Custo Med Ergometer custo ec5000, Operating Manual

Page 1: ...EXT 0001 DK 1585 Version 001 2015 11 13 EL 20100043500 Operating Manual Ergometer custo ec5000...

Page 2: ...Manufacturer ergoline GmbH Lindenstra e 5 72475 Bitz Germany Telefon 49 0 7431 9894 0 Fax 49 0 7431 9894 128 E Mail info ergoline com Internet www ergoline com...

Page 3: ...translated into another language without the prior written consent of custo med GmbH and ergoline GmbH The current version can be downloaded from this website www customed de in the section SUPPORT Ma...

Page 4: ...4 Ergometer custo ec5000 EXT 0001 DK 1585 Version 001 2015 11 13...

Page 5: ...tment 20 Saddle Adjustment 20 Control Terminal Smart 21 Turning the System On 21 Operating Mode with Control Terminal Smart 21 PC Mode 22 Control Terminal Plus 23 Turning the System On 23 Operating Mo...

Page 6: ...6 Ergometer custo ec5000 EXT 0001 DK 1585 Version 001 2015 11 13...

Page 7: ...inspection and repair of the device must read and understand the content of this manual be fore using or working with it Paragraphs with special symbols are of particular importance If unauthorized i...

Page 8: ...ck Hazard When the ergometer is connected to other equipment or if a medical system is created it must be ensured that the added leakage currents do not present a hazard In case of questions please co...

Page 9: ...conds 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 ec5000 is a...

Page 10: ...Scheduled date of the next inspection e g March 2011 Toggle switch ON voltage Toggle switch OFF voltage CE mark per the Medical Device Directive 93 42 EEC of the European Union Notified body T V S D P...

Page 11: ...Speed readout for patient 3 Connectors e g for blood pressure cuff SpO2 4 Adjustment of handlebar angle 5 Castors 6 Baseplate large 7 Leveling feet to adjust the ergometer to uneven floors 8 Sockets f...

Page 12: ...e to transport the ergometer When you have reached the new location lower the ergometer very carefully to avoid damage SETUP Place the ergometer on a horizontal level floor The ergometer must be set u...

Page 13: ...Stand in front of the ergometer looking at the control panel and firmly grasp the handlebar with both hands Then tilt the ergometer carefully to one side it is recom mended to do this with the help of...

Page 14: ...he cable to the metal frame b Return the ergometer carefully to its upright position and make sure that it is not standing on the power cord UNDERSIDE OF THE ERGOMETER Note Disconnection from Power Su...

Page 15: ...r control of the ergometer with analog signals and for the remote start function The connection cable is plugged into the 9 pole socket of the connection panel Port 1 or the USB port and secured at th...

Page 16: ...bing to the handlebar with the supplied Velcro tape Open the large Velcro tape and wrap it around the handlebar Secure the cuff tubing with the small Velcro tape but do not exert pressure on the tubin...

Page 17: ...he microphone must be located exactly on the brachial artery Locate the artery by palpation if required The red tab identifies the position of the microphone The accurate placement of the microphone i...

Page 18: ...p inside the cuff either remove the cuff immediately from the arm or disconnect the cuff tubing from the control terminal The same measures are recommended if the cuff does not deflate correctly When...

Page 19: ...the control and configura tion of the ergometer SPEED READOUT A speed readout as well as three LEDs on the control ter minal inform the patient of the speed too slow too fast or correct this readout i...

Page 20: ...Repeat these steps if necessary When the clamping force is appropriate lock the clamping lever by folding it down The handlebar is not designed to support the full body weight Optionally the height o...

Page 21: ...key you initiate a blood pressure measure ment Pressing the key a second time during a measure ment will stop the measurement OPERATING MODE WITH CONTROL TERMINAL SMART Ergometers with the control ter...

Page 22: ...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 START SCREEN Note During an exerc...

