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.
F.1:Technical Data ................................................................................................... 79
F.2:The Speed-correlated Capacity of Brake Power Control.................................... 80
Version: 12/01
3
er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
Operation Manual
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/circulation 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 controlled 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 measurement 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 ergometer 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, conforming 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 control 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.
er900L Operation Manual
Art-Nr: 475.043
4
Version: 12/01
Operation Manual
Introduction
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 damage 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 partof 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 knowledge and experience in the construction, production and operation of the device.
The Operation Manual may be extended via special statements by the operating company, e.g. for supervision and obligatory registrations, internal maintenance plans, testing intervals.
1.1Comments 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.“
Version: 12/01
5
er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
Operation Manual
Introduction
1.2Product Relevant Regulations
-EC-Directive 93/42/EEC concerning medical products of June, the 14th 1993
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.
er900L Operation Manual
Art-Nr: 475.043
6
Version: 12/01
Operation Manual
Safety Notices
Ergometer
Type er900L
2Safety Notices
2.1Safety
Complying to the safety comments protects from potential injuries and prevents improper application of the ergometer. Each operator of this ergometer as well as personnel 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 .
2.2Application 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.
2.3Fundamental 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 EN606011-2 (1993). These regulations are however, not contained within this handbook.
The ergometer must only be operated in perfect working order in technical 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
Version: 12/01
7
er900L Operation Manual
Art-Nr: 475.043
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. Especially 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 electrical requirements meet IEC 601-1.
This device is not suitable for use in rooms or areas where there is danger of explosion. .
Always observe accident prevention precautions when operating this
device.
Operation Manual
Safety Notices
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.
2.4Normative Notices
2.4.1Notice 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 display. 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.
2.5Requirements 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.
er900L Operation Manual
Art-Nr: 475.043
8
Version: 12/01
Operation Manual
Safety Notices
Ergometer
Type er900L
2.6Safety 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.
2.7Measurement 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.
2.7.1Routine 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.
2.7.2Periodic Accuracy Verification for Blood Pressure Unit
EC-Directive 93/42/EEC operator regulations stipulate that the automatic blood pressure unit in the ergometer´s console must undergo a routine technical inspection every
two years. (see page II in this operators Manual)
2.7.3Load 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.
Version: 12/01
9
er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
Operation Manual
Safety Notices
2.8Identification plate, Labelling
er900L Operation Manual
Art-Nr: 475.043
10
label with serial number
Version: 12/01
Operation Manual
Installation
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.
3.1Installation 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.
3.2Scope of Delivery
The standard scope of delivery consists of :
1blood pressure cuff
2locking castors.
3thermal paper for printer (2 rolls)
4Measurement head with rear cover
5arm support, left
6running board, left + right (not visible)
7head support
not in picture:
paper roll holder
crepe paper roll.
mains cable, 5 m
Final test protocol
3481 7
5
6
Operation Manual
optional :
8Handle, right with mounting right
9legrest (left + right)
connecting cable to ECG (not in picture)
Version: 12/01
11
9
2
er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
3.3Accessories
Order No.Description
100.948Thermal paper roll (1 Set = 10 pieces)
200.194Cuff for ergometry, adults
200.199Cuff for ergometry, adults (connecting hose 2 m)
200.230Cuff for ergometry, long version for strong arms
200.231Cuff for ergometry, special (strong arms/connecting hose2 m)
200.200Cuff for ergometry, children
313.420.9Polar Receiver er900
424.016Polar chest belt
200.2052. arm rest with support (right)
200.206Handle, right with mounting right
200.209leg rest attachable, left + right (only for couch width 60 cm)
200.207Swivelling arrest out of stainless steel (dimensions 450 x 300 mm)
200.210Infusion holder
300.940pedal shoes right + left complete
480.016crepe paper roll
Operation Manual
Installation
475.043er900L Operation Manual, English Version
475.190er900 Service Manual, English Version
3.4Transport
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.
er900L Operation Manual
Art-Nr: 475.043
12
Version: 12/01
Operation Manual
Putting into Operation
Ergometer
Type er900L
4Putting into Operation
Check the mains fuse at the respective workstation prior to putting into operation the
device. Minimal fuse value: 16A.
