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GE Healthcare

eBike PC
Firmware Version 3

Operator’s Manual

2018112-071 ENG Revision C


Note

The information in this manual only applies to the eBike PC, firmware version 3. It does not apply to earlier firmware
versions.

Due to continuing product innovation, specifications in this manual are subject to change without notice.

CardioSmart, CardioSys, CASE, and MAC are trademarks owned by GE Medical Systems Information Technologies, a
General Electric Company going to market as GE Healthcare.

© 2011, 2012 General Electric Company. All rights reserved.

2 eBike PC 2018112-071 Revision C


Contents

1 About This Manual 6

2 Intended Use, Safety Information 7

3 Setup and Mains Connection 11

4 Preparation 14

5 Running an Exercise Test 20

6 Taking the Blood Pressure 25

7 Configuration 27

8 Error Messages 33

9 Cleaning, Maintenance, Disposal 34

10 Technical Specifications 35

11 Order Information 38

12 Appendix 39

2018112-071 Revision C eBike PC 3


General Information

General Information
 The product eBike PC bears the CE marking CE-  The safety information given in this manual is
0123 (notified body TÜV Süd Product Service classified as follows:
GmbH, Ridlerstr. 65, 80339 München, Germany)
indicating its compliance with the provisions of the Danger
Council Directive 93/42/EEC about medical devices indicates an imminent hazard. If not avoided, the
and fulfills the essential requirements of Annex I of hazard will result in death or serious injury.
this directive. It is an MDD class IIa product.
 The device fulfills the requirements of standard EN/ Warning
IEC 60601-1 "Medical Electrical Equipment, Part 1:
indicates a hazard. If not avoided, the hazard can
General Requirements for Safety" as well as the
result in death or serious injury.
interference protection requirements of standard EN/
IEC 60601-1-2 "Electromagnetic Compatibility –
Caution
Medical Electrical Devices" and all applicable
amendments. indicates a potential hazard. If not avoided, this
hazard may result in minor personal injury or
 It is protection class II equipment.
product/property damage.
 The device is in radio-interference protection class B
in accordance with CISPR11/EN 55011.
 To ensure patient safety and interference-free
 The CE marking covers only the accessories listed in
operation and to guarantee the specified measuring
the "Order Information" chapter.
accuracy, we recommend only original equipment
 This manual is an integral part of the equipment. It accessories as available through GE Healthcare
should be available to the equipment operator at all distribution. The user is responsible if accessories
times. Close observance of the information given in from other manufacturers are used.
the manual is a prerequisite for proper equipment
 GE Healthcare is responsible for the effects on safety,
performance and correct operation and ensures
reliability, and performance of the device, only if
patient and operator safety. Please note that
– assembly operations, extensions, readjustments,
information pertinent to several chapters is given
modifications, or repairs are carried out by GE
only once. Therefore, carefully read the manual
Healthcare or by persons authorized by GE
once in its entirety.
Healthcare
 If unauthorized personnel opens the control terminal,
– the device is used in accordance with the
damaging the calibration sticker, any warranty claim
instructions given in this manual.
shall become void.
 This manual reflects the equipment specifications and
applicable safety standards valid at the time of
printing. All rights are reserved for devices, circuits,
techniques, software programs, and names appearing
in this manual.
 On request GE Healthcare will provide a Service
Manual.

4 eBike PC 2018112-071 Revision C


General Information

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
1 800 558 7044 (USA only)
1 800 668 0732 (Canada only)
Fax +1 414 355 3790

The country of manufacture appears on the device label.

2018112-071 Revision C eBike PC 5


About This Manual

1 About This Manual

1.1 Revision History


This manual is subject to the GE Healthcare change order
service. The revision code, a letter that follows the
document part number, changes with every update of the
manual.

Part number/Revision Date Comment

2018112-071 Revision A 2011-02 Initial Release

2018112-071 Revision B 2011-06 Changes in section 2.1

2018112-071 Revision C 2012-06 Changes in sections 3, 10,


11, 12

1.2 Manual Purpose


This manual contains the instructions necessary to
employ the product safely and in accordance with its
function and intended use.

Where necessary the manual identifies additional sources


of relevant information and/or technical assistance.

1.3 Intended Audience


This manual is geared for clinical professionals. Clinical
professionals are expected to have working knowledge of
medical procedures, practices, and terminology as
required for completing these examinations.

6 eBike PC 2018112-071 Revision C


Intended Use, Safety Information

2 Intended Use, Safety Information


7
NIBP

2.1 Intended Use


1 eBike

The eBike PC is intended to be used by trained operators


2 under direct supervision of a licensed health care
3 practitioner, in hospitals, clinics, physician’s offices and
8 rehabilitation centers.
4
The eBike PC is used to perform a reproducible and
comparable examination under a defined, pedal speed
10
independent load.
11
The eBike PC is intended to be used on adult and
12 adolescent (greater than 12 to 21 years of age) patients
and children (greater than 2 to 12 years of age) if their
6
height and weight is within the limits defined in
“Technical Specifications” on page 35.
7
NIBP The eBike PC is a computer-controlled, medical-grade
1 eBike
bicycle ergometer. At pedal speeds between 30 and 130
2 RPM and loads between 6 and 999 W, the ergometer
operates independent of the pedal speed. Figure 10-1
3
shows the speed-independent range.
4 The ergometer is only intended to be used as instructed in
15
9
this manual for exercise tests as well as for rehabilitation
10 of cardiac and cardiovascular patients. If the ergometer is
5
11 used for other purposes, the manufacturer cannot be held
liable for personal injuries or property damage resulting
12
from unintended use of the equipment.

6 Two eBike models are available: eBike basic and eBike


comfort. What differentiates the eBike comfort from the
eBike basic is the manual height adjustment for the
Figure 2-1 Controls and indicators eBike basic (top), handlebar and the electric height adjustment for the
eBike comfort (bottom)
1 Control terminal saddle. The patient may remain seated on the saddle
2 Connection for blood pressure cuff, type BF applied while it is raised or lowered.
part ( ) The eBike PC can be used both as a stand-alone device
3 Adjusts angle of handlebar and in conjunction with GE Healthcare
4 Blood pressure cuff electrocardiographs (See “Connection to GE
5 Adjusts height of handlebar (eBike comfort only) Electrocardiographs”). When used in conjunction with an
6 Castors electrocardiograph, the electrocardiograph will control
7 Speed readout for patient the bicycle ergometer. Furthermore, the
8 Adjusts height of saddle (eBike basic only) electrocardiograph starts the sphygmomanometer
9 Indicates saddle height (eBike comfort only) (option) integrated in the ergometer. Additional blood
10 Power switch pressure measurements can be initiated manually.
11 Connection panel
12 Leg levellers to ensure ergometer stability The display on the control terminal indicates the current
measuring values.

The connected electrocardiograph provides a full


documentation of the test.

2018112-071 Revision C eBike PC 7


Intended Use, Safety Information

Scheduled date of the next inspection


(e.g., March 2011).
Note
Ergometers supplied without BP module can be
retrofitted for BP measurement. NRTL label for the USA and Canada.

