Operators Manual
148 Pages
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eBike EL
2018112-036 - C
eBike EL Firmware Version 1.7
Operator's Manual 2018112-036 ENG
Revision C
NOTE: The information in this manual only applies to eBike EL, firmware version 1.7. It does not apply to earlier firmware versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.
CardioSmart, CardioSoft, CardioSys, CASE, and MAC are trademarks owned by GE Medical Systems Information Technologies, a General Electric Company going to market as GE Healthcare. All other marks are owned by their respective owners.
© 2004, 2007. General Electric Company. All rights reserved.
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eBike EL
2018112-036 Revision C August 2007
Contents
Intended Use, Safety Information
6
Setup and Mains Connection
11
Preparation
15
Running an Exercise Test
22
Taking the Blood Pressure
27
Configuration
28
Error Codes
34
Cleaning, Maintenance, Disposal
35
Technical Specifications
38
Order Information
40
Appendix
41
Revision History This manual is subject to the change order service of GE Medical Systems Information Technologies. The revision code, a letter that follows the document part number, changes with every update of the manual. P/N / Revision
Date
Comment
2018112-014 Revision A
December 2004
Initial Release
2018112-014 Revision B
July 2005
ECO 080 463
2018112-036 Revision A
October 2005
MR 55686
2018112-036 Revision B
November 2006
ECO 085 811
2018112-036 Revision C
August 2007
ECO 087 883 Revised pages: 8, 35, 36, 40
2018112-036 Revision C
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General Information
y The safety information given in this manual is
General Information
classified as follows:
y The product eBike EL bears the CE marking CE0123 (notified body TÜV Süd Product Service
Danger
GmbH, Ridlerstr. 65, 80339 München, Germany)
indicates an imminent hazard. If not avoided, the
indicating its compliance with the provisions of the
hazard will result in death or serious injury.
Council Directive 93/42/EEC about medical devices and fulfills the essential requirements of Annex I of this directive. It is an MDD class IIa product.
Warning
y The device fulfills the requirements of standard EN
indicates a hazard. If not avoided, the hazard can result in death or serious injury.
60601-1 "Medical Electrical Equipment, Part 1: General Requirements for Safety" as well as the interference protection requirements of standard EN
Caution
60601-1-2 "Electromagnetic Compatibility – Medical
indicates a potential hazard. If not avoided, this
Electrical Devices".
hazard may result in minor personal injury or
y The device is in radio-interference protection class B
product/property damage.
in accordance with CISPR11/EN 55011. y The CE marking covers only the accessories listed in
y To ensure patient safety and interference-free operation and to guarantee the specified measuring
the "Order Information" chapter.
accuracy, we recommend only original equipment
y This manual is an integral part of the equipment. It should be available to the equipment operator at all
accessories as available through GE Medical Systems
times. Close observance of the information given in
distribution. The user is responsible for the use of
the manual is a prerequisite for proper equipment
accessories from other manufacturers. y GE Medical Systems Information Technologies is
performance and correct operation and ensures patient and operator safety. Please note that
responsible for the effects on safety, reliability, and
information pertinent to several chapters is given
performance of the device, only if
only once. Therefore, carefully read the manual
– assembly operations, extensions, readjustments,
once in its entirety.
modifications, or repairs are carried out by GE
y If unauthorized personnel opens the control terminal,
Medical Systems Information Technologies or by
damaging the calibration sticker, any warranty claim
persons authorized by GE Medical Systems
shall become void.
Information Technologies
y This manual reflects the equipment specifications and
– the device is used in accordance with the instructions given in this manual.
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. y On request GE Medical Systems Information Technologies will provide a detailed Service Manual.
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2018112-036 Revision C
General Information
Manufacturer: ergoline GmbH Lindenstraße 5 D-72475 Bitz, Germany Tel. +49 7431 9894-0 Fax +49 7431 9894-127 Distributor: GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel. +1.414.355.5000 888.558.5120 (USA only) Fax +1.414.355.3790
The country of manufacture appears on the device label.
2018112-036 Revision C
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Intended Use, Safety Information
1
Intended Use, Safety Information
1.1 Intended Use The eBike EL is a computer-controlled, medical-grade
The eBike EL can be used both as a standalone device
bicycle ergometer for supine exercise tests, specially
and in conjunction with GE Medical Systems
designed for stress echocardiography. At pedal speeds
Information Technologies electrocardiographs (See
between 30 and 130 RPM and loads between 20 and
“Connection to Electrocardiographs” on page 14.) When
999 W, the ergometer operates independent of the pedal
used in conjunction with an electrocardiograph, the
speed. Figure 9-1 shows the speed-independent range.
electrocardiograph will control the bicycle ergometer. Furthermore, the electrocardiograph starts the
The eBike EL must only be used in cardiovascular
sphygmomanometer (option) integrated in the ergometer.
diagnostics at rest and during exercise tests.
