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GE Healthcare

eBike III Basic


eBike III Comfort
Firmware Version GF 1

Manual

2018112-301 ENG Revision B


Note
The information in this manual only applies to the eBike III (basic, comfort), firmware version GF 1. It does not apply to earlier
firmware versions.

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.

© 2017 General Electric Company. All rights reserved.


Contents

General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6


Revision History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Manual Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Intended Audience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Intended Use, Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . 6

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Mechanical assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Controls and Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Connecting the Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Connection to GEHC Electrocardiographs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Connectivity eBike III to GE ECG devices . . . . . . . . . . . . . . . . . . . . . . 14


eBike III to CASE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
eBike III to CARDIOSOFT / CS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
eBike III to MAC 2000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
eBike III to MAC 5500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18


Adjusting Saddle and Handlebar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Adjusting the saddle height of the eBike comfort . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Applying the Blood Pressure Cuff. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Connecting the Blood Pressure Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Taking the Blood Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22


Blood Pressure Module — Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Performing a Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Measurement Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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

Cleaning, Maintenance, Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Electromagnetic Compatibility EN 60601-1-2. . . . . . . . . . . . . . . . . . . . 39

2018112-301 Revision B eBike III Basic, eBike III Comfort 3


4 eBike III Basic, eBike III Comfort 2018112-301 Revision B
General Information • The safety information given in this manual is classi-
fied as follows:
• The product eBike III bears the CE marking CE‑0123
(Notified Body: TÜV), indicating its compliance with the Danger
provisions of the Council Directive 93/42/EEC about indicates an imminent hazard. If not avoided, the hazard will
medical devices and fulfills the essential r­ equirements result in death or serious injury.
of Annex I of this directive.
The CE marking covers only the accessories listed in
the Order Information chapter. Warning
The device is an MDD class IIa product. indicates a hazard. If not avoided, the hazard may result in
minor injury and/or product/property damage.
• The device fulfills the requirements of standard
EN 60601-1 “Medical electrical equipment, Part 1:
General Requirements for Safety" as well as the
in­terference protection requirements of standard Caution
EN 60601-1-2 "Electromagnetic Compatibility – indicates a potential hazard. If not avoided, the hazard may
Medical Electrical Devices". result in minor injury and/or product/property damage.
The radio-interference emitted by this product is with-
in the limits specified in EN 55011, class B.
• To ensure patient safety and interference-free
• The symbol means: protection class II. operation and to guarantee the specified measuring
accuracy, we recommend only original equipment ac-
• This manual is an integral part of the device. It should cessories as available through GE Healthcare distribu-
be available to the device operator at all times. Close tion. The user is responsible if accessories from other
observance of the information given in the manual manufacturers are used.
is a prerequisite for proper device performance and
correct operation and ensures patient and operator • GE Healthcare is responsible for the effects on safety,
safety. Please note that information pertinent to sever- reliability, and performance of the device, only if
al chapters is given only once. Therefore carefully read
the manual once in its entirety. - assembly operations, extensions, readjustments,
modifications, or repairs are carried out by GE Health­
• The symbols mean: care or by persons authorized by GE Healthcare
- the device is used in accordance with the instruc-
Consult accompanying documents. tions given in this manual.
They indicate points that are of particular importance
in the operation of the device.

• Observance of the safety information protects from


injuries and prevents inappropriate use of the device.
All device users and persons responsible for assembly, ergoline GmbH
maintenance, inspection and repair of the device must Lindenstrasse 5
read and understand the content of this manual, be- D-72475 Bitz
fore using or working with it. Paragraphs with special Germany
symbols are of particular importance.
Tel.: +49-(0)-7431 - 9894-0
• If unauthorized individuals open the control terminal, Fax: +49-(0)-7431 - 9894-128
damaging the calibration sticker, any warranty claim e-mail: info@ergoline.com
shall become void. http: www.ergoline.com

• This manual reflects the device specifications and ap- Distributor:


plicable safety standards valid at the time of printing. GE Medical Systems
All rights are reserved for devices, circuits, techniques, Information Technologies, Inc.
software programs, and names appearing in this manual. 8200 West Tower Avenue
Milwaukee, WI 53223, USA
• On request GE Healthcare will provide a Field Service Tel.: +1 414 355 5000
Manual. 1 800 558 5120 (US only)

• 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.

2018112-301 Revision B eBike III Basic, eBike III Comfort 5


About This Manual
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


2018112-301 Revision A 2016-03 Initial Release
2018112-301 Revision B 2017-06 Addendum on page 9

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.

6 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Safety Information

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.

