ergoline Ergometrics er900L User manual

Operation Manual
ergometrics er900L
Art-Nr: 475.043 !Version: 12/01B

Version: 12/01 Operation Manual er900L
Art-Nr: 475.043
Operation Manual for Ergometer er900L
Printed in Germany.
We reserve the right of modifications due to technical development at any time and without prior notice.
Reprinting, translation and copying in any form - also in parts - is only permitted after prior written consent
by the manufacturer.
This Operation Manual is not registered for automatic update in case of eventual alterations.
Information regarding the latest version is available from the manufacturer.
This Operation Manual Ergometer ergometrics 900L
Version: 12/01 B
is valid for following Software-Versions:
V.236, V.240 and V.243
ergoline GmbH
Lindenstraße 5
D-72475 Bitz
Tel.: [phone] - 0
Fax: [phone] - 127
e-mail: [email protected]
internet: http://www.ergoline.com

Version: 12/01 Operation Manual er900L
Art-Nr: 475.043

Operation Manual
Version: 12/01 1er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
Contents
Table of Contents
EC Declaration of Conformity
Table of Contents.............................................................................................. 1
Foreword ........................................................................................................... 4
1. Introduction ....................................................................................................... 5
1.1 Comments by the Manufacturer for the Operating Company ................................. 5
1.2 Product Relevant Regulations .............................................................................. 6
1.3 Warranty Regulation ............................................................................................ 6
2 Safety Notices ................................................................................................... 7
2.1 Safety .................................................................................................................. 7
2.2 Application as directed ........................................................................................ 7
2.3 Fundamental Safety Comments ........................................................................... 7
2.4 Normative Notices ............................................................................................... 8
2.4.1 Notice for EMC (electromagnetic compatibility) ................................................... 8
2.5 Requirements for Operating Personnel ................................................................ 8
2.6 Safety and Device Protecting Features................................................................ 9
2.7 Measurement Accuracy Verification ..................................................................... 9
2.7.1 Routine Control of the Blood Pressure Measurement Unit .................................... 9
2.7.2 Periodic Accuracy Verification for Blood Pressure Unit ........................................ 9
2.7.3 Load Unit Inspection ............................................................................................ 9
2.8 Identification plate, Labelling .............................................................................. 10
3. Installation ....................................................................................................... 11
3.1 Installation steps ................................................................................................ 11
3.2 Scope of Delivery .............................................................................................. 11
3.3 Accessories ...................................................................................................... 12
3.4 Transport ........................................................................................................... 12
4 Putting into Operation .................................................................................... 13
4.1 Operating elements and Connections ................................................................ 13
4.2 Measurement head............................................................................................ 14
4.2.1 Keyboard .......................................................................................................... 14
4.3 Connectors and Interfaces ................................................................................. 15
4.3.1 Power Connection ............................................................................................. 15
4.3.2 Connector for Blood Pressure Cuff .................................................................... 15
4.3.3 Signal Connections ........................................................................................... 16
4.4 Power on Sequence .......................................................................................... 17

Operation Manual
er900L Operation Manual 2Version: 12/01
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Ergometer
Type er900L
5 Operation ......................................................................................................... 18
5.1 The Computer - Your Helper............................................................................... 18
5.2 The Display Unit ................................................................................................ 19
5.2.2 Displayed Parameters and their Meanings ........................................................ 19
5.3 The Printer ........................................................................................................ 20
5.3.1 Configuration of Printer ...................................................................................... 20
5.3.2 Printed Parameters ........................................................................................... 20
6 Ergometry Process......................................................................................... 21
6.1 General Preparations ........................................................................................ 21
6.1.1 Preparing the Patient......................................................................................... 21
6.1.2 Preparation for ECG Acquisition ....................................................................... 22
6.2 Preparation of the Ergometer (ECG Type P1 or P2) ......................................... 23
6.2.1 Basic Preparations for all Programs .................................................................. 23
6.2.2 Entries Peculiar to the use of Program 0 ............................................................ 24
6.2.3 Entries Peculiar to the use of Program 9 ............................................................ 24
6.3 Preparations for control by ECG or PC .............................................................. 25
6.4 Starting the Ergometry ....................................................................................... 25
6.4.1 Starting Ergometry with Internal Control.............................................................. 25
6.4.2 Starting an ECG or PC Controlled Ergometry .................................................... 25
6.5 Flowchart for complete Ergometry Process ....................................................... 26
6.6 Ergometric Protocol .......................................................................................... 29
6.7 Manual Control of Ergometry session ................................................................ 30
7 Configuration .................................................................................................. 31
7.1 General ............................................................................................................. 31
7.2 Call-up of the Monitor Program .......................................................................... 31
7.3 Base Settings.................................................................................................... 34
7.3.1 Date and Time ................................................................................................... 34
7.3.2 Select Unit for Pressure Display ........................................................................ 35
7.3.3 ECG Start Pulse Duration (only for remote start of ECG).................................... 36
7.3.4 Select LANGUAGE ........................................................................................... 37
7.3.5 RPM Control ...................................................................................................... 38
7.3.6 Other Parameters .............................................................................................. 39
7.4 Defining an Ergometry Program ........................................................................ 40
7.4.1 Setup of Automatic Program 0 .......................................................................... 41
7.4.2 Definition of Programs 1-8................................................................................. 42
7.4.3 Definition of Program 9 for Pulse-Steady-State Training .................................... 44
Contents