CE Mark per the Medical Device


Biocompatibility
Directive 93/42/EEC.
The parts of the equipment described in this
manual, including all accessories, that come in Manufacturer’s identification.
contact with the patient during the intended use,
fulfill the biocompatibility requirements of the Date of manufacture.
applicable standards if used as intended. If you The number found under this symbol is
have questions in this matter, please contact GE the date of manufacture in the YYYYMM
Healthcare or its Sales Representatives. format.

PVC-free.
2.2 Equipment Symbols

With this button on the control terminal, Latex-free.


you can either bring up the main menu or
go back one menu level. Suitable for indicated arm circumference.

NIBP
With this button on the control terminal, a
blood pressure measurement can be
initiated before or during the exercise Small size.
test. The same button can be used to stop
a blood pressure measurement. Standard size.
Symbol ’type B applied part’.
Large size.

Symbol ’type BF applied part’. Transport and storage label:


top.

Caution, consult accompanying Transport and storage label:


documents. keep dry.

Protection class II equipment. Transport and storage label:


fragile.

Transport and storage label:


This symbol indicates that the waste of approved temperature range.
electrical and electronic equipment must
not be disposed as unsorted municipal Transport and storage label:
waste and must be collected separately. approved humidity, non-condensing.
Consult operating instructions.
Transport and storage label:
This symbol indicates that the device was approved pressure range.
tested and certified according to the
Russian safety standards specified by Transport and storage label:
GOST. do not stack.

Catalog number.

Serial number.

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Intended Use, Safety Information

2.3 Safety Information

Danger Warning
Explosion Hazard — Equipment Failure —
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 30 RPM.
Warning
Patient Hazard, Equipment Damage — Shock Hazard —
– Protect the eBike from direct sunlight. – When the ergometer is connected to other
Otherwise equipment components may reach equipment or if a medical system is created, it
inadmissibly high temperatures. The eBike is a must be ensured that the added leakage currents
medical device and must NEVER be used do not present a hazard. If you have questions
outdoors. Furthermore, the device has no about this issue, please contact your GE
additional protection against ingress of Healthcare dealer or GE Healthcare Service.
humidity. Humidity that has entered the device – For use, the ergometer may only be connected to
may cause equipment failure and can increase electric installations that fulfill the local
the risk of electric shock. requirements.
Also, do not operate the eBike in the vicinity of Patient Hazard —
power installations, because they may impair
The German Medical Device Operator Ordinance
equipment functions.
(MPBetreibV, § 5) demands that users
Risk to Persons —
– must have been trained in the use of the
Before using the ergometer, the operator must
ergometer
ascertain that it is in correct working order and
– must be familiar with the routines for the
operating condition. In particular, the cables and
handling and assembly of the ergometer
connectors must be checked for signs of damage.
Damaged parts must be replaced immediately, – must be familiar with and observe the safety
before use. rules and regulations for the operation of this
type of equipment
Equipment Failure —
– The special shielded cables supplied by GE – must be informed about any other pertinent
Healthcare must be used to connect the device to rules and regulations (e.g. safety instructions)
other pieces of equipment. – must be informed about the potential hazards
arising from the use of this type of equipment.

2018112-071 Revision C eBike PC 9


Intended Use, Safety Information

Special NIBP Safety Instructions

Warning Note
Patient Hazard — – The blood pressure module and the approved
– Do not use a cuff to take blood pressure accessories are defibrillation-proof and can
measurements on patients suffering from sickle remain attached to the patient during
cell anemia or where 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 inflation
severe blood coagulation disease. In these procedure will be aborted and the cuff will
instances, the user must make a decision for or deflate. As a redundant safety precaution, the
against automatic blood pressure cuff is immediately deflated when the cuff
measurements. pressure exceeds 310 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
Caution overpressure in the cuff. The cuff must
Compromised Measuring Accuracy — immediately deflate.
– Arrhythmias occurring frequently during a – Measurements that do not yield a valid
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
– Electromagnetic fields may also impair the seconds or if an adequate pressure does not
measuring accuracy. build up in the cuff within a reasonable period
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.

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Setup and Mains Connection

3 Setup and Mains Connection

Setup
Set up the ergometer where you intend to use it and adjust
the two leg levellers 12 for ergometer stability (Figure 2-
1). Protect the ergometer and, in particular, the saddle
cover from direct sunlight
Figure 3-1 Leg levellers
Turning the Control Terminal
The control terminal can be installed with the display
facing the patient or the operator (Figure 3-2). It is
recommended to install the control terminal with the
display toward the operator and the speed indication
toward the patient (See “Speed Readout for Patient”).

 Undo the screws on the left and right of the control


terminal (Figure 3-2).
 Turn the control terminal.
 Secure the control terminal by tightening the screws.

Figure 3-2 Turning the control terminal

2018112-071 Revision C eBike PC 11


Setup and Mains Connection

Mains Connection
 Stand in front of the ergometer and grasp both handles
Caution
of the handlebar.
Equipment Damage — Before connecting the
ergometer to the power line, make sure that the  Tip the ergometer forward all the way and carefully
voltage rating of your local power line matches the lay it on its handlebar (Figure 3-3).
value indicated on the device nameplate. The Now you can access the connector panel on the underside
nameplate is located on the back of the ergometer, of the ergometer.
at the bottom.
 Connect the power cord to socket a (Figure 3-4).
 Mount the strain relief b as shown in Figure 3-4.

Connection to GE Electrocardiographs
electrocardiograph connection cable connector
on eBike
CardioSys 22336203 port 1
CardioSoft *) 22336203 port 1
2017911-131 USB
CASE 22336203 port 1
CardioSmart ST**) 2006795-002 port 1
MAC 1200 ST 2006795-002 port 1
Figure 3-3 Mounting position MAC 1600 ST 2006795-002 port 1
MAC 5000 ST/ 2008110-001 analog
5500 ST (connection 2008114-001 port 3
only via COM
module
(Figure 3-6)***

*) Connection also possible via USB port. In this case,


however, the corresponding driver needs to be installed
first (see enclosed CD). For driver installation
instructions, please refer to the Field Service Manual.
Figure 3-4 Connecting the power cord
**) eBike with integrated BP module only

***) Only trained service technicians are authorized to


install the COM module (part no. 2017911-132) and
perform the configuration (see Field Service Manual).

Upon delivery, the eBike is configured for


communication with digitally controlled
electrocardiographs.
Figure 3-5 Connector panel
For use with electrocardiographs with an analog control
system (MAC 5000 ST/5500 ST), the following settings
are required (see “Configuration” on page 27):
– at Default Mode: PC Mode
– at EKG Type: Analog / Digital
 Install a strain relief to secure the cable connection.

Figure 3-6 COM module

12 eBike PC 2018112-071 Revision C


Setup and Mains Connection

Transport
 Disconnect all connected cables.
 Stand in front of the ergometer and grasp both handles
of the handlebar.
 Tip the ergometer forward until it rests only on the
castors.
 Wait until you have achieved an equilibrium before
moving the ergometer.
 When you have reached the new location, lower the
ergometer very carefully. Otherwise, severe damage
may occur.

Caution
Figure 3-7 Transport Equipment Damage — Avoid strong vibrations of
the ergometer during transport.

2018112-071 Revision C eBike PC 13


Preparation

4 Preparation

4.1 Turning the Device On and Testing


Its Performance
 Push the power switch (10, Figure 2-1) to turn on the
eBike ergometer (green indicator lights up).
 Make sure that the patient does not pedal at the time
the ergometer is switched on and during the selftest.

