Operating Manual Ergometrics ER 900 (English)

Operation Manual ergometrics er900 Art-Nr: 475.037



Version: 05/02

Operation Manual for Bicycle Ergometer er900

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 possible alterations. Information regarding regar ding the latest version is available from the manufacturer. manufactu rer.

This Operation Manual

Ergometer ergometrics 900 Version: 05/02

is valid for the following Software-Versions:

V.236, V.240 and V.243 ergoline GmbH Lindenstraße 5 D-72475 Bitz Tel.: el.: +49 +49 743 7431 1 98 98 94 94 - 0 Fax: Fax: +49 +49 743 7431 1 98 98 94 94 - 127 127 e-ma e-mailil:: info info@e @erg rgol olin ine. e.co com m internet: internet: http://www http://www.ergolin .ergoline.com e.com Version: 05/02

er900 Operation Manual Art-No: 475.037

Operation Manual for Bicycle Ergometer er900

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 possible alterations. Information regarding regar ding the latest version is available from the manufacturer. manufactu rer.

This Operation Manual

Ergometer ergometrics 900 Version: 05/02

is valid for the following Software-Versions:

V.236, V.240 and V.243 ergoline GmbH Lindenstraße 5 D-72475 Bitz Tel.: el.: +49 +49 743 7431 1 98 98 94 94 - 0 Fax: Fax: +49 +49 743 7431 1 98 98 94 94 - 127 127 e-ma e-mailil:: info info@e @erg rgol olin ine. e.co com m internet: internet: http://www http://www.ergolin .ergoline.com e.com Version: 05/02


Version: 05/02


  

Ergometer Type er900

Table of Contents EC Declaration of Conformity Table of Contents.............................................................................................. 1 Foreword ........................................................................................................... 4 1. 1.1 1.2 1.3

Introduction ....................................................................................................... 5 Comments by the Manufacturer for the User ......................................................... 5 Product Relevant Regulations .............................................................................. 6 Warranty Regulation ............................................................................................ 6

2.

Safety Notices ................................................................................................... 7

2.1 2.2 2.3 2.4 2.4.1 2.5 2.6 2.7 2.8

Safety.................................................................................................................. 7 Intended Use ....................................................................................................... 7 Basic Safety Comments ...................................................................................... 7 Normative Notices ............................................................................................... 8 Notice for EMC (electromagnetic compatibility) ................................................... 8 Requirements for Operating Personnel ................................................................ 8 Safety and Device Protecting Features................................................................ 9 Maintenance, Safety Relevant and Metrological Inspections................................. 9 Identification Plate, Labelling ............................................................................. 10

3. 3.1 3.2 3.3 3.4

Installation ....................................................................................................... 11 Installation Steps ............................................................................................... 11 Scope of Delivery .............................................................................................. 11 Accessories ...................................................................................................... 12 Transport ........................................................................................................... 12

4. 4.1 4.2 4.2.1 4.3 4.3.1 4.3.2 4.3.3 4.4

Putting into Operation .................................................................................... 13 Operating Elements and Connections................................................................ 13 Measurement Head ........................................................................................... 14 Keypad ............................................................................................................. 14 Connectors and Interfaces ................................................................................. 15 Power Connection ............................................................................................. 15 Connector for Blood Pressure Cuff .................................................................... 15 Signal Connections ........................................................................................... 16 Power on Sequence .......................................................................................... 17

Version: 05/02

1



  

5. 5.1 5.2 5.2.1 5.2.2 5.3 5.3.1 5.3.2

Operation ......................................................................................................... 18 The Computer - Your Helper ............................................................................... 18 The Display Unit ................................................................................................ 19 Displayed Parameters and their Meaning .......................................................... 19 Speed display for the patient ............................................................................. 20 The Printer ........................................................................................................ 21 Configuration of Printer ...................................................................................... 21 Printed Parameters ........................................................................................... 21

6. 6.1 6.1.1 6.2 6.2.1 6.2.2 6.2.3 6.3 6.4 6.4.1 6.4.2 6.5 6.6 6.7

Ergometry Process ......................................................................................... 22 General Preparations ........................................................................................ 22 Preparation of the Patient .................................................................................. 22 Preparation of the Ergometer (ECG Type P1 or P2) ......................................... 23 Basic Preparations for all Programs .................................................................. 23 Special Entries for to the Use of Program 0 ....................................................... 24 Special Entries for to the Use of Program 9 ....................................................... 24 Preparations for Control by ECG or PC ............................................................. 25 Starting the Ergometry ....................................................................................... 25 Starting Ergometry with Internal Control.............................................................. 25 Starting an ECG or PC Controlled Ergometry .................................................... 25 Flowchart for Complete Ergometry Process....................................................... 26 Ergometric Protocol .......................................................................................... 29 Manual Control of Ergometry Session ................................................................ 30

