ergoline ergoselect 100 Operator's Manual

Bicycle Ergometer Operator's Manual 2010000134000 • Version 04/2011 • English

please let us know and we will correct the issue as soon as possible. We reserve the right to modify the design and technical features of the device and are not bound by the information and illustrations provided in this manual. All trademarks appearing in this document are trademarks of their respective owners. Their protection is acknowledged. 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.: +49-(0) 7431 98 94 - 0 Fax: +49-(0) 7431 98 94 - 128 e-mail: [email protected] http: www.ergoline.com Printed in Germany

Declaration of Conformity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Setup and Mains Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Controls and Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Mounting the Control Terminal (P or K). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Connecting the Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Connecting the Blood Pressure Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Adjusting the Saddle and the Handlebar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Preparing the Patient for Blood Pressure Measurements. . . . . . . . . . . . . . . 18 Checking the Cuff Tubing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Control terminal P. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Operating Modes with Control Terminal P. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 PC Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Ergometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Settings with Control Terminal P. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Control Terminal K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Operating Modes with Control Terminal K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Speed readout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 PC Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Ergometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Training with Chip Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Settings for Control Terminals K . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Cleaning, Maintenance, Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . 48 Technical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Electromagnetic Compatibility EN 60601-1-2 . . . . . . . . . . . . . . . . . . . 55 Contents

General Information • The product ergoselect bears the CE marking CE‑0123 (Notified Body: TÜV), indicating its compliance with the provisions of the Council Directive 93/42/EEC about medical devices and fulfills the essential ­requirements of Annex I of this directive. The CE marking covers only the accessories listed in the Order Information chapter. The ergometer is an MDD class IIa product. • The device fulfills the requirements of standard EN 60601-1 "Medical Electrical Equipment, Part 1: General Requirements for Safety" as well as the interference protection requirements of standard EN 60601-1-2 "Electromagnetic Compatibility – Medical Electrical Devices". The radio-interference emitted by this product is within the limits specified in EN 55011, class B. • This manual is an integral part of the equipment. It should be available to the equipment operator at all times. Close observance of the information given in the manual is a prerequisite for proper device perfor‑ mance and correct operation and ensures patient and operator safety. Please note that information pertinent to several chapters is given only once. Therefore, read the manual once carefully in its entirety. • The symbols mean: Consult accompanying documents. It indicates points which are of particular importance in the operation of the device. • Observance of the safety information protects from injuries and prevents inappropriate use of the device. All equipment users and persons responsible for assembly, maintenance, inspection and repair of the device must read and understand the content of this manual, before using or work on it. Paragraphs with special symbols are of particular importance. • If unauthorized individuals open the control terminal, damaging the calibration sticker, any warranty claim shall become void. • This manual reflects the equipment specifications and applicable safety standards valid at the time of printing. All rights are reserved for devices, circuits, techniques, software programs, and names appearing in this manual. • On request ERGOLINE will provide a Field Service Manual. • The ERGOLINE quality management system complies with the standards ISO 9001: 2000 and EN ISO 13485: 2003. • The safety information given in this manual is classi‑ fied as follows: • To ensure patient safety, the specified measuring ac‑ curacy, and interference-free operation, we recom‑ mend using only original ERGOLINE accessories. The user is responsible if non-ERGOLINE accessories are used. • ERGOLINE is responsible for the safety, reliability, and performance of the equipment, only if - modifications and repair are carried out by ergoline GmbH or by an organization expressly authorized by ergoline GmbH - the equipment is used in accordance with the instructions given in this operator's manual. ergoline GmbH Lindenstrasse 5 72475 Bitz Germany Phone: +49-(0)-7431 - 9894 -0 Fax: +49-(0)-7431 - 9894 -128 e-mail: [email protected] http: www.ergoline.com / www.ergoline.eu Danger indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury. Caution indicates a potential hazard. If not avoided, the hazard may result in minor injury and/or product/property damage. Warning indicates a hazard. If not avoided, the hazard may result in minor injury and/or product/property damage.

Danger • Explosion Hazard • The device is not designed for use in areas where an explosion hazard may occur. Explosion hazards may result from the use of flammable anes- thetics, skin cleansing agents or disinfectants. Warning • Patient Hazard, Equipment Damage • Do not expose the ergoselect to direct sunlight to prevent sys- tem components from reaching inadmissible high temperatures. Do NOT use the ergoselect outdoors (medical device). Further- more the device has no additional protection against the ingress of humidity. Humidity inside the device may cause equipment malfunctions and increases the risk of an electric shock. Additionally, the device should not be operated in the vicinity of electric power plants, because they may impair equipment functions. The ergoselect ergometer may only be used in combination with accessories approved by ergoline GmbH. • Risk to Persons • Before using the ergometer, the operator must ascertain that it is in correct working order and operating condition. The cables and connectors, in particular, must be checked for signs of damage. Damaged parts must be replaced immediately, before use. • Equipment Malfunction • Only the special shielded cables supplied by ERGOLINE may be used to connect the device to other pieces of equipment. • Equipment Malfunction • Cellular telephones may not be used in the immediate vicinity of the ergometer, because they might interfere with the proper functioning of the ergometer. Electromagnetic interference most probably exists when the watt reading is unstable. If the displayed value changes fre- quently even though the speed is above 30 RPM, this may be due to electro­magnetic interference. Warning • Shock Hazard • When the ergometer is connected to other equipment or if a medical system is created, it must be ensured that the added leakage currents do not present a hazard. 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 installations that fulfill the local requirements. • Patient Hazard • The German Medical Device Operator Ordinance (MPBetreibV, § 5) demands that users • must be trained in the use of the ergometer • must be familiar with the routines for handling and assembly of the ergometer • must be familiar with and observe the safety rules and regulations for operation of this type of equipment • must be informed about any other pertinent rules and regu- lations (e.g. safety features) • must be informed about the potential hazards arising from the use of this type of equipment. Safety Information Hint Removing the power cord results in complete disconnection from mains (all poles).. Danger 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 responsible 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. • 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

