The ergometer switches to the chip card mode and reads the data stored on the card 39 min sec Watt_ 1 min Recovery phase End Previous Display Training running CONFIGURATION MENU Reading card READING THE CHIP CARD DATA The name and the weight stored on the card are displayed You can use the arrow keys to enter the current weight Press the Next key and the initial screen will display You can initiate the displayed training protocol or select another protocol from the chip card The chip card training session proceeds in the same way as the exercise tests stored in the ergometer TERMINATING THE TRAINING SESSION After termination of the training session automatic ter mination when the programmed recovery phase has been completed or manual termination the test subject can state how the test was perceived BORG scale Subsequently all training data are written to the chip card and are then available for analysis with a special program e g opticare basic 40 Training Chipcard Sumner DEW Weight 93 kg Weight Next Make settings ENTERING THE WEIGHT Training Chipcard Stress very very heavy heavy a little stronger easy very
50. st the speed drops below 30 RPM the load readout starts blinking on the display e To reactivate the saddle height adjustment function press and the arrow keys will again be displayed e Additional blood pressure measurements an be initiated with K 99 PC Mope Use the softkeys on the right and left 1 to position the bar cursor on PC MODE and confirm the selection with SELECT The display changes the ergometer is waiting for com mands from the external ECG unit With the arrrow keys the saddle height can be electrically adjusted on the ergoselect 200 on the ergoselect 400 these keys adjust the height of the drive unit As soon as the ergometer receives commands from the controlling ECG unit or PC the exercise test will start and the corresponding values will be displayed The exercise test can only be terminated with the corre sponding command from the controlling ECG unit Note e All functions are locked while the ergometer is operating in PC mode except for the saddle height adjustment and the blood pressure key e To reactivate the saddle height adjustment function press and the arrow keys will again be displayed e Additional blood pressure measurements can be initiated with ED PC Mode MAIN MENU INITIAL SCREEN 1 2 A DISPLAY DURING EXERCISE TEST current load in watts most recent BP value systolic diastolic values or cuff pressure during inflation duration
51. table angle On the ergoselect 200 the height of the handlebar can ad ditionally be adjusted with clamping lever 2 the horizon tal bar should be approximately at the samel level as the saddle 4 E WU ADJUSTING SADDLE AND HANDLEBAR 1 Adjustment of the handlebar angle 2 Adjustment of the handlebar height ergoselect 200 only 3 Adjustment of the saddle height ergoselect 100 only 4 Saddle height display ergoselect 200 only Note Tighten the clamping levers only as far as necessary NOT with maximum force Lubricate the clamping lever threads quarterly at minimum using a suitable lubricant e g OKS470 17 PREPARING THE PATIENT FOR BLOOD PRESSURE MEASUREMENTS Curr SIZE Always choose the cuff size suitable for the patient s arm The maximum arm circumference is indicated on the cuff MICROPHONE POSITION Before applying the cuff check the position of the micro phone inside the red pocket on the inside of the cuff When the microphone Is inside the pocket its metal side must face the arm APPLYING THE CUFF The center of the microphone must be located exactly on the brachial artery Locate the artery by palpation if required The red tab identifies the position of the micro phone The accurate placement of the microphone Is the primary condition for reliable pressure measurement during exer cise tests The cuff must be applied directly on the skin it may not be applied on top of
52. te e The saddle height ergoselect 200 can be changed during an exercise test e To reactivate the saddle height adjustment function press and the arrow keys will again be displayed e Additional blood pressure measurements can be initiated with ED TERMINATING AN EXERCISE TEST The exercise phase can be terminated manually at any time with the RECOVERY key The load will immediately be reduced to 25 watts but a higher or lower value can be selected manually It is recommended that the patient continues to pedal in the recovery phase RECOVERY PHASE The END key in the middle will terminate the test 25 MANUAL Use the softkeys on the right and left t to position the bar cursor on MANUAL and confirm the selection with SELECT In this operating mode the user controls the entire exercise test by selecting the loads stage times and by initiating blood pressure measurements MAIN MENU The exercise test Is started with the Start key afterwards the load can be set and changed with the 5 W and 5 W keys in increments of 1 W up to 25 W as config ured Blood pressure measurements an be initiated with ED INITIAL SCREEN OF A MANUAL EXERCISE TEST TERMINATING AN EXERCISE TEST The exercise test can be terminated manually at any time with the END key located in the middle The load will immediately drop to O watt There is no recovery phase in the manual mode SCREEN DISPLA

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