ergoline Ergoselect 4 Operator's Manual

ergoline Ergoselect 4 Operator's Manual

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Ergometer
Operator's Manual
201000433000 • Version 2021-06-01 / Rev 04 • English

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  • Page 1 4 / 5 Ergometer Operator‘s Manual 201000433000 • Version 2021-06-01 / Rev 04 • English...
  • Page 3 This manual also describes optional components that are not included in the standard scope of delivery of this product. 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.
  • Page 4: Table Of Contents

    ........ergoselect 4 / 5...
  • Page 5 ........5.4.4 ergoline Digital Chest Strap .
  • Page 6 13.9 Family of characteristics of the load periods according to IEC 60601-1 ..Electromagnetic Compatibility EN 60601‑1‑2 ..... ergoselect 4 / 5...
  • Page 7: General Information

    1 General Information 1 General Information • The product ergoselect bears the CE marking CE-0123 • On request ergoline will provide a Field Service Manual. (Notified Body: TÜV), indicating its compliance with the provisions of the Council Directive 93/42/EEC about • The implemented quality management system covers medical devices and fulfills the essential requirements all aspects of the ergoline operations as per EN ISO...
  • Page 8: Safety Information - Basic Device

    30 RPM, this may be take priority over the above mentioned requirements. due to electromagnetic interference. If in doubt, please consult your local dealer or ergoline GmbH. Note Only the removal of the power cord will result in an all­pole disconnection of the device from the...
  • Page 9: Contraindications

    • progression of heart block to second or third degree medical device. • cardiac arrest Clinical criteria • excessive fatigue • severe chest pain, dyspnoea, or dizziness • > 20 mmHg reduction in systolic blood pressure • rise in blood pressure ergoselect 4 / 5...
  • Page 10: Intended Patient Group

    If you have questions in this matter, please contact ergoline or an ergoline representative. 2.6 Applicable Laws, Regulations...
  • Page 11: Symbols

    Ridlerstr. 65, 80339 München, Germany. Transport and storage label: approved pressure range. Nationally Recognized Testing Laboratory NRTL label for the USA and Canada. Transport and storage label: do not stack. Do not lean against device: tipping hazard. ergoselect 4 / 5...
  • Page 12: Setup And Mains Connection

    Sockets for power cord and connection cables (underside of ergometer) Power switch (toggle switch [ I / 0 ]) Saddle adjustment with clamping lever Figure 4 – 1: ergoselect 4 M Control terminal T Speed readout for patient Connectors (e.g., for blood pressure cuff, SpO2)
  • Page 13: Transport

    Extend the foot concerned until the ergometer no longer wobbles. Figure 4 – 4: Leveling feet of the ergometer In case of delicate flooring, it is recommended to place a mat under the ergometer to protect the flooring from damage by the feet. ergoselect 4 / 5...
  • Page 14: Mounting The Control Terminal

    Using the height spacer and 2 Allen screws with washers , screw the gooseneck to the sides of the control terminal adapter. Figure 4 – 6: Leadwire holder components Figure 4 – 7: Mounting the leadwire holder ergoselect 4 / 5...
  • Page 15: Connecting The Power Cord

    • Using the supplied strain relief, attach the power cord to the metal frame Return the ergometer carefully to its upright position and make sure that it is not standing on the power cord. Figure 4 – 9: Underside of the ergometer ergoselect 4 / 5...
  • Page 16: Data Interfaces

    Note Connection Cables Use only connection cables approved by ergoline. A special PC driver software, which can be obtained from ergoline, is required for operation via the USB port. ergoselect 4 / 5...
  • Page 17: Connecting Ecg Leadwires

    • Open the large Velcro tape and wrap it around the handlebar. • Secure the cuff tubing with the small Velcro tape, but Figure 4 – 14: Velcro tape to secure the cuff tubing do not exert pressure on the tubing. ergoselect 4 / 5...
  • Page 18: Connecting The Spo2 Sensor

    Do not use the sensor if you detect any signs of damage. Connect the sensor cable to the corresponding socket on the underside of the control terminal. Figure 4 – 15: Connecting the oxygen saturation sensor SpO2 port ergoselect 4 / 5...
  • Page 19: Applied Parts

