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GE Ebike
GE Ebike
GE Ebike
Manual
Due to continuing product innovation, specifications in this manual are subject to change without notice.
CASE, and MAC are trademarks owned by GE Medical Systems Information Technologies, a General Electric Company going
to market as GE Healthcare.
General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Mechanical assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Controls and Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Connecting the Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Connection to GEHC Electrocardiographs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Speed Readout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Handlebar Adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Saddle Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Control Terminal M. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Operating Mode with Control Terminal M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
• The ergoline quality management system complies The country of manufacture appears on the device label.
with the standards ISO 9001: 2008 and EN ISO 13485:
2003-AC2007.
Manual Purpose
This manual contains the instructions necessary to employ The ergometer is only intended to be used as instructed in
the product safely and in accordance with its function and this manual for exercise tests as well as for rehabilitation
intended use. of cardiac and cardiovascular patients. If the ergometer is
used for other purposes, the manufacturer cannot be held
Where necessary the manual identifies additional sources liable for personal injuries or property damage resulting
of relevant information and/or technical assistance. from unintended use of the equipment.
Two eBike models are available: eBike basic and eBike com-
Intended Audience fort. What differentiates the eBike comfort from the eBike
basic is the electric height adjustment for the saddle. The
This manual is geared for clinical professionals. Clinical patient may remain seated on the saddle while it is raised or
professionals are expected to have working knowledge of lowered.
medical procedures, practices, and terminology as required
for completing these examinations. The eBike III can be used in conjunction with GE Healthcare
electrocardiographs (See “Connectivity eBike III to GE ECG
devices“). When used in conjunction with an electrocar-
diograph, the electrocardiograph will control the bicycle
Intended Use, Safety Information ergometer. Furthermore, the electrocardiograph starts the
sphygmomanometer (option) integrated in the ergometer.
Intended Use Additional blood pressure measurements can be initiated
manually.
The eBike III is intended to be used by trained operators
under direct supervision of a licensed health care practiti- The display on the control terminal indicates the current
oner, in hospitals, clinics, physician’s offices and rehabilita- measuring values.
tion centers.
The connected electrocardiograph provides a full docu-
The eBike III is used to perform a reproducible and compa- mentation of the test.
rable examination under a defined, pedal speed indepen-
dent load.
Note application parts
The eBike III is intended to be used on adult and adolescent
(greater than 12 to 21 years of age) patients and child- Application components are components that are directly in con-
ren (greater than 2 to 12 years of age) if their height and tact with the human body (eg, blood pressure measuring devices).
weight is within the limits defined in “Technical Specifica-
tions” on page 31.
Note - Stability
The eBike III is a computer-controlled, medical-grade bi-
cycle ergometer. At pedal speeds between 30 and 130 RPM • Ensure the stability of the ergometer. If the maximum per-
and loads between 6 and 999 W, the ergometer operates mitted patient weight is exceeded by 10%, the stability of
independent of the pedal speed. the ergometer can no longer be guaranteed. It may become
unstable as a result.
Danger Warning
• Explosion Hazard • • Shock Hazard •
The device is not designed for use in areas where an explosion When the ergometer is connected to other equipment or if a
hazard may occur. medical system is created, it must be ensured that the added
Explosion hazards may result from the use of flammable anes- leakage currents do not present a hazard. In case of questions,
thetics, skin cleansing agents, or disinfectants. please contact GE Healthcare or its sales representatives.
• Risk to Persons •
Note
Before using the ergometer, the operator must ascertain that it is
in correct working order and operating condition. The cables and Only the removal of the power cord will result in an all pole
connectors, in particular, must be checked for signs of damage. disconnection of the device from mains.
Damaged parts must be replaced immediately.
Caution
Note
Latex-free.
Caution: Consult accompanying documents.
Large size.
REF Order number.
Transport and storage label:
top.
SN Serial number.
18
21
nächster
17 Prüftermin
22
01 gemäss MPBetreibV
12
Scheduled date of the next inspection keep dry.
(e.g., March 2017).