7. 7.1 7.2 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.4 7.4.1 7.4.2 7.4.3

Configuration .................................................................................................. 31 General ............................................................................................................. 31 Call-up of the Monitor Program .......................................................................... 31 Basic Settings ................................................................................................... 34 Date and Time ................................................................................................... 34 Select Unit for Pressure Display ........................................................................ 35 ECG Start Pulse Duration (only for remote start of ECG).................................... 36 Select Language ............................................................................................... 37 RPM Control...................................................................................................... 38 Other Parameters .............................................................................................. 39 Defining an Ergometry Program ........................................................................ 40 Setup of Automatic Program 0 .......................................................................... 41 Definition of Programs 1-8................................................................................. 42 Definition of Program 9 for Pulse-Steady-State Training .................................... 44


2

Version: 05/02

  


8. 8.1 8.1.1 8.1.2 8.2 8.2.1 8.2.2 8.2.3

Structure of Programs.................................................................................... 46 General Structure of Programs 1-8 .................................................................... 46 Factory Settings ................................................................................................ 46 Creating Your Own Load Program ..................................................................... 47 Systematic Setup of Programs .......................................................................... 48 Setup of Automatic Load Program 0 .................................................................. 48 Setup of the Fully Programmable Load Programs 1-8........................................ 52 Setup of Program 9, Steady-Pulse (Cardiovascular Training)............................. 54

9. 9.1 9.2

Cleaning .......................................................................................................... 57 Cleaning the Unit ............................................................................................... 57 Cleaning the Blood Pressure Cuff ...................................................................... 57

A.1

Appendix A: Interfaces ................................................................................... 59 Input and Output Pin Specifications.................................................................... 59

B.1 B.1.1 B.1.2 B.1.2 B.1.4

Appendix B: Monitor Program ....................................................................... 71 Additional Settings in the Monitor Program ........................................................ 71 Setting the ECG Type ........................................................................................ 71 Setting the Baud Rate ....................................................................................... 72 Switching Between Internal and External Load Control ....................................... 73 Hardware Diagnostics ....................................................................................... 74 Appendix C: Program Listing ........................................................................ 75

D.1 D.1.1 D.2

Appendix D: Indicators .................................................................................. 76 PWC Values...................................................................................................... 76 What is a PWC Value? ...................................................................................... 76 Training Indicator ............................................................................................... 77

E.1. E.2.

Appendix E: HR Recording ........................................................................... 78 Heart Rate Feedback from ECG ....................................................................... 78 Pulse Monitor .................................................................................................... 78

Appendix F: Specification .............................................................................. 79 F.1: Technical Data ........................................................................................................ 79 F.2: The Speed-correlated Capacity of Brake Power Control ......................................... 80

Version: 05/02

3



  

Foreword: We are pleased with your decision to purchase our computerized ergometer er900. This is the appropriate decision for quality and performance. The computerized ergometer er900 has been specially designed with the medical and ergonomic requirements in mind for quick and valid stress analysis of the cardiovascular 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 a 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. The computer controlled execution of all measurements and analysis of results markedly simplifies the work of the 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. We hope that you are successful in your work with the ergometrics er900 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 protects against danger and risk for life and limb, and prevents from improper application of the Ergometer. Please comply with all warning signs at the ergometer. Replace missing or damaged signs 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. By the above guidelines, a save and smooth operation is achieved, delays due to repairs are avoided, and the requirements for the optimal employment of the equipment are fulfilled. er900 Operation Manual Art-No: 475.037

4

Version: 05/02

  

1.


Introduction Within this Operation Manual, important comments to ensure the safety and to avoid potential damage are labelled with the following symbols:



Warning ! Describes a potentially 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 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 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.

1.1

Comments by the Manufacturer for the User As the user, you are responsible for : - the professional application as directed via expert personnel which has been instructed for 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 being accessible for the operating personnel. The following guidelines and regulations apply to the operation of the ergometer: - EN 60601-1 (1996) - EN 60601-1-2 (1993)

Version: 05/02

„Medical electrical equipment; General requirements for safety“ „Medical electrical equipment; General requirements for safety; 2.“

5



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 responsible for the safety and reliability of this device, if:  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 conforms to IEC 601-1 and  the device is operated in accordance with the Operation Manual.