For use, the ergometer must always be connected to electric


installations that fulfill the local requirements.
Warning
• Patient Hazard, Equipment Damage •
• Patient Hazard •
Do not expose the eBike III to direct sunlight to prevent system
components from reaching inadmissible high temperatures. The German Medical Device Operator Ordinance (MPBetreibV, § 5)
demands that users
Do NOT use the eBike III outdoors (medical device). Furthermore • must be trained in the use of the ergometer
the device has no additional protection against the ingress of • must be familiar with the routines for handling and
humidity. Humidity inside the device may cause equipment assembly of the ergometer
malfunctions and increases the risk of an electric shock. • must be familiar with and observe the safety rules and
regulations for operation of this type of equipment
Additionally, the device should not be operated in the vicinity of • must be informed about any other pertinent rules and
power systems, because they may impair equipment functions. regulations (e.g. safety instructions)
• must be informed about the potential hazards arising from
The eBike III may only be used in combination with accessories the use of this type of equipment.
approved by GE Healthcare. • make sure that no unauthorized changes are carried out.

• 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

• Equipment Malfunction • Additional equipment connected to medical electrical equip-


ment must comply with the respective IEC or ISO standards
Only the special shielded cables supplied by GE Healthcare may (e.g., IEC 60950 for data processing equipment).
be used to connect the device to other pieces of equipment. Furthermore all configurations shall comply with the require-
ments for medical electrical systems (see IEC 60601-1-1 or
clause 16 of the 3Ed. of IEC 60601-1, respectively).
• Equipment Malfunction •
Anybody connecting additional equipment to medical electrical
Cellular telephones may not be used in the immediate vicinity equipment configures a medical system and is therefore respon-
of the ergometer, because they might interfere with the proper sible that the system complies with the requirements for medical
functioning of the ergometer. electrical systems. Attention is drawn to the fact that local laws
Electromagnetic interference most probably exists when the take priority over the above mentioned requirements.
watt reading is unstable. If the displayed value changes fre-
quently even though the speed is above 30 RPM, this may be due If in doubt, please consult your local dealer or GE Healthcare.
to electro­magnetic interference.
• IEC 60601-1+Al +A2:1995: 6.8.2.c, 19.2.b, 19.2.c,
• IEC 60601-1:2005: 7.9.2.5, 8.1, 16.2.d,
• MDD 93/42/EEC: Annex I clause 13.6.c

2018112-301 Revision B eBike III Basic, eBike III Comfort 7


SAFETY INFORMATION FOR BIOCOMPATIBILITY
NON-INVASIVE BLOOD PRESSURE The parts of the product described in this manual,
MEASUREMENT including all accessories that come in contact with the
patient during the intended use, fulfill the biocompatibil-
ity requirements of the applicable standards if applied as
intended.
Warning
• Patient Hazard • If you have questions in this matter, please contact GE
Healthcare or its sales representatives.
Do not take blood pressure measurements with a cuff on pa-
tients suffering from sickle cell anemia or if skin lesions are likely
to occur.
APPLICABLE L AWS, REGULATIONS AND
The cuff may cause hematomas in patients with severe blood
coagulation disease. In these instances, the user must take a
DIRECTIVES
decision for or against automatic blood pressure measurements.
• 93/42/EEC (Medical Device Directive of the EU)
• DIN EN ISO 13485:2007 Quality management system
Caution • DIN EN ISO 9001:2008 Quality management system
• Compromised Measuring Accuracy •

Arrhythmias occurring frequently during a measurement may


compromise the accuracy of the measurement.
Valid measurements may not be possible under certain circum-
stances.

Electromagnetic fields are also capable of impairing the measur-


ing accuracy.

Note

• The blood pressure module and the approved accessories


are defibrillation-proof and can remain attached to the
patient during defibrillation.
• If the cuff pressure exceeds the maximum value of
300 mmHg during inflation, the inflation procedure will
be aborted and the cuff deflated. As a redundant safety
precaution, the cuff is immediately deflated when the cuff
pressure exceeds 320 mmHg.
You can check the proper functioning of this safety precau-
tion by abruptly bending your arm while the cuff is being
inflated, causing a brief overpressure in the cuff. The cuff
must deflate immediately.
• Measurements that do not yield a valid measurement will
not be repeated during the exercise test.
• If the inflation phase takes longer than 40 seconds or if an
adequate pressure does not build up in the cuff within a
reasonable period of time, the measurement will be aborted
and the cuff deflated.
• If a valid measurement cannot be completed within
120 seconds, the measurement will be aborted and the cuff
deflated.
• If the cuff pressure remains constant for some time, the
measurement will also be aborted and the cuff deflated.

8 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Symbols
Symbol ’type B applied part’. Manufacturer’s identification.
Type B applied parts have no direct contact with
patients and offer the lowest protection against
electric shock.
Date of manufacture.
The number found under this symbol is the year of
Symbol ’type BF applied part’. manufacture in the YYYY format.
Type BF applied parts are connected to the body
of the patient and provide a higher degree of pro-
tection against electric shock. The applied parts PVC-free.
are isolated.