Selftest running Note


When operating the ergometer in conjunction with
Figure 4-1 Initial screen during selftest the MAC 5000 ST/5500 ST, turn the devices on and
off in the following order:
ON: MAC 5000 ST/5500 ST first, eBike second

PC Mode OFF: eBike first, MAC 5000 ST/5500 ST second.

Ergometry
Manual The ergometer runs an automatic selftest (Figure 4-1).
Settings Then the main menu appears (Figure 4-2). When the
main menu appears, the ergometer is ready for operation.

Select Note
The device may be configured to default to one of
Figure 4-2 Main menu
the operating modes. In this case you will see the
initial screen of the selected operating mode instead
of the main menu. You can display the main menu
with the button (see section 7
"Configuration").
a NIBP
b
If an error code (e.g. “Internal fault NIBP defect
c
0010”) appears after the selftest, please refer to
“Error Messages” on page 33 for troubleshooting
d eBike e
information.
It is important to switch on the eBike before
applying the blood pressure cuff to the patient.

Figure 4-3 Control terminal buttons In addition to the three softkeys c, d, e (Figure 4-3) the
a Starts and stops a blood pressure measurement control terminal also accommodates buttons NIBP
a and
b Brings up the main menu or returns to the
b.
previous menu level
c, d, e Softkeys activating the function described above With button NIBP
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.

With the button, you can either bring up the main


menu or go back one menu level.

14 eBike PC 2018112-071 Revision C


Preparation

The functions of the three softkeys change with the


displayed menu. The function keys can be used to
activate the function displayed above. In the main menu,
PC-Betrieb
Ergometrie for example, the left and right softkeys are used to move
Manuell
Einstellungen the bar cursor up and down, while the softkey in the
middle is used to Select an option.
Auswahl
PC Mode: The ergometer will be controlled from the
electrocardiograph (see “PC Mode” on
page 20).
d c e Ergometry: The ergometer will be controlled by the
stored test protocols (see “Exercise Test”
Figure 4-4 Main menu
on page 22).

Manual: The ergometer will be controlled manually


(see “Manual” on page 24).
Einstellungen
S
P tCa- nBdeat r d ieb Betrieb
Settings: Ergometer configuration (see
P
Ero gg o rmaemt rmi e
K
M oa nn turealsl t “Configuration” on page 27).
L
E ai ns st ät en ldl e
u rnugnegn
Sprache
Auswahl
4.2 Changing the Language
Upon delivery of the ergometer, the screen texts are
displayed in German. Follow these steps to change the
d c e language:

 Press button b (Figure 4-3) to display the main


Figure 4-5 Settings menu menu (Figure 4-4).
 Using buttons d and e, position the bar cursor on
Einstellungen and press button c to confirm the
Sprache selection.
Deutsch
English The settings menu appears (Figure 4-5).
Français
Español  Using the cursor keys d and e, position the bar cursor
Italiano
Auswahl
on Sprache and press button c to confirm the
selection.
The language menu appears (Figure 4-6).

 Using the cursor keys d and e, position the bar cursor


d c e on your language and press button c to confirm the
selection.
Figure 4-6 Language menu

2018112-071 Revision C eBike PC 15


Preparation

4.3 Preparing the Patient


Adjusting Saddle and Handlebar
On the eBike basic, the saddle height is adjusted
manually (clamping lever 7, Figure 4-7), on the eBike
comfort, electrically.
NIBP

Adjust the saddle height as shown in Figure 4-7: There


eBike

7
should be a 10° angle between the axis formed by the
3
~10˚ upper body and the thigh when the pedal is in its lower
15
position.
8
5 Display 8 indicates the saddle height as a numeric value
(eBike comfort only).

Set the handlebar to a position where it is comfortable for


the patient to reach sitting upright. To do so, open clamping
lever 3. On the eBike comfort, you can also adjust the height
Figure 4-7 Adjusting saddle height and handlebar of the handlebar (clamping lever 5).
3 Adjusts angle of handlebar
5 Adjusts height of handlebar (eBike comfort only)
Note
7 Adjusts height of saddle (eBike basic only)
8 Indicates saddle height (eBike comfort only) – Adust the height of the handlebar. Tighten the
clamping lever securely. Do not overtighten.
a b c d e – Lubricate the threading of the clamping lever
once every 3 months, using a suitable grease
such as OKS 470.

Watt
0 min
0
/min
Adjusting the saddle height of the eBike comfort
/
 Ask the patient to sit on the saddle.
mmHg /min
 In the main menu, select the desired mode of
Saddle operation, e.g. PC Mode (Figure 4-8).
 Adjust the saddle height with the right and left
f g softkeys f, g.
Figure 4-8 PC Mode menu
a Blood pressure readings (systolic, diastolic) or cuff Note
pressure during measurement The patient may remain seated on the saddle while
b Current load the height is being adjusted. In PC Mode, the saddle
c Duration of exercise test (in "Manual" and
height adjustment buttons appear automatically
"Ergometry" modes only)
d Pulse rate (configurable) when the electrocardiograph start signal is
e Speed (revolutions/minute) detected.
f Saddle up
g Saddle down

16 eBike PC 2018112-071 Revision C


Preparation

Applying the Blood Pressure Cuff


Cuff Size

Caution
2017911-010 1,3 m
2017911-011 2,0 m

23
-33 cm
Erroneous Measurements —

14 cm
LATEX 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 4-9 Correct cuff size
When closing the Velcro strap, check that the index line
(a, Figure 4-10) at the metal clasp is inside the INDEX
range (b) identified by the arrow, and not outside.
a b

2017911-010 1,3 m
2017911-011 2,0 m
-33 cm 2017911-010 1,3 m
23 2017911-011 2,0 m
INDEX -33 cm
23
14 cm

LATEX
LATEX

Figure 4-10 Wrong cuff size


Microphone Position
Before applying the cuff, check the position of the
microphone inside the red pocket (on the inside of the
cuff): When inside the pocket, the microphone’s metal
side must face the arm.

Slip the microphone deep into the pocket and be sure not
to twist the microphone cable.

Figure 4-11 Inserting the microphone

2018112-071 Revision C eBike PC 17


Preparation

Cuff Application
The accurate placement of the microphone is the primary
condition for reliable pressure measurements during
exercise tests.

The center of the microphone must be located exactly


over the brachial artery.

Figure 4-12 Location of the brachial artery

You can locate the artery by palpation.

Figure 4-13 Palpating the brachial artery


The red tab identifies the position of the microphone.

Apply the cuff directly on the skin. Do NOT apply the


cuff over clothing, paper, etc. (being a PIEZO system, the
microphone uses the arterial pressure pulsations to
accomplish the measurement).

Apply the cuff approx. 2 cm above the bend of the


elbow. The cuff should be tight, but it should not
Figure 4-14 Applied cuff
constrict blood vessels. Make sure that the cuff does not
move during the exercise test.

A loose cuff would degrade the accuracy of the


measurement. Therefore, the eBike cancels the
measurement, if a minimum pressure is not attained
within a few seconds.

