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.
7 2 1 Turning the System On 7 2 2 Operating Modes 7 3 Control Terminal T 7 3 1 Turning the System On 7 3 2 Operating Modes with Control Terminal T Cleaning, Disinfection, and General Hygiene Measures ergoselect 12...
Page 6
12 2 Exercise Test Protocols 12 3 Test Protocols (control terminal T only) 12 4 Family of characteristics of the braking torque control range 12 5 Family of characteristics of the load periods according to IEC 60601-1 Electromagnetic Compatibility EN 60601-1-2 ergoselect 12...
1 General Information 1 General Information • On request, ergoline GmbH will provide a Field Service Danger Manual. In the case of failures, visible wear or defect: • Ensure that the device is de-energized. • The implemented quality management system covers •...
• To prevent personal injury and product/property damage, Only the special shielded cables supplied by ergoline GmbH may the hand grip must not be used by patients as an aid to be used to connect the device to other pieces of equipment.
2.2 Intended Use • patients under the influence of substances that impair vigilance (alcohol, drugs, medication). The medical device ergoselect 12 is a stress echo reclining Contraindications in exercise testing carried ergometer used on the intended patient population for the...
If you have questions in this matter, please contact ergo‑ line GmbH or an ergoline representative. 2.4 Applicable Laws, Regulations and Directives If you have questions regarding laws, regulations or direc‑ tives related to the product, please contact ergoline GmbH. ergoselect 12...
Emergency lowering approved pressure range Indicates the position of the button which can be used to lower the couch in an emergency Transport and storage label: do not stack This symbol indicates the overall weight of the medical device ergoselect 12...
• Check the device for damage before each use. • If you detect signs of damage or identify malfunctions, switch the device off. • Contact your service partner or the ergoline GmbH Service Department immediately. 4.1 Description of the Medical Device...
Several persons should be present to set up the ergoselect 12. Caution • Patient Hazard / Equipment Damage • The ergoselect 12 must be set up on a horizontal level floor. During assembly, the ergometer must be disconnected from the power line.
Figure 4 – 7: Loosen and remove retaining screws mounting attachment parts with perforated rails, make sure that the bolts of the knobs engage properly in the rails before tightening the knobs by turning them clockwise. Secure all attachment parts by turning the set screw clockwise. ergoselect 12...
Page 15
Provides support and security Inserted in • To prevent injuries, check that the saddle Saddle during the exercise test, espe‑ the saddle is firmly locked in the guide rail! cially when the patient is lying guide rail. on an inclined surface. ergoselect 12...
Page 16
(see chap‑ guide rail when adjusting the position of the patient is lying on an ter 10) the safety belt! inclined surface. • To prevent injuries, check thoroughly that the safety belt is securely clamped after adjusting its position! ergoselect 12...
Page 17
If your ergometer has a separate control terminal, be sure to route the connection cable to the control terminal out of the way to prevent any stumbling hazard. Furthermore, protect the control terminal from falling down. Figure 4 – 11: Introducing the saddle post into the guide rail ergoselect 12...
All ergoselect ergometers are equipped with a digital interface. (Special adapters are needed for analog control or the remote start capability. Please contact ergoline GmbH for these adapters.) Figure 4 – 13: Connection for ECG recorder / PC ECG system...
The control terminal allows you to adjust a number of parameters (such as the baud rate, ECG type) before use, or to initiate a manual blood pressure measurement. These adjustments should be referred to a qualified Service Engineer. Figure 4 – 15: Control terminal under the couch surface ergoselect 12...
ON: Battery low (battery needs to be replaced) Radio LED blinking rapidly: remote control tries to connect to the ergometer blinking slowly: connection is established illuminated: key command is executed Vertical adjustment of couch surface Lateral adjustment of couch surface ergoselect 12...
Position 1: an audio signal is heard. Press and hold keys in sequence until Position 2: an audio signal is heard. Press and hold keys in sequence until Position 3: an audio signal is heard. ergoselect 12...
• Rechargeable batteries are used for the emergency lowering function. These batteries need to be checked regularly and replaced when necessary. • Only qualified staff authorized by ergoline GmbH is allowed to check and replace the batteries. 5.5 Extending / Retracting the Pedal Unit...
Now you can adjust the incline and the lateral tilt of the terminal must be followed by a pause of 9 minutes. couch. Note • Patient Safety • When the pedal unit is retracted, a lateral tilt of the couch surface is not possible. ergoselect 12...