6

Version: 05/02

   

2.

Safety Notices

2.1

Safety


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 the unit or doing any work on this device. Special attention is required at sections labelled with additional symbols .

2.2

Intended Use a) The ergometer ergometrics 900 must only be used for precise cardiovascular tests under resting and stress test conditions. b) Special test methods, e.g. Echo-Cardiography or other high-risk test methods must not be performed by using the bicycle ergometer. For such purpose special supine ergometers are offered by ergoline. c) Application under outdoor conditions is not permitted. d) In case the ergometer is not being used according to above conditions, and if because of that any injuries or serious impact on individuals or damage of property is caused, the manufacturer cannot be held liable.

2.3 Note:

Basic Safety Comments 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 the precautions, the operation of the ergometer may involve certain risk or danger, especially in case of - improper application or, - application is not as directed. There is the hazard of injuries or of property damage, in case of noncon- formance to the Operation Manual, especially to the Safety Notes .

Version: 05/02

7



   

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 er900 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 it has to be taken care that proper grounding is achieved via a single power supply, e.g. wall socket. The ergometrics er900 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. 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 personnel.

2.4

Normative Notices

2.4.1

Notice for EMC (electromagnetic compatibility) - The EMC test was done with an interference level of 3 V/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 is only allowed to use special shielded cables provided by ergoline. - Strong transmitting equipment may not be operated in the immediate vicinity of this device. - Electromagnetic interferences will appear first by an instable value of load in the display. If the value changes without any reason while the speed is >30 /min, this may be 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 full command regarding the handling of the device, - be aware of the relevant safety requirements for the operation of such devices, and act accordingly (see Chap. „Introduction“), - be informed regarding additional regulations, e.g. safety regulations, - be informed regarding potential hazard and risk arising from the operation of such devices.


8

Version: 05/02

   

2.6


Safety and Device Protecting Features The device is equipped with the following safety and device protecting features : - High current protection which prevents damage to the device and potential danger to persons, e.g. in case of short circuit.

2.7

Maintenance, Safety Relevant and Metrological Inspections • Before each use, visually check the ergometer for mechanical damage. If you detect any damage or functional deficiencies which could impair the patient´s or operator´s safety, do not use ergometrics 900 until it is checked and repaired. • Maintenance: The user is responsible that the proper function of the ergometer is regularly checked in time intervals of at least six months. • Safety Relevant and Metrological Inspections The ergometrics 900 bicycle ergometer must be regularly inspected and maintained, in time intervals of two years, in accordance with lawful regulations. Alterations to the ergometer’s measurement capabilities are cause for re-certification. These inspections are to be performed by an ergoline authorized service technician. A) Routine Control of the Blood Pressure Measurement 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. B) Load Unit Inspection Based on the metrological check which is compulsory in Germany every two years, it is necessary to check the load accuracy of the ergometer. EC-Directive 93/42/EEC operator regulations requires qualified technical maintenance of the load unit at two years intervals. In all other countries, the frame and method of the metrological check depend on the legal regulations of each country.

Version: 05/02

9



2.8

   

Identification Plate, Labelling

label with serial number


10

Version: 05/02

  

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) Loosen screws and clamp lever for clamp fixture, and remove upper clamp jaw; Insert handlebar, secure, and screw tight with screws and clamp lever. Adjust appropriate handlebar position and fix position with clamp lever. 2) Insert measurement head with the tin flaps into the handlebar pipe; Attach grounding cable, connection cable and tubing. 3) Adjust black rear cover onto the measurement head and tighten with screw. 4) Insert saddle pipe into the guidance and tighten with clamp lever. 5) Feed saddle bellows into the saddle pipe, and put on to the intended notch . 6) Connect blood pressure cuff according to 4.3.2 at the measurement head. 7) 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

4

3 2

2 5 1

blood pressure cuff thermal paper for printer (2 rolls)

3

handle bar

4

measurement head with rear cover

5

saddle bar with saddle and folding bellows not in picture: mains cable, 2,5 m Final test protocol Operation Manual

optional : connecting cable to ECG (not in picture)

Version: 05/02

11


  


