ergoline ergoselect 50 Operator's Manual
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ergoline ergoselect 50 Operator's Manual

ergoline ergoselect 50 Operator's Manual

Bicycle ergometer
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ergoselect 50
Bicycle Ergometer
Operator's Manual
201000147000 • Version 03/2010 • English

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  • Page 1 50 Bicycle Ergometer Operator's Manual 201000147000 • Version 03/2010 • English...
  • Page 2 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 Lindenstraße 5 72475 Bitz Germany Tel.:...

  • Page 3: Table Of Contents

    ontents Declaration of Conformity General Information Safety Information Intended Use Setup and Mains Connection Controls and Indicators Mounting the Control Terminal Transport Setup Connecting the Power Cord Connecting the ECG Cable Preparing the Patient Adjusting the Saddle and the Handlebar Operation Control terminal P Turning the System On Operating Modes with Control Terminal P...
  • Page 4 - 4 -...

  • Page 5: Declaration Of Conformity

    eClaration of onformity - 5 -...
  • Page 6 - 6 -...

  • Page 7: General Information

    • This manual reflects the equipment specifications and applicable safety standards valid at the time of ergoline GmbH printing. All rights are reserved for devices, circuits, Lindenstrasse 5 techniques, software programs, and names appearing 72475 Bitz in this manual. Germany • On request ERGOLINE will provide a Field Service Phone: +49-(0)-7431 - 9894 -0 Manual. Fax: +49-(0)-7431 - 9894 -128 e-mail: info@ergoline com http: www ergoline com / www ergoline eu - 7 -...

  • Page 8: Safety Information

    Explosion hazards may result from the use of flammable anes- leakage currents do not present a hazard. thetics, skin cleansing agents or disinfectants. 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 Warning installations that fulfill the local requirements.

  • Page 9: Intended Use

    The optibike is a computer‑controlled medical e rgometer. At pedal speeds between 30 and 130 RPM and loads between 6 and 400 watt, the ergometer operates independent of the pedal speed. The speed‑independent range is shown in the Appendix (Technical Specifications). The optibike ergometer may only be used in exercise test‑ ing as well as for rehabilitation of cardiac and cardiovas‑ cular 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 injuries or property damage resulting from the unintended use of the equipment. ioCompatiBility The parts of the product described in this manual, includ‑ ing all accessories that come 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. ppliCaBle eGUlations anD ireCtives 93/42/EEC (Medical Device Directive of the EU) • 89/336/EEC (Electromagnetic Compatibility Directive • of the EU) - 9 -...
  • Page 10 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.b, 19.2.c, · IEC 60601‑1:2005: 7.9.2.5, 8.1, 16.2.d, · MDD 93142lEEC: Annex I clause 13.6.c - 10 -...

  • Page 11: Setup And Mains Connection

    etUp anD ains onneCtion ontrols anD nDiCators 50 - ergoselect controls connections and indicators 1 Control terminal model P 2 Adjustment of the handlebar angle 3 Castors 4 Speed display (RPM) for patient 5 Adjustment of the saddle height 6 Power switch (green button) 7 Levelling devices to adjust the ergometer to uneven floors 8 Sockets for power cord and connection cables ( underside of ergometer) - 11 -...

  • Page 12: Mounting The Control Terminal

    For short distances, the ergoselect 50 can be lifted at the Caution saddle and rolled away on its castors. • Equipment Damage • To cover greater distances, however, we recommend the following method: Avoid strong vibrations of the ergoselect 50 during transport. • Disconnect the power cord from the wall outlet. • Rotate the handlebar towards the front. Tighten the clamping lever. • Stand in front of the ergoselect 50, grasp the handle‑ bar and tilt the ergoselect 50 towards you until it is standing on the castors only and is balanced. • It is now possible to transport the ergoselect 50. • When you have reached the new location, lower the ergoselect 50 very carefully to avoid damage.

  • Page 13: Setup

    etUp Place the ergoselect 50 on a level floor. The ergoselect 50 must be set up in a secure and stable position ‑ the two levelling feet at the back make for easy adjustment to uneven floor surfaces. Extend the foot con‑ cerned until the ergoselect 50 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. The ergometer can be transported by means of the 2 front castors. evelling feet of the ergoselect ergoMeter onneCtinG the ower • Rotate the handlebar towards the front. • Tilt the ergometer carefully towards you all the way until it rests on the handlebar. sseMbly position of the ergoselect ergoMeter - 13 -...
  • Page 14 • Plug in the power cord on the underside of the ergometer. • Guide the power cord under the strain relief and screw the strain relief to the frame: the plastic pin must lock into place in the boring provided. ower cord with installed strain relief • Put the ergometer back on its feet and set the handle‑ bar to the correct position. Caution • Equipment Damage • • Connect the power cord to a wall outlet. 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.