Additional blood pressure measurements can be initiated When the optional leg rests are attached, it may also be
manually.
used as a medical exam or treatment table. The display on the control terminal indicates the current The intended use includes adherence to the information
measuring values.
given in this manual. The connected electrocardiograph provides a full If the ergometer is used for other purposes, the
documentation of the test.
manufacturer cannot be held liable for personal injuries or property damage resulting from unintended use of the
Biocompatibility
equipment.
The parts of the equipment described in this
The eBike EL is also available with a separate control
manual, including all accessories, that come in
terminal, set up at a distance from the ergometer. With
contact with the patient during the intended use,
this version, the control terminal is connected to the
fulfill the biocompatibility requirements of the
ergometer by means of a 2.5 meter coiled cable. A speed
applicable standards if used as intended. If you
readout on a gooseneck replaces the control terminal.
have questions in this matter, please contact GE Medical Systems Information Technologies or its Sales Representatives.
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Intended Use, Safety Information
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1
11
2 3
12
4 NIBP
5
13
eBike
14 15 16
6
17 18
7 19
8 9
Fig. 1-1 Controls and indicators Clamping lever for adjustment of the head support, release button for drop section 14
10
Paper roll
11
Upper handgrip, adjustable
2
Arm rest for blood pressure measurements (on stress-echo beds with blood pressure module only)
12
Remote control for adjustment of bed surface and saddle
3
Handgrip (prop for mounting the bed and dismounting)
4
Speed readout for patient
13 14 15
5
Control terminal
6
Power switch
Armpit support, adjustable Drop section Connector for blood pressure cuff, on both sides of the bed, type B applied part ( ) (on stress-echo beds with blood pressure module only)
7
Connector panel (power input, fuses, etc.)
8
Leg rest (option)
9
Castors, locking
16 17 18 19
Hip support, adjustable Nameplate Outrigger Footboard
1
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Intended Use, Safety Information
1.2 Equipment Symbols With this button on the control terminal, you can either bring up the main menu or go back one menu level. NIBP
With this button on the control terminal, a blood pressure measurement can be initiated before or during the exercise test. The same button can be used to stop a blood pressure measurement. Symbol at the blood pressure cuff connector: type B applied part. Caution, consult accompanying documents. Caution, consult accompanying documents. Type B applied part. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Consult operating instructions. This symbol indicates that the device was tested and certified according the Russian safety standards specified by GOST. Catalog number. Serial number. CE Mark per the Medical Device Directive 93/42/EEC. Manufacturer’s identification
Date of manufacture. The number found under this symbol is the date of manufacture in the YYYYMM format.
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Intended Use, Safety Information
1.3 Safety Information Warning
Danger
Equipment Failure -
Explosion Hazard - The device is not designed for use in areas where an
– Cellular telephones must not be used in the
explosion hazard may occur. An explosion hazard
immediate vicinity, because they may interfere
may result from the use of flammable anesthetics,
with the proper functioning of the ergometer.
skin cleansing agents and disinfectants.
Electromagnetic interference most probably exists when the Watt reading is unstable. Values changing frequently even though the speed is
Warning
above 30 RPM may be due to electromagnetic
Patient Hazard, Equipment Damage -
interference.
– Protect the eBike EL from direct sunlight to prevent equipment components from reaching
Shock Hazard -
inadmissibly, high temperatures. Do NOT use
– When the ergometer is connected to other
the eBike EL outdoors (medical device).
equipment or if a medical system is created, it
Furthermore, the equipment has no special
must be ensured that the added leakage currents
provisions against the ingress of humidity.
do not present a hazard. If you have questions
Humidity inside the equipment may cause
about this issue, please contact your GE
equipment failure and increase the risk of an
Medical Systems Information Technologies
electric shock.
dealer or GE Medical Systems Information
Furthermore, the equipment should not be
Technologies Service.
operated in the vicinity of power plants, because
– For use, the ergometer must only be connected
they could impair the proper functioning of the
to electric installations that fulfill the local
equipment.
requirements.
