eBike EL Firmware Version 1.5 Operators Manual

Operators Manual

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Page 1

eBike EL

2018112-014 - 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

2018112-014 Revision B

eBike EL

eBike EL Firmware Version 1.5

Operator's Manual 2018112-014 ENG

Revision B

NOTE: The information in this manual only applies to eBike EL, 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.

eBike EL

2018112-014 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

2018112-014 Revision A

December 2004

Initial Release

2018112-014 Revision B

July 2005

ECO 080 463

2018112-014 Revision B

eBike EL

General Information

General Information On request GE Medical Systems Information

The product eBike EL bears the CE marking CE-

Technologies will provide a detailed Service Manual.

0123 (notified body TÜV) indicating its compliance with the provisions of the Council Directive 93/42/

The ergoline quality management system complies

EEC about medical devices and fulfills the essential requirements of Annex I of this directive. It is an

with the standards DIN EN ISO 9001 and EN 46001. 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 Medical Systems Information Technologies

once in its entirety. 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 EL

2018112-014 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.

2018112-014 Revision B

eBike EL

Intended Use, Safety Information

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

The eBike EL can be used both as a standalone device

bicycle ergometer for supine exercise tests, specially

and in conjunction with GE Medical Systems

designed for stress echocardiography. At pedal speeds

Information Technologies electrocardiographs (See

between 30 and 130 RPM and loads between 20 and

“Connection to Electrocardiographs” on page 13.) When

999 W, the ergometer operates independent of the pedal

used in conjunction with an electrocardiograph, the

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

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

The eBike EL must only be used in cardiovascular

sphygmomanometer (option) integrated in the ergometer.

diagnostics at rest and during exercise tests.

Additional blood pressure measurements can be initiated When the optional leg rests are attached, it may also be

manually.

used as a medical exam or treatment table. The display on the control terminal indicates the current The intended use includes adherence to the information

measuring values.

given in this manual. The connected electrocardiograph provides a full If the ergometer is used for other purposes, the

documentation of the test.

manufacturer cannot be held liable for personal injuries or property damage resulting from unintended use of the

Biocompatibility

equipment.

The parts of the equipment described in this

The eBike EL is also available with a separate control

manual, including all accessories, that come in

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

contact with the patient during the intended use,

this version, the control terminal is connected to the

fulfill the biocompatibility requirements of the

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

applicable standards if used as intended. If you

readout on a gooseneck replaces the control terminal.

have questions in this matter, please contact GE Medical Systems Information Technologies or its Sales Representatives.

eBike EL

2018112-014 Revision B

Intended Use, Safety Information

2 3

4 NIBP

eBike

14 15 16

17 18

7 19

8 9

Fig. 1-1 Controls and indicators Clamping lever for adjustment of the head support, release button for drop section 14

Paper roll

Upper handgrip, adjustable

Arm rest for blood pressure measurements (on stress-echo beds 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

13 14 15

Control terminal

Power switch

Armpit support, adjustable Drop section Connector for blood pressure cuff, on both sides of the bed, type B applied part ( ) (on stress-echo beds with blood pressure module only)

Connector panel (power input, fuses, etc.)

Leg rest (option)

Castors, locking

16 17 18 19

Hip support, adjustable Nameplate Outrigger Footboard

2018112-014 Revision B

eBike EL

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 is unstable. Values changing frequently even though the speed is

Warning

above 30 RPM may be due to electromagnetic

Patient Hazard, Equipment Damage -

interference.

– Protect the eBike EL from direct sunlight to prevent equipment components from reaching

Shock Hazard -

inadmissibly, high temperatures. Do NOT use

– When the ergometer is connected to other

the eBike EL outdoors (medical device).

equipment or if a medical system is created, it

Furthermore, the equipment has no special

must be ensured that the added leakage currents

provisions against the ingress of humidity.

do not present a hazard. If you have questions

Humidity inside the equipment may cause

about this issue, please contact your GE

equipment failure and increase the risk of an

Medical Systems Information Technologies

electric shock.

dealer or GE Medical Systems Information

Furthermore, the equipment should not be

Technologies Service.

operated in the vicinity of power plants, because

– For use, the ergometer must only be connected

they could impair the proper functioning of the

to electric installations that fulfill the local

equipment.

requirements.