Safety Information for Non‑Invasive Blood Pressure Measurement Warning • Patient Hazard • Do not take blood pressure measurements with a cuff on patients suffering from sickle cell anemia or where skin lesions are likely to occur. The cuff may cause hematomas in patients with severe blood coagulation disease. In these instances, the user must take a decision for or against automatic blood pressure measure- ments. Caution • Compromised Measuring Accuracy • Arrhythmias occurring frequently during a measurement may compromise the accuracy of the measurement. In certain cases, a valid measurement will not be possible. Electromagnetic fields are also capable of impairing the mea- suring accuracy. Note • The blood pressure module and the approved accessories are defibrillation-proof and may remain attached to the patient during defibrillation. • If the cuff pressure exceeds the maximum value of 300 mmHg during inflation, the inflation procedure will be aborted and the cuff deflated. As a redundant safety precaution, the cuff is immediately deflated when the cuff pressure exceeds 320 mmHg. You can check the proper functioning of this safety precau- tion by abruptly bending your arm while the cuff is being inflated, causing a brief overpressure in the cuff. The cuff must deflate immediately. • Measurements that did not yield a valid measurement will not be repeated during the exercise test. • If the inflation phase takes longer than 40 seconds or if an adequate pressure does not build up in the cuff within a reasonable period of time, the measurement will be aborted and the cuff deflated. • If a valid measurement cannot be completed within 120 seconds, the measurement will be aborted and the cuff deflated. • If the cuff pressure remains constant for some time, the measurement will also be aborted and the cuff deflated. Intended Use The ergoselect is a computer-controlled medical ­ergometer. At pedal speeds between 30 and 130 RPM and loads between 6 and 999 watt, the ergometer operates indepen‑ dent of the pedal speed. The speed-independent range is shown in the Appendix (Technical Specifications). The ergoselect ergometer may only be used in exercise testing as well as for rehabilitation of cardiac and cardio‑ vascular 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 inju‑ ries or property damage resulting from the unintended use of the equipment. Biocompatibility 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. Applicable Laws, Regulations and Directives • 93/42/EEC (Medical Device Directive of the EU) • 89/336/EEC (Electromagnetic Compatibility Directive of the EU) • EN 1060-1 Non-invasive sphygmomanometers, Part 1: General requirements • EN 1060-3 Non-invasive sphygmomanometers, Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

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

Setup and Mains Connection Controls and Indicators 1 Control terminal (model P or model K) 2 Blood pressure cuff connection (option) 3 Adjustment of the handlebar angle 4 Blood pressure cuff 5 Adjustment of the handlebar height (ergoselect 200 only) 6 Castors 7 Speed display (RPM) for patient 8 Adjustment of the saddle height (ergoselect 100 only) 9 Digital saddle height indication (ergoselect 200 only) 10 Power switch (green button) 11 Sockets for power cord and connection cables ­(underside of ergometer) 12 Levelling devices to adjust the ergometer to uneven floors ergoselect 100 - controls, connections and indicators ergoselect 200 - controls, connections and indicators

Levelling feet of the ergoselect ergometer Caution • Equipment Damage • Avoid strong vibrations of the ergoselect during transport. Transport For short distances, the ergoselect can be lifted at the saddle and rolled away on its castors. To cover greater distances, however, we recommend the following method: • Disconnect the power cord from the wall outlet. • Rotate the handlebar towards the front. Tighten the clamping lever. • Stand in front of the ergoselect, grasp the handlebar and tilt the ergoselect towards you until it is standing on the castors only and is balanced. • It is now possible to transport the ergoselect. • When you have reached the new location, lower the ergoselect very carefully to avoid damage. Setup Place the ergoselect on a level floor. The ergoselect must be set up in a secure and stable posi‑ tion - the two levelling feet at the back make for easy adjustment to uneven floor surfaces. Extend the foot concerned until the ergoselect 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. Transporting the ergoselect

Mounting the Control Terminal (P or K) 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. Connecting the Power Cord Set the handlebar to the front upper position and secure. Tilt the ergoselect carefully towards you until it rests on the handlebar. Assembly position of the ergoselect ergometer Different orientations of the control terminal Caution • Equipment Damage • 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.

b a Connection panel a Power input b Lock Hint • disconnection • Removing the power cord results in complete disconnection from mains (all poles). Danger • Patient Hazard • To insure a safe connection to the protective ground system, power cords of type „hospital only“ or „hospital grade“ have to be used! Power cord with installed strain relief 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.

Connecting the ECG Cable ergoselect ergometers can be connected to electrocardio‑ graphs and PC-based ECG systems of most manufacturers. Different connection cables are available to support differ‑ ent communication modes (digital, analog, remote start, etc.). The appropriate cable is plugged into the corresponding socket on the connection panel (Port 1, USB) and secured with the strain relief. Hint • connecting cables • Only use connecting cables released by ergoline. To use the integrated USB connector, a special driver is required - contact ergoline. EKG / PC connection USB PC connection via USB (virtual COM) PORT 1 Digital connection RS232 (remote control by PC or ECG recorder,

Connecting the Blood Pressure Cuff • Connect the microphone at (1). • Slip the cuff tubing onto the fitting (2) and engage. To disconnect, push back the connector's knurled sleeve. Artifacts that may be caused by patient movements during the exercise test, must be avoided if possible, while the blood pressure is being taken. Therefore, do not forget to attach the cuff tubing to the handlebar with the supplied Velcro tape: • Open the large Velcro tape and wrap around handlebar. • Secure the cuff tubing with the small Velcro tape, but do not exert pressure on the tubing. Transport • Disconnect the power cord and the connection cables. • Stand in front of the ergometer, grasp the handlebar and tilt the ergometer towards you until it is standing on the castors only and balanced. • When you have reached the new location, lower the ergometer very carefully to avoid damage. Caution • Equipment Damage • Avoid strong vibrations of the ergometer during transport. Blood pressure cuff connections 1 Microphone connection 2 Cuff tubing Velcro tape to secure the cuff tubing