Latex-free.
Caution: Consult accompanying documents.

RoHS RoHS compliant.


Compliant

Protection class II equipment.

Suitable for indicated arm circumference.


This symbol indicates that the waste of electrical
and electronic equipment must not be disposed of
as unsorted municipal waste and must be collected
separately. Small size.
Consult Operating Manual!

The device was tested and certified according to Standard size.


the Russian GOST safety standards.

Large size.
REF Order number.
Transport and storage label:
top.
SN Serial number.

Transport and storage label:


20
19

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

Transport and storage label:


Toggle switch ON (voltage). fragile.

Toggle switch OFF (voltage). Transport and storage label:


approved temperature range.

CE mark per the Medical Device


Directive 93/42/EEC of the European Union. Transport and storage label:
Notified body: TÜV SÜD Product Service GmbH, approved humidity, non-condensing.
Ridlerstr. 65, 80339 München, Germany.

Eurasian Conformity Mark. Conformity to applica- Transport and storage label:


ble technical regulations of Customs Union. approved pressure range.

Nationally Recognized Testing Laboratory Transport and storage label:


NRTL label for the USA and Canada. do not stack.

2018112-301 Revision B eBike III Basic, eBike III Comfort 9


Mechanical assembly
Controls and Indicators
1 Control terminal M
1 2
3
2 Speed readout for patient

3 Connectors (e.g. for blood pressure cuff)


4
4 Adjustment of handlebar angle

5 Castors
10
6 Baseplate (small)
9

7 Leveling feet to adjust the ergometer to uneven floors

8 Sockets for power cord and connection cables


(underside of ergometer) 8

9 Power switch (toggle switch [ I / 0 ] ) 6


7
10 Saddle adjustment with clamping lever
5

eBike III basic

1 Control terminal M
1 2
3
2 Speed readout for patient

3 Connectors (e.g. for blood pressure cuff)


4
4 Adjustment of handlebar angle

5 Castors

6 Baseplate (large)
9
7 Leveling feet to adjust the ergometer to uneven floors

8 Sockets for power cord and connection cables


(underside of ergometer) 8

9 Power switch (toggle switch [ I / 0 ] ) 6


7

eBike III comfort

10 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Transport
For short distances, the ergometer can be lifted at the Caution
saddle and rolled away on its castors. • Equipment Damage •

To cover greater distances, however, we recommend the Avoid strong vibrations of the ergometer during transport.
following method:

• Disconnect the power cord and the connection cables.

• Rotate the handlebar towards the front and tighten


the clamping lever.

• Stand in front of the ergometer, grasp the handlebar


and tilt the ergometer towards you until it is standing
on the castors only and is balanced.

• It is now possible to transport the ergometer.

• When you have reached the new location, lower the


ergometer very carefully to avoid damage.

Transporting the eBike III

Setup
Place the ergometer on a horizontal level floor.

The ergometer must be set up in a secure and stable


position; the two leveling feet at the back make for easy
adjustment to uneven floors. An optional stabilizer plate is
available to enhance the stability.

Extend the foot concerned until the ergometer no longer    


wobbles.
Levelling feet of the eBike III ergometer
In case of delicate flooring, it is recommended to place
a mat under the ergometer to protect the flooring from
damage by the feet.

2018112-301 Revision B eBike III Basic, eBike III Comfort 11


Connecting the Power Cord
Stand at one side of the ergometer and firmly grasp the
handlebar and the saddle with both hands.

Then tilt the ergometer carefully to one side (it is recom-


mended to do this with the help of a second person) and
place it on the floor so that it rests on the handlebar.

Caution
• Equipment Damage •

Before connecting the ergometer to the power line, check that


the line voltage corresponds to the ratings on the type plate. The
type plate is located on the back of the ergometer, at the bottom.

Assembly position

The connection panel is located on the underside of the b


ergometer.

• Connect the power cord to socket (a).

• Using the supplied strain relief, attach the cable to the a


metal frame (b).

Return the ergometer carefully to its upright position and


make sure that it is not standing on the power cord.

Underside of the Ergometer

Note
• Disconnection from Power Supply •

Pressing the power switch or removing the power cord discon-


nects the device from the power supply. a
Removing the power cord results in a complete disconnection of
the device from the power supply (all poles).

Ensure that the power plug is readily accessible at all times.

Connecting the power cord


a Power input
b Strain relief

12 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Connection to GEHC Electrocardiographs
electrocardiograph connection cable connector on eBike
CardioSoft *) 22336203 port 1
Caution
• Equipment Damage •
2017911-131 USB port
CASE 22336203 port 1
Before connecting the ergometer to the power line, check that
MAC 2000 ST 2006795-001 port 1 the line voltage corresponds to the ratings on the type plate. The
MAC 5500 ST 2008110-001 analog type plate is located on the back of the ergometer, at the bottom.
(connection only via 2008114-001 port 3
COM module**)

*) 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.