3.3

Accessories Order No. 100.948 200.194 200.199 200.230 200.231 200.200 313.420.9 424.016 200.892 300.937 200.850 475.037 475.190

3.4

Description Thermal paper roll (1 Set = 10 pieces) Cuff for ergometry, adults Cuff for ergometry, adults (connecting hose 2 m) Cuff for ergometry, long version for strong arms Cuff for ergometry, special (strong arms/connecting hose 2 m) Cuff for ergometry, children Polar receiver er900 Polar chest-belt Triathlon handle bar er900, incl. Polar receiver cable extension Adjustable cranks, pediatric size Saddle for children, incl saddle pipe and saddle bellows er900 Operation Manual, English Version er900 Service Manual

Transport



Please ensure that the mains cable is removed prior to transporting the device.

During transport within the same room respectively within the same building, hold onto the ergometer such that the measurement head is pointing towards you. Take hold of the handle bar at both sides, and pull the ergometer towards yourself, so that it is resting on the casters only, and is in balance. Now you may pull the ergometer easily to the working space within the room. Please be careful when putting the ergometer down. Otherwise the WSG (= wire string gauge) of the driving unit may be damaged.


12

Version: 05/02

    

4.


Putting into Operation Check the mains fuse at the respective workstation prior to putting the device into operation. Maximal fuse value: 16A

4.1

Operating Elements and Connections 4 5

6 3

7 1 2

9

8

1 power connector, fuse 2 main power switch 3 clamp handle for seat adjustment 4 clamp handle for handlebar angle adjustment 5 console with keypad, display and printer 6 blood pressure cuff 7 clamp handle for handlebar height adjustment 8 transport casters 9 levelling feet for optimal stability

Version: 05/02

13


    


4.2

Measurement Head

4.2.1

Keypad

1

3

7

8 9 10 11 12 13 14 15 16

2

4 1 2 3 4

LCD-Display paper ejection slot numeric keypad START to start the ergometric process 5 STOP for interrupting the load increments 6 END to stop the ergometric process 7 MONITOR to call up the monitor program: to program ergometer, test routines, adjustments, and assign standard settings 8 RETURN to confirm and store entries 9 PROGR. key to call up, and make temporary modifications to, ergometric programs 10 PWC to call up definable PWC values subsequent to an ergometric process er900 Operation Manual Art-No: 475.037

5

6

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 (internal, external or turned off)

14 Copy

produces a copy of the result protocol

15

toggle QRS beep on/off

16

printer paper feed

14

Version: 05/02

    

4.3

Connectors and Interfaces

4.3.1

Power Connection

1) Make sure that the power switch is in the “Off” position (not depressed).

 4.3.2


2) Connect the unit’s power plug via the supplied mains cable to a power outlet with the same voltage as indicated on the label

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.

Connector for Blood Pressure Cuff

The microphone cable is to be connected via RCA-Jack to J12 The cuff tube is to be connected via Luer-Lok to J16 with the measurement head Version: 05/02

15


Ergometer Type er900 4.3.3

    

Signal Connections

1

2

3

1) Digital RS232 interface connector for PC or ECG. 2) Analog interface for analog control and analog data transfer to ECG. 3) Fiber-optic connector for POLAR receiver, or HR input from an ECG.



The interface pin configuration as well as related technical data are in the appendix of this Operation Manual.


16

Version: 05/02

    

4.4


Power 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 W r = HR= 000 /min t = S = 000 mmHg D = PROG 0 BPM OFF

Version: 05/02

000 /min 00 min 000 mmHg PR. INT

17


  


5.

Operation

5.1

The Computer - Your Helper The ergometrics er900 for stress testing was designed so that the ergometric process can be conducted simply - quickly - precisely- 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 Programs No. 1 through 8

Load Program No. 9 Pulse-Steady-State

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.

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.

Special program for pulse-steadystate-training. A selected heart rate will be maintained over the entire training period.

With Circulation Monitoring

Without 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.

Blood pressure module is off. The circulation condition is not monitored and exceeding alarm limits do not cause an alarm.


Use of the Blood Pressure Module without Load

Manual Intervention

Experimental Program

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.

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.