The cuff tab must be located below the metal clasp


(Figure 4-15).
Figure 4-15 Cuff tab
Connecting the Blood Pressure Cuff,
Securing the Cuff Tubing
 Connect the microphone to a (Figure 4-16).
 Connect the cuff tubing to the connection sleeve b. It
must properly lock into place. To disconnect the
tubing, push the knurled sleeve backward.

Figure 4-16 Connections for microphone a and cuff


tubing b

18 eBike PC 2018112-071 Revision C


Preparation

When the blood pressure is taken during exercise tests,


care must be taken to prevent motion artifacts.

For this reason the Velcro tape supplied with the


equipment must be used to secure the cuff tubing to the
handlebar:

 Open the large Velcro tape and wrap it around the


handlebar as shown in Figure 4-17.
Figure 4-17 Securing the cuff tubing
 Use the small Velcro tape to secure the cuff tubing.
Take care not to squeeze the cuff tubing.
 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.
 Instruct your patient to avoid excessive contractions
of the muscles in their upper arm during a blood
pressure measurement and to put their hands flat on
the handlebar without grasping it. Consider turning
the hands upside down, i.e., with the palm facing up.
For additional important information on blood pressure
measurements, please refer to “Taking the Blood
Pressure” on page 25.

Warning
Patient Hazard — If, by mistake, excessive pressure
builds up in the cuff, either remove the cuff
immediately from the patient’s arm or disconnect
Figure 4-18 Cuff tubing the cuff tubing at the control terminal. The same
applies when the cuff does not deflate correctly.

2018112-071 Revision C eBike PC 19


Running an Exercise Test

5 Running an Exercise Test


a
5.1 Speed Readout for Patient
b There are three LEDs on the speed display that tell the
patient whether they are pedaling too fast, too slow or at
c the correct speed. The limit values can be configured (see
“Configuration” on page 27).
Figure 5-1 Speed readout for patient
a illuminates when the speed is low 5.2 PC Mode
b illuminates when the speed is correct
c illuminates when the speed is high Selecting and Starting the Operating Mode
In PC mode, the connected electrocardiograph will
control the ergometer. All you can do is initiate a blood
PC Mode pressure measurement with NIBP
.
Ergometry  Using the right or left softkey, position the bar cursor
Manual on PC Mode, then press the softkey in the middle to
Settings Select the option.
The initial menu will appear (Figure 5-3).
Select
Note
Figure 5-2 Main menu The device may be configured to default to one of
the operating modes. In this case you will see the
a b c d e initial screen of the selected operating mode instead
of the main menu. You can display the main menu
with the button (see “Configuration” on

Watt
0 min
0
/min
page 27).

Now the ergometer waits for the start signal from the
/ electrocardiograph.

mmHg /min  When you have finished preparing the patient, initiate
the exercise test on the electrocardiograph.
Saddle
 The ergometer will emit three beeps and the speed
display will blink three times to indicate the
f g beginning of the test. Now the patient should start
pedaling.
Figure 5-3 PC mode initial menu
a Blood pressure readings (systolic, diastolic) or cuff
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)
f Saddle up
g Saddle down

20 eBike PC 2018112-071 Revision C


Running an Exercise Test

Note
To quit the PC mode, turn the ergometer off and on
again.
If the patient’s pedal speed drops below 30 revs/
min, the load indication (b, Figure 5-3) starts
blinking. Should this condition persist for more
than 20 seconds, the displayed watt reading will
change to "0".
The load indication will also blink when patients do
not pedal within the range corresponding to the
family of characteristics shown in Figure 10-1,
because in this case their speed is below the
required load.

2018112-071 Revision C eBike PC 21


Running an Exercise Test

5.3 Exercise Test


Selecting and Starting the Operating Mode
Protocols In the exercise test mode, the protocols stored in the
1. WHO ergometer will control the device.
2. BAL  Using the right and left softkey in the main menu,
3. Hollmann
position the bar cursor on Ergometry, then press the
4. STD.France softkey in the middle to Select the option.
5. Standard
Select Note
The device may be configured to default to one of
Figure 5-4 Protocol menu the operating modes. In this case you will see the
initial screen of the selected operating mode instead
of the main menu. You can display the main menu
with the button (see “Configuration” on
page 27).

The protocol menu appears (Figure 5-4). The bar cursor


highlights the test protocol used last. With the right and
left softkeys you can choose among the 15 protocols.
a b c d e With the softkey in the middle you Select the option and
display the initial screen (Figure 5-5).

25 0
Watt min
0
/min
 When you have finished preparing the patient, Start
the test with the softkey in the middle.
The ergometer will emit three beeps and the speed
display will blink three times to indicate the beginning of
/ the test. The exercise test clock (c, Figure 5-5) will start
mmHg /min at the same time. When, after approximately 15 seconds,
Start the basic load appears at b, the patient should begin
pedaling.
Figure 5-5 Ergometry mode
a Blood pressure readings (systolic, diastolic)
b Basic load (appears 15 seconds after activation of
Start) Note
c Duration of exercise test The protocol details are listed in the Appendix.
d Pulse rate (configurable)
e Speed (revolutions/minute) Refer to section “Configuration” on page 27 for
protocol editing instructions.

22 eBike PC 2018112-071 Revision C


Running an Exercise Test

Adjustments During the Exercise Test


After the test has begun, the displayed information will
change (Figure 5-6). Now you can increase or decrease

25 1
Watt min
58
/min
the load with the right and left softkeys (increments
configurable between 1 and 25 W) or advance to the
recovery phase with the softkey in the middle.

/
mmHg /min
+5W Recovery -5W
Figure 5-6 Ergometry mode Ending the Test
The test ends automatically when all stages, including the
recovery phase, have been completed. It is also possible

25 16 58
Watt min /min
to end the test manually at any time. To abort the test,
press the softkey in the middle to advance to the recovery
phase (Figure 5-7).

During the recovery phase, the patient continues to pedal.


/ The load during recovery is reduced to a preset value.
mmHg /min However, you can increase or decrease the load
+5W End -5W manually.

With the softkey in the middle you End the test.


Figure 5-7 Recovery phase

2018112-071 Revision C eBike PC 23


Running an Exercise Test

5.4 Manual
Selecting and Starting the Operating Mode
In the manual operating mode, you have to control the
ergometer manually, i.e., basic load, load increase, etc.

25
Watt min
0 0
/min
have to be entered manually. Blood pressure
measurements, too, have to be started with the NIBP

button.

/  Using the right and left softkeys in the main menu,


position the bar cursor on Manual, then press the
mmHg /min
softkey in the middle to Select the option.
+5W Start -5W
The initial screen appears (Figure 5-8).
Figure 5-8 Manual mode initial screen
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
of the main menu. You can display the main menu

25 15 58
Watt min /min
with the
page 27).
button (see “Configuration” on

 Adjust the basic load with the right and left softkeys.
/ The increment is configurable between 1 and 25 W.
mmHg /min  When you have finished preparing the patient, Start
+5W End -5W the test with the softkey in the middle.
The ergometer will emit three beeps and the speed
Figure 5-9 Manual mode
display will blink three times to indicate the beginning of
the test. The exercise test clock will start at the same time.
Now the patient should begin pedaling.

The button label Start will change to End (Figure 5-9).


With this button, you can terminate the test.

There is no recovery phase in the manual mode.