**) Only trained service technicians are authorized to install


the COM module (part no. 2018111-340) and perform the
configuration (see Field Service Manual).

Upon delivery, the eBike is configured for communication


with digitally controlled electrocardiographs.
Mounting position
For use with electrocardiographs with an analog control
system (MAC 5000 ST/5500 ST), the following settings are
required:

– at Default Mode: PC Mode


– at ECG Type: Analog / Digital

Only trained service technicians are authorized to make


these settings and perform the configuration.
COM module
• Install a strain relief to secure the cable connection.

The connection cable is plugged into the 9-pole socket of


the connection panel (Port 1) or the USB port and secured
at the metal frame with an additional strain relief.

Connection to electrocardiograph/PC-based ECG system


USB PC connection via USB (virtual COM)
PORT 1 Digital connection (remote control from
PC or ECG recorder),
connection for cable adapter
(analog interface + remote start)

Note
• Connection Cables •

Use only connection cables approved by GE Healthcare.

A special PC driver software is required for operation via the


USB port.

2018112-301 Revision B eBike III Basic, eBike III Comfort 13


Connectivity eBike III to GE ECG devices
eBike III to CASE

eBike III

CASE

Connections

cable: 22336203

eBike: PORT 1 (RS-232)

CASE: COM 1 or COM 2

cable 22336203

Cable PIN settings

eBike (DSUB-9 male) CASE (DSUB-9 female)

Pin 2 Pin 3
Pin 3 Pin 2
Pin 5 Pin 5

14 eBike III Basic, eBike III Comfort 2018112-301 Revision B


eBike III to CARDIOSOFT / CS

eBike III

CARDIOSOFT / CS

Connections

cable: 2017911-131

eBike: USB

CARDIOSOFT / CS: USB

cable 2017911-131

2018112-301 Revision B eBike III Basic, eBike III Comfort 15


eBike III to MAC 2000

eBike III

MAC 2000

Connections

cable: 2006795-001

eBike: PORT 1 (RS-232)

MAC 2000: RS-232

cable 2006795-001
Cable PIN settings

eBike (DSUB-9 male) MAC 2000 (DSUB-9 male)

Pin 2 Pin 3
Pin 3 Pin 2
Pin 5 Pin 5

16 eBike III Basic, eBike III Comfort 2018112-301 Revision B


EBIKE III TO MAC 5500

EBIKE III + COM MODULE

#1 #2

MAC 5500

CONNECTIONS (2 CABLES)

cable #1: 2008110-001 cable #2: 2008114-001

eBike: ANALOG at COM module eBike: PORT 3 (RS-232) at COM module

MAC 5500: ANA / TTL MAC 5500: Jack #2 (P5)

CABLE PIN SETTINGS

cable #1 2008110-001 (analog)


Pin 1 Pin 2
Case Pin 5

EBIKE + COM MODULE MAC 5500

cable #2 2008114-001 (RS-232)


Pin 1 Pin 8
Pin 2 Pin 4
Pin 5 Pin 6

EBIKE + COM MODULE MAC 5500

2018112-301 Revision B eBike III Basic, eBike III Comfort 17


Preparing the Patient
Adjusting Saddle and Handlebar
On the eBike basic, the saddle height is adjusted manually
1 , on the eBike comfort, electrically 2 .

Adjust the saddle height as shown in Figure 1: There should


be a 10° angle between the axis formed by the upper body 2
and the thigh when the pedal is in its lower position.

Patient display indicates the saddle height as a numeric 3


value (eBike comfort only).
1
Set the handlebar to a position where it is comfortable
for the patient to reach sitting upright. To do so, open
clamping lever 3 .
ca. 10°

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)

18 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Applying the Blood Pressure Cuff
Cuff Size

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.

Figure 2 Wrong cuff size


Microphone Position
Before applying the cuff, check the position of the micro-
phone inside the red pocket (on the inside of the cuff):
When 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 3 Correct microphone position

Figure 4 Inserting the microphone

2018112-301 Revision B eBike III Basic, eBike III Comfort 19


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

The center of the microphone must be located exactly over


the brachial artery.

Figure 1 Location of the brachial artery

You can locate the artery by palpation.

Figure 2 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 micro-
phone 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 constrict blood Figure 3 Applied cuff
vessels. Make sure that the cuff does not move during the
exercise test.

A loose cuff would degrade the accuracy of the measure-


ment. 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).