18

Version: 05/02

  

5.2

The Display Unit

5.2.1

Displayed Parameters and their Meaning


P = 000 W r = 000 /min HR = 000 /min t = 00 min S = 000 mmHg D = 000 mmHg PROG 0 BPM OFF PR. INT

P = 000 W

= current load in Watts (Po= initial load, Pmax=maximum load)

n

= current revolutions per minute

= 000 /min

HR = 000 /min

= heart rate at the time of the last blood pressure reading (current heart rate in case of continuous HR-signal )

t

= duration of the ergometry in min

= 00 min

S = 000 mmHg

= systolic value of the last blood pressure reading (the measurement 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)

BPM ON/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: 05/02

19



  

Speed display for the patient On the patient’s side, the measuring head has a display to show the current speed. Next to the speed display there are LEDs which show the most favorable conditions for measurement. For blood pressure measurement at rest and following the post-load phase for the recovery measurement, the “stop” lamp is on. This means that the patient should stop cycling. t the beginning of every load stage, the ergometer computer suggests a speed to the patient which is best for achieving the best reproducible increase in heart frequency. At the suggested speed, the patient reaches an ideal total pulse curve, because muscle friction is kept as low as possible. During the ergometric test, the system monitors whether the patient keeps to the suggested speed by means of the two LEDs to the right of the speed display. If the patient’s speed falls too far, the upper LED flashes (<<>>n- ). Patient’s display window:



rev Stop <<>>n-

(faster) (slower)

The indicated speeds are medically sound recommendations. They should be maintained because this is the best way of achieving reproducible measuring results. This ergometer operates independent of speed in the range between 30 and 130 crank revolutions, thus always guaranteeing load precision in all other speed ranges within the “ characteristic curve of the working range of the braking torque control “.


20

Version: 05/02

  

5.3

The Printer

5.3.1

Configuration 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: PR INT = The integrated system printer is enabled and prints all displayed parameters immediately after each load change and/or blood pressure measurement. PR EXT = The integrated printer is disabled. All data are exported to another system (ECG, PC or external printer) and printed there. PR 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.) 5.3.2

Printed 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. Load Protocol: Documents the blood pressure reading at rest, at each load increment and after each blood pressure reading during the load phase and the elapsed time at termination. Version: 05/02

21

3. Summary Protocol: A summary of the ergometry with the PWC values and the training index at the end of the total ergometry.



   

6.

Ergometry Process

6.1

General Preparations

6.1.1

Preparation of the Patient

1. Have the patient take his place on the saddle. 2. Position the saddle such that an angle of approx. 10 degrees exists between the extended axis of the upper body and the thigh when the pedal is at its lowest position. Ask the patient to stand on the pedals while you adjust the saddle position. Saddle height is ad justed by loosening the saddle clamp screw and moving the saddle to the correct position. 3. Move the handlebar to a position such that the test subject can comfortably sit upright. To do this, loosen the handlebar height clamp handle and adjust appropriately. Next you can adjust the angle of the handlebar by loosening the handlebar angle clamp handle. 4. Check to see that all of the adjustment clamps are secured. (Do not tighten these with extreme force.) 5. Put the blood pressure cuff on the patient’s arm. Position it so that the microphone (marked with a red ring) is right over the Arteria Brachialis on the inner side of the upper arm. Be sure that the cuff is not placed so that it can touch another object when the patient has placed his hand on the handlebar.

° 0 1 r . p p a

clamp handle for handlebar angle clamp handle for handlebar height clamp handle for saddle height

microphone fixed over the arteria brachialis

cuff position


22

Version: 05/02

   

6.2

Preparation of the Ergometer (ECG Type P1 or P2)

 6.2.1


These preparation instructions are only applicable to usage of the ergometer in conjunction with interface modes ECG-Type P1 or P2, see Appendix A. The ergometer can only be controlled by its own program in these modes.

Basic Preparations for all Programs 1. Press the red key „PROG.“ and select the appropriate program for the patient with the numeric keypad.



2. Enter the patient’s weight. The ergometer needs this information to calculate exact PWC values. PROG x Wt. = xxx HR < xxx S < xxx mmHg D < xxx mmHg Po = xxx W Pmax = xxx W INTERV.BPM = xx min.

3. When necessary, you can alter any parameter to create a special ergometric session. These alterations will be lost as soon as the special session is ended. Then the program will again show the standard base values (see chapter 7. „Configuration“).



Altered parameters that are entered prior to program start are lost after the end of the ergometric session.

Version: 05/02

23



   

Special Entries for to the Use of Program 0 When using program 0, the maximum heart rate (HR) should always be entered specifically for the individual patient. Since this value serves as the target frequency for loading, it must be specifically adapted to the age and health of the patient. The remaining parameters, in particular the alarm parameter, should be established in the configuration so that even a weak patient can perform the ergometric session without danger. Here also, all other parameters may be altered for a specific ergometric session.

