eBike L Firmware Version 1.5 Operators Manual

Operators Manual

316 Pages

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File Name: GE Healthcare - eBike L Firmware Version 1.5 Operators Manual.pdf

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Page 1

eBike L

2018112-013 - B

Anhang

11 Anhang Interne Ergometrieprogramme Programm

Anfangs-

Stufen-

Last-

NIBP-

Erhol-

last [W]

dauer

stufe [W]

Vorlauf [s]

last [W]

dauer [min]

[min] 1. WHO

Stufe

2. BAL

Stufe

3. Hollmann

Stufe

4. STD.France

Stufe

5. Standard

Stufe

10.

Stufe

11.

Stufe

12.

Stufe

13.

Stufe

14.

Stufe

15.

Stufe

Einstellbereich

Stufe

20 ...100

1 ... 30

1 ... 400

40 ... 90

20 ... 100

1 ... 99

2018112-013 Revision B

eBike L

eBike L Firmware Version 1.5

Operator's Manual 2018112-013 ENG

Revision B

NOTE: The information in this manual only applies to eBike L, firmware version 1.5. It does not apply to earlier firmware versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

CardioSmart, CardioSoft, CardioSys, CASE, and MAC are trademarks owned by GE Medical Systems Information Technologies, a General Electric Company going to market as GE Healthcare. All other marks are owned by their respective owners. © 2005 General Electric Company. All rights reserved. 2

eBike L

2018112-013 Revision B July 2005

Contents

Intended Use, Safety Information

Setup and Mains Connection

Preparation

Running an Exercise Test

Taking the Blood Pressure

Configuration

Error Codes

Cleaning, Maintenance, Disposal

Technical Specifications

Order Information

Appendix

Revision History This manual is subject to the change order service of GE Medical Systems Information Technologies. The revision code, a letter that follows the document part number, changes with every update of the manual. P/N / Revision

Date

Comment

2018112-013 Revision A

December 2004

Initial Release

2018112-013 Revision B

July 2005

ECO 080 463

2018112-013 Revision B

eBike L

General information

General Information The product eBike L bears the CE marking CE-0123

On request GE Medical Systems Information Technologies will provide a detailed Service Manual.

(notified body TÜV) indicating its compliance with the provisions of the Council Directive 93/42/EEC

The ergoline quality management system complies

about medical devices and fulfills the essential

with the standards DIN EN ISO 9001 and EN 46001.

requirements of Annex I of this directive. It is an

The safety information given in this manual is

MDD class IIa product.

classified as follows:

The device fulfills the requirements of standard EN 60601-1 "Medical Electrical Equipment, Part 1:

Danger

General Requirements for Safety" as well as the

indicates an imminent hazard. If not avoided, the

interference protection requirements of standard EN

hazard will result in death or serious injury.

60601-1-2 "Electromagnetic Compatibility – Medical Electrical Devices".

Warning

The device is in radio-interference protection class B

indicates a hazard. If not avoided, the hazard can

in accordance with CISPR11/EN 55011.

result in death or serious injury.

The CE marking covers only the accessories listed in the "Order Information" chapter.

Caution

This manual is an integral part of the equipment. It

indicates a potential hazard. If not avoided, this

should be available to the equipment operator at all

hazard may result in minor personal injury or

times. Close observance of the information given in

product/property damage.

the manual is a prerequisite for proper equipment performance and correct operation and ensures

To ensure patient safety and interference-free

patient and operator safety. Please note that information pertinent to several chapters is given

operation and to guarantee the specified measuring

only once. Therefore, carefully read the manual

accuracy, we recommend using only original GE

once in its entirety.

Medical Systems Information Technologies

The symbol

accessories. The user is responsible for the use of

means: Consult accompanying

accessories from other manufacturers.

documents. It indicates points which are of particular importance in the operation of the equipment.

GE Medical Systems Information Technologies is responsible for the effects on safety, reliability, and

If unauthorized personnel opens the control terminal, damaging the calibration sticker, any warranty claim shall become void.

– assembly operations, extensions, readjustments, modifications, or repairs are carried out by GE

This manual reflects the equipment specifications and

Medical Systems Information Technologies or by persons authorized by GE Medical Systems

applicable safety standards valid at the time of printing. All rights are reserved for devices, circuits, techniques, software programs, and names appearing

Information Technologies – the device is used in accordance with the instructions given in this manual.

in this manual.

performance of the device, only if

eBike L

2018112-013 Revision B

General information

GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Telephone: +1.414.355.5000 888.558.5120 (USA only) Fax: +1.414.355.3790

The authorized representative for GE Medical Systems Information Technologies, Inc., in Europe is: GE Medical Systems Information Technologies GmbH Munzinger Str. 3 D-79111 Freiburg, Germany Tel. +49.761.45.43.0 Fax +49.761.45.43.233 Manufacturer: ergoline GmbH Lindenstraße 5 D-72475 Bitz, Germany The country of manufacture appears on the device label.