Figure 4 Cuff tab

Connecting the Blood Pressure Cuff


• Slip the cuff tubing onto the fitting (1) and engage.
To disconnect, push back the connector‘s knurled
sleeve.
1 2
• Connect the microphone cable for blood pressure
measurement to the intended port (2) so that it clicks
into place.
Blood pressure cuff connections
1 Fitting for connection of cuff tubing
2 Microphone connection

20 eBike III Basic, eBike III Comfort 2018112-301 Revision B


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 equip-
ment 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 1.
Figure 1 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.

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.

2018112-301 Revision B eBike III Basic, eBike III Comfort 21


Taking the Blood Pressure
Blood Pressure Module — Functional
Description

The blood pressure module takes the patient’s blood pres-


sure 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.

The auscultatory method uses a microphone to acquire


and evaluate the Korotkov sounds.

The device continues to inflate the cuff (up to 300 mmHg


max.) as long as pressure pulsations can be sensed; the Waveform representing the pressure decrease in the cuff
inflation phase varies from patient to patient. during a measurement: systolic pressure at 140 mmHg,
diastolic pressure at 80 mmHg
The first blood pressure measurement of an exercise test is
the baseline measurement taken before the patient starts
pedalling. Both measuring methods (oscillometric and
auscultatory) are employed. A measurement is considered Note
to be valid, when both results agree within a given toleran-
ce. While the baseline measurement is taken, the patient • Apply the blood pressure cuff before initiating a blood
should not pedal or move. Reliable measurements during pressure measurement.
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 19).
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 initi-


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

22 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Performing a Measurement
Always switch on the eBike III before applying the blood
pressure cuff to the patient. At power-up, the eBike III
checks the sensors and zeroes it. If the cuff is already
applied, it may not be entirely depressurized. The eBike III
would display an error message in this case.

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 hand round so
that the palm faces upward.

Baseline BP measurements taken at rest are important for


the proper artifact filter and gain settings.

The baseline measurement is always the first measurement


initiated by the system (e.g., CardioSoft, CASE).

The patient should not move while baseline measurements Caution


are taken. In no event should patients start pedalling. Incorrect Measurements, Baseline BP Measurement – A mea-
surement manually initiated at the control terminal is NOT a
If the results of the baseline measurement appear to be baseline measurement for the subsequent exercise test.
incorrect or implausible, the exercise test must be termina-
ted at the ECG system and restarted. 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.

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.

To verify the measurement accuracy of the eBike III, first


complete three measurements with the eBike III on one
arm and simultaneously with a reference unit on the other
arm. Then exchange the two units, leaving the cuffs in
place, and perform another three measurements.

Compare the mean values from these six measurements.

2018112-301 Revision B eBike III Basic, eBike III Comfort 23


Operation
The following sections describe the control and configura-
tion of the ergometer.

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.

24 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Handlebar Adjustment
Set the handlebar to a position where it is comfortable to
reach while sitting upright.

Fold up the clamping lever to unlock the handlebar.

When the handlebar is in the correct position, fold down


the clamping lever to lock the handlebar and check that
the lever is tightened. 1
With the ergometer standing firmly, check that the handle-
bar is tight. Adjust the clamping force of the clamping
lever if necessary. Handlebar adjustment
1 Clamping lever
Adjust the clamping force by opening the clamping lever
and turning the setting screw clockwise about a quarter Note
revolution with a flat-blade screwdriver. Then check the
clamping force. Repeat these steps if necessary. When the • Lock the clamping levers only as tight as necessary, NOT
clamping force is appropriate, lock the clamping lever by with maximum force.
folding it down.
• Lubricate the thread of the saddle clamping lever periodi-
The handlebar is not designed to support the full body cally with a suitable lubricant (e.g., OKS470).
weight.

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).

When adjusting the height at the display press the appro-


priate arrow key on the right to raise or lower the saddle.
The RPM display shows the actual saddle height.

Note Saddle height display

• During an exercise test, the saddle height can be adjusted


with and .

2018112-301 Revision B eBike III Basic, eBike III Comfort 25


Control Terminal M
Turning the System On
You turn the ergometer on by pressing the power switch.
The ergometer runs a self-test. Subsequently, the start
screen displays.

0 -- 0
Watt min / min

---/--- 0
mmHg ♥ / min

Note Control Terminal Type “M“

• Instruct the patient not to pedal while the ergometer is


being turned on and during the self-test.

• Apply the blood pressure cuff to the patient AFTER the


ergometer has been turned on and the self-test completed.

0 -- 0
Watt min / min

---/--- 0
mmHg ♥ / min

Control terminals M are entirely operated by remote con-


trol (e.g., from an ECG recorder or a PC).

With this key you initiate a blood pressure measure-


ment. Pressing the key a second time during a measure-
ment will stop the measurement.
Control Terminal Type “M“ with NIBP

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:

An external device (e.g., an ECG recorder, a PC-based ECG Start screen


system) controls the ergometer - no intervention at all is
required at the ergometer.