    The ECG module is not an applied part with defibrillation protection. Before a defibrillation pulse is released, the ECG leadwires must be removed from the patient because it CANNOT be excluded that they conduct the defibrillation energy to the ECG module. ergoselect 4 / 5...
  • Page 20: Disposable Electrodes

    Use only the recommended contact spray (ergofluid). • Attach the electrodes (see figure 5 – 1), briefly tap on the electrode to generate suction: the pump starts up • Adjust the vacuum intensity if necessary (see section “ECG Mode” on page 48) ergoselect 4 / 5...
  • Page 21: Checking The Ecg Signal

    5.2.1 Contraindications 5.2.2 Intended Purpose • The BP module is not intended for use in ICUs or ambu- The ergoline blood pressure module is intended to measure lances. the systolic and diastolic blood pressure on the upper arm at rest and during dynamic exercise by a non-invasive, •...
  • Page 22: Safety Information For Non-Invasive Blood Pressure Measurement

    The cuff is only intended for application on the upper arm (left/right). The maximum arm circumference is indicated on the cuff. Warning Do not apply the cuff on a lesion because this may entail further damage. Figure 5 – 3: Correct cuff size ergoselect 4 / 5...
  • Page 23: Applying The Cuff

    Check decision for or against automatic blood pressure measure­ that only the cuff compresses the upper arm. ments. • If the cuff is applied too loosely, the measurement result will be incorrect. ergoselect 4 / 5...
  • Page 24: Microphone Position

    Figure 5 – 6: Microphone placement on the artery The cuff tab must be located below the metal clasp (see illustration at right). Figure 5 – 7: Correct cuff position (tab) ergoselect 4 / 5...
  • Page 25: Checking The Cuff Tubing

    • arrhythmias (cardiac rhythm disturbances) • hypothermia (low body temperature) • hypovolemia (reduced blood volume) • hypotension (low blood pressure) • vasoconstriction in shock ergoselect 4 / 5...
  • Page 26: Intended Purpose

    5 Applied Parts 5.3.2 Intended Purpose The ergoline SpO2 pulse oximetry module is used for the non-invasive measurement of functional oxygen saturation in human arterial blood (SpO2) at rest and during dynamic exercise. The medical device is intended for use in professional healthcare institutions for inpatient and outpatient care.
  • Page 27: Applying The Softtip Spo2 Sensor

    Do not use the thumb. nails before application of the SpO2 sensor. • The fingernail should be facing up. Make sure that long fingernails do not interfere with proper sensor application. For further information, go to https://www.envitec.com ergoselect 4 / 5...
  • Page 28: Applying The Standard Spo2 Sensor

    Figure 5 – 10: Applying the standard SpO2 sensor (example) Figure 5 – 11: Applying the standard SpO2 sensor (example) 5.3.6 Applying the Ear Sensor Apply the ear sensor according to the manufacturer's instructions. Figure 5 – 12: Applying the ear sensor (example) ergoselect 4 / 5...
  • Page 29: Heart Rate Monitoring System

    • Heart rate measuring systems may be inaccurate. • Incorrect or excessive training can have serious or even fatal consequences. • If the patient is about to faint or feels dizzy, the training should be immediately interrupted and you should consult a physician. ergoselect 4 / 5...
  • Page 30: Ergoline Digital Chest Strap

    To improve contact, moisten the electrode surfaces (grooved area) on the inside with electrode gel or spray. Figure 5 – 13: ergoline digital chest strap • The strap is placed correctly when it is tight against the Transmitter unit body below the chest muscles/breasts. The ergoline logo...
  • Page 31 • For further information, go to https://www.polar.com/uk-en/products/heart-rate-sensors Figure 5 – 16: Applying the chest strap ergoselect 4 / 5...
  • Page 32: Operation

    Clamping lever Danger With the ergometer standing firmly, check that the handlebar is tight by trying to push the handlebar downwards from above. Adjust the clamping force of the clamping lever if necessary. ergoselect 4 / 5...
  • Page 33: Saddle Adjustment