Operation Manual
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Art-Nr: 475.043
Ergometer
Type er900L
8 Structure of Programs .................................................................................... 46
8.1 General Structure of Programs 1-8 .................................................................... 46
8.1.1 Factory Settings ................................................................................................ 46
8.1.2 Creating Your Own Load Program ..................................................................... 47
8.2 Systematic Setup of Programs .......................................................................... 48
8.2.1 Setup of Automatic Load Program 0.................................................................. 48
8.2.2 Setup of the Fully Programmable Load Programs 1-8........................................ 52
8.2.3 Setup of Program 9, Steady-Pulse (Heart & Circulation Training) ....................... 54
9. Cleaning .......................................................................................................... 56
9.1 Cleaning the Unit ............................................................................................... 56
9.2 Cleaning the Blood Pressure Cuff ...................................................................... 56
Appendix A: Interfaces ................................................................................... 57
A.1 Input and Output Pin Specifications.................................................................... 57
Appendix B: Monitor Program ....................................................................... 70
B.1 Additional Settings in the Monitor Program ........................................................ 70
B.1.1 Setting the ECG Type ........................................................................................ 70
B.1.2 Setting the Baud Rate ....................................................................................... 71
B.1.2 Switching Between Internal and External Load Control ....................................... 72
B.1.4 Hardware Diagnostics ....................................................................................... 73
Appendix C: Program Listing ........................................................................ 74
Appendix D: Indicators .................................................................................. 74
D.1 PWC Values ...................................................................................................... 75
D.1.1 What is a PWC Value? ...................................................................................... 75
D.2 Training Indicator ............................................................................................... 76
Appendix E: HR Recording ........................................................................... 74
E.1. Heart Rate Feedback from ECG ....................................................................... 77
E.2. Pulse Monitor .................................................................................................... 77
Appendix E: Specification ............................................................................. 79
F.1: Technical Data ................................................................................................... 79
F.2: The Speed-correlated Capacity of Brake Power Control.................................... 80
Contents