  • Page 15: Connecting The Ecg Cable

    PORT 1 Digital interface connector (remote control through PC or ECG) Hint • connecting cables • Only use connecting cables released by ergoline. Use of the USB connection requires a special PC driver software (available from ergoline). - 15 -...

  • Page 16: Preparing The Patient

    reparinG the atient DjUstinG the aDDle anD the anDleBar On the ergoselect 50, you adjust the saddle height manu‑ ally with a clamping lever. 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 suitable angle. djusting saddle and handlebar Adjustment of the handlebar angle Adjustment of the saddle height Note • Tighten the clamping levers only as far as necessary, NOT with maximum force.

  • Page 17: Operation Control Terminal P

    Control terminal P UrninG the ystem ergoline ergoline You turn the ergometer on by pressing the power switch ‑ the green indicator in the switch lights up. GmbH GmbH The ergometer runs a self‑test. Subsequently, the main menu displays. Selftest running Note test screen • Instruct the patient not to pedal while the ergometer is being turned on and during the self-test. •...

  • Page 18: Operating Modes With Control Terminal P

    peratinG oDes with ontrol erminal 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. peeD reaDoUt At the top of the control terminal, there is a speed readout for the patient as well as three LEDs that inform the p atient of the speed: too slow, too fast or correct. The ranges for the respective speed ratings depend on the selected load (see "Technical Specifications"). peed readout speed low (patient should pedal faster) correct speed speed high (= patient should pedal slower) Note •...

  • Page 19: Pc Mode

    pC m Use the softkeys on the right and left (↑ ↓) to position the PC Mode bar cursor on PC MODE and confirm the selection with Ergometry SELECT. Manual Settings ↑ ↓ Select ain Menu 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). Saddle nitial screen 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. PC Mode isplay during exercise test current load in watts most recent BP value (systolic/diastolic values) or cuff pressure during inflation duration of exercise test (min) heart rate at the time of the BP measurement (BPM)

  • Page 20: Ergometry

    rGometry Use the softkeys on the right and left (↑ ↓) to position the PC Mode bar cursor on ERGOMETRY and confirm the selection with Ergometry SELECT. Manual Settings Select ain Menu Protocols The stored test protocols available for selection will be displayed. There are five fixed protocols (protocols 1 to 1. WHO 5, see Appendix) , whereas protocols 6 to 15 are user‑ 2. BAL programmable. 3. Hollmann The protocol menu provides an overview of the test 4. STD. France phases: 50 W / 2 min / 25 W 5. Standard e.g.: means: initial (basic) load 50 watts Select stage time 2 minutes load increment 25 watts electing an exercise test protocol Use the softkeys on the right and left (↑ ↓) to position the bar cursor on one of the protocols and confirm the selec‑...
  • Page 21 Note • The saddle height (ergoselect 200) can be changed during an exercise test. • To reactivate the saddle height adjustment function, press and the arrow keys will again be displayed. • Additional blood pressure measurements can be initiated with erminatinG an xerCise The exercise phase can be terminated manually at any time...

  • Page 22: Manual

    anUal Use the softkeys on the right and left (↑ ↓) to position the PC Mode bar cursor on MANUAL and confirm the selection with Ergometry SELECT. Manual Settings In this operating mode the user controls the entire exercise test by selecting the loads, stage times and by initiating blood pressure measurements. Select ain 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 Start + 5 W + 5 W - 5 W - 5 W nitial screen of a Manual exercise test erminatinG an xerCise The exercise test can be terminated manually at any time with the END key located in the middle. The load will immediately drop to 0 watt. There is no recovery phase in the manual mode. + 5 W - 5 W creen display during the test - 22 -...

