ergoline ergoselect 100 Operator's Manual
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ergoline ergoselect 100 Operator's Manual

ergoline ergoselect 100 Operator's Manual

Bicycle ergometer
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ergoselect 100 / 150 / 200
Bicycle Ergometer
Operator's Manual
201000134000 • Version 2024-09-02 / Rev 08 • English

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Summary of Contents for ergoline ergoselect 100

  • Page 1 100 / 150 / 200 Bicycle Ergometer Operator’s Manual 201000134000 • Version 2024-09-02 / Rev 08 • English...
  • Page 2 This manual is not subject to any change order service. Please contact the manufacturer for the latest document revision. The document „Cleaning, and Disinfecting ergoline Medical Devices“ (Part No. 201000641000) in its most recent version is also part of this manual. This document is exclusively made available for download from the ergoline website www.ergoline.com. ergoline GmbH Lindenstraße 5...

  • Page 3: Table Of Contents

    ontents ontents General Information Symbols Intended Use Intended Purpose Clinical Benefit Indications, Contra-indications and Exclusions, Criteria for Termination Intended User Intended Patient Group Biocompatibility Safety Information Setup and Mains Connection Controls and Indicators Transport Setup Mounting the Control Terminal (P or K) Connecting the Power Cord Connecting the ECG Cable Connecting the Blood Pressure Cuff...
  • Page 4 Cleaning, Disinfection and General Hygiene Measures General Product Information Accessories / Compatible Devices Technical Specifications Electromagnetic Compatibility EN 60601-1-2 - 4 -...

  • Page 5: General Information

    If not avoided, the hazard may result in minor injury and/or product/property damage. • The implemented quality management system covers all aspects of the ergoline operations as per EN ISO 13485. CAUTION • To ensure patient safety, the specified measuring accuracy, and interference-free operation, we recom- indicates a potential hazard.

  • Page 6: Symbols

    ymbols Symbol ’type B applied part’ Type B applied parts have no direct contact with Manufacturer patients and offer the lowest protection against electric shock Date of manufacture Symbol 'type BF applied part' The number found under this symbol is the date of Type BF applied parts are connected to the body manufacture in the YYYY-MM-DD format of the patient and provide a higher degree of pro-...
  • Page 7 Transport and storage label: do not stack Consult operator’s manual Prescription only Caution: U S Federal Law restricts this device to sale by or on the order of a physician Not made with natural rubber latex Not made with DEHP Do not throw away Do not use if package is open or damaged MR unsafe...

  • Page 8: Intended Use

    ntended ntended UrPose — any acute or severe disease of other organ systems, e.g., nephritis, poorly controlled diabetes mellitus, The medical device is an ergometer used to apply stress to or electrolyte disturbances a patient’s cardiovascular and musculoskeletal systems and —...

  • Page 9: Intended User

    — Heart failure — Hypotension, syncope and shock If you have questions in this matter, please contact ergoline — Death (rare; estimated frequency: GmbH or an ergoline representative. 1 per 10,000 tests, but probably less) •...

  • Page 10: Safety Information

    • Equipment Malfunction • Furthermore, all configurations must meet the requirements Only the special shielded cables supplied by ergoline may be of the applicable medical systems standards (see 3rd edition used to connect the device to other pieces of equipment.
  • Page 11 WARNING NOTICE • The SpO module should only be used for the purpose and Only the removal of the power cord will result in an all-pole in the manner described in this manual. disconnection of the device from the power line. •...

  • Page 12: Setup And Mains Connection

    Blood pressure cuff Adjustment of the handlebar height (ergoselect 150 / 200 only) Castors Speed display (RPM) for patient Adjustment of the saddle height (ergoselect 100 / 150 only) Digital saddle height indication (ergoselect 200 only) 100 / 150 - ergoselect...

  • Page 13: Transport

    ransPort For short distances, the ergoselect can be lifted at the saddle and rolled away on its castors. CAUTION To cover greater distances, however, we recommend the • Equipment Damage • following method: Avoid strong vibrations of the ergoselect during transport. •...

  • Page 14: Mounting The Control Terminal (P Or K)

    oUntInG the ontrol ermInal 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. ifferent orientations of the control terminal onneCtInG the ower...
  • Page 15 The connection panel is located on the underside of the ergometer. • Plug the power cord into socket (a) and use the sup- plied lock (b) to secure it against disconnection. • Using the supplied strain relief, attach the cable to the metal frame.

  • Page 16: Connecting The Ecg Cable

    PC-based ECG systems of most manufacturers. Different connection cables are available to support different communication modes (digital, analog, remote start, etc.). All ergoline ergometers are equipped with a digital inter- face (special adapters, which can be obtained from ergo- eKg / pc...

  • Page 17: Connecting The Spo 2 Sensor

    onneCtInG the lood ressUre • Connect the microphone at (1). • Slip the cuff tubing onto the fitting (2) and engage. To disconnect, push back the connector's knurled sleeve. lood pressure cuff connections Microphone connection Artifacts that may be caused by patient movements during Cuff tubing the exercise test, must be avoided if possible, while the blood pressure is being taken.