(e.g., from an ECG recorder or a PC). mmHg ♥ / min Figure 7 – 4: Start screen Note • Instruct the patient not to pedal while the ergometer is being turned on and during the self-test. ergoselect 12...
(see below) 3 duration of exercise test (min) 4 heart rate at the time of the BP measurement (BPM) 5 pedal speed (RPM) mmHg ♥ / min Figure 7 – 7: Exercise test screen 2 ergoselect 12...
With this key you display the main menu or return to the previous menu level. The functions of these three softkeys change with the displayed menu – the key label describing the function is shown on the display. Figure 7 – 10: Keypad P ergoselect 12...
Figure 7 – 11: Main menu The start screen will be displayed – the ergometer is wait‑ ing for commands from the external ECG unit. Watt / min mmHg ♥ / min PC Mode Figure 7 – 12: Start screen ergoselect 12...
Page 28
and the arrow keys will again be displayed. 7.2.2.2 Ergometry Use the softkeys on the right and left (↑ ↓) to position the bar cursor on Ergometry and confirm the selection with PC Mode Select. Ergometry Manual Settings Select Figure 7 – 15: Main menu ergoselect 12...
Page 29
– 5 W Figure 7 – 18: Display during the exercise test Note • The saddle height can be adjusted during an exercise test. • To activate the saddle height adjustment, press the arrow keys will be displayed then. ergoselect 12...
Page 30
/ min 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 7 – 22: Display during the exercise test ergoselect 12...
Page 31
Use the softkeys on the right and left (↑ ↓) to position the Figure 7 – 26: Selecting the exercise test protocol to configure bar cursor on the protocol to change (No. 6 to 15) and confirm the selection with Select. ergoselect 12...
Page 32
Depending on your choice, each key press will change the +/– 1 Watt load by +/–1, 5, 10 or 25 watts. +/– 5 Watt +/– 10 Watt +/– 25 Watt Select Figure 7 – 30: Selecting the increment for manual load changes ergoselect 12...
↑ ↓ keys and saved with Select. 30.06.2022 The time is adjusted in the same way. Time 09:00:00 You exit the configuration with Select Figure 7 – 33: Setting the date Date 30.06.2022 Time 09:00:00 Select Figure 7 – 34: Setting the day ergoselect 12...
Page 34
ECG unit. The selection is part of the installation procedure. • The "Analog/Digital" and "Digital" communication is only possible when PC Mode is selected from the main menu or when this is the default mode. ergoselect 12...
Page 35
751 – 850 118 – 125 851 – 950 > 125 951 – 999 > 130 Pulse Display The pulse readout on the display can be turned off. Display Pulse Display Select Figure 7 – 38: Setting the pulse readout ergoselect 12...
The reclining ergometer runs a self‑test. Subsequently, the main menu displays. Figure 7 – 40: Self-test screen The ergometer software is controlled from the touch panel. PC Mode Ergometry Training/Test Manual Setup Figure 7 – 41: Main menu ergoselect 12...
Manual The reclining ergometer is controlled manually, i.e., the user Manual performs all load changes via the display. Figure 7 – 45: Manual mode Setup Used to configure the reclining ergometer. Setup Figure 7 – 46: Setup mode ergoselect 12...
Page 38
[ I / 0 ] key. To switch off the pump, press the appropriate key [ low ], [ middle ], [ high ] for about 3 seconds. Figure 7 – 48: ECG screen Confirm all inputs with the [ ] key. ergoselect 12...
Page 39
• the stage time (form 1 to 30 min), • the stage rate (increment, from 1 to 400 W). Basic Load 30 W Stage Time 2 min Stage Rate 25 W Figure 7 – 51: Exercise test protocol – screen 2 ergoselect 12...
Page 40
You change the load with the [ + 5 W ] and [ – 5 W ] keys. – 5 W The actual load change can be set in the configuration menu between +/–1 W and +/–25 W (see chapter 7.3.2.5 Setup, section Load Change on page 44). Figure 7 – 54: Starting an exercise test ergoselect 12...
Page 41
Test protocol you want to edit. Training/Test 0. Protocol 1 1. Protocol 2 2. Protocol 3 3. Inactive 4. Inactive 5. Inactive 6. Inactive 7. Inactive 8. Inactive 9. Inactive Figure 7 – 57: Selecting the training / test protocol ergoselect 12...
Page 42
Recovery Time 3 min Inputs are confirmed with the [ ] key. Load Change Stage Time 20 sec Weight 3 kg Figure 7 – 60: Editing parameters – screen 2 ergoselect 12...
