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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.
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........5.4.4 ergoline Digital Chest Strap .
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13.9 Family of characteristics of the load periods according to IEC 60601-1 ..Electromagnetic Compatibility EN 60601‑1‑2 ..... ergoselect 4 / 5...
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...
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...
• 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...
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...
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)
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...
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...
• 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...
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...
• 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...
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...
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...
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...
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, •...
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...
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...
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...
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.
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...
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...
• 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...
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...
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• 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...
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...
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...
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...
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...
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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...
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...
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...
(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 •...
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(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...
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...
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...
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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...
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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...
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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...
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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...
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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...
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...
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...
[ 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...
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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...
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...
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(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...
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– 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...
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...
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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...
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(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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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.
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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...
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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...
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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...
[ 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...
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...
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[ ] 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...
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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...
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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...
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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...
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[ 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...
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14: (ID = _ _ _) 11: (ID = _ _ _) 15: (ID = _ _ _) 12: (ID = _ _ _) 16: (ID = _ _ _) Figure 9 – 78: Setup – HR belt number, screen 2 ergoselect 4 / 5...
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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...
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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...
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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...
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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...
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...
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...
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.
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...
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+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...
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...
+ 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...
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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...
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...
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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...
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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...
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