24 eBike PC 2018112-071 Revision C


Taking the Blood Pressure

6 Taking the Blood Pressure

Blood Pressure Module — Functional


Description
The blood pressure module takes the patient's blood
pressure at rest, using both the oscillometric method and
the auscultatory method.

The criteria for the oscillometric method are the pressure


pulsations superimposed, with every systole, on the air
pressure in the cuff. A pressure transducer measures the
pressure pulsations, converts them into electric signals
and evaluates them.
Figure 6-1 Waveform representing the pressure
decrease in the cuff during a measurement: The auscultatory method uses a microphone to acquire
systolic pressure at 140 mmHg, diastolic
and evaluate the Korotkov sounds.
pressure at 80 mmHg
The device continues to inflate the cuff (up to 300 mmHg
max.) as long as pressure pulsations can be sensed; the
inflation phase varies from patient to patient.
Note The first blood pressure measurement of an exercise test
Apply the blood pressure cuff before initiating a is the baseline measurement taken before the patient
blood pressure measurement. starts pedalling. Both measuring methods (oscillometric
and auscultatory) are employed. A measurement is
considered to be valid, when both results agree within a
given tolerance. While the baseline measurement is
taken, the patient should not pedal or move. Reliable
measurements during the exercise tests when motion
artifact cannot be avoided can only be expected after a
successful baseline value has been established.

During the exercise test, measurements are only taken


with the auscultatory method. It is important for this
method that the microphone is placed directly above the
brachial artery (see “Applying the Blood Pressure Cuff”
on page 17). A microphone that is not in the correct
position on the arm may cause invalid measurements.

In the PC Mode and in Ergometry, measurements are


initiated according to the selected test protocol, in the
Manual mode, they are initiated with NIBP
. Additional
measurements can be taken with NIBP
; the same button
can be used to stop a measurement in progress.

2018112-071 Revision C eBike PC 25


Taking the Blood Pressure

Performing a Measurement Measurement Accuracy


Always switch on the eBike before applying the blood Blood pressure measurements can be influenced by
pressure cuff to the patient. At power-up, the eBike numerous circumstances. Among these are distractions in
checks the sensors and zeroes it. If the cuff is already the test lab, such as persons walking around and loud
applied, it may not be entirely depressurized. The eBike noise.
would display an error message in this case (see “Error
Even minor movements are capable of increasing the
Messages” on page 33).
blood pressure. Also, patients should not speak during a
Instruct your patient to avoid excessive contractions of measurement, as this can also result in higher BP values.
the muscles in their upper arm during a blood-pressure
If readings from both arms are to be compared, the two
measurement and to put their hands flat on the handlebar
measurements must be taken simultaneously. The results
without grasping it. Consider turning the hand round so
may be clearly different.
that the palm faces upward.
To verify the measurement accuracy of the eBike, first
Baseline BP measurements taken at rest are important for
complete three measurements with the eBike on one arm
the proper artifact filter and gain settings.
and simultaneously with a reference unit on the other
The baseline measurement is always the first arm. Then exchange the two units, leaving the cuffs in
measurement initiated by the system (e.g., CardioSoft, place, and perform another three measurements.
CASE).
Compare the mean values from these six measurements.
The patient should not move while baseline
Blood pressure measurements determined with eBike are
measurements are taken. In no event should patients start
equivalent to those obtained by a trained observer using
pedalling.
the cuff/stethoscope auscultation method within the
If the results of the baseline measurement appear to be limits prescribed by the American National Standards
incorrect or implausible, the exercise test must be Institute for manual or electronic measurements.
terminated at the ECG system and restarted.
Particularly in patients with frequent arrhythmias,
erroneous measurements may occur during
Caution
determination of the systolic and diastolic pressures.
Incorrect Measurements, Baseline BP
Measurement - A measurement manually initiated
at the control terminal is NOT a baseline
measurement for the subsequent exercise test.
The system must have completed the preceding
exercise test.

Before the new attempt, check the cuff application and


microphone position and, if required, inform the patient
again about the correct behavior during measurements.

26 eBike PC 2018112-071 Revision C


Configuration

7 Configuration

Some Basic Facts


A number of device settings can be configured to suit
your needs and preferences. The device will save your
PC Mode selections and automatically activates them when it is
Ergometry turned on again.
Manual  Using the right and left softkeys in the main menu,
Settings position the bar cursor on Settings, then press the
softkey in the middle to Select the option.

Select The configuration menu appears (Figure 7-2).

 Using the right and left softkeys, position the bar


Figure 7-1 Main menu
cursor on the parameter to change and Select the
option.
Having completed the changes, exit the configuration
menu with .

Settings Note
Default Mode The device may be configured to default to one of
Protocols the operating modes. In this case you will see the
Contrast initial screen of the selected operating mode instead
Load Change of the main menu. You can display the main menu
Language with the button.

Select
Note
Figure 7-2 Configuration menu – Upon delivery, the ergometer is configured for
communication with digitally controlled
electrocardiographs.
– When you operate the ergometer in conjunction
with the MAC 5000 ST/5500 ST (analog
control), select "PC Mode" in the "Default
Mode" menu and "Analog/Digital" in the
"EKG Type" menu.

Default Mode
Default Mode In this menu you choose the default mode activated when
the ergometer is turned on.
Menu
 Using the arrow buttons, choose an operating mode,
PC Mode
then Select the option to exit the menu.
Ergometry
Manual  Quit the configuration mode with .

Select

Figure 7-3 Default Mode menu

2018112-071 Revision C eBike PC 27


Configuration

Editing the Test Protocol


The first 5 test protocols are fixed and cannot be changed.
Protocols 6 through 15 can be edited as needed. The
Protocols protocol details to edit are:
1. WHO
2. BAL – basic load
3. Hollmann – stage time
4. STD.France – load stage (load increment)
5. Standard  On the protocol editing screen (Figure 7-5) highlight
Select the parameter to change with the bar cursor (e.g.
Basic Load) and confirm your choice with Select.
Figure 7-4 Selecting a protocol The basic load is displayed in reverse video (Figure 7-6).

 Now use the right and left softkeys to change the


initial load and confirm the new value with Select.
Protocol
6. Edit the other parameters in the same way, when needed.
Basic Load 25 W  Quit the configuration mode with .
Stage Time 2 min These are the adjustment ranges:
Load Stage 25 W
Parameter Adjustment Range

basic load 20 to 100 W


Select
stage time 1 to 30 minutes
Figure 7-5 Editing a protocol load stage 1 to 400 W

Protocol
6. Note
Basic Load 25W Chapter 12 in the Appendix provides an overview of
Stage Time 2 min the exercise test protocols stored in the ergometer.
Load Stage 25 W

Select

Figure 7-6 Basic load displayed in reverse video

28 eBike PC 2018112-071 Revision C


Configuration

Contrast
The contrast can be adjusted from 0 to 100% in steps of
5%.
Contrast

50 %

Select

Figure 7-7 Changing contrast


Load Change
The increments available to change the load are 1, 5, 10
Load Change and 25 W

+/- 1 Watt
+/- 5 Watt
+/- 10 Watt
+/- 25 Watt

Select

Figure 7-8 Changing increments

Language
Choose the language for the displayed texts.
Language
Deutsch
English
Français
Español
Italiano
Select

Figure 7-9 Selecting the language

2018112-071 Revision C eBike PC 29


Configuration

Beep
On this screen you enable and disable the QRS beep for
Beep blood pressure measurements.