Preparing the Patient Adjusting the Saddle and the Handlebar On the ergoselect 100, you adjust the saddle height manu‑ ally with a clamping lever. On the ergoselect 200, the saddle height is electrically adjusted with the correspond‑ ing keys on the control terminal (the display below the saddle indicates the saddle height). 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. On the ergoselect 200, the height of the handlebar can ad‑ ditionally be adjusted with clamping lever 2 - the horizon‑ tal bar should be approximately at the samel level as the saddle. Adjusting saddle and handlebar 1 Adjustment of the handlebar angle 2 Adjustment of the handlebar height (ergoselect 200 only) 3 Adjustment of the saddle height (ergoselect 100 only) 4 Saddle height display (ergoselect 200 only) Note • Tighten the clamping levers only as far as necessary, NOT with maximum force. • Lubricate the clamping lever threads quarterly at minimum, using a suitable lubricant (e.g. OKS470).

Preparing the Patient for Blood Pressure Measurements Cuff Size Always choose the cuff size suitable for the patient's arm. The maximum arm circumference is indicated on the cuff. Microphone Position Before applying the cuff, check the position of the micro‑ phone inside the red pocket (on the inside of the cuff): When the microphone is inside the pocket, its metal side must face the arm. Applying the Cuff The center of the microphone must be located exactly on the brachial artery. Locate the artery by palpation, if required. The red tab identifies the position of the micro‑ phone. The accurate placement of the microphone is the primary condition for reliable pressure measurement during exer‑ cise tests. The cuff must be applied directly on the skin, it may not be applied on top of clothing, paper, etc. Apply the cuff ­approx. 2 cm above the bend of the elbow. The cuff should be tight, but it should not constrict blood vessels. The cuff may not move during the exercise test. Correct microphone position Wrong cuff size Microphone placement on the artery Correct cuff size

Correct cuff position (tab) Caution • Patient Hazard • Apply the cuff directly on the skin. Make sure that rolled up sleeves do not impede blood circulation in the upper arm. Loose cuffs will cause erroneous measurements; overtight cuffs may constrict blood vessels or cause skin lesions and hemato- mas. • Incorrect Measurements • A loose cuff would degrade the accuracy of the measurement. Therefore, the computer aborts the measurement, if a mini- mum pressure is not attained within a few seconds. Warning • Patient Hazard • If, by accident, an excessive pressure builds up inside the cuff , either remove the cuff immediately from the arm or disconnect the cuff tubing from the control terminal. The same measures are recommended, if the cuff does not deflate correctly. When you close the Velcro strap, check that the metal clasp (a) is inside the marked index range (b), and not outside. The cuff tab must be located below the metal clasp (see illustration at right). Checking the Cuff Tubing 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. Secure the cuff tubing with the Velcro tape attached to the handlebar. Instruct your patient to move as little as possible during a blood pressure measurement and, in particular, to avoid excessive contractions of the muscles in the upper arm. Distance between knee and tubing

ergoline GmbH ergoline GmbH Operation The ergometers of the ergoselect series are available with two versions of the control terminal whose functionalities differ. The following sections describe the control and configura‑ tion of the ergometer. Control terminal P Turning the System On 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 menu displays. Control terminal P Control terminal K Note • Instruct the patient not to pedal while the ergometer is being turned on and during the self-test. • Apply the blood pressure cuff to the patient AFTER the er- gometer has been turned on and the self-test completed. • The device can be configured to default to one of the operating modes. If this option is selected, the initial screen of the selected operating mode (e.g. Ergometry) will be displayed instead of the main menu. With the key, you can display the main menu. • If an error message (e.g. E:01) appears immediately after the self-test, please refer to the "Troubleshooting" section for advice. Self-test screen Selftest running Main menu PC Mode Ergometry Manual Settings Select The ergometer software is controlled with 5 keys: With this key you display the main menu or return to the previous menu level. With this key you initiate a blood pressure mea‑ surement. A measurement in progress can be aborted with the same key. The functions of these three softkeys change with the displayed menu - the key label describing the function is shown on the display. Keypad P

Operating Modes with Control Terminal P 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. Speed readout At the top of the control terminal, there is a speed readout for the patient as well as three LEDs that inform the ­patient of the speed: too slow, too fast or correct. The ranges for the respective speed ratings depend on the selected load (see "Technical Specifications"). Speed readout 1 speed low (patient should pedal faster) 2 correct speed 3 speed high (= patient should pedal slower) Note • If, during an exercise test, the speed drops below 30 RPM, the load readout starts blinking on the display. • To reactivate the saddle height adjustment function, press and the arrow keys will again be displayed. • Additional blood pressure measurements an be initiated with .

↑ ↓ PC Mode Ergometry Manual Settings Select Saddle Main menu Initial screen PC Mode Use the softkeys on the right and left (↑ ↓) to position the bar cursor on PC MODE and confirm the selection with SELECT. 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). 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. Note • All functions are locked while the ergometer is operating in PC mode, except for the saddle height adjustment and the blood pressure key . • To reactivate the saddle height adjustment function, press and the arrow keys will again be displayed. • Additional blood pressure measurements can be initiated with . PC Mode Display during exercise test 1 current load in watts 2 most recent BP value (systolic/diastolic values) or cuff pressure during inflation 3 duration of exercise test (min) 4 heart rate at the time of the BP measurement (BPM) 5 pedal speed (RPM)