  • Page 23: Settings With Control Terminal P

    ettinGs with ontrol erminal Some of the device settings are configurable to meet spe‑ PC Mode cific requirements. The settings will be saved and remain Ergometry stored even when the ergometer is switched off. Manual Use the softkeys on the right and left (↑ ↓) to position the Settings bar cursor on SETTINGS and confirm the selection with SELECT. The configuration menu displays. Select When all changes have been made, you can exit the con‑ ain Menu figuration menu with the key. Settings Default Mode Use the softkeys on the right and left (↑ ↓) to position the Protocols bar cursor on the parameter to change and confirm the Contrast selection with SELECT. Load Change Language Select onfiguration Menu Default Mode efaUlt Menu In this menu you choose the default mode activated when PC Mode the ergometer is turned on. When first turned on, the Ergometry ergometer will display this menu.
  • Page 24 Protocol Use the right and left softkeys ↑ ↓ to select the parameter to edit. Basic Load 25 W Stage Time 2 min Load Stage 25 W Select electing the paraMeter to edit Protocol When confirmed with SELECT, the corresponding value ap‑ pears in reverse video and can be changed with the arrow keys ↑ ↓. Basic Load 25 W Stage Time 2 min Load Stage 25 W Pressing SELECT will save the new value. Select All other parameters are edited in the same way. You exit the configuration with diting the paraMeter value Contrast ontrast The display contrast is adjustable in the range from 50 % 0 to 100%. Select djusting the display contrast Load Change hanGe +/-...
  • Page 25 Language anGUaGe Deutsch The texts can be displayed in different English languages. Francais Espanol Italiano Auswahl anguage Menu Beep The audio signal emitted during blood pressure measure‑ ments can be turned on and off. Off Select eep during MeasureMents oftware ersion Select this option to view the installed software version. Date To begin with, you select DATE or TIME and confirm the 22. 08. 2007 selection. Then the value displayed in reverse video can be edited with the ↑ ↓ keys and saved with SELECT. Time The time is adjusted in the same way. 17 : 33 : 05 Select You exit the configuration with etting the date Date 22. 08. 2007 Time 17 : 33 : 05 Select etting the day - 25 -...
  • Page 26 eKG t 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 eKg t ntering the ype password All ergoselect ergometers support the following communi‑ cation modes: • 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. • Analog / Digital An analog voltage controls the load ‑ blood pressure measurements can be initiated with digital commands. • Digital (default) The communication with the ergo m eter is entirely controlled with digital commands. EKG Type • Analog IN‑OUT Analog with pulse The entire communication (load control and BP mea‑ Analog / Digital surements) is controlled with analog signals. Digital No digital data will be sent.
  • Page 27 Here you determine the RPM limits. When these limits are exceeded, the LEDs for high or low speed (RPM) will Min ↑ 0 ... 70 illuminate. Select the value to change (Min. or Max.) and confirm with Max. ↓ 50 ... 130 SELECT. Using the arrow keys, change the value and save the new Select value with SELECT. etting the liMit values 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 respective loads: Load (watts) Green RPM range (1/min)
  • Page 28 - 28 -...

  • Page 29: Cleaning, Maintenance, Disposal

    leaninG aintenanCe isposal Warning eneral leaninG • Shock Hazard • Wipe the device surface down with a cloth moistened with soap water or a disinfectant. • Disconnect the device from the power line before cleaning. The cloth should not be dripping wet; do not allow liquids to enter the device. • Equipment Damage • Recommendeddisinfectants are, for example: ‑ Fugaten spray • Do not allow liquids to enter the equipment. ‑ Lysoform or Devices into which liquids have entered must be immedi- ‑ Promanum N ately cleaned and checked by a service technician, before...
  • Page 30 Before eaCh Use 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. eChniCal afety nspeCtions anD eChniCal nspeCtions of the easUrinG ystem 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 sphygmomanometer 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 e rgometer. isposal 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. - 30 -...

  • Page 31: Technical Specifications

    eChniCal peCifiCations rGometer Model ergometer system ergoselect 50 Operating Mode continuous operation Power 100 ‑ 240 V / 50 ‑ 60 Hz (60 VA max.) specification power cord US: SJT 2xAWG16 125 V / 10 A „hospital“ or „ hospital grade“ specification internal backup battery: IEC: CR 2032 / 3 V 230 mAh Braking Principle computer‑controlled eddy current brake with torque measurement; speed independent to DIN VDE 0750‑0238 Load Range 6 ‑ 400 watts, speed independent (see diagrams) Speed Range 30 to 130 RPM Deviation of Measured Load to DIN VDE 0750‑0238 Load Increments user programmable Internal Protocols...
  • Page 32 Dimensions, Weight 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) Safety Standards DIN EN 60601‑1, DIN EN 60601‑1‑2, DIN VDE 0750‑238 Protection Class / Degree of Protection II / B (to DIN EN 60601‑1) MDD Classification class IIa to 93/42 EEC RF Emission class B to DIN EN 55011 / 5.0 DIN EN 60601‑1‑2 Environment 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:...
  • Page 33 amily of CharaCteristiCs of the BraKinG torqUe Control ranGe black: speed‑independent range to DIN VDE 0750‑0238 black + grey: speed‑independent range of the ergoselect ergometer ieC 60601-1 amily of CharaCteristiCs of loaD DUration DUe to Under permanent load conditions the shown load and pause times (white) have to be observed. - 33 -...
  • Page 34 - 34 -...

  • Page 35: Electromagnetic Compatibility En 60601-1-2

    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...
  • Page 36 ’ – e UiDanCe anD anUfaCtUrer eClaration leCtromaGnetiC mmUnity 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...
  • Page 37 ’ – e UiDanCe anD anUfaCtUrer eClaration leCtromaGnetiC mmUnity 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...
  • Page 38 eCommenDeD separation DistanCes Between portaBle anD moBile 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...
  • Page 40 GmbH Lindenstraße 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...

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