 6.2.3

Always enter the maximum heart rate (HR) for program 0 specific to the age and strength of the patient. When possible, provide the ergometer with a continuous heart rate by using an ear/finger clip, a pulse monitor or the HR feedback from an ECG.

Special Entries for to the Use of Program 9 Patient specific maximum heart rate (HR) should also be entered for program 9 to reflect the patient’s training requirements.



Only use program 9 when a continuous heart rate source is used. That is, when an ear/finger clip, a pulse monitor or a HR feedback from an ECG is connected.


24

Version: 05/02

   

6.3


Preparations for Control by ECG or PC The ergometer must be specifically configured to the controlling ECG-Type or PC, see Appendix. The ECG or PC is then in total control of the ergometry. Any entries that may have been made on the ergometer are therefore nullified. There is no preparation of the ergometer to be made on the console. Configure your ECG or PC in accordance with the appropriate operator’s instructions for ergometry. Start the ergometric session with the ECG or PC.

6.4

Starting the Ergometry

6.4.1

Starting Ergometry with Internal Control 1. Check to see if all the parameters are correctly entered. 2. Start the ergometric procedure by pressing the red „START“ key. The ergometer will begin by measuring the blood pressure value at rest.



6.4.2

Starting an ECG or PC Controlled Ergometry Start the ergometric program on your ECG or PC in accordance with the corresponding instructions. After a successful start the ergometer will begin by measuring the blood pressure value at rest.

Version: 05/02

25


   


6.5

Flowchart for complete Ergometry Process



This ergometric process flow description is only valid for use of the ergometer under internal control. When control is exercised by an ECG or PC refer to the documentation for those devices.

Legend: = input via operating personnel

= Print-out

= action via ergometer

Selection of Specific Ergometric Program Assign patient to patient group, and select program for this patient accordingly, or select the automatic program 0 for patients who you cannot be classified, or select program 9 for patients who are to undergo Pulse-Steady-State training. .

Possible Modification of Parameters Prior to beginning an ergometric session you may alter any parameter for this specific ergometry.

Start of Ergometry Press the red „START“ key to begin the ergometric session.

Blood Pressure Measurement at Rest Immediately after starting the ergometer, the blood pressure measurement at rest will be taken. It is important that the patient remains absolutely still during this measurement as the filter parameters for the blood pressure during stress are established by this measurement. Artifacts during this measurement may lead to false results under stress.



Print-out of the Blood Pressure Measurement at Rest The resulting blood pressure data will either be printed out on the internal printer or fed to the ECG via the RS232 interface and documented there.

Establishment of the Initial Load P o The load program will begin with initial load Po when the blood pressure data has been put out.

First Blood Pressure Measurement under Stress Blood pressure measurement will begin at the pre-programmed interval.

Output of Load and Blood Pressure Data Blood pressure and load data readings are either printed by the internal printer or passed over the RS232 interface to an ECG for documenting there. .

Proceeding to First Load increment The load will be increased by the programmed first load increment as soon as data has been put out.

1 er900 Operation Manual Art-No: 475.037

26

Version: 05/02

   


1 Second Blood Pressure Measurement under Stress Blood pressure will be measured again at the programmed interval.

The measured blood pressure data and the current load data will either be printed by the internal printer or passed over the RS232 interface to an ECG for documenting there.

Advancing to the Second Load Increment The load will be increased by the programmed second load increment as soon as data has been put out.

   n-th Blood Pressure Measurement under Stress Blood pressure will be measured again at the programmed interval. .

The measured blood pressure data and the current load data will either be printed by the internal printer or passed over the RS232 interface to an ECG for documenting there.

Proceeding to the n-th Load Increment The load will be increased by the programmed n-th load increment as soon as data has been put out.

Concluding the Load Program and Transition to Recovery Phase The load program will end and the recuperative phase will begin after the red „ END“ key is pressed once. The load will be reduced to 25 Watt for the first minute of the recovery phase and reduced to zero beginning with the second minute. The patient should continue to pedal for at least the first minute to avoid venous congestion in the legs. If the load program is terminated after a blood pressure measurement, the final protocol will be printed which contains the load, RPM, and heart rate data at the time of termination. No termination protocol will be printed if termination occurs during an ongoing blood pressure measurement.