Risk to Persons -
Patient Hazard -
Before using the ergometer, the operator must
The German Medical Device Operator Ordinance
ascertain that it is in correct working order and
(MPBetreibV, § 5) demands that users
operating condition. In particular, the cables and
– must have been trained in the use of the
connectors must be checked for signs of damage.
ergometer
Damaged parts must be replaced immediately,
– must be familiar with the routines for handling
before use.
and assembly of the ergometer
Equipment Failure -
– must be familiar with and observe the safety
– The special shielded cables supplied by GE
rules and regulations for operation of this type
Medical Systems Information Technologies
of equipment
must be used to connect the device to other
– must be informed about any other pertinent
pieces of equipment.
rules and regulations (e.g. safety provisions) – must be informed about the potential hazards arising from the use of this type of equipment.
2018112-036 Revision C
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Safety Information, NIBP
Special NIBP Safety Information Note
Warning
– The blood pressure module and the approved
Patient Hazard -
accessories are defibrillation-proof and can
– Do not take blood pressure measurements with a cuff on patients suffering from sickle cell
remain attached to the patient during
anemia or in whom skin lesions are likely to
defibrillation.
occur.
– If the cuff pressure exceeds the maximum value
– The cuff may cause hematomas in patients with
of 300 mmHg during inflation, the procedure
severe blood coagulation disease. In these
will be aborted and the cuff will deflate. As a
instances, the user must make a decision for or
redundant safety precaution, the cuff deflates
against automatic blood pressure
immediately when the cuff pressure exceeds
measurements.
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
Caution
immediately deflate.
Compromised Measuring Accuracy -
– Measurements that did not yield a valid
– Arrhythmias occurring frequently during a measurement may compromise the accuracy of
measurement will not be repeated during the
the measuring values. In certain cases, a valid
exercise test.
measurement will not be possible.
– If the inflation phase takes longer than 40 seconds or if an adequate pressure does not
– Electromagnetic fields may also impair the
build up in the cuff within a reasonable period
measuring accuracy.
of time, the measurement will be aborted and the cuff will deflate. – If a valid measurement cannot be completed within 120 seconds, the measurement will be aborted and the cuff will deflate. – If the cuff pressure remains constant for some time, the measurement will also be aborted and the cuff will deflate.
Applicable laws, regulations and directives – 93/42/EEC (Medical Device Directive of the EU)
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Setup and Mains Connection
2
Setup and Mains Connection
Setup The eBike EL is mounted on a wooden pallet for transport. A wrench (size SW 17) or similar tool is required to remove the ergometer from the pallet and for all other assembly operations described in this manual. Caution Patient Hazard, Equipment Damage - – During the following assembly operations, the ergometer must be disconnected from the power line. – When you have purchased the ergometer model with the separate control panel, make sure that the connection cable does not present a stumbling hazard. Also secure the control panel against falling down.
Warning Patient Hazard - Lock all castors (9, Figure 1-1) before operating the ergometer. When the castors are not locked, the device may move sideways, squeezing one of the persons present, particularly when the patient mounts the ergometer. Mounting Castors and the Outrigger Warning Patient Hazard, Equipment Damage - Mount the outrigger before using the ergometer. Otherwise the device might fall over during the stress test. y Use the supplied screws to mount the four castors. y Using the supplied screws, attach the outrigger to the frame (Fig. 2-1). y Set up the ergometer and adjust the leg of the outrigger so that it is flat on the floor.
Fig. 2-1 Mounting the outrigger
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Setup and Mains Connection
Installing and Removing the Transport Lock P TO
y Remove the red transport lock situated between frame and drive unit. Before transporting the device again, reinstall the transport lock as described below: y Connect the ergometer to the power supply. y Adjust the bed in the horizontal position. y Screw the bottom end of the transport lock to the frame (the upper end is labelled TOP, Fig. 2-2). y Tilt the bed until the upper end of the transport lock
Fig. 2-2 Installing the transport locks Caution
can be easily screwed to the drive unit. y Disconnect the device from the power supply.
Equipment Damage - Avoid strong vibrations of the ergometer during transport. If the ergometer needs to be transported over long distances, reinstall the transport locks.
Note Keep the transport locks and fixing screws, because the transport locks must be reinstalled before transporting the ergometer.
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Setup and Mains Connection
Installing Additional Accessories y Slide the support for the arm rest into the guide rail on the right and secure it in the desired position 2 (Fig. 24); (on stress-echo beds with blood pressure module only). y Install the leg rest 8 (option). y Install the paper roll holder and insert a paper roll 10. y Attach the handgrip 11: To do so, clamp the handgrip in the support and secure it in the appropriate position. y Connect the blood pressure cuff: a
b
The blood pressure cuff can be connected on the right or on the left side of the bed 15. For stress Fig. 2-3 Blood pressure cuff connections a Microphone jack b
echocardiography, connect the blood pressure cuff on the right side.