On
Off
Software Version
Select to display the installed software version.
Select

Figure 7-10 Enabling - disabling the QRS beep

Date and Time


Select to adjust date and time.
Date  First choose the parameter to adjust (date or time) and
22.10.2003 confirm with Select.
When you select the date, the bar cursor will first
Time
highlight the day (Figure 7-12).
12:44:49  Change the value with the arrow buttons and confirm
with Select. The bar cursor moves to the month.
Select
 Change the values for month and year in the same
way.
Figure 7-11 Adjusting the date
 Follow the same steps to adjust the time.

Date
22.10.2003
Time
12:44:49

Select
Figure 7-12 Adjusting the date

30 eBike PC 2018112-071 Revision C


Configuration

EKG Type
In this menu you toggle between digital and analog
control of the ergometer. Access to this menu is protected
EKG Type with a password.

 Using the arrow buttons, enter the value "003" in the


003 password box and confirm with Select.
Now you will see Figure 7-14.

 Using the arrow buttons, choose the "EKG Type",


Select then confirm with Select.

Figure 7-13 Entering the password

EKG Type

Analog / Digital
Digital

Select

Figure 7-14 Changeover from digital to analog control

2018112-071 Revision C eBike PC 31


Configuration

RPM
In this menu you choose the limit values for an "RPM
RPM alert", when the LED for high or low speed (RPM) lights
up on the speed display.
Min. 0 . . 70:
54 /min  Use the arrow buttons to choose the minimum or
maximum RPM parameter and confirm with Select.
Max. 50 . . 130:
65 /min  Change the RPM limit value with the arrow buttons
and confirm with Select.
Select The minimum value can be adjusted between 0 and
70 RPM, the maximum value between 50 and 130. With
Figure 7-15 Adjusting RPM limit values the limit values shown in Figure 7-15, the LED for the
low speed lights up if the patient pedals below 54 RPM,
the LED for the high speed lights up above 65 RPM.

The set RPM range is only permitted for a precisely


Load (W) "green" RPM Range (revs/min)
defined load range. It is automatically adapted as
6 - 150 54 - 64 (default setting) indicated in the RPM and load table (Figure 7-16). The
151 - 250 58 - 65 "high RPM" or "low RPM" LED remains illuminated on
the patient’s speed readout until the patient pedals at the
251 - 350 68 - 75
correct speed which is indicated by the green LED.
351 - 450 78 - 85

451 - 550 88 - 95

551 - 650 98 - 105

651 - 750 108 - 115

751 - 850 118 - 125

851 - 950 > 125

951 - 999 > 130

Figure 7-16

Pulse Display
With the menu item "Pulse Display" you enable and
disable indication of the pulse rate.

32 eBike PC 2018112-071 Revision C


Error Messages

8 Error Messages

Error Message Cause Remedy

Internal Fault NIBP defect 0010 The pressure sensor for blood Turn off the ergometer with the power switch,
pressure measurements could not wait approx. 5 seconds, then switch it on again.
be initialized. Be sure to switch on Should the error message persist, have the
the eBike before applying the cuff ergometer checked by trained service
to the patient. technicians before using it again. This is a
general recommendation and applies whenever
an error message is displayed.

2018112-071 Revision C eBike PC 33


Cleaning, Maintenance, Disposal

9 Cleaning, Maintenance, Disposal

9.1 Cleaning, Disinfection 9.2 Maintenance


Cleaning and Disinfecting the Equipment Checks before each use
Surface
 Before each use, visually check the device and the
cables for signs of mechanical damage.
Warning
Shock Hazard – Before cleaning the device, If you detect damage or impaired functions that may
disconnect it from the power line. result in a hazard to the patient or the operator, the device
must be repaired before it can be used again.
Equipment Damage – Liquids must not be allowed
to enter the device. Devices into which liquids have Technical Safety Inspections, Inspections of
entered must be immediately cleaned and checked the Measuring System
by a trained service technician, before they can be
The technical safety inspections and the inspections of
reused.
the measuring system must be completed every two years
Do not use acids or alkaline solution (household
according to the rules of the art by trained service
cleaners) or caustic disinfectants. We recommend
technicians. Please contact your local authorized dealer
Fugaten spray, Lysoform or Promanum N for
for details.
disinfection.
Similarly, the automatic sphygmomanometer in the
 Wipe the device surface down with a cloth moistened control terminal must be checked and calibrated by an
with soap water or a disinfectant. The cloth must not authorized specialist every two years to fulfill legal
be dripping wet; liquids must not enter the device. requirements.

The date of the next inspection is indicated on the


Cleaning and Disinfecting the Blood
inspection sticker attached next to the nameplate on the
Pressure Cuff
ergometer.
Note Ergometer Adjustment
For cleaning and disinfection instructions, please
refer to the information supplied with the blood For a description, please refer to the Service Manual
pressure cuff. available on request from GE Healthcare.

Cleaning Cables
9.3 Disposal of the Product
 Disconnect cables from the device before cleaning
them. Do not dispose the product described in this
Operator Manual as unsorted municipal
 Use a cloth moistened with soap water to wipe the
waste. It must be collected separately.
cables clean. Do not immerse the cables in liquid.
Please contact an authorized representative
of the manufacturer for information con-
cerning the decommissioning of your
equipment.
Consult operating instructions.

34 eBike PC 2018112-071 Revision C


Technical Specifications

10 Technical Specifications children are used: minimum height 110 cm)


– mechanical adjustment for eBike basic, electric
Ergometer adjustment for eBike comfort
– numeric indication of saddle height on eBike comfort
Model
Handlebar Adjustment
– modular ergometer system eBike basic, eBike
comfort – continuous, 360°, for patient heights between
120 and 210 cm, rigid steering column on eBike
Operating Mode
basic, height-adjustable steering column on eBike
– continuous operation comfort
Power Supply Crank Length
– 100 to 240 V, 50 to 60 Hz – 170 mm
Power Consumption Display
– 60 VA max. – 68 x 34 mm, 128 x 64 pixels
Braking Principle Interfaces
– computer-controlled eddy current brake with torque – 1 x RS232: 9-pin Sub-D
measurement; speed independent to DIN VDE 0750-
– 1 x USB
238
In conjunction with the COM module (part no.
Load Range
2017911-132):
– 6 to 999 W, speed (RPM)-independent
– analog input for target load: 8-pin DIN socket
RPM Range
– analog output for current load: 8-pin DIN socket
– 30 to 130 RPM (see Figure 10-1) Environment
Load Error
Operation
– to DIN VDE 0750-238
– temperature between +10 and + 40 °C (50 and 104 °F)
±3 W between 25 and 60 W and ±5% max. between
– relative humidity 30 to 75 %, no condensation
60 and 400 W
– atmospheric pressure 700 to 1060 hPa
– acc. to manufacturer:
±3 W max. between 6 and 60 W and ±5% max. Transport and Storage
between 60 and 999 W – temperature between -20 and + 70 °C (-4 and 158 °F)
Load Increments – relative humidity between 10 and 95 %, no
– configurable: 1, 5, 10 or 25 W condensation