+ 5 W - 5 W Ergometry Use the softkeys on the right and left (↑ ↓) to position the bar cursor on ERGOMETRY and confirm the selection with SELECT. The stored test protocols available for selection will be displayed. There are five fixed protocols (protocols 1 to 5, see Appendix) , whereas protocols 6 to 15 are user-pro‑ grammable. The protocol menu provides an overview of the test phases: e.g.: 50 W / 2 min / 25 W means: initial (basic) load 50 watts stage time 2 minutes load increment 25 watts Use the softkeys on the right and left (↑ ↓) to position the bar cursor on one of the protocols and confirm the selec‑ tion with SELECT. The exercise test is started with the "Start" key, a blood pressure measurement at rest may precede the test (see "Settings"). When the basic load appears on the display (after approx. 15 seconds or upon termination of the blood pressure measurement) and the patient's RPM indicator blinks, the patient should start pedalling. The internal protocol will now control the entire exercise test - the display always indicates the current values. With the +5 W and -5 W keys, the current load can be changed at any time (in increments of +/-1 W up to +/-25 W, as configured). Screen display during the test PC Mode Ergometry Manual Settings Select Protocols 1. WHO 2. BAL 3. Hollmann 4. STD. France 5. Standard Select Main menu Selecting an exercise test protocol Initial exercise test screen Start Recovery

+ 5 W - 5 W Terminating an Exercise Test The exercise phase can be terminated manually at any time with the RECOVERY key. The load will immediately be reduced to 25 watts, but a higher or lower value can be selected manually. It is recommended that the patient continues to pedal in the recovery phase. The END key in the middle will terminate the test. End 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 . Recovery phase

+ 5 W - 5 W + 5 W - 5 W PC Mode Ergometry Manual Settings Select Main menu Manual Use the softkeys on the right and left (↑ ↓) to position the bar cursor on MANUAL and confirm the selection with SELECT. In this operating mode the user controls the entire exercise test by selecting the loads, stage times and by initiating blood pressure measurements. 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 . Terminating an Exercise Test 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. Start Initial screen of a manual exercise test Screen display during the test + 5 W - 5 W End

Settings with Control Terminal P 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. Use the softkeys on the right and left (↑ ↓) to position the bar cursor on SETTINGS and confirm the selection with SELECT. The configuration menu displays. When all changes have been made, you can exit the con‑ figuration menu with the key. Use the softkeys on the right and left (↑ ↓) to position the bar cursor on the parameter to change and confirm the selection with SELECT. Default Mode In this menu you choose the default mode activated when the ergometer is turned on. When first turned on, the ergometer will display this menu. Use the softkeys on the right and left (↑ ↓) to position the bar cursor on your preferred default mode and save the selection with SELECT. Protocols Protocols 6 - 15 are user-programmable (protocols 1 - 5 are fixed, see Appendix for protocol parameter details). Standard values for the following parameters can be entered: - initial load - stage time - load increment (load increase with each stage) Use the softkeys on the right and left (↑ ↓) to position the bar cursor on the protocol to change (No. 6 - 15) and confirm the selection with SELECT. PC Mode Ergometry Manual Settings Select Main menu Configuration menu Settings Default Mode Protocols Contrast Load Change Language Select Selecting the default mode Default Mode Menu PC Mode Ergometry Manual Select Selecting the exercise test protocol to edit Protocols 1. WHO 2. BAL 3. Hollmann 4. STD. France 5. Standard Select

Use the right and left softkeys ↑ ↓ to select the parameter to edit. When confirmed with SELECT, the corresponding value ap‑ pears in reverse video and can be changed with the arrow keys ↑ ↓. Pressing SELECT will save the new value. All other parameters are edited in the same way. You exit the configuration with . Contrast The display contrast is adjustable in the range from 0 to 100%. 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 20 Watts. Selecting the parameter to edit Protocol 6. Basic Load 25 W Stage Time 2 min Load Stage 25 W Select Editing the parameter value Protocol 6. Basic Load 25 W Stage Time 2 min Load Stage 25 W Select Adjusting the display contrast Load Change +/- 1 Watt +/- 5 Watt +/- 10 Watt +/- 25 Watt Select Contrast 50 % Select Selecting the increment for manual load changes

Language The texts can be displayed in different languages. Beep The audio signal emitted during blood pressure measure‑ ments can be turned on and off. Software Version Select this option to view the installed software version. Date/Time To begin with, you select DATE or TIME and confirm the selection. Then the value displayed in reverse video can be edited with the ↑ ↓ keys and saved with SELECT. The time is adjusted in the same way. You exit the configuration with . Language menu Language Deutsch English Francais Espanol Italiano Auswahl Beep during BP measurements Beep On Off Select Setting the date Date 22. 08. 2007 Time 17 : 33 : 05 Select Setting the day Date 22. 08. 2007 Time 17 : 33 : 05 Select

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. 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 ergo­meter is entirely controlled with digital commands. • Analog IN-OUT The entire communication (load control and BP mea‑ surements) is controlled with analog signals. No digital data will be sent. Select the communication mode and confirm with SELECT. Selecting the ergometer communication mode EKG Type Analog with pulse Analog / Digital Digital Analog IN-OUT Select Note • The EKG Type needs to be selected only when the ergom- eter is connected to an 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. Entering the EKG Type password EKG Type 003 Select

RPM Here you determine the RPM limits. When these limits are exceeded, the LEDs for high or low speed (RPM) will illuminate. Select the value to change (Min. or Max.) and confirm with SELECT. Using the arrow keys, change the value and save the new value with SELECT. Setting the RPM limit values RPM Min ↑ 0 ... 70 54 Max. ↓ 50 ... 130 64 Select 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) 6 - 150 54 - 64 (adjustable) 151 - 250 58 - 65 251 - 350 68 - 75 351 - 450 78 - 85 451 - 550 88 - 95 551 - 650 98 - 105 651 - 750 108 - 115 751 - 850 118 - 125 851 - 950 > 125 951 - 999 > 130 Pulse Display The pulse readout on the display can be turned off.

