Operators Manual
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Page 1
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eBike L
2018112-033 - C
Anhang
11 Anhang Interne Ergometrieprogramme Programm
Anfangs-
Stu-
Last-
NIBP-
Erhol-
Erhol-
last [W]
fendauer
stufe [W]
Vorlauf [s]
last [W]
dauer [min]
[min] 1. WHO
Stufe
25
2
25
60
25
99
2. BAL
Stufe
50
3
50
60
25
99
3. Hollmann
Stufe
30
3
40
60
25
99
4. STD.France
Stufe
30
3
30
60
25
99
5. Standard
Stufe
20
1
25
60
25
99
6.
Stufe
25
2
25
60
25
99
7.
Stufe
25
2
25
60
25
99
8.
Stufe
25
2
25
60
25
99
9.
Stufe
25
2
25
60
25
99
10.
Stufe
25
2
25
60
25
99
11.
Stufe
25
2
25
60
25
99
12.
Stufe
25
2
25
60
25
99
13.
Stufe
25
2
25
60
25
99
14.
Stufe
25
2
25
60
25
99
15.
Stufe
25
2
25
60
25
99
Einstellbereich
Stufe
20 ...100
1 ... 30
1 ... 400
40 ... 90
20 ... 100
1 ... 99
2018112-033 Revision C
eBike L
39
eBike L Firmware Version 1.7
Operator's Manual 2018112-033 ENG
Revision C
NOTE: The information in this manual only applies to eBike L, 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 L
2018112-033 Revision C August 2007
Contents
Intended Use, Safety Information
6
Setup and Mains Connection
11
Preparation
14
Running an Exercise Test
20
Taking the Blood Pressure
25
Configuration
26
Error Codes
32
Cleaning, Maintenance, Disposal
33
Technical Specifications
36
Order Information
38
Appendix
39
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
2018112-013 Revision A
December 2004
Initial Release
2018112-013 Revision B
July 2005
ECO 080 463
2018112-033 Revision A
October 2005
MR 55686
2018112-033 Revision B
November 2006
ECO 085 811
2018112-033 Revision C
August 2007
ECO 087 883 Revised pages: 8, 33, 34, 38
2018112-033 Revision C
eBike L
3
General information
y The safety information given in this manual is
General Information
classified as follows:
y The product eBike L bears the CE marking CE-0123 (notified body TÜV Süd Product Service GmbH,
Danger
Ridlerstr. 65, 80339 München, Germany) indicating
indicates an imminent hazard. If not avoided, the
its compliance with the provisions of the Council
hazard will result in death or serious injury.
Directive 93/42/EEC about medical devices and fulfills the essential requirements of Annex I of this
Warning
directive. It is an MDD class IIa product.
indicates a hazard. If not avoided, the hazard can
y The device fulfills the requirements of standard EN
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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2018112-033 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.
2018112-033 Revision C
eBike L
5
Intended Use, Safety Information
1
Intended Use, Safety Information
1.1 Intended Use The eBike L is a computer-controlled, medical-grade
The eBike L can be used both as a stand-alone device and
bicycle ergometer for supine exercise tests. At pedal
in conjunction with GE Medical Systems Information
speeds between 30 and 130 RPM and loads between 20
Technologies electrocardiographs. (See “Connection to
and 999 W, the ergometer operates independent of the
Electrocardiographs” on page 13.) When used in
pedal speed. Figure 9-1 shows the speed-independent
conjunction with an electrocardiograph, the
range.
electrocardiograph will control the bicycle ergometer. Furthermore, the electrocardiograph starts the
The eBike L is designed exclusively for use in
sphygmomanometer (option) integrated in the ergometer.
cardiovascular diagnostics at rest and during exercise
Additional blood pressure measurements can be initiated
tests.
manually. When the optional leg rests are attached, it may also be The display on the control terminal indicates the current
used as a medical exam table.
measuring values. The intended use includes adherence to the information The connected electrocardiograph provides a full
given in this manual.
documentation of the test. If the ergometer is used for other purposes, the manufacturer cannot be held liable for personal injuries
Biocompatibility
or property damage resulting from unintended use of the
The parts of the equipment described in this
equipment.
manual, including all accessories, that come in
The eBike L is also available with a separate control
contact with the patient during the intended use,
terminal, set up at a distance from the ergometer. With
fulfill the biocompatibility requirements of the
this version, the control terminal is connected to the
applicable standards if used as intended. If you
ergometer by means of a 2.5 meter coiled cable. A speed
have questions in this matter, please contact GE
readout on a gooseneck replaces the control terminal.