Moment of inertia – atmospheric pressure 500 to 1060 hPa


Dimensions and Weight
– 10 kg x m2
Flywheel Mass – width 460 mm, handlebar approx. 575 mm
– length 900 mm
– 7 kg
– height 900 mm min., 1350 mm max.
Internal Protocols
– weight approx. 61 kg (eBike basic), 69 kg (eBike
– 5 fixed protocols, 10 user-configurable protocols
comfort)
Patient Weight

– 160 kg max.
Saddle Height Adjustment

– continuous for patient height between 120 and


210 cm (when the special saddle and pedals for

2018112-071 Revision C eBike PC 35


Technical Specifications

Blood Pressure Module resting BP readings of both methods for plausibility

Measuring Principle

– auscultatory method, oscillometric method; for


resting BP, the results from both measurements are
compared for plausibility
Measuring Range

– systolic pressure: 40 to 300 mmHg


– diastolic pressure: 40 to 300 mmHg
– pulse rate: 35 to 230 beats/minute
Measuring Error

– pressure readout error: ± 3 mmHg


– readout resolution: ± 1 mm Hg
Inflation Pressure Figure 10-1 Family of characteristics of the braking
torque control range
– 300 mmHg max., adapts automatically to systolic
black: speed-independent range to DIN
pressure VDE 0750-238
Inflation Speed black + grey: speed-independent range
eBike basic, eBike comfort
– 6 seconds to 140 mmHg; 18 seconds to 300 mmHg
Max. Cuff Pressure Note
– If the patient’s pedal speed drops below 30 revs/
– 300 mmHg
min, the load indication starts blinking and the
Deflation Rate load is set to "0 W". Should this condition
– pulse-dependent deflation rate, approx. 3 mmHg/ persist for more than 20 seconds, the displayed
pulse or 3 mmHg/second and printed load will be "0 W".
Calibration – The load indication will also blink when
patients do not pedal within the range
– with external pressure meter
corresponding to the family of characteristics
Artifact Rejection shown in Figure 10-1, because in this case their
– automatic artifact rejection and comparison of the speed is below the required load.

Noise Level (dB)

RPM 25 W 50 W 75 W 100 W 150 W 200 W 250 W 300 W

40 45 45 49 51 49

50 47 47 48 49 56 58 58

60 48 48 49 50 53 54 59 61

70 50 50 51 52 53 54 55 57

80 52 52 53 54 57 57 59 60

90 53 52 52 52 53 56 57 59

100 53 52 52 52 53 54 57 59

110 54 53 53 53 56 56 57 58

120 55 55 54 54 55 56 58 58

36 eBike PC 2018112-071 Revision C


Technical Specifications

Family of characteristics of the load intervals according to IEC 60601-1

Figure 10-2 Family of characteristics of the load intervals

2018112-071 Revision C eBike PC 37


Order Information

11 Order Information

Subject to change. Always refer to latest list of


2017911-012 Blood pressure cuff with microphone,
accessories.
large, width 15 cm, for circumference
from 31 to 42 cm, length of tubing
Note
1.30 m
Not all parts listed below may be available in some
countries. 2017911-011 Blood pressure cuff with microphone,
standard, width 13 cm, for
circumference from 24 to 32 cm, long
2017911-101 Bicycle ergometer eBike basic with
tube (2 m)
control terminal PC, incl. power cord,
operator's manual, without connection 2017911-013 Blood pressure cuff with microphone,
cable to electrocardiograph large, width 15 cm, for circumference
from 31 to 42 cm, long tube (2 m)
2017911-103 Bicycle ergometer eBike basic with
control terminal PC and blood pressure 2017911-044 Velcro tape to secure cuff tubing
module, incl. blood pressure cuff 2017911-015 Fixture for child's saddle
(standard), power cord, operator's
2017911-016 Child's saddle
manual, without connection cable to
electrocardiograph 2017911-017 Sport saddle

2017911-105 Bicycle ergometer eBike comfort with 2017911-019 Child's pedal, adjustable
control terminal PC, incl. power cord, 22336203 Connection cable for CardioSys,
operator's manual, without connection CardioSoft, CASE, CASE 8000,
cable to electrocardiograph MicroLab, length 5 m
2017911-107 Bicycle ergometer eBike comfort with 2006795-002 Connection cable for CardioSmart ST,
control terminal PC and blood pressure MAC 1200 ST, MAC 1600 ST, length
module, incl. blood pressure cuff 5m
(standard), power cord, operator's
2008110-001 Analog connection cable for
manual, without connection cable to
MAC 5000 ST/5500 ST, length 4.6 m
electrocardiograph
2008114-001 Digital connection cable for MAC 5000
Add-ons ST/5500 ST, length 4.6 m

(installation by trained service technicians only). 2017911-131 USB cable, length 5 m

2017911-130 USB driver CD


2017911-133 Blood pressure module
2017911-140 Power cord, Europe, length 2.5 m
2017911-132 COM module
2017911-141 Power cord, UK, length 2.5 m

Accessories 2017911-142 Power cord, USA, length 2.5 m

2017911-143 Power cord, China, length 2.5 m


2017911-010 Blood pressure cuff with microphone,
2017911-144 Power cord, South Africa, length 2.5 m
standard, width 13 cm, for
circumference from 24 to 32 cm, length 2017911-145 Power cord, Australia, length 2.5 m
of tubing 1.30 m
Operator manuals in other languages are available
2017911-014 Blood pressure cuff with microphone,
through GE Healthcare.
small, width 10.0 cm, for circumference
from 17 to 26 cm, length of tubing
1.30 m

38 eBike PC 2018112-071 Revision C


Appendix

12 Appendix

Internal Exercise Test Protocols

Protocol Basic Stage Load NIBP Recovery Recovery


Load [W] Time Stage [W] Lead Time Load [W] Time
[minutes] [seconds] [minutes]

1. WHO stage 25 2 25 60 25 99

2. BAL stage 50 3 50 60 25 99

3. Hollmann stage 30 3 40 60 25 99

4. STD.France stage 30 3 30 60 25 99

5. Standard stage 20 1 25 60 25 99

6. stage 25 2 25 60 251) 99

7. stage 25 2 25 60 251) 99

8. stage 25 2 25 60 251) 99

9. stage 25 2 25 60 251) 99

10. stage 25 2 25 60 251) 99

11. stage 25 2 25 60 251) 99

12. stage 25 2 25 60 251) 99

13. stage 25 2 25 60 251) 99

14. stage 25 2 25 60 251) 99

15. stage 25 2 25 60 251) 99

Adjustment stage 20 to 100 1 to 30 1 to 400 40 to 90 20 to 100 1 to 99


Range

1) equivalent to selected initial load

2018112-071 Revision C eBike PC 39


Appendix

Electromagnetic Compatibility (EMC)


Changes or modification to this system not expressly Warning
approved by GE Healthcare could cause EMC issues with Use of portable phones or other radio frequency
this or other equipment. This system is designed and (RF) emitting equipment near the system may cause
tested to comply with applicable regulation regarding unexpected or adverse operation.
EMC. It needs to be installed and put into service
according to the EMC information stated as follows.