    Saddle adjustment at the display Saddle up Saddle down Note Press the [ Saddle ] key or the key to enable adjustment of the saddle: the adjustment keys will be displayed (or use the buttons on the control terminal). ergoselect 4 / 5...
  • Page 34: Mechanical Saddle Adjustment

    The gas pressure spring must be relieved for adjust­ ment of the saddle height. No patient is allowed Figure 6 – 7: Saddle adjustment with gas pressure spring on the saddle while the height is being adjusted. ergoselect 4 / 5...
  • Page 35: Control Terminal M

    Ergometers with control terminal M support the following operating mode: PC Mode An external device (e.g. an ECG recorder, a PC-based ECG system) controls the ergometer – no intervention at all is required at the ergometer. ergoselect 4 / 5...
  • Page 36 BP measurement (BPM) pedal speed (RPM) Note During an exercise test, the saddle height can be adjusted with mmHg ♥ / min Figure 7 – 5: Exercise test screen 2 ergoselect 4 / 5...
  • Page 37: Control Terminal P

    A measurement in progress can be aborted with the same key.  The functions of these three softkeys change Figure 8 – 3: Keypad P with the displayed menu – the key label describing the function is shown on the display. ergoselect 4 / 5...
  • Page 38: Operating Modes With Control Terminal P

    Figure 8 – 4: Main menu The start screen will be displayed – the ergometer is waiting for commands from the external ECG unit. Watt / min mmHg ♥ / min PC Mode Figure 8 – 5: Start screen ergoselect 4 / 5...
  • Page 39: Ergometry

    (see below) icon indicating wireless connection (Bluetooth or WLAN) duration of exercise test (min) heart rate measurement with the ergoline digital chest strap heart rate at the time of the BP measurement (BPM) pedal speed (RPM) Note •...
  • Page 40 (in increments of +/–1 W up to +/–25 W, as configured). mmHg ♥ / min + 5 W Recovery – 5 W Figure 8 – 11: Display during the exercise test Note The saddle height can be adjusted during an exercise test. ergoselect 4 / 5...
  • Page 41: Manual

    The load will immediately drop to 0 watt. 138/96 There is no recovery phase in the manual mode. mmHg ♥ / min + 5 W – 5 W Figure 8 – 15: Display during the exercise test ergoselect 4 / 5...
  • Page 42: Settings With Control Terminal P

    Ergometry Use the softkeys on the right and left (↑ ↓) to position the bar cursor on your preferred default mode and save the Manual selection with Select. Select Figure 8 – 19: Selecting the default mode ergoselect 4 / 5...
  • Page 43 You exit the configuration with Select Figure 8 – 22: Editing the parameter value Contrast The display contrast is adjustable in the range from Contrast 0 to 100 %. 50 % Select Figure 8 – 23: Adjusting the display contrast ergoselect 4 / 5...
  • Page 44 Figure 8 – 26: Beep during BP measurements Software Version Select this option to view the installed software version. Software Version EF 1.5 X 6 MTK: 30.06.2021 Figure 8 – 27: Display of the installed software version ergoselect 4 / 5...
  • Page 45 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 Figure 8 – 30: Entering the ECG Type password ergoselect 4 / 5...
  • Page 46 Select the value to change (Min. or Max.) and confirm with Select. /min Using the arrow keys, change the value and save the new Select value with Select. Figure 8 – 32: Setting the RPM limit values ergoselect 4 / 5...
  • Page 47 HR belt Select key. Repeat these steps for each numeral until the 0 0 6 6 3 0 0 complete number has been entered. Select Figure 8 – 35: Setting the HR belt no., screen 2 ergoselect 4 / 5...
  • Page 48: Control Terminal T

    The ergometer runs a self-test. Subsequently, the main menu displays. Figure 9 – 2: Self-test screen The ergometer software is controlled from the touch panel. PC Mode Ergometry Training/Test Manual Setup Figure 9 – 3: Main menu ergoselect 4 / 5...
  • Page 49: Operating Modes With Control Terminal T