Medical Systems Information Technologies or its Sales Representatives.
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eBike L
2018112-033 Revision C
Intended Use, Safety Information
10
1
11
2 3 4
11
NIBP
5
eBike
12 6
13
7 14
8 9
Fig. 1-1 Controls and indicators 1
Clamping lever for adjustment of the head support
10
Paper roll
2
Arm rest for blood pressure measurements (right or left, on systems with blood pressure module only)
11
Remote control for adjustment of bed surface and saddle
3
Handgrip (prop for mounting the bed and dismounting)
12
4
Speed readout for patient
Connector for blood pressure cuff, on both sides of the bed, type B applied part ( ) (on systems with blood pressure module only)
5
Control terminal
6
Power switch
13 14
Nameplate Footboard
7
Connector panel (power input, fuses, etc.)
8
Leg rest (option)
9
Castors, locking
2018112-033 Revision C
eBike L
7
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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eBike L
2018112-033 Revision C
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 changes frequently even though the speed is above
Warning
30 RPM .
Patient Hazard, Equipment Damage -
Shock Hazard -
– Protect the eBike L from direct sunlight to
– When the ergometer is connected to other
prevent equipment components from reaching inadmissbly high temperatures. Do NOT use the
equipment or if a medical system is created, it
eBike L outdoors (medical device).
must be ensured that the added leakage currents
Furthermore, the equipment has no special
do not present a hazard. If you have questions
provisions against the ingress of humidity.
about this issue, please contact your GE
Humidity inside the equipment may cause
Medical Systems Information Technologies
equipment failure and increase the risk of an
dealer or GE Medical Systems Information
electric shock.
Technologies Service.
Furthermore, the equipment should not be
– For use, the ergometer must only be connected
operated in the vicinity of power plants, because
to electric installations that fulfill the local
they could impair the proper functioning of the
requirements.
equipment.
Patient Hazard -
Risk to Persons -
The German Medical Device Operator Ordinance
Before using the ergometer, the operator must
(MPBetreibV, § 5) demands that users
ascertain that it is in correct working order and
– must have been trained in the use of the
operating condition. In particular, the cables and
ergometer
connectors must be checked for signs of damage.
– must be familiar with the routines for handling
Damaged parts must be replaced immediately,
and assembly of the ergometer
before use.
– must be familiar with and observe the safety
Equipment Failure -
rules and regulations for operation of this type
– The special shielded cables supplied by GE
of equipment
Medical Systems Information Technologies
– must be informed about any other pertinent
must be used to connect the device to other
rules and regulations (e.g. safety provisions)
pieces of equipment.
– must be informed about the potential hazards arising from the use of this type of equipment.
2018112-033 Revision C
eBike L
9
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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eBike L
2018112-033 Revision C
Setup and Mains Connection
2
Setup and Mains Connection
Caution
Setup
Equipment Damage - Avoid strong vibrations of the ergometer during
The eBike L is mounted on a wooden pallet for transport.
transport. If the ergometer needs to be transported
A wrench (size SW 17) or similar tool is required to
over long distances, reinstall the transport locks.
remove the ergometer from the pallet and for all other assembly operations described in this manual.
Caution
Caution
Equipment Damage -
Patient Hazard, Equipment Damage -
When you have purchased the ergometer model During the following assembly operations, the
with the separate control panel, make sure that the
ergometer must be disconnected from the power
connection cable does not present a stumbling
line.
hazard. Also secure the control panel against falling down.
Mounting the Castors y Use the supplied screws to mount the four castors. 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.
2018112-033 Revision C
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11
Setup and Mains Connection
Installing Additional Accessories y Slide the support for the arm rest into the guide rail on the right or left and secure it in the desired position 2 (Fig. 2-2); (on systems 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 Connect the blood pressure cuff: The blood pressure cuff can be connected on the right or on the left side of the bed 12. a
b
– Connect the microphone to a (Fig. 2-1). – Connect the cuff tubing to the connection sleeve
Fig. 2-1 Blood pressure cuff connections a Microphone jack b
b. It must properly lock into place. To disconnect the tubing, push the knurled sleeve backward.
Socket for cuff tubing
10 2
NIBP
eBi ke
12
8
Fig. 2-2 Installing accessories
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eBike L
2018112-033 Revision C
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. 2-3).
nameplate on the rear beam of the framework (13,
y Secure the connector with the supplied lock a.