Warning
The equipment or system should not be used
adjacent to, or stacked with, other equipment. If
adjacent or stacked use is necessary, the equipment
or system should be tested to verify normal
operation in the configuration in which it is being
used.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The eBike PC is intended for use in the electromagnetic environment specified below. It is the responsibility of the
customer or user to ensure that the eBike PC is used in such an environment

Emissions Test Compliance Electromagnetic Environment – Guidance

RF emissions to Group 1 The eBike PC uses RF energy only for its internal
EN 55011 function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.

RF emissions to Class B The eBike PC is suitable for use in all establishments


EN 55011 including domestic and those directly connected to the
public low-voltage power supply network that
Harmonic emissions to EN Class A
supplies buildings used for domestic purposes.
61000-3-2

Voltage fluctuations/flicker Complies


emissions to EN 61000-3-3

40 eBike PC 2018112-071 Revision C


Appendix

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The eBike PC is intended for use in the electromagnetic environment specified below. It is the responsibility of the
customer or user to ensure that the eBike PC is used in such an environment

Immunity Test EN 60601 Test Level Compliance Electromagnetic Environment –


Level Guidance

Electrostatic discharge ± 6 kV contact ± 6 kV Floors should be wood, concrete or


(ESD) to ceramic tile. If floors are covered with
± 8 kV air ± 8 kV
EN 61000-4-2 synthetic material, the relative humidity
should be at least 30%.

Electrical fast transient/ ± 2 kV for power supply ± 2 kV Mains power should be that of a typical
burst to EN 61000-4-4 lines commercial or hospital environment.
passed
± 1 kV for input/output lines

Surge to EN 61000-4-5 ± 1 kV differential mode ± 1 kV Mains power should be that of a typical


commercial or hospital environment.
± 2 kV common mode ± 2 kV

Voltage dips, short < 5 % UT < 5 % UT Mains power should be that of a typical
interruptions and voltage (> 95 % dip in UT) for commercial or hospital environment. If
variations on power 0.5 cycles the user of the eBike PC requires
supply input lines to EN continued operation during power mains
40 % UT 40 % UT
61000-4-11 interruptions, it is recommended that the
(60 % dip in UT) for 5 cycles
eBike PC be powered from an
70 % UT uninterruptible power supply or a battery.
(30 % dip in UT) for 70 % UT
25 cycles

< 5 % UT
(> 95 % dip in UT) for < 5 % UT
5 seconds

Power frequency (50/ 3 A/m passed Power frequency magnetic fields should
60 Hz) magnetic field to be at levels characteristics of a typical
EN 61000-4-8 location in a typical commercial or
hospital environment. The eBike PC has
no components susceptible to magnetic
fields.

NOTE UT is the AC mains voltage prior to application of the test level.

2018112-071 Revision C eBike PC 41


Appendix

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The eBike PC is intended for use in the electromagnetic environment specified below. It is the responsibility of the
customer or user to ensure that the eBike PC is used in such an environment

Immunity Test EN 60601 Test Level Compliance Electromagnetic Environment –


Level Guidance

Portable and mobile RF communications


equipment should be used no closer to the
eBike PC, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF to EN 3 Veff 3V
d = 1.2 P
61000-4-6 150 kHz to 80 MHz
d = 1.2 P for 80 MHz to 800 MHz
Radiated RF to EN 61000- 3 V/m 3 V/m
4-3 80 MHz to 2.5 GHz d = 2.3 P for 800 MHz to 2.5 GHz

where P is the output power rating of the


transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey a, should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.

a ) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF
compliance level above, the eBike PC 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 PC.

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

42 eBike PC 2018112-071 Revision C


Appendix

Recommended Separation Distances between Portable and Mobile


RF Communication Equipment and the eBike PC

The eBike PC is intended for use in the electromagnetic environment specified below on which radiated RF
disturbances are controlled. The customer or the user of the eBike PC can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the eBike PC as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum Output Separation Distance According to Frequency of Transmitter


Power of Transmitter in
in meters
watts
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 P d = 1.2 P d = 2.3 P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.7 3.7 7.37

100 11.7 11.7 23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.

2018112-071 Revision C eBike PC 43


Appendix

Compliant Cables and Accessories

Warning
The use of accessories, transducers and cables
other than those specified may result in increased
emissions or decreased immunity performance of
the equipment or system.

The table below lists cables, transducers, and other


applicable accessories with which GE Healthcare claims
EMC compliance.

Note
Any supplied accessories that do not affect EMC
compliance are not included

22336203 Connection cable for CardioSys,


CardioSoft, CASE, CASE 8000

2006795-002 Connection cable for CardioSmart ST,


MAC 1200 ST, MAC 1600 ST

2008110-001 Analog connection cable for


MAC 5000 ST / MAC 5500 ST

2008114-001 Digital connection cable for


MAC 5000 ST / MAC 5500 ST

2017911-131 USB cable

44 eBike PC 2018112-071 Revision C


Index

A L
Accessories 38 Language Selection 29
Adjusting Saddle and Handlebar 16 Language, Select 15
Applying the Blood-Pressure Cuff 17 Load Increments, Selection 29

B M
Biocompatibility 8 Mains Connection 12
Blood pressure cuff, cleaning and disinfection 34 Maintenance 34
Manual Mode 24
C Manual Purpose 6
MDD 4
Cables, Cleaning 34
MENU button 14
Caution 4
Microphone position 17
CE marking 4
Checks before each use 34
Configuration 27 N
Contrast adjustment 29 NIBP button 14
Control terminal PCplus 7 Noise level 36
Cuff application 18
Cuff size 17 P
PC Mode 20
D Power switch 14
Danger 4, 9 Preparing the Patient 16
Date, Adjust 30
Dimensions 35 Q
Disposal of the Product 34
QRS beep, on/off 30
E R
eBike basic 7
eBike comfort 7 Revision History 6
EKG Type 32
Electrocardiographs, connection of 12 S
Electromagnetic Compatibility (EMC) 40 Saddle height 16
Environment 35 Safety Information 9
Equipment symbols 8 Selftest 14
Error messages 33 Setup and Mains Connection 11
Exercise Test 22 Softkeys 15
Exercise Test Protocols, Internal 39 Software version, view 30
Exercise tests, configuration 28
Explosion hazard 9
T
Taking the Blood Pressure 25
F Technical safety inspections 34
Family of characteristics 36 Technical Specifications 35
Time, Adjust 30
G Transport 13
General information 4
W
I Warning 4
Weight 35
Intended Audience 6
Intended Use 7

2018112-071 Revision C eBike PC 45


ergoline GmbH
Lindenstrasse 5
D-72475 Bitz
Germany
Tel: +49 7431 9894-0
Fax: +49 7431 9894-127

GE Medical Systems
Information Technologies, Inc. GE Medical Systems Asia Headquarters
8200 West Tower Avenue Information Technologies, GmbH GE China Co., Ltd.
Milwaukee, WI 53223 USA Munzinger Straße 5 No1 Huatuo Road,
Tel: +1 414 355 5000 79111 Freiburg Zhangjiang Hi-Tech Park Pudong,
1 800 558 7044 (US only) GERMANY Shanghai, P.R.China 201203
1 800 668 0732 (Canada only) Tel: +49 761 4543 - 0 Tel: +86 21 38777888
Fax: +1 414 355 3790 Fax: +49 761 4543 - 233 Fax: +86 21 38777402

www.gehealthcare.com

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