11
02
03 10
09
04
08
05
07
06
5 Castors
10
6 Baseplate (small)
9
1 Control terminal M
1 2
3
2 Speed readout for patient
5 Castors
6 Baseplate (large)
9
7 Leveling feet to adjust the ergometer to uneven floors
To cover greater distances, however, we recommend the Avoid strong vibrations of the ergometer during transport.
following method:
Setup
Place the ergometer on a horizontal level floor.
Caution
• Equipment Damage •
Assembly position
Note
• Disconnection from Power Supply •
Note
• Connection Cables •
eBike III
CASE
Connections
cable: 22336203
cable 22336203
Pin 2 Pin 3
Pin 3 Pin 2
Pin 5 Pin 5
eBike III
CARDIOSOFT / CS
Connections
cable: 2017911-131
eBike: USB
cable 2017911-131
eBike III
MAC 2000
Connections
cable: 2006795-001
cable 2006795-001
Cable PIN settings
Pin 2 Pin 3
Pin 3 Pin 2
Pin 5 Pin 5
#1 #2
MAC 5500
CONNECTIONS (2 CABLES)
Adjusting the saddle height of the eBike Figure 1 1 Adjusts angle of handlebar
2 Adjusts height of saddle (eBike basic only)
comfort
3 Indicates saddle height (eBike comfort only)
• Ask the patient to sit on the saddle.
• Adjust the saddle height with the right and left arrow
keys.
Patient display
Note
Figure 2 PC Mode menu
The patient may remain seated on the saddle while the height is a Blood pressure readings (systolic, diastolic) or cuff
being adjusted. pressure during measurement
b Current load
c Duration of exercise test (in „Manual“ and
„Ergometry“ modes only)
d Pulse rate (configurable)
e Speed (revolutions/minute)
Caution
• Erroneous Measurements •
If the cuffs are not the correct size, the measured values may be
incorrect.
Always use the cuff size suitable for the patient’s arm. The
maximum arm circumference is indicated on each cuff.
Figure 1 Correct cuff size
When closing the Velcro strap, check that the index line
(a, Figure 2) at the metal clasp is inside the INDEX range (b)
identified by the arrow, and not outside.
Slip the microphone deep into the pocket and be sure not
to twist the microphone cable.
Apply the cuff directly on the skin. Do NOT apply the cuff
over clothing, paper, etc. (being a PIEZO system, the micro-
phone uses the arterial pressure pulsations to accomplish
the measurement).
The cuff tab must be located below the metal clasp (Figure 4).
For this reason the Velcro tape supplied with the equip-
ment must be used to secure the cuff tubing to the
handlebar:
• Check that the cuff tubing does not knock against the
patient’s knee, when the patient is pedalling and the
hand rests on the handlebar.
Warning
• Patient Hazard •
Figure 2 Cuff tubing
If, by mistake, excessive pressure builds up in the cuff, either re-
move the cuff immediately from the patient’s arm or disconnect
the cuff tubing at the control terminal. The same applies when
the cuff does not deflate correctly.
Measurement Accuracy
Blood pressure measurements can be influenced by nu- Blood pressure measurements determined with eBike III are
merous circumstances. Among these are distractions in the equivalent to those obtained by a trained observer using
test lab, such as persons walking around and loud noise. the cuff/stethoscope auscultation method within the limits
prescribed by the American National Standards Institute
Even minor movements are capable of increasing the blood for manual or electronic measurements.
pressure. Also, patients should not speak during a measu-
rement, as this can also result in higher BP values. Particularly in patients with frequent arrhythmias, errone-
ous measurements may occur during determination of the
If readings from both arms are to be compared, the two systolic and diastolic pressures.
measurements must be taken simultaneously. The results
may be clearly different.
Patient display
Speed Readout
A speed readout as well as three LEDs on the control ter
minal inform the patient of the speed: too slow, too fast or
correct. 1
2
The ranges for the respective speed ratings depend on the 3
selected load (see “Specifications”).
Speed Readout
Note 1 speed low (patient should pedal faster)
2 correct speed
• If, during an exercise test, the speed drops below 30 RPM, 3 speed high (= patient should pedal slower)
the load readout starts blinking on the display and the load
is reduced to zero.
Saddle Adjustment
Saddle adjustment
On the different ergometer models, the saddle height is at the control terminal
adjusted in different ways: (eBike III comfort)
1 Saddle up
1 2
- with a clamping lever (mechanical) (eBike III basic), 2 Saddle down
- with a motor (eBike III comfort).