  • Page 18: Preparing The Patient

    2 Adjusting the height of the handlebar (ergoselect 150 / 200 only) Before allowing the patient to lean on the handlebar, check 3 Adjusting the height of the saddle (ergoselect 100 / 150 only) the clamp as follows: 4 Saddle height display (ergoselect 200 only) DANGER •...

  • Page 19: Blood Pressure Module

    lood ressUre odUle afety nformatIon for nvasIve lood ressUre easUrement WARNING NOTICE • Patient Hazard • • If the cuff pressure exceeds the maximum value of 300 mmHg during inflation, the inflation procedure will Do not take blood pressure measurements with a cuff on pa- be aborted and the cuff deflated.
  • Page 20 Always choose the cuff size suitable for the patient’s arm. The maximum arm circumference is indicated on the cuff. orrect cuff size When you close the Velcro strap, check that the metal clasp (a) is inside the marked index range (b), and not outside.

  • Page 21: Checking The Cuff Tubing

    The cuff tab must be located below the metal clasp (see illustration at right). orrect cuff position heCKInG the UbInG 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.

  • Page 22: Module

    sat ® smart odUle ntended UrPose The reusable SMARTsat® pulse oximetry sensors are intended to be used for non-invasive continuous monito- ring and/or random monitoring of the functional oxygen saturation of arterial hemoglobin (SpO ) and pulse rate in adults and children, depending on the sensor type used. SMARTsat®...
  • Page 23 Intravascular dyes: Taking medicine or other preparations that change blood color or the administration of intravascular dyes (such as methylene blue or indocyanine green, etc.) can drastically falsify the measurement results. Other: Other conditions that may degrade pulse oximeter perfor- mance or affect the accuracy of the measurement include: —...

  • Page 24: Alarm System

    larm ystem The ergoselect bicycle ergometer does not have an alarm system for detecting a physiological alarm status (low SpO or pulse rate values). - 24 -...

  • Page 25: Operation

    Control terminal P Control terminal K ontrol ermInal UrnInG the ystem ergoline 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 GmbH menu displays.

  • Page 26: Operating Modes With Control Terminal P

    PeratInG odes wIth ontrol ermInal An ergoselect ergometer with a control terminal P supports 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-...

  • Page 27: 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.

  • Page 28: 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 dis played.
  • Page 29 NOTICE • 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 initia- ted with ermInatInG an xerCIse The exercise phase can be terminated manually at any time...

  • Page 30: 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.

  • Page 31: 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.
  • Page 32 Protocol Use the softkeys ↑ ↓ to select the parameter to edit. Select Step At Select, for example, you can choose the protocol type: Basic Load 25 W Stage Time 2 min - Step (load increase in steps) or Load Stage 25 W - Ramp (continuous load increase).
  • Page 33 anGUaGe Language The texts can be displayed in different languages. Deutsch English Français Español Italiano Select anguage menu Beep The audio signal emitted during blood pressure measure- ments can be turned on and off. Select eep during measurements oftware ersIon Select this option to view the installed software version.

  • Page 34: Analog In-Out

    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.
  • Page 35 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.

  • Page 36: Control Terminal K

    UrnInG the ystem ergoline 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 GmbH menu displays. NOTICE Selftest running • Instruct the patient not to pedal while the ergometer is being turned on and during the self-test.

  • Page 37: Operating Modes With Control Terminal K

    PeratInG odes wIth ontrol ermInal An ergoselect ergometer with a control terminal K supports the following operating modes: 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.

  • Page 38: Pc Mode

    PC m When the PC Mode key has been pressed, the screen ap pears as shown at right. The ergometer is waiting for commands from the external ECG unit. Saddle ↑ Saddle ↓ 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).

  • Page 39: Ergometry

    rGometry The ergometer is controlled by an internally stored protocol. Pressing the "Ergometry" key will display the test protocol Ergometry WHO used last. ↑ Saddle Press the "Start" key to re-start the protocol, or press the "Select" key to display the protocol parameters or to switch ↓...
  • Page 40 djUstments UrInG the xerCIse Press the key to display the configuration menu. This is what you can do during the test Load + Recovery phase • increase or decrease the current load in increments (adjustable between 1 watt and 25 watts), Load –...

  • Page 41: Manual

    anUal In this operating mode the user controls the entire exercise test by selecting the loads, stage times and by initiating blood pressure measurements. Load + Saddle ↑ The exercise test is started with the "Start" key, afterwards the load can be set and changed with the [Load +] and Load –...

  • Page 42: Training

    raInInG Cardiologic training sessions can be performed with ergo- select ergometers equipped with control terminal K. For a detailed description of the protocols, please refer to Training No.1 Pulse the Appendix. ↑ Saddle Pressing the "Training" key will display the training protocol used last.