2018112-013 Revision B

eBike L

Intended Use, Safety Information

1.1 Intended Use The eBike L is a computer-controlled, medical-grade

The eBike L can be used both as a stand-alone device and

bicycle ergometer for supine exercise tests. At pedal

in conjunction with GE Medical Systems Information

speeds between 30 and 130 RPM and loads between 20

Technologies electrocardiographs. (See “Connection to

and 999 W, the ergometer operates independent of the

Electrocardiographs” on page 12.) When used in

pedal speed. Figure 9-1 shows the speed-independent

conjunction with an electrocardiograph, the

range.

electrocardiograph will control the bicycle ergometer. Furthermore, the electrocardiograph starts the

The eBike L is designed exclusively for use in

sphygmomanometer (option) integrated in the ergometer.

cardiovascular diagnostics at rest and during exercise

Additional blood pressure measurements can be initiated

tests.

manually. When the optional leg rests are attached, it may also be The display on the control terminal indicates the current

used as a medical exam table.

measuring values. The intended use includes adherence to the information The connected electrocardiograph provides a full

given in this manual.

documentation of the test. If the ergometer is used for other purposes, the manufacturer cannot be held liable for personal injuries

Biocompatibility

or property damage resulting from unintended use of the

The parts of the equipment described in this

equipment.

manual, including all accessories, that come in

The eBike L is also available with a separate control

contact with the patient during the intended use,

terminal, set up at a distance from the ergometer. With

fulfill the biocompatibility requirements of the

this version, the control terminal is connected to the

applicable standards if used as intended. If you

ergometer by means of a 2.5 meter coiled cable. A speed

have questions in this matter, please contact GE

readout on a gooseneck replaces the control terminal.

Medical Systems Information Technologies or its Sales Representatives.

eBike L

2018112-013 Revision B

Intended Use, Safety Information

2 3 4

NIBP

eBike

12 6

7 14

8 9

Fig. 1-1 Controls and indicators 1

Clamping lever for adjustment of the head support

Paper roll

Arm rest for blood pressure measurements (right or left, on systems with blood pressure module only)

Remote control for adjustment of bed surface and saddle

Handgrip (prop for mounting the bed and dismounting)

Speed readout for patient

Connector for blood pressure cuff, on both sides of the bed, type B applied part ( ) (on systems with blood pressure module only)

Control terminal

Power switch

13 14

Nameplate Footboard

Connector panel (power input, fuses, etc.)

Leg rest (option)

Castors, locking

2018112-013 Revision B

eBike L

Intended Use, Safety Information

1.2 Safety Information Warning

Danger

Equipment Failure -

Explosion Hazard - The device is not designed for use in areas where an

– Cellular telephones must not be used in the

explosion hazard may occur. An explosion hazard

immediate vicinity, because they may interfere

may result from the use of flammable anesthetics,

with the proper functioning of the ergometer.

skin cleansing agents and disinfectants.

Electromagnetic interference most probably exists when the Watt reading changes frequently even though the speed is above

Warning

30 RPM .

Patient Hazard, Equipment Damage -

Shock Hazard -

– Protect the eBike L from direct sunlight to

– When the ergometer is connected to other

prevent equipment components from reaching inadmissbly high temperatures. Do NOT use the

equipment or if a medical system is created, it

eBike L outdoors (medical device).

must be ensured that the added leakage currents

Furthermore, the equipment has no special

do not present a hazard. If you have questions

provisions against the ingress of humidity.

about this issue, please contact your GE

Humidity inside the equipment may cause

Medical Systems Information Technologies

equipment failure and increase the risk of an

dealer or GE Medical Systems Information

electric shock.

Technologies Service.

Furthermore, the equipment should not be

– For use, the ergometer must only be connected

operated in the vicinity of power plants, because

to electric installations that fulfill the local

they could impair the proper functioning of the

requirements.

equipment.

Patient Hazard -

– The eBike L may only be used in conjunction

The German Medical Device Operator Ordinance

with accessories approved by GE Medical

(MPBetreibV, § 5) demands that users

Systems Information Technologies.