26 eBike III Basic, eBike III Comfort 2018112-301 Revision B


The display changes - the ergometer is waiting for com-
mands from the external ECG unit.
0 -- 0
Watt min / min

---/--- 0
mmHg ♥ / min

Start screen

1   2   
3    
4   5

As soon as the ergometer receives commands from the


controlling ECG unit or PC, the exercise test will start and
the corresponding values will be displayed. 120 15 76
Watt min / min
The exercise test can only be terminated with the corre-
sponding command from the controlling ECG unit.
138/96 122
mmHg ♥ / min

Display during exercise test


1 current load in watts
2 most recent BP value (systolic/diastolic values)
3 duration of exercise test (min)
4 heart rate at the time of the BP measurement (BPM)
5 pedal speed (RPM)

1
Note

• All functions are locked while the ergometer is operating in


159 122
mmHg ♥ / min
PC mode, except for the saddle height adjustment and the
blood pressure key.
Display during BP measurement
• To reactivate the saddle height adjustment function, press 1 cuff pressure during inflation and bar graph indicating
and the arrow keys will again be displayed. microphone signal strength

• Additional blood pressure measurements can be initiated


with .

2018112-301 Revision B eBike III Basic, eBike III Comfort 27


CLEANING, MAINTENANCE, DISPOSAL
GENERAL CLEANING
Warning
Wipe the device surface down with a cloth moistened with • Shock Hazard •
soap water or a disinfectant.
The cloth should not be dripping wet; do not allow liquids • Disconnect the device from the power line before cleaning.
to enter the device.
• Equipment Damage •

• Do not allow liquids to enter the equipment.


CLEANING THE SADDLE Devices into which liquids have entered must be immedi-
ately cleaned and checked by a service technician, before
Clean the saddle with a soft and dry or moist cloth (Disin- they can be reused.
fectants used should not contain any alcohol).
• Do not use acids, alkaline solutions (household cleaners) or
caustic disinfectants.

DISINFECTION
Only the following disinfectants are approved for disinfec- Hint
tion: • Strictly observe the manufacturer’s instructions for use.

Schülke & Mayr GmbH:


• Antifect ® AF, FF, FD 10
• Terralin ® (0,5 %)
• Quartamon Med ®

B. Braun Melsungen AG:


• Hexaquart plus ® (0,5 % / 5,0 %)
• Hexaquart S ® (1,5 % / 5,0 %)
• Meliseptol ®
• Melsept SF ® (0,5 % / 5,0 %)

ECOLAB:
• Incidin Foam ®

28 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Cleaning the Blood Pressure Cuff
Removing the Microphone
Pull the end of the cuff through the metal clasp and fold
out the cuff.
Pull on the short Velcro tab to open the microphone pock-
et and carefully remove the microphone.

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

Clean the microphone with a cloth moistened with alcohol


or soap water. Warning
Allow the microphone to dry before reinserting it in its • Equipment Damage •
pocket.
• Cuff, microphone and tubing may not under any circum-
stances:
Disinfection - be immersed in liquids
- be cleaned in a water bath or in running water.
For disinfection, spray a disinfectant sparingly on the cuff,
the tubing and the microphone.
After the contact time indicated by the manufacturer, wipe
all components dry.

Only the following disinfectants are approved for disinfec- Hint


tion: • Strictly observe the manufacturer’s instructions for use.

Schülke & Mayr GmbH:


• Antifect ® AF, FF, FD 10
• Terralin ® (0,5 %)
• Quartamon Med ®

B. Braun Melsungen AG:


• Hexaquart plus ® (0,5 % / 5,0 %)
• Hexaquart S ® (1,5 % / 5,0 %)
• Meliseptol ®
• Melsept SF ® (0,5 % / 5,0 %)

ECOLAB:
• Incidin Foam ®

Inserting the Microphone


Slip the microphone into the pocket, the metal side facing
the arm.

Guide the microphone cable out of the pocket and to the


right of the Velcro tab. Then close the tab.

Fold the end of the cuff over and introduce it into the
metal clasp.

Inserting the Microphone

2018112-301 Revision B eBike III Basic, eBike III Comfort 29


Maintenance
Checks before each use
Before each use, visually inspect the device for signs of
damage. If you detect damages or impaired functions
which may result in a hazard to the patient or the operator,
the device must be repaired before it can be used again.

Technical Safety Inspections,


Inspections of the Measuring System
The technical safety inspections and the inspections of
the measuring system must be completed every two years
(only in Germany) according to the rules of the art by
trained service technicans and for compliance with Ger-
man legislation. We recommend observing the same inter-
val for technical safety inspections in all other countries.
Please contact your local authorized dealer for details.
Similarly, the automatic sphygmomanometer in the control
terminal must be checked and calibrated by an authorized
specialist every two years to fulfill legal requirements.
The date of the next inspection is indicated on the
inspection sticker attached next to the type plate on the
­ergometer.