Figure 1-1).
y Install the strain relief as shown in Fig. 2-3. 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 L with integrated BP module only Fig. 2-3 Connector panel
electrocardiographs (analog control):
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
e
Digital interface RS232
f
Digital interface RS232 (for Service only)
Upon delivery, the eBike L is configured for communication with digitally controlled 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.
2018112-033 Revision C
eBike L
13
Preparation
3
Preparation
3.1 Turning the Device On and Testing Its Performance y Push the power switch (6, Figure 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 L 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
NIBP
NIBP
a and
b.
a blood pressure measurement can be
initiated before or during the exercise test. The same
a
b
NIBP
Ergometry
button can be used to stop a blood pressure measurement.
PC Mode
c
Manual
With the button
c
, you can either bring up the main
menu or go back one menu level.
Settings 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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eBike L
2018112-033 Revision C
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).
Fig. 3-4 Main menu
3.2 Changing the Language a
Upon delivery of the ergometer, the screen texts are displayed in German. Follow these steps to change the
a
NIBP
Einstellungen Standard Betrieb Programme Kontrast Laständerung Sprache Ton Software-Version Datum / Uhrzeit EKG-Typ
c
language:
b
y Select Einstellung (Fig. 3-4).
d
The settings menu appears (Fig. 3-5).
Auswahl
Auswahl vornehmen
y Using the cursor keys b, position the bar cursor a on Sprache c and press button d.
eBike
The language menu appears (Fig. 3-6). 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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eBike L
15
Preparation
3.3 Preparing for the Examination Caution
a
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 handgrip 11 are not capable of supporting the full
b
body weight and should not be used as a mounting/ dismounting aid.
c 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.
Adjusting the Bed A remote control (Fig. 3-7) is available to adjust the saddle and the position of the bed. Buttons b: adjust the longitudinal tilt (0 to 45°) 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 saddle
Buttons c: adjust the saddle 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 both buttons for one of the motors are pressed at the same time.
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eBike L
2018112-033 Revision C
Preparation
Preparing Bed and Patient Before the patient mounts the ergometer, set up the bed as follows: y Move the saddle to the bottom position. y Adjust the bed to an angle of 45° for easy mounting of the ergometer. y If installed, remove the leg rest on the side where the patient will mount the ergometer (Fig. 3-8). y Ask the patient to mount the bed. y Adjust the pedal shoes - if present - to the patient's shoe size and secure the feet in the pedal shoes by tightening the Velcro straps. y Reinstall the leg rest.
Fig. 3-8 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 Note – After adjustment of the clamping levers, tighten them securely. Do not overtighten. – Lubricate the threading of the clamping levers
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
once every 3 months, using a suitable grease
head.
such as OKS 470.
2018112-033 Revision C
eBike L
17
Preparation
Applying the Blood Pressure Cuff Note Observe the following order when applying the
14 cm
blood pressure cuff: 2017911-010 1,3 m 2017911-011 2,0 m -33 cm 23
1. Switch on the eBike and wait for the main menu to appear.
LATEX
2. Apply the blood pressure cuff.
Caution Erroneous Measurements - Fig. 3-9 Correct cuff size
– Select a cuff size suitable for the circumference of the patient’s arm. The maximum permitted circumference is indicated on each cuff. When
a
b
closing the Velcro fastener, ensure that the index line at the metal clasp (a, Fig. 3-10) is within the INDEX range (b) identified by the
2017911-010 1,3 m 2017911-011 2,0 m -33 cm 23 14 cm
INDEX
arrow and not outside.
2017911-010 1,3 m 2017911-011 2,0 m -33 cm 23
LATEX
– Apply the cuff directly on the skin. Rolled up
LATEX
sleeves must not impede blood circulation in the upper arm. Use only the cuffs listed in chapter 10. – Loose cuffs will cause erroneous
Fig. 3-10 Wrong cuff size
measurements; overtight cuffs may constrict blood vessels or cause skin lesions or hematomas. y Ensure that the microphone is correctly positioned in the red cuff pocket: the metal side must face the artery. y Apply the deflated cuff on the patient’s arm. Take care that – the bottom end of the cuff does not reach the bend of the elbow – the microphone (identified by the red tab and white arrow) is exactly above the brachial artery (Fig. 3-12). To ensure accurate blood pressure measurements during an exercise test, the microphone (red tab) must be in the correct position. – the tab is placed below the metal clasp as shown
Fig. 3-11 Applying the cuff
in Fig. 3-11. y Tighten the cuff and close the Velcro fastener. Ensure that the cuff does not slip down or impede circulation of the blood.
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2018112-033 Revision C