    Figure 9 – 7: Manual mode Setup Setup Used to configure the ergometer. The button disappears within 2 minutes after the ergometer was switched on. This interval can be modified in the Service menu. Figure 9 – 8: Setup mode ergoselect 4 / 5...
  • Page 50: Pc Mode

    [ I / 0 ] key. To switch off the pump, the displayed key [ low ], [ middle ] or [ high ] must be pressed for about 3 seconds. Figure 9 – 10: ECG screen All inputs are confirmed with the [   ] key. ergoselect 4 / 5...
  • Page 51 Description PC Mode on assigning heart rate belts, see chapter 9.2.6 “Setup”, section “HR Belt Number” on page 74. HR Belt 7 10 8 11 9 12 0 15 Figure 9 – 13: Selecting the heart rate belt ergoselect 4 / 5...
  • Page 52: Ergometry

    Recovery Time: 2 min Recovery Load: 25 W It is not possible to edit the parameters of the "Ramp" program type. Ramp Type: Basic Load: 30 W Slope: 50 W/min Recovery Time: 2 min. Recovery Load: 25 W ergoselect 4 / 5...
  • Page 53 (6 W ... 100 W) The other parameters can be edited in the same way, they Stage Time 2 min will overwrite the current values. Stage Rate 25 W Figure 9 – 19: Exercise test protocol, basic load, screen 2 ergoselect 4 / 5...
  • Page 54 – 5 W Figure 9 – 21: Terminating an exercise, screen 1 118/96 25:00 Stop 1/min mmHg mm:ss 1/min 1/min const. + 5 W – 5 W Figure 9 – 22: Terminating an exercise, screen 2 ergoselect 4 / 5...
  • Page 55: Training / Test

    The results must be • Recovery. verified and evaluated by a qualified physician to obtain a diagnosis and set up a therapy plan. The defined protocol steps depend on the selected protocol type (see table on page 54). ergoselect 4 / 5...
  • Page 56 Recovery Load Load during the recovery phase Pulse, Constant, Interval, Interval HR, PWC, Ramp test Recovery Time Duration of recovery stage Pulse, Constant, Interval, Interval HR, PWC, Ramp test Weight Patient weight ergoselect 4 / 5...
  • Page 57 (alpha-) numeric keypad or a keyboard will be displayed. Warm-Up Time 2 min Inputs are confirmed with the [   ] key. The following sections describe each protocol type in detail. Figure 9 – 25: Changing the input level ergoselect 4 / 5...
  • Page 58 Figure 9 – 27: Protocol type "Pulse" – level 2 118/96 15:00 Stop 1/min mmHg mm:ss 1/min 1/min const. + 5 W – 5 W Figure 9 – 28: Example of a heart rate controlled training ergoselect 4 / 5...
  • Page 59 3 min Figure 9 – 30: Protocol type "Constant" – level 2 118/96 15:00 Stop 1/min mmHg mm:ss 1/min 1/min const. + 5 W – 5 W Figure 9 – 31: Example of a constant load training ergoselect 4 / 5...
  • Page 60 60 sec Figure 9 – 34: Protocol type "Interval" – level 3 118/96 15:00 Stop 1/min mmHg mm:ss 1/min 1/min const. + 5 W – 5 W Figure 9 – 35: Example of an interval training ergoselect 4 / 5...
  • Page 61 Figure 9 – 38: Protocol type "Interval HR" – level 3 118/96 15:00 Stop 1/min mmHg mm:ss 1/min 1/min const. + 5 W – 5 W Figure 9 – 39: Example of an interval HR training ergoselect 4 / 5...
  • Page 62 6 min Recovery Load 25 W Figure 9 – 40: Protocol type "Countdown" --/-- 03:50 Stop 1/min mmHg mm:ss 1/min 1/min + 5 W – 5 W Figure 9 – 41: Example of a "Countdown" training ergoselect 4 / 5...
  • Page 63 3 min Figure 9 – 43: Protocol type "Ramp test" – level 2 --/-- 03:30 Stop 1/min mmHg mm:ss 1/min 1/min + 5 W – 5 W Figure 9 – 44: Example of a ramp test ergoselect 4 / 5...
  • Page 64 Figure 9 – 47: Protocol type "PWC Test" – level 3 --/-- 07:30 Stop 1/min mmHg mm:ss 1/min 1/min PWC1 = 0 W + 5 W – 5 W Figure 9 – 48: Example of a PWC test ergoselect 4 / 5...
  • Page 65: Training With Chip Card