Page 23: ...with the same key The functions of these three softkeys change with the displayed menu the key label describing the function is shown on the display KEYPAD PLUS PC Mode Ergometry Manual Settings Selec...

Page 24: ...an ECG recorder a 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...

Page 25: ...om 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...

Page 26: ...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 o...

Page 27: ...lower value can be selected manually It is recommended that the patient continue to pedal in the recovery phase The END key in the middle will terminate the test Note The saddle height can be adjusted...

Page 28: ...y 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 can be initiated with TERMINATING AN EXERCISE TEST The...

Page 29: ...en first turned on after delivery the ergometer will display this menu Use the softkeys on the right and left to position the bar cursor on your preferred default mode and save the selection with SELE...

Page 30: ...video and can be changed with the arrow keys Pressing SELECT will save the new value You exit the configuration with CONTRAST The display contrast is adjustable in the range from 0 to 100 LOAD CHANGE...

Page 31: ...d software version DATE TIME To begin with you select DATE 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...

Page 32: ...pressure measurements can be initiated with digital commands Digital default The communication with the ergometer is entirely controlled with digital commands Analog IN OUT The entire communication l...

Page 33: ...PM LIMIT VALUES SETTING THE PULSE READOUT Note 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 respectiv...

Page 34: ...34 Ergometer custo ec5000 EXT 0001 DK 1585 Version 001 2015 11 13...

Page 35: ...ergometer software is controlled from the touch panel Note Instruct the patient not to pedal while the ergometer is being turned on and during the self test Apply the blood pressure cuff to the patie...

Page 36: ...rcise test the available protocols 5 preconfigured editable protocols and 10 user configurable protocols 5 of which are preconfigured are saved in the ergometer see chapter Settings TRAINING TEST Ten...

Page 37: ...ves commands from the controlling ECG unit or PC the exercise test will start and the corresponding values will be displayed The display shows heart rate 1 min blood pressure mmHG oxygen saturation in...

Page 38: ...lm Std Fr Standard Programm 6 Programm 7 Programm 8 Programm 9 Programm 10 ERGOMETRY Pressing the Ergometry key in the main menu activates the ergometry mode The different exercise test protocols will...

Page 39: ...ers the recovery time from 1 to 30 min and the recovery load from 6 to 100 W With the 1 key you return to the previous screen Touch the light gray field e g at Basic Load a submenu with input field an...

Page 40: ...100 50 0 0 5 10 15 20 25 1 min 200 150 100 50 0 W 200 150 100 50 0 0 5 10 15 20 25 1 min 200 150 100 50 0 TERMINATING THE PROGRAM Once the full protocol has been completed it terminates automatically...

Page 41: ...ete control over the ergometer and initiates blood pressure measurements Pressing the Start key initiates the exercise test the 5 W and 5 W keys are used to control the load The increments for the loa...

Page 42: ...e Version Language SETUP MENU DEFAULT MODE SETUP SETUP WITH CONTROL TERMINAL The Setup key opens the configuration menu where various program functions can be defined To access a menu touch the corres...

Page 43: ...s in the list are editable To reach the level for editing of the individual protocol pa rameters first touch the protocol that you want to modify e g 5 Program 6 and then touch the Edit key To change...

Page 44: ...Step 2 Basic Load 30 W Stage Time 2 min Stage Rate 25 W To configure the protocol parameters light gray fields touch one of the parameters Edit the parameter as appropriate and confirm the modifi cat...

Page 45: ...an accidental change this setting is protected with a password A submenu opens when you touch EKG Type on the display Enter the code number 3 via the numeric keypad and confirm with the key The follo...

Page 46: ...Test menu To edit the protocol parameters first touch the Training Test protocol you want to edit Then press the Edit key The individual parameters light gray fields can now be ed ited by touching th...

Page 47: ...OAD CHANGE With this function you select the increments for load changes HR BELT NUMBER If during the training the test subject wears a chest belt to measure the heart rate the corresponding chest bel...