– The eBike EL must only be used in conjunction

Patient Hazard -

with accessories approved by GE Medical

The German Medical Device Operator Ordinance

Systems Information Technologies.

(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 handling

operating condition. In particular, the cables and

and assembly of the ergometer

connectors must be checked for signs of damage.

– must be familiar with and observe the safety

Damaged parts must be replaced immediately,

rules and regulations for operation of this type

before use.

of equipment

Equipment Failure -

– must be informed about any other pertinent

– The special shielded cables supplied by GE

rules and regulations (e.g. safety provisions)

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 EL

2018112-014 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)

2018112-014 Revision B

eBike EL

Setup and Mains Connection

Setup The eBike EL is mounted on a wooden pallet for transport. A wrench (size SW 17) or similar tool is required to remove the ergometer from the pallet and for all other assembly operations described in this manual. Caution Patient Hazard, Equipment Damage - – During the following assembly operations, the ergometer must be disconnected from the power line. – When you have purchased the ergometer model with the separate control panel, make sure that the connection cable does not present a stumbling hazard. Also secure the control panel against falling down.

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. Mounting Castors and the Outrigger Warning Patient Hazard, Equipment Damage - Mount the outrigger before using the ergometer. Otherwise the device might fall over during the stress test. Use the supplied screws to mount the four castors. Using the supplied screws, attach the outrigger to the frame (Fig. 2-1). Set up the ergometer and adjust the leg of the outrigger so that it is flat on the floor.

Fig. 2-1 Mounting the outrigger

eBike EL

2018112-014 Revision B

Setup and Mains Connection

Installing and Removing the Transport Lock P TO

Remove the red transport lock situated between frame and drive unit. Before transporting the device again, reinstall the transport lock as described below: Connect the ergometer to the power supply. Adjust the bed in the horizontal position. Screw the bottom end of the transport lock to the frame (the upper end is labelled TOP, Fig. 2-2). Tilt the bed until the upper end of the transport lock

Fig. 2-2 Installing the transport locks Caution

can be easily screwed to the drive unit. Disconnect the device from the power supply.

Equipment Damage - Avoid strong vibrations of the ergometer during transport. If the ergometer needs to be transported over long distances, reinstall the transport locks.

Note Keep the transport locks and fixing screws, because the transport locks must be reinstalled before transporting the ergometer.

2018112-014 Revision B

eBike EL

Setup and Mains Connection

Installing Additional Accessories Slide the support for the arm rest into the guide rail on the right and secure it in the desired position 2 (Fig. 24); (on stress-echo beds with blood pressure module only). Install the leg rest 8 (option). Install the paper roll holder and insert a paper roll 10. Attach the handgrip 11: To do so, clamp the handgrip in the support and secure it in the appropriate position. Connect the blood pressure cuff: a

The blood pressure cuff can be connected on the right or on the left side of the bed 15. For stress Fig. 2-3 Blood pressure cuff connections a Microphone jack b

echocardiography, connect the blood pressure cuff on the right side.

Socket for cuff tubing

– Connect the microphone to a (Fig. 2-3). – Connect the cuff tubing to the connection sleeve b. It must properly lock into place. To disconnect the tubing, push the knurled sleeve backward. Use the supplied screws to attach the footboard to the transverse brace on the right 19.

10 11

NIBP

eBi ke

Fig. 2-4 Installing accessories

eBike EL

2018112-014 Revision B

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. 2-5).

nameplate on the rear beam of the framework (17,

Secure the connector with the supplied lock a.

Fig. 1-1).

Install the strain relief as shown in Fig. 2-5. 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 EL with integrated BP module only electrocardiographs (analog control): Fig. 2-5 Connector panel a

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

Upon delivery, the eBike EL is configured for

Digital interface RS232

communication with digitally controlled

Digital interface RS232 (for Service only)

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.