ergoline GmbH ergoline GmbH Control Terminal K Turning the System On 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 menu displays. Note • Instruct the patient not to pedal while the ergometer is being turned on and during the self-test. • Apply the blood pressure cuff to the patient AFTER the ergometer has been turned on and the self-test been completed. • The device may be configured to default to one of the operating modes. If this option is selected, the initial screen of the selected operating mode (e.g. Ergometry) will be displayed instead of the main menu. With the key, you can display the main menu. • If an error message (e.g. E:01) appears immediately after the self-test, please refer to the "Troubleshooting" section for advice. Self-test screen Selftest running Main menu The ergometer software is controlled with 8 keys: With this key you display the main menu or return to the previous menu level. With this key you initiate a blood pressure mea‑ surement. A measurement in progress can be aborted with the same key. The functions of these six softkeys change with the displayed menu - the key label describing the function is shown on the display. Keypad K Exercise Test PC Mode Training Manual Test Settings

Operating Modes with Control Terminal K An ergoselect ergometer with a control terminal K 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"). TRAINING Ten different training protocols with warm-up, exer‑ cise and recovery phases can be custom-configured (see chapter "Settings"). A POLAR receiver is integrated in the ergometer and provides the relevant data for heart-rate controlled Speed readout 1 speed low (patient should pedal faster) 2 correct speed 3 speed high (= patient should pedal slower) Note • If, during an exercise test, the speed drops below 30 RPM, the load readout starts blinking on the display. • To reactivate the saddle height adjustment function, press and the arrow keys will again be displayed. • Additional blood pressure measurements can be initiated with . training sessions. TEST Integrated test protocols (steep ramping test, PWC tests) allow an assessment of the physical fitness. MANUAL The ergometer is controlled manually, i.e., the user performs all load changes via the keypad. SETTINGS Used to configure the ergometer. Speed readout At the top of the control terminal, there is a speed readout for the patient as well as three LEDs that inform the ­patient of the speed: too slow, too fast or correct. The ranges for the respective speed ratings depend on the selected load (see "Technical Specifications").

↑ 12 ↓ Initial screen in PC mode PC Mode When the PC Mode key has been pressed, the screen appears as shown at right. The ergometer is waiting for commands 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 key adjust the height of the drive unit). 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. Note • All functions are locked while the ergometer is operating in PC mode, except for the saddle height adjustment and the blood pressure key . • To reactivate the saddle height adjustment function, press and the arrow keys will again be displayed. • Additional blood pressure measurements can be initiated with . • Changing the display mode: Instead of the waveforms, the individual parameter values can be displayed at a large scale. With the key, you display the menu; with the key at the bottom right, you select the DISPLAY. The blood pressure values will now be displayed with large digits. With each subsequent activation of the key at the bottom right you scroll through the following values: - heart rate - test duration - load (Watt) - RPM - graphic display Saddle Saddle PC Mode: Waiting for start Exercise test running Display during exercise test 1 most recent BP value (systolic/diastolic pressures) or cuff pressure during inflation 2 heart rate (BPM) 3 duration of exercise test (minutes:seconds) 4 current load in watts 5 pedal speed (RPM) Exercise test running BP displayed with large digits

↑ 12 ↓ ↑ ↓ Ergometry The ergometer is controlled by an internally stored proto‑ col. Pressing the "Ergometry" key will display the test protocol used last. Press the "Start" key to re-start the protocol, or press the "Select" key to display the protocol parameters or to switch to another test protocol. There are five fixed protocols (protocols 1 - 5, see Appendix), whereas protocols 6 - 15 are user-program‑ mable. With the arrow keys you can display the test protocol. With "Select" you confirm the selection. The selected exercise test is started with the "Start" key, a blood pressure measurement at rest may precede the test (see "Settings"). The display changes to the exercise test screen, where load and heart rate are represented both by numeric values and waveforms. When the basic load appears on the display (after approx. 15 seconds or upon termination of the blood pressure measurement) and the patient's RPM indicator blinks, the patient should start pedalling. The internal protocol will now control the entire exercise test - the display always indicates the current values. Initial screen of an exercise test Ergometry WHO Saddle Saddle Start Select Make settings Protocol WHO Basic Load 25 Watt Stage Time 2 min Load Stage 25 Watt Recovery Load 25 Watt Recovery Time 10 min NIBP Lead Time 60 sec Select Select protocol Exercise test running Display during exercise test 1 most recent BP value (systolic/diastolic pressures) or cuff pressure during inflation 2 heart rate (BPM) 3 duration of exercise test (minutes:seconds) 4 current load in watts 5 pedal speed (RPM) Selecting the test protocol

↑ 12 ↓ Adjustments During the Exercise Test Press the key to display the configuration menu. This is what you can do during the test • increase or decrease the current load in increments (adjustable between 1 watt and 25 watts) • hold the current load • end the exercise phase and advance to the recovery phase • terminate the test. Pressing again displays another menu where you can change the saddle height and the display mode (see "PC Mode"). Terminating the Test Once the full protocol has been completed, the test will be terminated. However, it is possible at any time to manually terminate the test or switch to the recovery phase (see above). Configuration menu I Load + Recovery phase Load - End Load const. Previous Make settings Configuration menu II Saddle Saddle Previous Display Make settings

↑ 12 ↓ Manual In this operating mode the user controls the entire exercise test by selecting the loads, stage times and by initiating blood pressure measurements. The exercise test is started with the "Start" key, afterwards the load can be set and changed with the [Load +] and [Load +] keys (in increments of 1 W up to 25 W, as config‑ ured). Blood pressure measurements can be initiated with . Terminating an Exercise Test 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. Screen display in manual mode Load + Saddle Load - Saddle Start Ergometry: Waiting for start