    As an alternative to the training protocols saved in the ergometer, it is possible to load training protocols from a chip card. The PC software “ergoline opticare basic” is used to write the training protocols to the chip card. Upon completion of the training session, the ergometer saves the entire session (incl.
  • Page 66 Ratings from “Very, very light” to “Very, very hard” can be somewhat hard selected with the arrow keys. hard very hard Inputs are confirmed with the [   ] key. Figure 9 – 53: Entering the exertion rating ergoselect 4 / 5...
  • Page 67 When this mode is selected, training sessions can only be performed when a chip card is inserted. The training parameters are usually defined by physicians/ therapists and saved to the chip card. The training results are directly written back to the chip card. ergoselect 4 / 5...
  • Page 68 9) The patient exercises with the new, modified training protocol. The training results are directly written to the chip card again. 10) This procedure from step 3 onwards can be repeated indefinitely. ergoselect 4 / 5...
  • Page 69: Manual

    [ Stop ] key. 1/min mmHg mm:ss 1/min 1/min The load will immediately drop to 0 watt. There is no recovery phase in the manual mode. + 5 W – 5 W Figure 9 – 57: Terminating a manual test ergoselect 4 / 5...
  • Page 70: Setup

    A submenu opens when you touch ECG Type on the display. Date/Time Regulation (0* ... 9999*) Enter the code number "3" via the numeric keypad and Service Beep confirm with the [   ] key. Software Version Language Figure 9 – 60: Setup menu ergoselect 4 / 5...
  • Page 71 [   ] key. Load Change With this function, you select the increments for load changes. Load Change +/– 1 Watt +/– 5 Watt +/– 10 Watt +/– 25 Watt Individually Figure 9 – 62: Setup – load change ergoselect 4 / 5...
  • Page 72 The 3 LEDs on the control panel show the patient whether the pedal speed is high, low or correct. Min. 0 … 70 54 1/min Max. 50 … 130 65 1/min Figure 9 – 65: Setup – RPM, screen 1 ergoselect 4 / 5...
  • Page 73 0. WHO 1. BAL 2. Hollm 3. Std Fr 4. Standard 5. Programm 6 6. Programm 7 7. Programm 8 8. Programm 9 9. Programm 10 Figure 9 – 68: Setup – protocols, screen 1 ergoselect 4 / 5...
  • Page 74 Touch the Cancel key [   ] to exit the menu item. With the [    2. ] and [    1. ] keys, you toggle between the different screens. Figure 9 – 72: Setup – protocols, screen 5 ergoselect 4 / 5...
  • Page 75 [ PWC Test 2   ], [ PWC Test 3   ] and [ Inactive   ]. You scroll Warm-Up Load 20 W through the Type options by tapping the [   ] key. Configure the parameters as required by the selected type. Warm-Up Time 2 min Figure 9 – 75: Editing parameters, screen 1 ergoselect 4 / 5...
  • Page 76 14: (ID = _ _ _) 11: (ID = _ _ _) 15: (ID = _ _ _) 12: (ID = _ _ _) 16: (ID = _ _ _) Figure 9 – 78: Setup – HR belt number, screen 2 ergoselect 4 / 5...
  • Page 77 3 min Figure 9 – 80: Setup – regulation method, screen 2 Beep The audio signal emitted during blood pressure measure- ments can be turned on and off. Beep Figure 9 – 81: Setup – beep ergoselect 4 / 5...
  • Page 78 Figure 9 – 83: Setup menu, screen 2 Display Switch the pulse readout on or off. Display Select the blood pressure unit: mmHg (millimeter of mer- cury) or kPa (kilopascal). Pulse Display NIBP mmHg/kPa mmHg Figure 9 – 84: Setup – display ergoselect 4 / 5...
  • Page 79 Quick Start When the Quick Start function is activated, a manual training session will start automatically only after the pedal speed Quick Start exceeds 30 rpm. Figure 9 – 87: Activating the Quick Start mode ergoselect 4 / 5...
  • Page 80 With the [   ] key, the input is confirmed, with the [   ] key, it is discarded. Initial Load man. 25 W Initial Load man. (0 W ... 200 W) Figure 9 – 89: Initial load, manual training, screen 2 ergoselect 4 / 5...
  • Page 81: Accessory / Compatible Devices