Disposal
The product described in this operator manual must not
be disposed of as unsorted municipal waste and must be
collected separately.

Please contact your authorized manufacturer ergoline GmbH


for information concerning the disposal of your equip-
ment. There is no waste approval. Proper disposal is docu-
mented by ergoline GmbH.
Consult operating instructions!

30 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Technical Specifications
Ergometer
Model modular ergometer system eBike III
models eBike III basic, eBike III comfort

Operating mode continuous operation

Power 100 – 240 V / 50 – 60 Hz (max. 60 VA or 90 VA)

specifications of the US power cord:


SPT 2x18AWG 125 V / 10 A
“hospital” or “hospital grade”

Braking principle computer-controlled eddy current brake


with torque measurement;
speed independent to DIN VDE 0750-0238

Load range 6 . . . 999 Watt, speed (RPM)-independent


(see diagrams)

Speed range 30 . . . 130 RPM

Load accuracy to DIN VDE 0750-0238

Load increments user programmable

Permitted patient weight eBike III basic: 160 kg (352 lb)


eBike III comfort: 200 kg (440 lb)

Saddle height adjustment eBike III basic: manual adjustment (standard)


eBike III comfort: electrical adjustment of the saddle
height with digital indication of the
current saddle height

Handlebar adjustment continuous handlebar adjustment over 360°

Crank length 170 mm (cranks with adjustable length available as


optional accessories)

Displays control terminal M with 93 x 70 mm LCD,


128 x 64 pixels and 7-segment RPM display

Interfaces PORT 1 (DSUB-9-pole):


remote control from PC or ECG recorder

USB:
remote control from PC (driver required)

option:
COM module (analog)

Dimensions, weight length: 1030 mm (40.55 in)


width: 490 mm (19.29 in) (width of handlebar approx.
530 mm (20.86 in))
height: 1140 to 1400 mm (44.88 to 55.11 in)
weight: eBike III basic: approx. 61 kg (134 lb)
eBike III comfort: approx. 69 kg (152 lb)

2018112-301 Revision B eBike III Basic, eBike III Comfort 31


Safety standards DIN EN 60601-1, DIN EN 60601-1-2,
DIN VDE 0750-238

Protection class / degree of protection II / B (ergometer)


BF (blood pressure module)

MDD classification class IIa to 93/42 EEC

RF emission class B to DIN EN 55011 / 5.0


DIN EN 60601-1-2

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

Blood Pressure Module


Measuring method auscultatory method (Korotokov), oscillometric; for rest-
ing BP, the results from both measurements are com-
pared for plausibility

Measuring range systolic pressure: 40 to 280 mmHg


diastolic pressure: 40 to 280 mmHg
pulse rate: 35 to 230 bpm

Measurement error, systematic systolic pressure: +/– 3 mmHg


diastolic pressure: +/– 3 mmHg
(temperature: +15 to +25 °C (59 to 77 °F))

Standard deviation (clinical trial) systolic/diastolic pressure: 7 mmHg (max.)

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)

Max. cuff pressure 300 mmHg

Cuff deflation method pulse-dependent deflation rate


approx. 3 mmHg/beat or approx. 3 mmHg/s

Calibration calibration with external pressure meter

Artifact rejection automatic artifact rejection

32 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Family of characteristics of the braking torque control range
rpm

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

black: speed-independent range to DIN VDE 0750-0238


black + grey: speed-independent range of the eBike III ergometer

2018112-301 Revision B eBike III Basic, eBike III Comfort 33


Order Information
Subject to change. Always refer to latest list of accessories.

Note

Not all parts listed below may be available in some countries..

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

(installation by trained service technicians only).

2018111-340 COM module


For use with the MAC 5500 ST electro­
cardiograph

2017911-047 Stabilizer plate for eBike comfort


For a safe stand and better stability

Accessories

2017911-051 Blood pressure cuff with microphone,


standard, width 13 cm, for circumference
from 24 to 32 cm, length of tubing 1.30 m

2017911-052 Blood pressure cuff with microphone,


small, width 10.0 cm, for circumference
from 17 to 26 cm, length of tubing 1.30 m

34 eBike III Basic, eBike III Comfort 2018112-301 Revision B


2017911-053 Blood pressure cuff with microphone,
large, width 15 cm, for circumference
from 31 to 42 cm, length of tubing 1.30 m