Socket for cuff tubing
– Connect the microphone to a (Fig. 2-3). – Connect the cuff tubing to the connection sleeve b. It must properly lock into place. To disconnect the tubing, push the knurled sleeve backward. y Use the supplied screws to attach the footboard to the transverse brace on the right 19.
10 11
2
NIBP
5
eBi ke
15
19
8
Fig. 2-4 Installing accessories
2018112-036 Revision C
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Setup and Mains Connection
Connection Mains Connection
Caution Equipment Damage - Before connecting the
You will find the connector panel on the back of the drive
ergometer to the power line, check that the voltage
unit (7, Fig. 1-1).
rating of your local power line matches the value indicated on the device nameplate. You will find the
y Connect the power cord to socket a (Fig. 2-5).
nameplate on the rear beam of the framework (17,
y Secure the connector with the supplied lock a.
Fig. 1-1).
y Install the strain relief as shown in Fig. 2-5. Please note that different strain reliefs are supplied for various cable sizes. Connection to Electrocardiographs The software supports communication with the following electrocardiographs: electrocardiographs (digital control):
a
b 4
f
2
1
5
4 3
7
PORT 2
PORT 3
2 5
1
3 6
8
c
ANALOG
d
e PORT 1
electrocardiograph
connection cable
connector on eBike
CardioSys
22336203
port 1, e
CardioSoft
22336203
port 1, e
CASE
22336203
port 1, e
CASE 8000
22336203
port 1, e
MicroLab
22336203
port 1, e
CardioSmart ST*) 22338002
port 3, b
MAC 1200 ST
port 3, b
22338002
SERVICE
*) eBike EL with integrated BP module only electrocardiographs (analog control): Fig. 2-5 Connector panel a
Power input, instrument fuses
electrocardiograph
connection cable
connector on eBike
b
Digital interface RS232
MAC 5000 ST
c
Analog I/O
2008110-001 2008114-001
ANALOG, c port 3, b
d
for Service
Upon delivery, the eBike EL is configured for
e
Digital interface RS232
communication with digitally controlled
f
Digital interface RS232 (for Service only)
electrocardiographs. For use with electrocardiographs with an analog control system (MAC 5000 ST), the following settings are required (see chapter 6 "Configuration"): – at Default Mode: PC mode – at EKG Type: Analog / Digital y Install a strain relief to secure the cable connection.
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Preparation
3
Preparation
3.1 Turning the Device On and Testing Its Performance y Push the power switch (6, Fig. 1-1) to turn on the ergometer (green indicator lights up). y Make sure that the patient does not pedal at the time the ergometer is switched on and during the selftest. The ergometer runs an automatic selftest (Fig. 3-1). Then the main menu appears (Fig. 3-2). When you see the main Selftest running
menu, the ergometer is ready for operation.
Fig. 3-1 Initial screen during selftest Note The device may be configured to default to one of the operating modes. In this case you will see the initial screen of the selected operating mode instead
Ergometry
of the main menu. You can display the main menu
PC Mode
with the
button (see chapter 6
"Configuration").
Manual
If an error code (e.g. E:01) appears after the selftest, please refer to chapter 7 for troubleshooting information.
Settings
Make sure that the eBike EL is turned on before the blood pressure cuff is applied to the patient.
Choose function
Fig. 3-2 Main menu
In addition to the six softkeys c (Fig. 3-3) the control terminal also accommodates buttons With button
a
Ergometry
Manual
b.
a blood pressure measurement can be
button can be used to stop a blood pressure measurement.
PC Mode
c
a and
initiated before or during the exercise test. The same
b
NIBP
NIBP
NIBP
c
With the button
Settings
, you can either bring up the main
menu or go back one menu level.
Choose function
eBike
Fig. 3-3 Control terminal buttons a Starts and stops a blood pressure measurement b Brings up the main menu or returns to the previous menu level c Softkeys activating the function described next to them
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Preparation
The functions of the six softkeys change with the displayed menu. The function keys can be used to activate the function displayed next to them. In the main menu, for example, the top softkey on the left initiates the a
Ergometry mode, the softkey in the middle on the right
NIBP
Ergometrie
activates the Manual mode.
PC-Betrieb
Ergometry:
Manuell
The ergometer will be controlled by the stored test protocols (see section 4.3).
Einstellung Auswahl vornehmen
PC Mode:
The ergometer will be controlled from the electrocardiograph (see section 4.2).
eBike
Manual:
The ergometer will be controlled manually (see section 4.4).
Settings:
Ergometer configuration (see chapter 6).