0 -- 0
Watt min / min
---/--- 0
mmHg ♥ / min
0 -- 0
Watt min / min
---/--- 0
mmHg ♥ / min
0 -- 0
Watt min / min
Operating Mode with Control Terminal M ---/--- 0
eBike III with the control terminal M support the following mmHg ♥ / min
operating mode:
---/--- 0
mmHg ♥ / min
Start screen
1 2
3
4 5
1
Note
DISINFECTION
Only the following disinfectants are approved for disinfec- Hint
tion: • Strictly observe the manufacturer’s instructions for use.
ECOLAB:
• Incidin Foam ®
Cleaning
Clean the cuff and tubing with a moist cloth.
You can use a dishwashing liquid or mild soap water
(no cleaning agents containing alcohol). Removing the Microphone
ECOLAB:
• Incidin Foam ®
Fold the end of the cuff over and introduce it into the
metal clasp.
Disposal
The product described in this operator manual must not
be disposed of as unsorted municipal waste and must be
collected separately.
USB:
remote control from PC (driver required)
option:
COM module (analog)
Environment operation:
temperature: +10 to +40 °C (50 to 104 °F)
rel. humidity 30 to 75%, no condensation
atmospheric pressure: 800 to 1060 hPa
transport and storage:
temperature: –20 to +70 °C (–4 to 158 °F)
rel. humidity 10 to 95%, no condensation
atmospheric pressure: 500 to 1060 hPa
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)
1
min
130
120
110
100
90
80
70
60
50
40
30
20
10
0
25 100 200 300 400 500 600 700 800 900 1000 Watt
Load
Note
2017911-301 Bicycle ergometer eBike III basic with 2017911-305 Bicycle ergometer eBike III comfort with
control terminal M control terminal M
2017911-303 Bicycle ergometer eBike III basic with 2017911-307 Bicycle ergometer eBike III comfort with
blood pressure module and control blood pressure module and control
terminal M terminal M
Add-ons
Accessories
ERGOLINE
LINDENSTR. 5
72475 BITZ, GERMANY
ASSEMBLED IN GERMANY
USB DRIVER
REF 2017911-130
ERG705463 REV. D
2016-03-01
Note
RF emissions to EN 55011 Group 1 The eBike III 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 eBike III ergometer is suitable for use in all estab-
lishments, including domestic and those directly con-
Harmonic emissions to EN 61000-3-2 Class A nected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Voltage fluctuations/flicker emissions Complies
to EN 61000-3-3
Electrostatic discharge (ESD) ± 6 kV contact ± 6 kV Floors should be wood, concrete or ceramic tile.
to EN 61000-4-2 ± 8 kV air ± 8 kV If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Electrical fast transient/burst ± 2 kV for power supply ± 2 kV passed Mains power should be that of a typical commer-
to EN 61000-4-4 lines cial or hospital environment.
± 1 kV for input and output
lines
Surge to EN 61000-4-5 ± 1 kV differential mode ± 1 kV Mains power should be that of a typical commer-
± 2 kV common mode N/A cial or hospital environment.
Voltage dips, short interrup- < 5 % UT < 5 % UT Mains power should be that of a typical commercial
tions and voltage variations (> 95 % dip in UT) for 0.5 or hospital environment. If the user of the eBike III
on power supply input lines cycles ergometer requires continued operation during
to EN 61000-4-11 power mains interruptions, it is recommended
40 % UT 40 % UT that the eBike III ergometer be powered from an
(60 % dip in UT) for 5 cycles uninterruptible power supply or a battery.
70 % UT 70 % UT
(30 % dip in UT) for 25
cycles
< 5 % UT < 5 % UT
(> 95 % dip in UT) for 5 s
Power frequency (50/60 Hz) 3 A/m passed Power frequency magnetic fields should be at levels
magnetic field characteristic of a typical location in a typical
to EN 61000-4-8 commercial or hospital environment.
The eBike III ergometer has no components suscep-
tible to magnetic fields.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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 transmit-
ters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the eBike III ergometer is used
exceeds the applicable RF compliance level above, the eBike III 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 eBike III ergometer.
b) Over the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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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