  • Page 43: Training With 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.
  • Page 44 Training Chipcard The name and the weight stored on the card are displayed. Sumner You can use the arrow keys to enter the current weight. David Weight + 93 kg Press the "Next" key and the initial screen will display. Weight –...

  • Page 45: Settings For Control Terminals K

    ettInGs for ontrol ermInals 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. Settings Select SETTINGS to display the configuration menu. Default Mode When all changes have been made, you can exit the con- Protocols figuration menu with the...
  • Page 46 Use the softkeys ↑ ↓ to select the parameter to edit. Protocol Select Step At Select, for example, you can choose the protocol type: Basic Load 25 Watt ↑ Stage Time - Step (load increase in steps) or - Ramp (continuous load increase). Load Stage 25 Watt NIBP Lead Time 60...
  • Page 47 hanGe 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 25 watts. +/– 1 Watt ↑ +/– 5 Watt +/– 10 Watt +/–...
  • Page 48 Date/Time To begin with, you select DATE or TIME and confirm the selection. Then the value displayed in reverse video can be edited Date with the ↑ ↓ keys and saved with SELECT. ↑ 30. 06. 2024 Time The time is set in the same way. 17 : 33: 51 ↓...
  • Page 49 Training For all training modes (pulse, constant load and interval), the warmup phase, the duration of the training session Select Pulse and the recovery phase are defined first. Basic Load Watt Depending on the selected training mode, you can edit the ↑...
  • Page 50 eKG t The selected EKG Type determines the communication EKG Type 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.
  • Page 51 Here you determine the RPM limits. When these limits are exceeded, the LEDs for high or low speed (RPM) will illuminate. Min ↑ 0 ... 70 ↑ Select the value to change (Min. or Max.) and confirm with SELECT. Max ↓ 50 ...

  • Page 52: Cleaning, Disinfection And General Hygiene Measures

    The document “Cleaning and Disinfection ergoline Medical Devices” (Part No. 201000641000) in its most recent version is also part of this manual. This document is ex- clusively made available for download from the ergoline website www.ergoline.com. IsInfeCtIon The cleaning of the SpO sensors from “bluepoint medical...

  • Page 53: General Product Information

    Manual as unsorted municipal waste. It must be collected separately. Please contact the authorized manufacturer ergoline GmbH to obtain information concerning the decommissioning of your equipment. There is no proper waste management, proper disposal is documented by ergoline GmbH. - 53 -...

  • Page 54: Accessories / Compatible Devices

    CCessorIes omPatIble evICes Part number 705786 Pedals, extra wide, with comfort pedal straps (set) 705944 Comfort pedal straps, with ratchet (set) 705905 Pedal cranks, adjustable consisting of: — pedal crank (set, left +right) adjustment range of 75 to 175 mm 705942 Pedal cranks, adjustable w/o tools adjustment range of 75 to 175 mm...

  • Page 55: Technical Specifications

    PeCIfICatIons rGometer Model modular ergometer system ergoselect models ergoselect 100 P / K, ergoselect 150 P / K, ergoselect 200 P / K Operating Mode continuous operation Power 100 - 240 V / 50 - 60 Hz (100 VA max.)
  • Page 56 RS232 by PC or ECG recorder, remote start of ECG recorder (optional) USB: digital remote control by PC (driver required) Dimensions, Weight ergoselect 100 / 150: length: 900 mm width: 420 mm (width of handlebar: approx. 535 mm)
  • Page 57 Measurement Error, systematic systole: +/- 3 mmHg diastole: +/- 3 mmHg (temperature: +10 ... +40 °C) Standard deviation (clinical trial) systole / diastole: 7 mmHg (max.) Inflation Pressure 300 mmHg max.; during inflation the inflation pressure automatically adapts to patient's BP Inflation Rate between approx.

  • Page 58: T Est P Rotocols

    esPonse Parameter Specification Display of first value The time until the first value is displayed after application depends on the measurement conditions (perfusion, motion artifacts) and is in the following range: : 3 to 7 s; Puls Rate: 5 to 8 s. Data update period Typically, the displayed data update period is 1 s.
  • Page 59 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 the load PerIods aCCordInG to Under permanent load, the load periods and pauses (white) shall be observed. - 59 -...

  • Page 60: Electromagnetic Compatibility En 60601-1-2

    60601-1-2 Changes or modifications to this system not expressly approved by ergoline could cause EMC issues with this or WARNING other equipment. • RF Interference • This system is designed to comply with applicable regula- Use of portable telephones or other radio frequency (RF) tions regarding EMC.
  • Page 61 ’ – e UIdanCe and anUfaCtUrer eClaratIon leCtromaGnetIC mmUnIty The ergoselect ergometer is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that the ergoselect ergometer is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance...
  • Page 62 ’ – e UIdanCe and anUfaCtUrer eClaratIon leCtromaGnetIC mmUnIty The ergoselect ergometer is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that the ergoselect ergometer is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level...
  • Page 63 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.
  • Page 66 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...

This manual is also suitable for:

Ergoselect 150Ergoselect 200

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