Operation Manual
er900L Operation Manual 4Version: 12/01
Art-Nr: 475.043
Ergometer
Type er900L Foreword
Foreword:
We are pleased that you chose to purchase our computerized ergometer ergometrics er900L.
This is the appropriate decision for quality and performance in heart/circulation testing.
The computerized ergometer er900L has been specially designed with the medical and
ergonomic requirements in mind for quick and definitive stress analysis of the heart/circula-
tion system. Computer control makes a fully automatic process of the entire spectrum of
ergometrics. Numerous programming options ensure that for every patient type there is an
applicable specific stress or training program ready at the touch of a button. Manually con-
trolled stress analysis can also be carried out by the operator, independent of programs,
through manual entry of the load data. Programs in progress may also be interrupted to
control subsequent load steps by hand.
The built-in automatic blood pressure meter was especially designed for ergometrics. It
assures that systole, diastole and heart rate limits are continuously, automatically, monitored
even under stress condition. The computer controlled execution of all measurements and
analysis of results markedly simplifies the work of operating personnel. Accordingly, the
patient can be more closely observed and instructed. This allows the ergometric process to
be performed with the highest level of safety.
The display integrated into the console provides the operator continuously with current meas-
urement data. The integrated printer provides continuous documentation of all measurements
resulting from the ergometric process.
This handbook is intended for operators of the unit. It explains all the functions of the ergom-
eter in detail and in such a manner that operation of the unit can be learned through its use. It
can also be used as a reference.
We hope that you are successful in your work with the ergometrics er900L ergometer. We
always welcome your constructive remarks and improvement suggestions with regard to the
unit as well as to this handbook.
Your ergoline team
Attention !
This Operation Manual is a part of the unit in accordance with EN 60601-1:1990. It
should always be kept close to the unit. The necessary safety considerations, con-
forming to EC Guideline 93/42 EC are in chapter 2 of this manual.
Complying to the Safety Considerations is protecting against danger and risk for
life and limb, and prevents from improper application of the Ergometer.
Please comply with all sign of danger at the Ergometer. Replace lacking or damaged
sign immediately.
Familiarize yourself with the appropriate handling of the ergometer and all its con-
trol facilities prior to operating the equipment.
While being at work, it is too late !
Never allow that a person without the necessary expert knowledge is operating the
equipment.

Operation Manual
Version: 12/01 5er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
1. Introduction
Within this Operation Manual, important comments to ensure the safety and to avoid
potential damage are labelled with following symbols:
Warning !
Describes a potential dangerous situation.
Failure to comply may lead to death or serious injuries, or may cause dam-
age to the equipment or to the environment.
!Important !
Application hints to achieve an optimal application of the device and further
helpful information.
This Operation Manual is an integral part of the device, and has to be available at the
equipment at any time.
This Operation Manual is designed by the manufacturer according to his best knowl-
edge and experience in the construction, production and operation of the device.
The Operation Manual may be extended via special statements by the operating com-
pany, e.g. for supervision and obligatory registrations, internal maintenance plans, test-
ing intervals.
1.1 Comments by the Manufacturer for the Operating Company
As operating company, you are responsible for :
- The professional and application as directed via expert personnel which has been
instructed into the correct operation of the equipment,
- Compliance to the safety relevant information and maintenance comments,
- Compliance to the safety regulations, safety comments as well as the precautions in
respect to vocational safety and accident prevention.
- The technical instruction of the operating personnel at the device and for having taken
notice of the Operation Manual.
- The Operation Manual is accessible for the operating personnel.
Following guidelines and regulations apply to the operation of the ergometer:
- EN 60601-1 (1996) „Medical electrical equipment; General requirements for
safety“
- EN 60601-1-2 (1993) „Medical electrical equipment; General requirements for
safety; 2.“
Introduction

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Ergometer
Type er900L
1.2 Product Relevant Regulations
- EC-Directive 93/42/EEC concerning medical products of June, the 14th 1993
- EC-Directive 89/336/EEC concerning „Electromagnetic compatibility“
1.3 Warranty Regulation
ergoline GmbH is only then, responsible for the safety and reliability of this
device when:
"all revisions, enhancements, repairs and service to the device are carried out by
ergoline authorized personnel, e.g. an ergoline dealer,
"ambient electrical service where the device is installed conform to IEC 601-1 and
"the device is operated in accordance with the Operation Manual.
Introduction

Operation Manual
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Art-Nr: 475.043
Ergometer
Type er900L
2 Safety Notices
2.1 Safety
Complying to the safety comments protects from potential injuries and prevents im-
proper application of the ergometer. Each operator of this ergometer as well as per-
sonnel which is in charge of installation, maintenance, examination or repair of this
ergometer, must have read and fully understood the contents of this Operation Manual
prior to operating or do any work on this device.
Special attention is required at sections labelled with additional symbols .
2.2 Application as directed
a) The supine ergometer er900L must only used for precise Cardio-Vascular tests un-
der resting and stress test conditions. With legrest attached (optional), the leaning
ergometer may also be used as couch for medical treatment
b) Application under outdoor conditions is not permitted.
c) In case the ergometer is not being used according to above conditions, and if be-
cause of that any injuries or serious impact on individuals, or if damage of property
is caused, then from this no liability of the manufacturer can be derived.
2.3 Fundamental Safety Comments
Note: We herewith notify that this manual is in accordance with regulations set forth by
the EC-Directive 93/42 EEC and the standards IEC601-1 (1996) and EN60601-
1-2 (1993). These regulations are however, not contained within this handbook.
The ergometer must only be operated in perfect working order in techni-
cal respect.
Despite of the precautions, the operation of the ergometer may involve certain
risk or danger, especially if
- improper application or,
- application is not as directed
are the cause.
There is the hazard of injuries or of property damage, in case of Nonconformance to
the Operation Manual, especially to the S a fe t y N o t e s
Safety Notices