4.1Operating elements and Connections
54 6
8
2
3
1
7
1Power connector, fuse and main power switch
2Couch and seat adjustment
3Mains power switch
10
9
11
4Shoulder support
5Handle with mounting for patient
6Head support
7Locking castors
8 Measurement head with keypad, display and printer
9Blood pressure cuff , connection to the left or right at choice
10 Arm rest for blood pressure measurement
11 leg erst left + right, attachle (optional)
Version: 12/01
13
er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
Putting into Operation
4.2Measurement head
Operation Manual
4.2.1Keyboard
2
1378
9
10
11
12
13
14
15
16
1LCD-Display
2Paper Ejection Slot
3Numeric Keypad
4STARTto start the ergometric
process
5STOPfor interrupting the load
increments
6ENDto stop the ergometric
process
7MONITOR to call up the monitor pro-
gram: to program ergometer, test routines, adjustments, and assign stan-
dard settings
8RETURNto confirm and store entries
9PROGR.key to call up, and make
temporary modifications to,
ergometric programs
10 PWCto call up definable PWC
values subsequent to an
ergometric process
456
11 BLOOD PRESS. I/0 to initiate or stop blood
pressure measurement ( at
anytime possible)
12 STARTto manually initiate a blood
pressure measurement, can
be done anytime when the
blood pressure is enabled
13 Printerswitches printer output (inter-
nal, external or turned off)
14 Copyproduces a copy of the re-
sult protocol
15Toggle QRS beep on/off
16Printer paper feed
er900L Operation Manual
Art-Nr: 475.043
14
Version: 12/01
Operation Manual
Putting into Operation
4.3Connectors and Interfaces
4.3.1Power Connection
Ergometer
Type er900L
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
!
4.3.2Connector for Blood Pressure Cuff
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.
2) Connect the unit’s power plug via the supplied mains cable to power outlet with same
voltage as indicated at the indication label
Version: 12/01
The microphone cable is to be
connected via RCA-Jack to J12
15
The cuff tube is to be connected
via Luer-Lok to J16 with the measure-
ment head .
er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
4.3.3Signal Connections
Operation Manual
Putting into Operation
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.
er900L Operation Manual
Art-Nr: 475.043
16
Version: 12/01
Operation Manual
Putting into Operation
Ergometer
Type er900L
4.4Power on Sequence
Mains power switch
The unit will subsequently execute a self-test. At the end of the self-test the main menu
will appear as below:
P = 000 Wr= 000 /min.
HF= 000 /min.t= 00 min.
S = 000 mmHg D= 000 mmHg
PROG 0 BP OFFPR. INT
Version: 12/01
17
er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
Operation Manual
Operation
5Operation
5.1The Computer - Your Helper
The half-leaning/leaning ergometer er900L was designed so that ergometric processes
could be conducted
simply - quickly - exactly - safely.
In order to achieve this, the computer is an indispensable aid. The integrated and especially designed blood pressure module for the ergometric process, makes computer
monitoring of the patient and his blood pressure condition largely autonomous. The
schematics below demonstrate the versatility of the unit .
Automatic Load
Program No. 0
Load program for patients whose
circulatory condition is not clear.
The ergometer tests the condition
of the patient’s circulatory system, and then selects an optimal
load program for the stress test.
With Circulation
Monitoring
Blood pressure and heart rate are
sampled and documented at the preset time interval. Heart rate and blood
pressure are simultaneously monitored for alarm limits and, if necessary, cause an alarm and abort the
load program.
Load Programs
No. 1 through 8
These load programs can be defined by the operator. Selection of
up to 12 load increments is possible. Blood pressure measurement
interval and parameter monitoring
are fully selectable.
Without Circulation
Monitoring
Blood pressure module is off. The
circulation condition is not monitored
and exceeding alarm limits do not
cause an alarm.
Manual Intervention
The preset program can be interrupted
at any time and the load levels may
be manually altered. When circulation conditions are being monitored
only load increments are interrupted.
Circulation data will continue to be
sampled, documented and checked
against alarm limit values in the preset time interval.
Load Program No. 9
Pulse-Steady-State
Special program for pulse-steadystate-training. A selected heart
rate will be maintained stable over
the entire training period.
Experimental Program
Prior to starting the program, each
program may be altered for this specific ergometry. These alterations are
not stored, and the standard settings
are restored after this ergometry.
Such sessions can also be manually
controlled and run with, or without,
circulation monitoring.
Use of the Blood
Pressure Module
without Load
er900L Operation Manual
Art-Nr: 475.043
18
Version: 12/01
Operation Manual
Operation
5.2The Display Unit
5.2.2Displayed Parameters and their Meanings
P = 000 Wr= 000 /min.
HF= 000 /min.t= 00 min.