– must have been trained in the use of the

Risk to Persons -

ergometer

Before using the ergometer, the operator must

– must be familiar with the routines for handling

ascertain that it is in correct working order and

and assembly of the ergometer

operating condition. In particular, the cables and

– must be familiar with and observe the safety

connectors must be checked for signs of damage.

rules and regulations for operation of this type

Damaged parts must be replaced immediately,

of equipment

before use.

– must be informed about any other pertinent

Equipment Failure -

rules and regulations (e.g. safety provisions)

– The special shielded cables supplied by GE Medical Systems Information Technologies

– must be informed about the potential hazards

must be used to connect the device to other

arising from the use of this type of equipment.

pieces of equipment.

eBike L

2018112-013 Revision B

Safety Information NIBP

Special NIBP Safety Information Note

Warning

– The blood pressure module and the approved

Patient Hazard -

accessories are defibrillation-proof and can

– Do not take blood pressure measurements with a cuff on patients suffering from sickle cell

remain attached to the patient during

anemia or in whom skin lesions are likely to

defibrillation.

occur.

– If the cuff pressure exceeds the maximum value

– The cuff may cause hematomas in patients with

of 300 mmHg during inflation, the procedure

severe blood coagulation disease. In these

will be aborted and the cuff will deflate. As a

instances, the user must make a decision for or

redundant safety precaution, the cuff deflates

against automatic blood pressure

immediately when the cuff pressure exceeds

measurements.

320 mmHg. You can check the proper functioning of this safety precaution by abruptly bending your arm while the cuff is being inflated, causing a brief overpressure in the cuff. The cuff must

Caution

immediately deflate.

Compromised Measuring Accuracy -

– Measurements that did not yield a valid

– Arrhythmias occurring frequently during a measurement may compromise the accuracy of

measurement will not be repeated during the

the measuring values. In certain cases, a valid

exercise test.

measurement will not be possible.

– If the inflation phase takes longer than 40 seconds or if an adequate pressure does not

– Electromagnetic fields may also impair the

build up in the cuff within a reasonable period

measuring accuracy.

of time, the measurement will be aborted and the cuff will deflate. – If a valid measurement cannot be completed within 120 seconds, the measurement will be aborted and the cuff will deflate. – If the cuff pressure remains constant for some time, the measurement will also be aborted and the cuff will deflate.

Applicable laws, regulations and directives – 93/42/EEC (Medical Device Directive of the EU)

2018112-013 Revision B

eBike L

Setup and Mains Connection

Caution

Setup

Equipment Damage - Avoid strong vibrations of the ergometer during

The eBike L is mounted on a wooden pallet for transport.

transport. If the ergometer needs to be transported

A wrench (size SW 17) or similar tool is required to

over long distances, reinstall the transport locks.

remove the ergometer from the pallet and for all other assembly operations described in this manual.

Caution

Equipment Damage -

Patient Hazard, Equipment Damage -

When you have purchased the ergometer model During the following assembly operations, the

with the separate control panel, make sure that the

ergometer must be disconnected from the power

connection cable does not present a stumbling

line.

hazard. Also secure the control panel against falling down.

Mounting the Castors Use the supplied screws to mount the four castors. Warning Patient Hazard - Lock all castors (9, Figure 1-1) before operating the ergometer. When the castors are not locked, the device may move sideways, squeezing one of the persons present, particularly when the patient mounts the ergometer.

eBike L

2018112-013 Revision B

Setup and Mains Connection

Installing Additional Accessories Slide the support for the arm rest into the guide rail on the right or left and secure it in the desired position 2 (Fig. 2-2); (on systems with blood pressure module only). Install the leg rest 8 (option). Install the paper roll holder and insert a paper roll 10. Connect the blood pressure cuff: The blood pressure cuff can be connected on the right or on the left side of the bed 12. a

– Connect the microphone to a (Fig. 2-1). – Connect the cuff tubing to the connection sleeve

Fig. 2-1 Blood pressure cuff connections a Microphone jack b

b. It must properly lock into place. To disconnect the tubing, push the knurled sleeve backward.

Socket for cuff tubing

10 2

NIBP

eBi ke

Fig. 2-2 Installing accessories

2018112-013 Revision B

eBike L

Setup and Mains Connection

Connection Mains Connection

Caution Equipment Damage - Before connecting the

You will find the connector panel on the back of the drive

ergometer to the power line, check that the voltage

unit (7, Fig. 1-1).

rating of your local power line matches the value indicated on the device nameplate. You will find the

Connect the power cord to socket a (Fig. 2-3).

nameplate on the rear beam of the framework (13,

Secure the connector with the supplied lock a.