2

Version: 05/02

27


   


2 First Blood Pressure Measurement during Recovery Blood pressure measurements continue to be taken during the recovery phase at the set interval.

Output of Measured blood Pressure Data The resulting blood pressure data are either printed by the internal printer or passed over the RS232 interface to an ECG for documenting there.

   n-th Blood Pressure Measurement during Recovery Blood pressure measurements continue to be taken during the recovery phase at the interval set.

Output of Measured Blood Pressure Data The resulting blood pressure data are either printed by the internal printer or passed over the RS232 interface to an ECG for documenting there.

Concluding Ergometry Ergometry is terminated completely by pressing the red „END“ key for a second time

Output of the Summary Protocol



The termination protocol is either printed by the internal printer or passed over the RS232 interface to an ECG for documenting there.



This process flowchart is only representative when the interval for blood pressure measurements and load increment are equal, otherwise the sequence of measurements and print-outs will be altered. Data output occurs basically at every value change in blood pressure or load. The sequence will also be altered if the program is manually modified.


28

Version: 05/02

   

6.6


Ergometric Protocol

An ergometric protocol is recorded during the ergometric session. The protocol is either produced by the internal printer or by an ECG. The picture below shows such a protocol as documented by the internal printer. Program parameters were: heart rate max. = 180, systole max. > 200, diastole max. > 130, initial load Po = 50 watt, maximum load Pmax. = 999 watt, blood pressure measurement interval = 01 min., load interval = 01 min., load change per interval = 25 watt. The PWC values to be ascertained were predefined for heart rates between 130 and 150 beats per minute. The values in this protocol are not representative of a patient as they were generated with a simulator.

blood pressure at rest

}

blood pressure measurements for individual load increments

termination of the load program with termination protocol

}

blood pressure measurements in the recovery phase

end of ergometry with concluding protocol

Version: 05/02

29



6.7

   

Manual Control of Ergometry session If necessary, the ergometry session , i.e. the load program may be manually controlled via the measurement head . That is done by starting a suitable ergometry program and then interrupting the automatic sequence of the program at the desired instant by pressing the key „STOP“. The requested load is then set by means of the white cursor keys.

Start of Ergometry Session Press the green button „START“ to begin the ergometric session.

Blood Pressure Measurement at Rest



Immediately after starting the ergometer, the blood pressure measurement at rest will be taken. It is important that the patient remains absolutely still during this measurement as the filter parameters for the blood pressure during stress are established by this measurement. Artefact during this measurement may lead to false results under stress.

Establishment of the Initial Load P o The load program will begin with initial load Po when the blood pressure data has been put out.

  Enable Manual Control By pressing the „STOP“ button, the automatic ergometer control is interrupted.

Increase or Decrease Load Manually By pressing the white cursor buttons, the load is adjusted at 5 Watt steps.

Terminate Load Program and Change to Recovery Phase The load program is stopped by pressing the green button “END”, and the recovery phase is started.

 



 

The interval of the blood pressure measurement still takes place automatically at the preset interval . Manual control is only possible if the following ECG-type is set: ECG-type P1, P2 or P10 (see Annex A or Annex B.1.1)


30

Version: 05/02

  

7.

Configuration

7.1

General


The ergometrics er900 ergometer has numerous setup options to allow the operator to adapt the device optimally. The most important configuration support is the monitor program. The monitor program allows the operator to use a set of menus to modify parameters.

7.2

Call-up of the Monitor Program Two yellow buttons on the measurement head are provided for management of the monitor program. Both of these buttons are at the upper right portion of the keypad and have the following basic functions: Call-up monitor program mode, as well as call-up of the various sub-menus. When in monitor program mode, the sub-menu at the position of the cursor is selected by pressing button „MONITOR“ once more.

Confirm and save changes made in monitor program or the appropriate submenu as well as exit from monitor program mode or a sub-menu. The programming diagrams on the next page illustrate the structure of the monitor program.