↑ 12 ↓ ↑ ↓ Training Cardiologic training sessions can be performed with er‑ goselect ergometers equipped with control terminal K. For a detailed description of the protocols, please refer to the Appendix. Pressing the "Training" key will display the training proto‑ col used last. Press the "Start" key to re-start the protocol, or press the "Select" key to display the protocol parameters or to switch to another training protocol. All training protocols 1 - 10 are user-configurable. (see "Settings for Control Terminals K"). Use the arrow keys to display the protocol to use and the corresponding parameters. Confirm the selection with the "Select" key. You initiate the training session with the "Start" key. The display changes to the training session screen, where load and heart rate are represented both by numeric values and by waveforms. When the basic load appears on the display (after approx. 15 seconds or upon termination of the blood pressure measurement) and the patient's RPM indicator blinks, the patient should start pedalling. The internal protocol will now control the entire training session - the display always indicates the current values. Initial screen of the training session Training No.1 Pulse Saddle Saddle Start Select Make settings Training No. 1 Pulse Basic Load 25 Watt Warmup 2 min Training time 20 min Recovery Load 20 Watt Recovery Time 3 Watt Load increment 8 Watt/min Training pulse 100 P/min Maximum load 80 Watt Select Select protocol Training running Display during exercise test 1 most recent BP value (systolic/diastolic pressures) or cuff pressure during inflation 2 heart rate (BPM) 3 duration of exercise test (minutes:seconds) 4 current load in watts 5 pedal speed (RPM) Selecting the training protocol

Adjustments During the Training Session Press the key to display the configuration menu. This is what you can do during the training session • end the training session and advance to the recovery phase, • directly terminate the training session, • change the display mode (see "PC Mode"). Training with Chip Card As an alternative to the training protocols saved in the ergometer, it is possible to load training protocols from the 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. load and heart rate waveforms) is saved to the chip card and can be reviewed and analyzed at the PC. Starting the Chip Card Training Session Select the "Training" mode and insert the chip card into the card reader (on the side of the control terminal). The ergometer switches to the chip card mode and reads the data stored on the card. Configuration menu Recovery phase End Previous Display Training running Reading the chip card data Training Chipcard Reading card!

↑ ↓ The name and the weight stored on the card are displayed. You can use the arrow keys to enter the current weight. Press the "Next" key and the initial screen will display. You can initiate the displayed training protocol or select another protocol from the chip card. The chip card training session proceeds in the same way as the exercise tests stored in the ergometer. Terminating the Training Session After termination of the training session (automatic ter‑ mination when the programmed recovery phase has been completed, or manual termination) the test subject can state how the test was perceived (BORG scale). Subsequently all training data are written to the chip card and are then available for analysis with a special program (e.g. opticare basic). Entering the weight Training Chipcard Sumner David Weight + 93 kg Weight - Next Make settings Entering the BORG value Training Chipcard Stress very very heavy very heavy heavy a little stronger easy very easy very very easy OK Writing to the chip card Training Chipcard Sumner David Training finished ! Writing card!

↑ ↓ ↑ ↓ Settings for Control Terminals K 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. Select SETTINGS to display the configuration menu. When all changes have been made, you can exit the con‑ figuration menu with the key. Use the softkeys (↑ ↓) to position the bar cursor on the pa‑ rameter to change and confirm the selection with SELECT. Default Mode In this menu you choose the default mode activated when the ergometer is turned on. When first turned on, the ergometer will display this menu. Use the softkeys (↑ ↓) to position the bar cursor on your preferred default mode and save the selection with SELECT. Protocols Protocols 6 - 15 are user-programmable (protocols 1 - 5 are fixed, see Appendix for protocol parameter details). Standard values for the following parameters can be entered: - initial load - stage time - load increment (load increase with each stage) - NIBP lead time (blood pressure measurement) - recovery load - recovery time Use the softkeys (↑ ↓) to position the bar cursor on the protocol to change (No. 6 - 15) and confirm the selection with SELECT. Selecting the exercise test protocol to edit Configuration menu Settings Default Mode Protocols Contrast Load Change Language Beep Software Version Date/Time Training Select EKG Type Choose function Protocols 1. WHO 2. BAL 3. Hollmann 4. STD. France 5. Standard 6. 25W / 2min / 25W 7. 25W / 2min / 25W 8. 25W / 2min / 25W 9. 25W / 2min / 25W Select 10. 25W / 2min / 25W Choose function

↑ ↓ ↑ ↓ ↑ ↓ Use the softkeys ↑ ↓ to select the parameter to edit. When confirmed with SELECT, the corresponding value ap‑ pears in reverse video and can be changed with the arrow keys ↑ ↓. Pressing SELECT will save the new value. All other parameters are edited in the same way. You exit the configuration with . Contrast The display contrast is adjustable in the range from 0 to 100%. Selecting the parameter to edit Protocol 6. Basic Load 25 Watt Stage Time 2 min Load Stage 25 Watt NIBP Lead Time 60 sec Recovery Load 25 Watt Recovery Time 2 min Select Choose function Editing the parameter value Protocol 6. Basic Load 25 Watt Stage Time 2 min Load Stage 25 Watt NIBP Lead Time 60 sec Recovery Load 25 Watt Recovery Time 2 min Select Choose function Editing the parameter value Contrast 50 % Select Choose function

↑ ↓ ↑ ↓ Load Change +/- 1 Watt +/- 5 Watt +/- 10 Watt +/- 25 Watt Select Selecting the increment for manual load changes 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 20 watts. Language The texts can be displayed in different languages. Beep The audio signal emitted during blood pressure measure‑ ments can be turned on and off. Software Version Select this option to view the ergometer's installed soft‑ ware version. Language menu Language Deutscht English Francais IBP-Espanol Italiano Select Choose function

↑ ↓ ↑ ↓ ↑ ↓ Date/Time To begin with, you select DATE or TIME and confirm the selection. Then the value displayed in reverse video can be edited with the ↑ ↓ keys and saved with SELECT. The time is set in the same way. You exit the configuration with . Training Ten training protocols consisting of warmup, training and recovery phase are user-configurable. Depending on the selected training mode (pulse, constant, interval), there will be different parameters to define for the training phase: First of all you select and confirm the protocol you wish to configure. Then you select the parameters with the arrow keys (↑ ↓) as usual and edit them. Setting the date Date/Time Date 22. 08. 2007 Time 17 : 33: 51 Select Choose function Changing the date Date/Time Date 22. 08. 2007 Time 17 : 33: 51 Select Choose function Selecting the exercise test protocol to edit Training 1. Pulse 2. Constant 3. Interval 4. Interval 5. Pulse 6. Pulse 7. Pulse 8. Pulse 9. Pulse Select 10. Pulse Choose function