Operation Manual
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Ergometer
Type er900L
It is necessary to ensure that no dangerous ground currents occur as a
result of attaching the ergometer to other devices. Device specifications
of the ergometrics er900L are in the appendix to this manual. Direct
your questions to your dealer or to ergoline’s service department. Es-
pecially at the coupling of several devices to a measurement system is
has to be taken care, that proper grounding is achieved via a single
power supply, e.g. wall socket.
The ergometrics er900L ergometer should only be operated where elec-
trical requirements meet IEC 601-1.
This device is not suitable for use in rooms or areas where there is dan-
ger of explosion. .
Always observe accident prevention precautions when operating this
device.
In the event that the pressure in the blood pressure cuff is too high,
remove the cuff from the patient's arm immediately.
!This unit may only be operated for therapy or diagnosis purposes under
the supervision of qualified personal.
2.4 Normative Notices
2.4.1 Notice for EMC (electromagnetic compatibility)
- The EMC test was done with a interference level of 3V/m. The device should not be
used in areas with a higher level.
- The device should not be used beside a high voltage system.
- To connect the device with other devices it's only allowed to use special shielded
cable provided by ergoline.
- Strong transmitting equipment may not be operated in the immediate vicinity of this
device..
- Electromagnetic interferences will appear first by a instable value of load in the dis-
play. If the value will change without reason while the speed is >30 1/min. It may be
that this is caused by an electromagnetic interference.
2.5 Requirements for Operating Personnel
The operating personnel of this ergometer have to be :
- properly instructed and trained regarding the operation of the ergometer,
- have to have full command regarding the handling of the device,
- have to aware of the applicable relevant safety requirements for the operation of
such devices, and act accordingly (see Chap. „Introduction“),
- have to be informed regarding additional regulations, e.g. safety regulations,
- have to be informed regarding potential hazard and risk arising from the operation of
such devices.
Safety Notices

Operation Manual
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Art-Nr: 475.043
Ergometer
Type er900L
2.6 Safety and Device Protecting Features
The device is equipped with following safety and device protecting features :
- High current protection which prevents damage to the device and potential danger to
person, e.g. in case of short circuit.
2.7 Measurement Accuracy Verification
Maintenance: The ergometrics 900L ergometer must be regularly inspected and main-
tained, in time intervals of two years, in accordance with lawful regulations. Alterations
to the ergometer’s measurement capabilities are cause for re-certification.
2.7.1 Routine Control of the Blood Pressure Measurement Unit
The automatic blood pressure measurement unit in the console of the ergometer must
be approved and recalibrated every two years by personnel authorized by ergoline.
2.7.2 Periodic Accuracy Verification for Blood Pressure Unit
EC-Directive 93/42/EEC operator regulations stipulate that the automatic blood pres-
sure unit in the ergometer´s console must undergo a routine technical inspection every
two years. (see page II in this operators Manual)
2.7.3 Load Unit Inspection
EC-Directive 93/42/EEC operator regulations requires qualified technical maintenance
of the load unit at two years intervals. This is to be performed by an ergoline authorized
service technician.
Safety Notices

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Ergometer
Type er900L
2.8 Identification plate, Labelling
Safety Notices
label with serial number

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Ergometer
Type er900L
3. Installation
This section describes the required installation steps in order to establish operational
readiness. The steps described are also required at initial installation after delivery of
the device.
3.1 Installation steps
1) Mount the locking castors.
2) Fix paper roll holder and fix crepe paper roll.
3) Mount arm support on the left hand side.
4) Fix the right running board on the support intended for via screws supplied.
5 )Connect blood pressure cuff according to 4.3.2 at the measurement head.
6) Connect mains cable according to 4.3.1 at the power inlet.
3.2 Scope of Delivery
The standard scope of delivery consists of :
1 blood pressure cuff
2 locking castors.
3 thermal paper for printer (2 rolls)
4 Measurement head with rear cover
5 arm support, left
6 running board, left + right (not visible)
7 head support
not in picture:
paper roll holder
crepe paper roll.
mains cable, 5 m
Final test protocol
Operation Manual
optional :
8 Handle, right with mounting right
9 legrest (left + right)
connecting cable to ECG (not in picture)
Installation
348 1 7
2
5
6
9