2018112-014 Revision B

eBike EL

Preparation

3.1 Turning the Device On and Testing Its Performance Push the power switch (6, Fig. 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 EL 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

Ergometry

Manual

a blood pressure measurement can be

button can be used to stop a blood pressure measurement.

PC Mode

a and

initiated before or during the exercise test. The same

NIBP

With the button

Settings

, you can either bring up the main

menu or go back one menu level.

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

eBike EL

2018112-014 Revision B

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).

3.2 Changing the Language

Fig. 3-4 Main menu

Upon delivery of the ergometer, the screen texts are a

displayed in German. Follow these steps to change the language:

NIBP

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

Select Einstellung (Fig. 3-4).

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

Using the cursor keys b, position the bar cursor a on

Auswahl

Sprache c and press button d.

Auswahl vornehmen

The language menu appears (Fig. 3-6).

eBike

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

2018112-014 Revision B

eBike EL

Preparation

3.3 Preparing for the Examination 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. Patient Hazard, Equipment Damage - Mount the

outrigger before using the ergometer. Otherwise the device might fall over during the stress test.

d P1

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.

Adjusting the Bed A remote control (Fig. 3-7) is available to adjust the saddle and the position of the bed. 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 lateral tilt (0 to 45°); the longitudinal tilt angle automatically limits the maximum lateral tilt d Press to adjust the saddle e Press to save and recall 3 stored patient positions f Press to save a patient position (together with P1, P2 or P3)

Buttons b: adjust the longitudinal tilt (0 to 45°) Buttons c: adjust the lateral tilt (0 to 45°) Buttons d: adjust the saddle Buttons e: save and recall three patient positions 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 two buttons are pressed at the same time. Note The lateral tilt can only be adjusted when the bed is in the horizontal position. The device will beep when you have reached the horizontal position that allows the bed to be tilted laterally.

eBike EL

2018112-014 Revision B

Preparation

Saving Patient Positions with P1, P2 or P3 Set the bed to the desired position with buttons b and c. Holding button "M" depressed, push one of the buttons P1, P2 or P3. Recalling Patient Positions with P1, P2 or P3 Hold one of the buttons P1, P2 or P3 depressed. The bed automatically moves to the stored position. Since both motors are synchronized, the stored position is reached faster than by manual adjustment. Note To streamline the echocardiographic workflow, we recommend saving the following three patient positions: P1: semirecumbent (for mounting and dismounting) P2: horizontal angle that allows adjustment of the lateral tilt (beep) P3: typical left lateral decubitus position

2018112-014 Revision B

eBike EL

Preparation

Preparing Bed and Patient Before the patient mounts the ergometer, set up the bed as follows: Move the bed back to the horizontal position, if the lateral tilt is adjusted. Move the saddle to the bottom position. Check that the drop section of the bed (Fig. 3-8) has properly locked into place. Adjust the longitudinal tilt to 45° for easy mounting of the ergometer. Adjust the hip and armpit supports as well as the armrest such that they do not hinder the patient Fig. 3-8 Drop section

mounting the bed. If installed, remove the leg rest on the side where the patient will mount the ergometer (Fig. 3-9). Ask the patient to mount the bed. Adjust the pedal shoes to the patient's shoe size and secure the feet in the pedal shoes by tightening the Velcro straps. Reinstall the 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 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

Fig. 3-9 Leg rest

head. Fold down the drop section (Fig. 3-8). To do so, pull Note – After adjustment of the clamping levers, tighten them securely. Do not overtighten. – Lubricate the threading of the clamping levers once every 3 months, using a suitable grease

on the release button 1 (Fig. 1-1). Set the hip support to a position where it will not interfere with the patient pedaling. Adjust the armpit support to the appropriate position.

such as OKS 470.

eBike EL

2018112-014 Revision B

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eBike EL Firmware Version 1.5 Operators Manual