Figure 1-1).

Install the strain relief as shown in Fig. 2-3. Please note that different strain reliefs are supplied for various cable sizes. Connection to Electrocardiographs The software supports communication with the following electrocardiographs: electrocardiographs (digital control):

b 4

4 3

PORT 2

PORT 3

2 5

3 6

ANALOG

e PORT 1

electrocardiograph

connection cable

connector on eBike

CardioSys

22336203

port 1, e

CardioSoft

22336203

port 1, e

CASE

22336203

port 1, e

CASE 8000

22336203

port 1, e

MicroLab

22336203

port 1, e

CardioSmart ST*) 22338002

port 3, b

MAC 1200 ST

port 3, b

22338002

SERVICE

*) eBike L with integrated BP module only Fig. 2-3 Connector panel

electrocardiographs (analog control):

Power input, instrument fuses

electrocardiograph

connection cable

connector on eBike

Digital interface RS232

MAC 5000 ST

Analog I/O

2008110-001 2008114-001

ANALOG, c port 3, b

for Service

Digital interface RS232

Digital interface RS232 (for Service only)

Upon delivery, the eBike L is configured for communication with digitally controlled electrocardiographs. For use with electrocardiographs with an analog control system (MAC 5000 ST), the following settings are required (see chapter 6 "Configuration"): – at Default Mode: PC Mode – at EKG Type: Analog / Digital Install a strain relief to secure the cable connection.

eBike L

2018112-013 Revision B

Preparation

3.1 Turning the Device On and Testing Its Performance Push the power switch (6, Figure 1-1) to turn on the 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. The ergometer runs an automatic selftest (Fig. 3-1). Then the main menu appears (Fig. 3-2). When you see the main Selftest running

menu, the ergometer is ready for operation.

Fig. 3-1 Initial screen during selftest Note The device may be configured to default to one of the operating modes. In this case you will see the initial screen of the selected operating mode instead

Ergometry

of the main menu. You can display the main menu

PC Mode

with the

button (see chapter 6

"Configuration").

Manual

If an error code (e.g. E:01) appears after the selftest, please refer to chapter 7 for troubleshooting information.

Settings

Make sure that the eBike L is turned on before the blood pressure cuff is applied to the patient.

Choose function

Fig. 3-2 Main menu

In addition to the six softkeys c (Fig. 3-3) the control terminal also accommodates buttons With button

NIBP

a and

a blood pressure measurement can be

initiated before or during the exercise test. The same

NIBP

Ergometry

button can be used to stop a blood pressure measurement.

PC Mode

Manual

With the button

, you can either bring up the main

menu or go back one menu level.

Settings Choose function

eBike

Fig. 3-3 Control terminal buttons a Starts and stops a blood pressure measurement b Brings up the main menu or returns to the previous menu level c Softkeys activating the function described next to them

2018112-013 Revision B

eBike L

Preparation

The functions of the six softkeys change with the displayed menu. The function keys can be used to activate the function displayed next to them. In the main menu, for example, the top softkey on the left initiates the a

Ergometry mode, the softkey in the middle on the right

NIBP

Ergometrie

activates the Manual mode.

PC-Betrieb

Ergometry:

Manuell

The ergometer will be controlled by the stored test protocols (see section 4.3).

Einstellung Auswahl vornehmen

PC Mode:

The ergometer will be controlled from the electrocardiograph (see section 4.2).

eBike

Manual:

The ergometer will be controlled manually (see section 4.4).

Settings:

Ergometer configuration (see chapter 6).

Fig. 3-4 Main menu

3.2 Changing the Language a

Upon delivery of the ergometer, the screen texts are displayed in German. Follow these steps to change the

NIBP

Einstellungen Standard Betrieb Programme Kontrast Laständerung Sprache Ton Software-Version Datum / Uhrzeit EKG-Typ

language:

Select Einstellung (Fig. 3-4).

The settings menu appears (Fig. 3-5).

Auswahl

Auswahl vornehmen

Using the cursor keys b, position the bar cursor a on Sprache c and press button d.

eBike

The language menu appears (Fig. 3-6). Using the cursor keys a, position the bar cursor on your language and press button b. Fig. 3-5 Settings menu

NIBP

Sprache Deutsch English Français Español Italiano

a b Auswahl

Auswahl vornehmen

eBike

Fig. 3-6 Language menu

eBike L

2018112-013 Revision B

Preparation

3.3 Preparing for the Examination Caution

Patient Hazard, Equipment Damage - Only the handgrip 3 (Fig. 1-1) may be used as an aid in mounting and dismounting. The arm rest 2 and handgrip 11 are not capable of supporting the full

body weight and should not be used as a mounting/ dismounting aid.

c Warning Patient Hazard - Lock all castors (9, Figure 1-1) before operating the ergometer. When the castors are not locked, the device may move sideways, squeezing one of the persons present, particularly when the patient mounts the ergometer.