Page 43
Default Mode Protocols Confirm inputs with the [ ] key and exit menus with the ECG Type Training/Test [ ] key. Load Change HR belt no. Date/Time Regulation Service Beep Software Version Language Figure 7 – 63: Setup menu ergoselect 12...
To change the name of a protocol, touch the protocol name and enter the new name from the keypad. Confirm Bezeichnung Description Protocol your inputs with the [ ] key. Figure 7 – 67: Setup – protocols, screen 3 ergoselect 12...
Page 45
A submenu opens when you touch ECG Type on the display. Date/Time Regulation Enter the code number "3" via the numeric keypad and (0* ... 9999*) (0* ... 9999*) Service confirm with the [ ] key. Beep Software Version Language Figure 7 – 70: Setup menu ergoselect 12...
Page 46
[ ] key. Load Change With this function, you select the increments for load changes. Load Change +/– 1 Watt +/– 5 Watt +/– 10 Watt +/– 25 Watt Figure 7 – 72: Setup – load change ergoselect 12...
Page 47
Inputs are confirmed with the [ ] key. Duration: load + Second Load control normal (0 min ... 15 min) (0 s ... 59 s) Duration: load + 3 min Duration load – 3 min Figure 7 – 76: Setup – regulation method, screen 2 ergoselect 12...
Page 48
Max. 50 … 130 65 1/min 65 1/min Figure 7 – 78: Setup – RPM, screen 2 Beep A short beep confirms each key press. The audible feedback can be enabled and disabled. Beep Figure 7 – 79: Beep setup ergoselect 12...
Page 49
Suomi Italiano Dansk Figure 7 – 81: Setup – language Display Press the [ 2. ] key to display the next screen and touch Display. Display Date/Time Service Service Figure 7 – 82: Setup – screen display 1 ergoselect 12...
Page 50
7 Control Terminals 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 7 – 83: Setup – screen display 2 ergoselect 12...
General Hygiene Measures 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. ergoselect 12...
GmbH every 2 years at the latest. For inspections of the measuring system (MTK) and calibra‑ tion, the ergoline test bench ergoTest 550 is available as a calibration tool. The date of the next mandatory inspection is indicated on the inspection sticker attached next to the type plate on the reclining ergometer.
The holder with the safety belt can be shifted on the stan‑ dard rail so that the ideal position for each patient can be found. Figure 10 – 3: Adjusting the safety belt position on the reclining ergometer * Accessory (option) ergoselect 12...
Page 54
To remove the safety belt from the couch, open the set screw and remove the safety belt with the holder from the standard rail. Note The safety belt can be used with or without the hip support. ergoselect 12...
Underarm support erg707.302 Hip support erg705.957 Armrest, curved, with bracket erg705.958 Arm rest, flat, with bracket erg705.960 Swiveling armrest erg707.227 Floor stand, large (for control terminal) erg705.955 Safety belt with holder erg705.883 Saddle, standard erg705.979 Saddle, wide ergoselect 12...
12 Technical Specifications 12 Technical Specifications 12.1 Ergometer Model Modular reclining ergometer system ergoselect model ergoselect 12 M / P / T Operating mode Saddle motor: ON 2min / OFF 18min Motors for table inclination: ON 1min / OFF 9min Load unit The times refer to a cold start of the ergometer at a maxi‑...
Page 57
+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 12...
Duration Load Change 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 12...
If operation of the ergometer continues after the indicated time interval, it is mandatory to observe the OFF and ON times. Caution When the defined load periods are exceeded or the required pauses are not observed, the exposed parts of the medical device may reach excessive temperatures. ergoselect 12...
13 Electromagnetic Compatibility EN 60601-1-2 Changes or modifications to this system not expressly Warning approved by ergoline GmbH could cause EMC issues with • RF Interference • this or other equipment. Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse This system is designed to comply with applicable regula‑...
Page 61
EN 61000‑4‑8 typical location in a typical commercial or hospi tal environment. The ergoselect ergometer has no com‑ ponents susceptible to magnetic fields. Note: UT is the a.c. mains voltage prior to application of the test level. ergoselect 12...
Page 62
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 12...
Page 63
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. ergoselect 12...
Page 64
13 Electromagnetic Compatibility EN 60601-1-2 201000514000 • Version 2022‑11‑16 / Rev 03 • English ergoselect 12...
Need help?
Do you have a question about the ergoselect 12 and is the answer not in the manual?
Questions and answers