Operators Manual
60 Pages
Preview
Page 1
ergoselect 100 / 200 Bicycle Ergometer Operator's Manual 2010000134000 • Version 04/2011 • English
This manual was written with the utmost care. Should you still find details that do not correspond with the system, 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.: Fax: e-mail: http:
+49-(0) 7431 98 94 - 0 +49-(0) 7431 98 94 - 128 [email protected] www.ergoline.com
Printed in Germany
Contents 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
-3-
Declaration of Conformity
-5-
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.
The safety information given in this manual is classi‑ fied as follows:
Warning indicates a hazard. If not avoided, the hazard may result in minor injury and/or product/property damage.
Caution indicates a potential hazard. If not avoided, the hazard may result in minor injury and/or product/property damage.
mean: •
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.
•
•
Danger
Consult accompanying documents. It indicates points which are of particular importance in the operation of the device. •
The ERGOLINE quality management system complies with the standards ISO 9001: 2000 and EN ISO 13485: 2003.
indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury.
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
•
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
On request ERGOLINE will provide a Field Service Manual.
Phone: +49-(0)-7431 - 9894 -0 Fax: +49-(0)-7431 - 9894 -128 e-mail: [email protected] http: www.ergoline.com / www.ergoline.eu -7-
Safety Information Danger
Warning
• Explosion Hazard •
• Shock 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 anesthetics, skin cleansing agents or disinfectants.
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.
Warning
• Patient Hazard, Equipment Damage • • Patient Hazard •
Do not expose the ergoselect to direct sunlight to prevent system components from reaching inadmissible high temperatures.
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 regulations (e.g. safety features) • must be informed about the potential hazards arising from the use of this type of equipment.
Do NOT use the ergoselect outdoors (medical device). Furthermore 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.
Hint
• Risk to Persons •
Removing the power cord results in complete disconnection from mains (all poles)..
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.
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 606011-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively).
• Equipment Malfunction • Only the special shielded cables supplied by ERGOLINE may be used to connect the device to other pieces of equipment.
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.
• 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 frequently even though the speed is above 30 RPM, this may be due to electromagnetic interference.
• • •
-8-
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
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).
Warning
• Patient Hazard •
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.
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 measurements.
Caution
Biocompatibility
• Compromised Measuring Accuracy •
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.
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 measuring accuracy.
If you have questions in this matter, please contact ERGOLINE or a representative.
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 precaution 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.
Applicable Laws, Regulations and Directives
-9-
•
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 606011-1 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
- 10 -
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)
ergoselect 100 - controls, connections and indicators
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 200 - controls, connections and indicators
- 11 -
Transport For short distances, the ergoselect can be lifted at the saddle and rolled away on its castors.
Caution • Equipment Damage •
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.
Avoid strong vibrations of the ergoselect during transport.
Transporting the ergoselect
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. Levelling feet of the ergoselect ergometer
- 12 -
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.
Different orientations of the control terminal
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
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.
- 13 -
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.
b a
Connection panel a b
Power input Lock
Power cord with installed strain relief
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!
- 14 -
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.
EKG / PC connection USB PORT 1
PC connection via USB (virtual COM) Digital connection RS232 (remote control by PC or ECG recorder,
Hint
• connecting cables • Only use connecting cables released by ergoline. To use the integrated USB connector, a special driver is required - contact ergoline.
- 15 -
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.
Blood pressure cuff connections 1 2
Microphone connection Cuff tubing
Velcro tape to secure the cuff 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.
- 16 -
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 2 3 4
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).
- 17 -
Adjustment of the handlebar angle Adjustment of the handlebar height (ergoselect 200 only) Adjustment of the saddle height (ergoselect 100 only) Saddle height display (ergoselect 200 only)
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. Correct cuff size
Wrong cuff size
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.
Correct microphone position
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.
Microphone placement on the artery
- 18 -
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).
Correct cuff position (tab)
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
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 hematomas.
Warning
• Patient Hazard •
• Incorrect Measurements •
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.
A loose cuff would degrade the accuracy of the measurement. Therefore, the computer aborts the measurement, if a minimum pressure is not attained within a few seconds.
- 19 -
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
Control terminal K
Control terminal P Turning the System On
ergoline GmbH
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.
Selftest running Note • • •
•
Self-test screen
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 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.
PC Mode Ergometry Manual Settings Select Main menu
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 - 21 -
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 2 3
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 .
- 22 -
speed low (patient should pedal faster) correct speed speed high (= patient should pedal slower)
PC Mode Use the softkeys on the right and left (↑ ↓) to position the bar cursor on PC MODE and confirm the selection with SELECT.
PC Mode Ergometry Manual Settings ↑
Select
↓
Main menu 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).
Saddle Initial screen
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.
PC Mode Display during exercise test 1 2 3 4 5
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 .
- 23 -
current load in watts most recent BP value (systolic/diastolic values) or cuff pressure during inflation duration of exercise test (min) heart rate at the time of the BP measurement (BPM) pedal speed (RPM)