↑ ↓ Editing the training protocol Training Select Pulse Basic Load 20 Watt Warmup 2 min Training time 20 min Recovery Load 20 Watt Recovery Time 3 min Load increment 8 W/min Training pulse 100 1/min Maximum load 50 Watt Select Choose function For all training modes (pulse, constant load and interval), the warmup phase, the duration of the training session and the recovery phase are defined first. Depending on the selected training mode, you can edit the corresponding parameters afterwards: • Pulse-controlled training: Training pulse: 40 - 250 1/min Maximum load: 1 - 999 Watt • Constant load: Training load: 1 - 999 Watt • Interval training: Load Stage 1: 1 - 999 Watt Stage Time 1: 10 - 300 sec Load Stage 2: 1 - 999 Watt Stage Time 2: 10 - 300 sec

↑ ↓ ↑ ↓ 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. 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 ergometer is entirely controlled with digital commands. • Analog IN-OUT The entire communication (load control and BP mea‑ surements) is controlled with analog signals. No digital data will be sent. Select the communication mode and confirm with SELECT. Selecting the ergometer communication mode Note • The EKG Type needs to be selected only when the ergom- eter is connected to an 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. Entering the EKG Type password EKG Type 003 Select Choose function EKG Type Analog with pulse Analog / Digital Digital Analog IN-OUT Select

↑ ↓ RPM Here you determine the RPM limits. When these limits are exceeded, the LEDs for high or low speed (RPM) will illuminate. Select the value to change (Min. or Max.) and confirm with SELECT. Using the arrow keys, change the corresponding value and save the new value with SELECT. Setting the RPM 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) 6 - 150 54 - 64 (adjustable) 151 - 250 58 - 65 251 - 350 68 - 75 351 - 450 78 - 85 451 - 550 88 - 95 551 - 650 98 - 105 651 - 750 108 - 115 751 - 850 118 - 125 851 - 950 > 125 951 - 999 > 130 Pulse Display The pulse readout on the display can be turned off. RPM Min ↑ 0 ... 70 54 Max. ↓ 50 ... 130 64 Select Choose function

Cleaning, Maintenance, Disposal General Cleaning Wipe the device surface down with a cloth moistened with soap water or a disinfectant. The cloth should not be dripping wet; do not allow liquids to enter the device. Recommendeddisinfectants are, for example: - Fugaten spray - Lysoform or - Promanum N Cleaning the Saddle Clean the saddle with a soft and dry or moist cloth. Disinfectants used should not contain any alcohol. Cleaning the Upholstery (e.g. couch ergometer) Wipe the upholstery down with a soft cloth moistened with soap water. The cloth should only be moist and not dripping wet. If the cleaning agents and disinfectants used are caustic or contain alcohol, they may damage and/or discolor the upholstery. Only the following disinfectants are approved: - Helipur® - Octenisept® - Neo-Kodan® - Cutasept® F - Wofasept® - Incidur spray Strictly observe the manufacturer's instructions for use. Warning • Shock Hazard • • Disconnect the device from the power line before clean- ing. • Equipment Damage • • Do not allow liquids to enter the equipment. Devices into which liquids have entered must be immedi- ately cleaned and checked by a service technician, before they can be reused. • Do not use acids, alkaline solutions (household cleaners) or caustic disinfectants.

Warning • Equipment Damage • • Cuff, microphone and tubing may not under any circum- stances: - be immersed in liquids - be cleaned in a water bath or in running water. Cleaning the Blood Pressure Cuff Removing the Microphone Pull the end of the cuff through the metal clasp and fold out the cuff. Pull on the short Velcro tab to open the microphone pocket and carefully remove the microphone. Cleaning, Disinfection Clean the cuff and tubing with a moist cloth. You can use a dishwashing liquid or mild soap water. Clean the microphone with a cloth moistened with alcohol or soap water. Allow the microphone to dry before reinserting it in its pocket. For disinfection, spray a disinfectant sparingly on the cuff, the tubing and the microphone. After the contact time indicated by the manufacturer, wipe all components dry. Inserting the Microphone Slip the microphone into the pocket, the metal side facing the arm. Guide the microphone cable out of the pocket and to the right of the Velcro tab. Then close the tab. Fold the end of the cuff over and introduce it into the metal clasp. Removing the Microphone Note Approved cleaning agents: • common dishwashing liquids • mild soap water • moist cloth Approved ingredients of disinfectants: • tenside • glycol, propanol and ethanol Approved disinfectants: • Fugaten spray • Promanum N Inserting the Microphone

Maintenance Checks 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. Technical Safety Inspections and Technical Inspections of the Measuring System 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 ­ergometer. Disposal 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.