S = 000 mmHg D= 000 mmHg
PROG 0 BP OFFPR. INT
Ergometer
Type er900L
P= 000 W= current load in Watts (Po= initial load,
P
=maximum load)
max
r= 000 /min= current revolutions per minute
HR = 000 /min= heart rate at the time of the last blood pressure reading
(current heart rate in case of continuous HR-signal )
t= 00 min= duration of the ergometry in min
S= 000 mmHg= systolic value of the last blood pressure reading (the mea-
surement may be displayed either in mmHg or kPa)
D= 000 mmHg= diastolic value of the last blood pressure reading (the
measurement may be displayed either in mmHg or kPa)
PROG 0= program selected (No. 0...9)
BP OFF= status of the blood pressure measurement (on or off)
PR. INT= status of the printer driver (Intern, Extern or Off)
Wt.= weight of the test subject
INT= interval of the blood pressure measurements in minutes
Version: 12/01
19
er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
Operation Manual
Operation
5.3The Printer
5.3.1Configuration of Printer
The printer may be configured in any one of three modes. This is done by pressing the
brown key „Printer“ (13). The status of the printer can be read from the lower right
corner of the display. The various configurations have the following meaning:
INT =The integrated system printer is enabled and prints all displayed parameters
immediately after each load change and/or blood pressure measurement.
EXT = The integrated printer is disabled. All data are exported to another system (ECG,
PC or external printer) and printed there.
OFF = The printer is turned off. (This setting is only valid for the current stress test and
will revert to „INT“ as soon as the current stress test is terminated.)
5.3.2Printed Parameters
The printer documents all parameters that are shown in the display. Printing will occur
immediately following each load change and/or blood pressure measurement. Printing
will also occur after the recovery period when the ergometry is aborted or comes to a
programmed termination. There are three parts of the ergometric protocol:
2.Recovery Protocol:
Documents each blood pressure measurement during the recovery phase.
1.Loading Protocol:
Documents the blood pressure reading
at rest , at each load increment and after each blood pressure measurement
during the load phase and the elapsed
time at termination.
er900L Operation Manual
Art-Nr: 475.043
3.Summary Protocol:
A summary of the ergometry with the PWC
values at the end of the total ergometry.
20
Version: 12/01
Operation Manual
Ergometry process
Ergometer
Type er900L
6.Ergometry Process
6.1General Preparations
6.1.1Preparing the Patient
As support for getting on or off the ergometer, the patient may only use hand
grip (A). The arm rest (D) and the hand grip (C) must not be used as support
for getting on/off the ergometer and must not be strained with the whole body
weight.
1) Place the backrest of the ergometer at a 45 degree angle so that the patient may
comfortably take his place.
2) Position the shoulder and headrests (C) such that they are outside the backrest area.
3) If there are leg rests (B), remove them, or at least the one on the side that the patient
will step up on.
4) Have the patient take his place on ergometer and put his feet on pedals.
5) Put the patient in the optimal position, such that his outstretched leg makes an angle
of 170 degrees between upper body and upper leg. Fix this position by adjusting the
saddle.
6) Now move the shoulder and headrests (C) such that the shoulder supports lightly
touch the shoulders.
C
hand grip
head rest
shoulder rest
locking
screws
A
hand grip
for
patient
D
arm rest
locking
screws
B
leg
support
Version: 12/01
B
21
er900L Operation Manual
Art-Nr: 475.043
Ergometer
Type er900L
Operation Manual
Ergometry process
7. Applying the Blood Pressure cuff :
*Feel for the position of arteria brachialis and position microphone (identified by
the red tab) precisely above arteria brachialis (E).
*Apply the airless cuff tightly at upper arm in order to prevent slipping during the
ergometry test, however not extremely tight.
*Apply cuff directly on skin, i.e. you must not use an intermediate layer out of
cloth, paper, .....
*The cuff should not touch the elbow.
*After application of cuff, the patient shold use the arm rest (F) as support (and
reduce thereby movement artefacts)
*Check that the cuff tubing is unimpeded and will not knock against any objects
when the patient has placed his hand at the handlebars and starts pedalling.
Move the armrest (D) accordingly toward the head or toward the leg. The con-
necting tube for the cuff should be as free as possible and not crimped or pinched
in any way.
*Advise the patient to keep his arm as still as possible during an ongoing
blood pressure measurement, and especially to avoid extreme contraction
of muscles of the upper arm.
E
- Microphone precisely above arteria brachialis
- Microphone position identified by red tab (cross)
6.1.3Preparation for ECG Acquisition
-Since in leaning/half-leaning ergometry
electrodes cannot be placed on the
patient’s back or extremities, position the
electrodes as shown in figure.
-Configure your ECG unit according to your
needs and proceed as described in this
manual in Chap. 7.4 „Ergometry Programing“ .
F
Application of BP cuff, er900L
RR
R
RR
C2
C1
C3
C4
C5
C6
LL
L
LL
er900L Operation Manual
Art-Nr: 475.043
22
NN
N
NN
FF
F
FF
Version: 12/01
B
Loading...
+ 58 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.