3.2 Changing the Language
Fig. 3-4 Main menu
Upon delivery of the ergometer, the screen texts are a
displayed in German. Follow these steps to change the language:
a
NIBP
Einstellungen Standard Betrieb Programme Kontrast Laständerung Sprache Ton Software-Version Datum / Uhrzeit EKG-Typ
c
y Select Einstellung (Fig. 3-4).
b
The configuration menu appears (Fig. 3-5).
d
y Using the cursor keys b, position the bar cursor a on
Auswahl
Sprache c and press button d.
Auswahl vornehmen
The language menu appears (Fig. 3-6).
eBike
y Using the cursor keys a, position the bar cursor on your language and press button b.
Fig. 3-5 Settings menu
a
NIBP
Sprache Deutsch English Français Español Italiano
a b Auswahl
Auswahl vornehmen
eBike
Fig. 3-6 Language menu
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Preparation
3.3 Preparing for the Examination Warning
a
Patient Hazard - Lock all castors (9, Figure 1-1) before operating the ergometer. When the castors are not locked, the device may move sideways, squeezing one of the
b
persons present, particularly when the patient mounts the ergometer. Patient Hazard, Equipment Damage - Mount the
c
outrigger before using the ergometer. Otherwise the device might fall over during the stress test.
d P1
P2
Caution
e
Patient Hazard, Equipment Damage - Only the handgrip 3 (Fig. 1-1) may be used as an aid in mounting and dismounting. The arm rest 2 and
P3
M
handgrip 11 are not capable of supporting the full body weight and should not be used as a mounting/
f
dismounting aid.
Adjusting the Bed A remote control (Fig. 3-7) is available to adjust the saddle and the position of the bed. Fig. 3-7 Remote control a Green indicator is illuminated while a button is pressed b Press to adjust the longitudinal tilt (0 to 45°) c Press to adjust the lateral tilt (0 to 45°); the longitudinal tilt angle automatically limits the maximum lateral tilt d Press to adjust the saddle e Press to save and recall 3 stored patient positions f Press to save a patient position (together with P1, P2 or P3)
Buttons b: adjust the longitudinal tilt (0 to 45°) Buttons c: adjust the lateral tilt (0 to 45°) Buttons d: adjust the saddle Buttons e: save and recall three patient positions The green indicator is illuminated while one of the buttons is activated. The adjustment will stop automatically when the respective end positions have been reached. The adjustment will also stop when two buttons are pressed at the same time. Note The lateral tilt can only be adjusted when the bed is in the horizontal position. The device will beep when you have reached the horizontal position that allows the bed to be tilted laterally.
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eBike EL
17
Preparation
Saving Patient Positions with P1, P2 or P3 y Set the bed to the desired position with buttons b and c. y Holding button "M" depressed, push one of the buttons P1, P2 or P3. Recalling Patient Positions with P1, P2 or P3 y Hold one of the buttons P1, P2 or P3 depressed. The bed automatically moves to the stored position. Since both motors are synchronized, the stored position is reached faster than by manual adjustment. Note To streamline the echocardiographic workflow, we recommend saving the following three patient positions: P1: semirecumbent (for mounting and dismounting) P2: horizontal angle that allows adjustment of the lateral tilt (beep) P3: typical left lateral decubitus position
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eBike EL
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Preparation
Preparing Bed and Patient Before the patient mounts the ergometer, set up the bed as follows: y Move the bed back to the horizontal position, if the lateral tilt is adjusted. y Move the saddle to the bottom position. y Check that the drop section of the bed (Fig. 3-8) has properly locked into place. y Adjust the longitudinal tilt to 45° for easy mounting of the ergometer. y Adjust the hip and armpit supports as well as the armrest such that they do not hinder the patient Fig. 3-8 Drop section
mounting the bed. y If installed, remove the leg rest on the side where the patient will mount the ergometer (Fig. 3-9). y Ask the patient to mount the bed. y Adjust the pedal shoes to the patient's shoe size and secure the feet in the pedal shoes by tightening the Velcro straps. y Reinstall the leg rest. There should be a 10° angle between the axis formed by the upper body and the thigh when the pedal is in its lower position. y Adjust the saddle until this angle is achieved. y Adjust the head support to a position where it rests against the shoulder when supporting the patient's
Fig. 3-9 Leg rest
head. y Fold down the drop section (Fig. 3-8). To do so, pull Note – After adjustment of the clamping levers, tighten them securely. Do not overtighten. – Lubricate the threading of the clamping levers once every 3 months, using a suitable grease
on the release button 1 (Fig. 1-1). y Set the hip support to a position where it will not interfere with the patient pedaling. y Adjust the armpit support to the appropriate position.
such as OKS 470.
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eBike EL
19