    10 Accessory / Compatible Devices 10 Accessory / Compatible Devices 10.1 Accessories Overview Part no. Designation Application Information erg705.802 Anti-tipping device for ergoselect 4 / 5, white Stability optional erg705.024 Standard saddle with standard receptacle (Ø 22 mm) Saddle included* erg705.084...
  • Page 82: Compatible Devices

    10 Accessory / Compatible Devices 10.2 Compatible Devices A large number of ECG and ergospirometry devices as well as PC software programs are compatible with ergoline ergometers via the ergoline interface protocol P10Vnnn. Please contact service@ergoline.com for more information. ergoselect 4 / 5...
  • Page 83: Cleaning, Disinfection And General Hygiene Measures

    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 exclusively made available for download from the ergoline website www.ergoline.com. ergoselect 4 / 5...
  • Page 84: General Product Information

    The date of the next inspection is indicated on the inspection sticker attached next to the type plate on the ergometer. ergoselect 4 / 5...
  • Page 85: Disposal

    The product described in this operator manual must not be disposed of as unsorted municipal waste; it must be collected separately. Please contact your authorized manufacturer ergoline GmbH for information concerning the disposal of your equipment. There is no proof of disposal. Proper disposal is documented by ergoline GmbH.
  • Page 86: Technical Specifications

    13 Technical Specifications 13.1 Ergometer Model modular ergometer system ergoselect models ergoselect 4, M / P / T, ergoselect 5, M / P / T Operating mode continuous operation Power supply 100 – 240 V ~ / 50 – 60 Hz max. 100 VA (max. 140 VA for...
  • Page 87 +10 to +40 °C rel. humidity: 30 to 75 %, no condensation atmospheric pressure: 800 to 1060 hPa transport and storage: temperature: –20 to +70 °C rel. humidity: 10 to 95 %, no condensation atmospheric pressure: 500 to 1060 hPa ergoselect 4 / 5...
  • Page 88: Blood Pressure Module [Option B]

    20 to 250 BPM Accuracy SpO2 70 % < SpO2 < 100 % < 2 % Pulse rate 1 BPM, max. 2 % of reading Sampling rate SpO2 300 Hz Connection Mini Med Calibration ChipOx® ergoselect 4 / 5...
  • Page 89: Ecg Module [Option A]

    Load Increment Stage Time Recovery Load Recovery Time [sec] [sec] [min] Ramp test PWC-130 (*) PWC-150 (*) PWC-170 (*) (*) the protocol advances to the recovery phase as soon as the target heart rate (130/150/170) is reached ergoselect 4 / 5...
  • Page 90: Family Of Characteristics Of The Braking Torque Control Range

    + gray: speed-independent range of the ergoselect ergometer 13.8 Family of characteristics of the load periods according to IEC 60601-1 Figure 13 – 2: Under permanent load, the load periods and pauses (white) shall be observed. ergoselect 4 / 5...
  • Page 91 14 Electromagnetic Compatibility EN 60601‑1‑2 14 Electromagnetic Compatibility EN 60601-1-2 Warning Changes or modifications to this system not expressly approved by ergoline could cause EMC issues with this or RF Interference other equipment. Use of portable phones or other radio frequency...
  • Page 92: Electromagnetic Compatibility En 60601-1-2

    EN 61000-4-8 a typical location in a typical com- mercial or hospital environment. The ergoselect ergometer has no components susceptible to magnetic fields. Note: UT is the a.c. mains voltage prior to application of the test level. ergoselect 4 / 5...
  • Page 93 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. ergoselect 4 / 5...
  • Page 94 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. 201000433000 • Version 2021-06-01 / Rev 04 • English ergoselect 4 / 5...
  • Page 96 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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