Page 48: ...Time 9 00 15 D Date 12 12 2014 T Time 00 9 00 15 DATE TIME Touch the respective fields to adjust date and time Enter day month year as well as hours minutes and sec onds via the numeric keypad Inputs...

Page 49: ...PM indica tion The three LEDs on the control panel show the patient whether the pedal speed is high low or correct Touch the light gray field to the right of Min or Max and enter the value via the num...

Page 50: ...aliano Dansk Display 1 Service Display Pulse Display On NIBP mmHg kPa mmHg LANGUAGE Here you choose the language for the user interface DISPLAY Press the 2 key to display the next screen and touch Dis...

Page 51: ...ample Fugaten spray Lysoform or Promanum N CLEANING THE SADDLE Clean the saddle with a soft and dry or moist cloth Disin fectants used should not contain any alcohol Warning Shock Hazard Disconnect th...

Page 52: ...uid 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 spar...

Page 53: ...rules of the art by a Service Engineer authorized by custo med Similarly the automatic sphygmomanometer in the control terminal must be checked and calibrated by an authorized specialist every two yea...

Page 54: ...54 Ergometer custo ec5000 EXT 0001 DK 1585 Version 001 2015 11 13...

Page 55: ...terminal Plus 5 fixed and 10 user programmable protocols manual load control control terminal Touch 5 preconfigured editable protocols and 10 user con figurable protocols 5 are preconfigured 10 addit...

Page 56: ...rder remote start of an ECG recorder option USB remote control from PC driver required option Bluetooth WLAN COM module Dimensions weight length 1030 mm width 490 mm width of handlebar approx 530 mm h...

Page 57: ...tic systolic pressure 3 mmHg diastolic pressure 3 mmHg temperature 15 to 25 C Standard deviation clinical trial systolic diastolic pressure 7 mmHg max Inflation pressure 300 mmHg max during inflation...

Page 58: ...ser programmable 25 2 25 25 99 Adjustment Range 20 100 1 30 1 400 20 100 1 99 With control terminal Plus the recovery load is fixed at 25 W TEST PROTOCOLS CONTROL TERMINAL TOUCH ONLY Protocol Basic Lo...

Page 59: ...TICS OF THE BRAKING TORQUE CONTROL RANGE black speed independent range to DIN VDE 0750 0238 black grey speed independent range of the ergometer FAMILY OF CHARACTERISTICS OF THE LOAD PERIODS ACCORDING...

Page 60: ...tem should be tested to verify normal operation in the configuration in which it is being used GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The ec5000 ergometer is intended for us...

Page 61: ...onment Surge to EN 61000 4 5 1 kV differential mode 2 kV common mode 1 kV N A Mains power should be that of a typical commer cial or hospital environment Voltage dips short interrup tions and voltage...

Page 62: ...in meters m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in t...

Page 63: ...ns equipment Rated Maximum Out put Power of Transmit ter W separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0...

Page 64: ...ektrisch 191 805 Lenkerverstellung elektrisch 191 806 Blutdruckmessung 191 807 SpO2 Messung mit Finger oder Ohrsensor 191 808 HF Empfang digital 191 809 HF Empfang POLAR 191 810 Bluetooth Schnittstell...

Page 65: ...URGXFW 6HUYLFH PE 5LGOHUVWU 0 QFKHQ HUPDQ RQIRUPLWlWVEHZHUWXQJV YHUIDKUHQ Conformity assessment procedure QKDQJ Appendix II ODVVH Class D ODVVLIL LHUXQJ QDFK Classification according to QKDQJ 5HJHO Ap...

Page 66: ...ermany Phone 49 0 89 710 98 00 Fax 49 0 89 710 98 10 Email info customed de Internet www customed de Manufacturer ergoline GmbH Lindenstra e 5 72475 Bitz Germany Telefon 49 0 7431 9894 0 Fax 49 0 7431...