Technical Specifications Ergometer Model modular ergometer system ergoselect models ergoselect 100 P / K, ergoselect 200P / K 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 - 999 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 Control Terminal P: • 5 fixed incremental exercise test protocols (e.g. WHO) • 10 user-programmable protocols • manual load control Control Terminal K: • 5 fixed incremental exercise test protocols (e.g. WHO) • 10 user-programmable protocols • manual load control • 4 fixed test protocols (e.g. PWC) • 10 user-programmable training protocols Permitted Patient Weight 160 kg Saddle Height Adjustment continuous, for patients between 120 cm and 210 cm ergoselect 100: manual adjustment of saddle height ergoselect 200: electrical adjustment of saddle height with digital readout Handlebar Adjustment for patient heights between 120 cm and 210 cm continuous handlebar adjustment over 360° ergoselect 100: rigid steering column ergoselect 200: height-adjustable steering column Crank Length 170 mm (cranks with adjustable length are optional accessories)

Displays LCD: 68 x 34 mm, 128 x 64 pixels (Control Terminal P) 115 x 88 mm, 320 x 240 pixels (Control Terminal K) additional LED display for speed (RPM) Interfaces PORT 1 (DSUB-9-pole): digital remote control RS232 by PC or ECG recorder, remote start of ECG recorder (optional) USB: digital remote control by PC (driver required) 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: 10 to 90%, no condensation atmospheric pressure: 500 to 1060 hPa Blood Pressure Module Measuring Method: auscultatory method, oscillometric; for resting BP, the results from both measurements are compared for plausibility Measuring Range systolic pressure: 40 to 280 mmHg diastolic pressure: 40 to 280 mmHg pulse rate: 35 to 230 P/min Measurement Error pressure readout error: +/- 3 mmHg readout resolution: +/- 1 mmHg Inflation Pressure 300 mmHg max.; during inflation the inflation pressure automatically adapts to patient's BP Inflation Rate between approx. 6 seconds (to 140 mmHg) and approx. 18 seconds (to 300 mmHg)

Max. Cuff Pressure 300 mmHg Cuff Deflation Method pulse-dependent deflation rate approx. 3 mmHg/beat or approx. 3 mmHg/s Calibration calibration with external pressure meter Artifact Rejection automatic artifact rejection and comparison of the rest‑ ing BP readings from both methods for plausibility Exercise Test Protocols Protocol initial load [W] time in stage [min] load increment [W] recovery load [W] recovery time [min] 1. WHO 25 2 25 25 99 2. BAL 50 3 50 25 99 3. Hollmann 30 3 40 25 99 4. STD France 30 3 30 25 99 5. Standard 20 1 25 25 99 6. - 15. (user-programmable) 25 2 25 25 99 Adjustment Range 20 - 100 1 - 30 1 - 400 20 - 100 (*) 1 - 99 (*) With Control Terminal P, the recovery load is fixed at 25 W. Test Protocols (Control Terminal K only) Protocol initial load [W] duration [sec] load increment [W] time in stage [sec] recovery load [W] recovery time [min] ramping protocol 0 120 25 10 0 99 PWC-130 (*) 25 120 25 120 25 99 PWC-150 (*) 50 120 50 120 25 99 PWC-170 (*) 75 120 50 120 25 99 (*) The program advances to the recovery phase as soon as the target heart rate (130/150/170) is reached.

Family 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 Family of characteristics of load duration due to IEC 60601-1 Under permanent load conditions the shown load and pause times (white) have to be observed.

Electromagnetic Compatibility EN 60601-1-2 Changes or modifications to this system not expressly approved by ergoline could cause EMC issues with this or other equipment. This system is designed to comply with applicable regula- tions regarding EMC. Its compliance with these requirements has been verified. It needs to be installed and put into service according to the EMC information stated as follows. Warning • RF INTERFERENCE • • Use of portable telephones or other radio frequency (RF) emitting equipment near the system may cause unexpect- ed or adverse operation. Caution • Equipment Malfunction • • The equipment or system should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the equipment or system should be tested to verify normal operation in the configuration in which it is being used. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions 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. Emissions Test Compliance Electromagnetic Environment - Guidance RF emissions to EN 55011 Group 1 The ergoselect ergometer uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions to EN 55011 Class B The ergoselect ergometer is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions to EN 61000-3-2 Class A Voltage fluctuations/flicker emissions to EN 61000-3-3 Complies

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 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 Electromagnetic Environment - Guidance Electrostatic discharge (ESD) to EN 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV ± 8 kV Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst to EN 61000-4-4 ± 2 kV for power supply lines ± 1 kV for input and output lines ± 2 kV passed Mains power should be that of a typical commer- cial or hospital environment. Surge to EN 61000-4-5 ± 1 kV differential mode ± 2 kV common mode ± 1 kV± 2 kV Mains power should be that of a typical commer- cial or hospital environment. Voltage dips, short interrup- tions and voltage variations on power supply input lines to EN 61000-4-11 < 5 % UT (> 95 % dip in UT) for 0.5 cycles 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles < 5 % UT (> 95 % dip in UT) for 5 s < 5 % UT 40 % UT 70 % UT < 5 % UT Mains power should be that of a typical com- mercial or hospital environment. If the user of the ergoselect ergometer requires continued operation during power mains interruptions, it is recom- mended that the ergoselect ergometer be powered from an uninterruptible power supply or a battery. Power frequency (50/60 Hz) magnetic field to EN 61000‑4‑8 3 A/m passed Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. The ­ergoselect ergometer has no components suscep- tible to magnetic fields. NOTE: UT is the a.c. mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 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 Electromagnetic Environment - Guidance Conducted RF to EN 61000-4-6 Radiated RF to EN 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 V 3 V/m Portable and mobile RF communications equip- ment should be used no closer to any part of the ergoselect ergometer, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2 √P d = 1.2 √P for 80 MHz to 800 MHz d = 2.3 √P for 800 MHz to 2.5 GHz where P is the rated output power rating of the transmitter in watts (W) according to the trans- mitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (a), should be less than the compliance level in each frequency range (b). Interference may occur in the vicinity of equipment marked with the following symbol 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. (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF trans- mitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ergoselect ergometer is used exceeds the applicable RF compliance level above, the ergoselect ergometer should be observed to verify normal operation. 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.

Recommended separation distances between portable and mobile RF 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 Output Power of Transmitter [W] Separation Distance According to Frequency of Transmitter [m] 150 kHz to 80 MHz d = 1.2 √P 80 MHz to 800 MHz d = 1.2 √P 800 MHz to 2.5 GHz d = 2.3 √P 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.17 1.17 2.33 10 3.7 3.7 7.37 100 11.7 11.7 23.3 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. 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.

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