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Ergometer
Type er900L
3.3 Accessories
Order No. Description
100.948 Thermal paper roll (1 Set = 10 pieces)
200.194 Cuff for ergometry, adults
200.199 Cuff for ergometry, adults (connecting hose 2 m)
200.230 Cuff for ergometry, long version for strong arms
200.231 Cuff for ergometry, special (strong arms/connecting hose2 m)
200.200 Cuff for ergometry, children
313.420.9 Polar Receiver er900
424.016 Polar chest belt
200.205 2. arm rest with support (right)
200.206 Handle, right with mounting right
200.209 leg rest attachable, left + right (only for couch width 60 cm)
200.207 Swivelling arrest out of stainless steel (dimensions 450 x 300 mm)
200.210 Infusion holder
300.940 pedal shoes right + left complete
480.016 crepe paper roll
475.043 er900L Operation Manual, English Version
475.190 er900 Service Manual, English Version
3.4 Transport
!!
!!
!Please ensure that the mains cable is removed prior to transporting the device.
After releasing the locking casters, the ergometer er900L may be easily moved to the
working space within the room.
Installation

Operation Manual
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Ergometer
Type er900L
4 Putting into Operation
Check the mains fuse at the respective workstation prior to putting into operation the
device. Minimal fuse value: 16A.
4.1 Operating elements and Connections
Putting into Operation
1
3
2
54 6
7
8
9
10
11
1 Power connector, fuse and main power switch
2 Couch and seat adjustment
3 Mains power switch
4 Shoulder support
5 Handle with mounting for patient
6 Head support
7 Locking castors
8 Measurement head with keypad, display and printer
9 Blood pressure cuff , connection to the left or right at choice
10 Arm rest for blood pressure measurement
11 leg erst left + right, attachle (optional)

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Ergometer
Type er900L
4.2 Measurement head
4.2.1 Keyboard
1 LCD-Display
2 Paper Ejection Slot
3 Numeric Keypad
4START to start the ergometric
process
5STOP for interrupting the load
increments
6END to stop the ergometric
process
7MONITOR to call up the monitor pro-
gram: to program ergom-
eter, test routines, adjust-
ments, and assign stan-
dard settings
8RETURN to confirm and store entries
9PROGR. key to call up, and make
temporary modifications to,
ergometric programs
10 PWC to call up definable PWC
values subsequent to an
ergometric process
1378
2
9
10
11
12
13
14
15
16
456
11 BLOOD PRESS. I/0 to initiate or stop blood
pressure measurement ( at
anytime possible)
12 START to manually initiate a blood
pressure measurement, can
be done anytime when the
blood pressure is enabled
13 Printer switches printer output (inter-
nal, external or turned off)
14 Copy produces a copy of the re-
sult protocol
15 Toggle QRS beep on/off
16 Printer paper feed
Putting into Operation

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Ergometer
Type er900L
The cuff tube is to be connected
via Luer-Lok to J16 with the measure-
ment head .
The microphone cable is to be
connected via RCA-Jack to J12
Putting into Operation
4.3 Connectors and Interfaces
4.3.1 Power Connection
1) Make sure that the unit power switch is in
the off position (not depressed).
!
When using an ergoline utility cart with suction device, connect the unit’s power
plug to one of the white outlets on the utility cart. The ergometer can then be switched
on and off together with the suction device.
4.3.2 Connector for Blood Pressure Cuff
2) Connect the unit’s power plug via the sup-
plied mains cable to power outlet with same
voltage as indicated at the indication label

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Type er900L
4.3.3 Signal Connections
1
23
1) Digital RS-232 interface connector for PC or ECG
2) Analog interface for analog control and analog data transfer to ECG.
3) Fiber-optic connector for ear/finger clip or HR input from and ECG
!The interface pin configuration as well as related technical data are in the
appendix of this Operation Manual.
Putting into Operation