2017911-044 Velcro tape to secure cuff tubing

2017911-015 Fixture for child’s saddle

2017911-016 Child’s saddle

2017911-017 Sport saddle

2017911-018 eBike saddle mount horizontally adjustable

2018112-301 Revision B eBike III Basic, eBike III Comfort 35


2017911-019 Child’s pedal, adjustable

22336203 Connection cable for CASE and Cardio­Soft/CS


with RS-232 interface, length 5 m

2006795-001 Connection cable for MAC 2000 ST,


length 5 m

2008110-001 Analog connection cable for MAC 5500 ST,


length 4.6 m

2008114-001 Digital connection cable for MAC 5500 ST,


length 4.6 m

2017911-131 Connection cable for CardioSoft/CS and


CASE Win 7 with USB interface, length
5.0 m

2017911-130 GE MEDICAL SYSTEMS


INFORMATION TECHNOLOGIES
USB driver CD
eBike III Basic
eBike III Comfort
© 2016
ALL RIGHTS RESERVED

ERGOLINE
LINDENSTR. 5
72475 BITZ, GERMANY

ASSEMBLED IN GERMANY

USB DRIVER

REF 2017911-130
ERG705463 REV. D

2016-03-01

36 eBike III Basic, eBike III Comfort 2018112-301 Revision B


2017911-140 Power cord, Europe, length 2.5 m

2017911-141 Power cord, UK, length 2.5 m

2017911-142 Power cord, USA, length 2.5 m

2017911-144 Power cord, South Africa, length 2.5 m

2017911-145 Power cord, Australia, length 2.5 m

Operator manuals in other languages are available through


GE Healthcare

2018112-301 Revision B eBike III Basic, eBike III Comfort 37


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 appli-


cable accessories with which GE Healthcare claims EMC
compliance.

electrocardiograph connection cable connector on eBike


CardioSoft *) 22336203 port 1
2017911-131 USB port
CASE 22336203 port 1
MAC 2000 ST 2006795-001 port 1
MAC 5500 ST 2008110-001 analog
(connection only via 2008114-001 port 3
COM module**)

*) 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.

**) Only trained service technicians are authorized to install


the COM module (part no. 2018111-340) and perform the
configuration (see Field Service Manual).

Note

Any supplied accessories that do not affect EMC compliance are


not included.

38 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Electromagnetic
Compatibility EN 60601-1-2
Changes or modifications to this system not expressly Warning
approved by ergoline may cause EMC issues with this or • RF Interference •
other equipment.
• Use of portable telephones or other radio frequency (RF)
This system is designed to comply with applicable regula- emitting equipment near the system may cause unexpected or
tions regarding EMC. adverse operation.

Its compliance with these requirements has been verified.


It needs to be installed and put into service according to Caution
the EMC information stated as follows. • Equipment Malfunction •

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

Emissions Test Compliance Electromagnetic Environment - Guidance

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

2018112-301 Revision B eBike III Basic, eBike III Comfort 39


Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The eBike III ergometer is intended for use in the electromagnetic environment specified below. It is the responsibility
of the customer or user to ensure that the eBike III ergometer is used in such an environment.

Immunity IEC 60601 Test Level Compliance Electromagnetic Environment -


Test Level Guidance

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.

40 eBike III Basic, eBike III Comfort 2018112-301 Revision B


Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The eBike III ergometer is intended for use in the electromagnetic environment specified below. It is the responsibility
of the customer or user to ensure that the eBike III ergometer is used in such an environment.

Immunity IEC 60601 Test Level Compliance Electromagnetic Environment -


Test Level Guidance

Portable and mobile RF communications equipment


should be used no closer to any part of the eBike III
ergometer, including cables, than the recommend-
ed separation distance calculated from the equa-
tion applicable to the frequency of the transmitter.

Recommended separation distance:


d = 1.2 √P

d = 1.2 √P for 80 MHz to 800 MHz

d = 2.3 √P for 800 MHz to 2.5 GHz

where P is the rated output power of the transmit-


Conducted RF to EN 61000-4-6 3 Vrms 3V ter in watts (W) according to the transmitter man-
150 kHz to 80 MHz ufacturer and d is the recommended separation
distance in meters (m).
Radiated RF to EN 61000-4-3 3 V/m 3 V/m
80 MHz to 2.5 GHz
Field strengths from fixed RF transmitters, as deter-
mined 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 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.

2018112-301 Revision B eBike III Basic, eBike III Comfort 41


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

Rated Maximum separation distance according to frequency of transmitter


­ utput Power of
O [m]
Transmitter [W]
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.

42 eBike III Basic, eBike III Comfort 2018112-301 Revision B


GE Medical Systems ergoline GmbH
Information Technologies, Inc. Lindenstrasse 5
8200 West Tower Avenue D-72475 Bitz
Milwaukee, WI 53223, USA Germany
Tel.: +1 414 355 5000 Tel.: +49 7431 9894-0
1 800 558 5120 (US only) Fax: +49 7431 9894-128

www.gehealthcare.com

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