Adjusting the Bed A remote control (Fig. 3-7) is available to adjust the saddle and the position of the bed. Buttons b: adjust the longitudinal tilt (0 to 45°) Fig. 3-7 Remote control a Green indicator is illuminated while a button is pressed b Press to adjust the longitudinal tilt (0 to 45°) c Press to adjust the saddle

Buttons c: adjust the saddle The green indicator is illuminated while one of the buttons is activated. The adjustment will stop automatically when the respective end positions have been reached. The adjustment will also stop when both buttons for one of the motors are pressed at the same time.

2018112-013 Revision B

eBike L

Preparation

Preparing Bed and Patient Before the patient mounts the ergometer, set up the bed as follows: Move the saddle to the bottom position. Adjust the bed to an angle of 45° for easy mounting of the ergometer. If installed, remove the leg rest on the side where the patient will mount the ergometer (Fig. 3-8). Ask the patient to mount the bed. Adjust the pedal shoes - if present - to the patient's shoe size and secure the feet in the pedal shoes by tightening the Velcro straps. Reinstall the leg rest.

Fig. 3-8 Leg rest

There should be a 10° angle between the axis formed by the upper body and the thigh when the pedal is in its Note – After adjustment of the clamping levers, tighten them securely. Do not overtighten. – Lubricate the threading of the clamping levers

lower position. Adjust the saddle until this angle is achieved. Adjust the head support to a position where it rests against the shoulder when supporting the patient's

once every 3 months, using a suitable grease

head.

such as OKS 470.

eBike L

2018112-013 Revision B

Preparation

Applying the Blood Pressure Cuff Note Observe the following order when applying the

14 cm

blood pressure cuff: 2017911-010 1,3 m 2017911-011 2,0 m -33 cm 23

1. Switch on the eBike and wait for the main menu to appear.

LATEX

2. Apply the blood pressure cuff.

Caution Erroneous Measurements - Fig. 3-9 Correct cuff size

– Select a cuff size suitable for the circumference of the patient’s arm. The maximum permitted circumference is indicated on each cuff. When

closing the Velcro fastener, ensure that the index line at the metal clasp (a, Fig. 3-10) is within the INDEX range (b) identified by the

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

INDEX

arrow and not outside.

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

LATEX

– Apply the cuff directly on the skin. Rolled up

LATEX

sleeves must not impede blood circulation in the upper arm. Use only the cuffs listed in chapter 10. – Loose cuffs will cause erroneous

Fig. 3-10 Wrong cuff size

measurements; overtight cuffs may constrict blood vessels or cause skin lesions or hematomas. Ensure that the microphone is correctly positioned in the red cuff pocket: the metal side must face the artery. Apply the deflated cuff on the patient’s arm. Take care that – the bottom end of the cuff does not reach the bend of the elbow – the microphone (identified by the red tab and white arrow) is exactly above the brachial artery (Fig. 3-12). To ensure accurate blood pressure measurements during an exercise test, the microphone (red tab) must be in the correct position. – the tab is placed below the metal clasp as shown

Fig. 3-11 Applying the cuff

in Fig. 3-11. Tighten the cuff and close the Velcro fastener. Ensure that the cuff does not slip down or impede circulation of the blood.

2018112-013 Revision B

eBike L

Preparation

Adjust the arm rest to a position where it supports the patient’s arm comfortably. The patient’s arm should remain on the arm rest during the examination. Check that the cuff tubing does not knock against any objects when the patient starts pedalling. Instruct your patient to avoid excessive contractions of the muscles in their upper arm during a blood pressure measurement and to leave the arm relaxed on the arm rest. For additional important information on blood pressure measurements, please refer to chapter 5.

Fig. 3-12

Warning

Microphone (identified by red tab) over brachial artery

Patient Hazard - If, by mistake, excessive pressure builds up in the cuff, either remove the cuff immediately from the patient’s arm or disconnect the cuff tubing at connector b (Fig. 2-1). The same applies when the cuff does not deflate correctly.

eBike L

2018112-013 Revision B

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Ergometers

eBike L Firmware Version 1.5 Operators Manual