Version: 05/02

31


  

Ergometer Type er900 MONITOR V.XXX ACTIVATE PROGRAM ADJUST CLOCK mmHg - kPa

ACTIVATE PROGRAM M PROGRAM No X  Max.HEARTFREQ. HR < XXX Max.Syst. S < XXXmmHg

 ADJUST CLOCK YEAR XX MONTH DAY XX HOUR MINUTE XX



M XX XX

ACTIVATE PROGRAM M max.Diast. D < XXXmmHg START LOAD Po = XXX W MAX. LOAD Pmax.=XXX W

 ACTIVATE PROGRAM Interv. BPM = XX min. PWC = XXX PWC = XXX TRAININGSIND. [Y/N]

 mmHg - kPa mmHg kPa

M (*) (*)

M



 MONITOR V.XXX TEST ADJUST TORQUE ADJUST OUTPUT

ACTIVATE PROGRAM LOAD STEP 01 : 12 INTERV.LOAD = XX min. LOAD CHANGE XXX W

M

TEST +- 5 Va = 5.XX V [ 0.2 ]  + 5 Vd = 5.XX V [ 0.3 ] +24 V = 2X.X V [ 6V ]

M

 LOAD EXT = 000 W TEST M U-TD = XXX [ 020 - 150 ] U-DMS = XXX [ 050 - 250 ] S = XXXmmHg D = XXXmmHg





1

ADJUST TORQUE

M

ZERO DMS-AMPL. MM SET CODE . . . U - DMS = XXX [050 - 250]  EV.RESET SPRING

ZERO DMS-AMPL. TORQUE

TORQUE MM SET CODE . . .  PUT 3 - 6 Kg WEIGHT = X.XX Kg

 ADJUST OUTPUT LOAD SYSTOLE

M BPM DIASTOLE

 ADJUST BPM OUTPUT SET CODE . . .

ADJUST LOAD OUTPUT MM SET CODE . . .  300 W = < > ADJUST SYS OUTPUT SET CODE . . . 300

mmHg =


<

MM

>

200 BPM = <



MM

>

ADJUST DIA OUTPUT MM SET CODE . . .  300 mmHg = < >

32

Version: 05/02

  

1

LOAD INT - EXT  INT EXT

M

[ * ] [*]

ZERO LOAD EXT SET CODE . . . . 

 MONITOR V.XXX LOAD INT/EXT ADJUST LOAD INPUT ECG RECORD


ADJUST LOAD INPUT

M

 ZERO LOAD LOAD EXT

MM

LOAD - ZERO = XXX W ADJUST LOAD INPUT SET CODE . . .  = 000 W

ECG RECORD XX sec

<

MM

>

M



P1 P2  P3 P4

* * * *

P5 P6 P7 P8

* * * *

P9 * M P10 * P11 * P12 *

 MONITOR ECG - TYPE TRANSM.SPEED LANGUAGE

V.XXX

TRANSM.SPEED  2400 Baud 4800 Baud

M (*) ( * )

LANGUAGE

M

 GER ( * ) FRZ ( * )

ENG ( * )

CONTR. RPM

 MONITOR V.XXX CONTR. RPM CONTR. INT / EXT RESERVE

 ON OFF

( * ) (*)

CONTR. INT / EXT MM  INT EXT

Version: 05/02

MM

( * ) (*)

33


  


7.3

Basic Settings

7.3.1

Date and Time The system has an integrated real-time clock that can be set by the monitor program. This clock is set correctly when the unit is delivered but may require re-setting, for example when changing from winter time to summer time. Proceed as follows:

 Press the button „MONITOR“. 

MONITOR V.XXX ACTIVATE PROGRAM ADJUST CLOCK mmHg - kPa

The monitor main menu will appear in the display.

  Using the cursor buttons in the alpha-

numeric keypad, move the cursor to the menu item ADJUST CLOCK.



MONITOR V.XXX ACTIVATE PROGRAM ADJUST CLOCK mmHg - kPa 

 Call up this subprogram by pressing the

button „MONITOR“ again. 

ADJUST YEAR DAY MINUTE

CLOCK XX XX XX

MONTH HOUR

M XX XX

 Use the numeric keypad to enter the cor-

rect time and date. The cursor will automatically advance from field to field. Use the arrow keys to move the cursor to a particular field.

  Confirm that the information is correct by

pressing the button „RETURN“ . The main menu will reappear.

  


You may now proceed to other menu items or exit the monitor program by pressing the „RETURN“ key again.

34

Version: 05/02

   7.3.2


Select Unit for Pressure Display It is possible to select either mmHg or the SI unit kPa for use in the print-out. Proceed as follows:  Press the button „MONITOR“. 



  Using the arrow keys in the alphanumeric

keypad, move the cursor to the menu item „mmHg - kPa“.



MONITOR V.XXX ACTIVATE PROGRAM ADJUST CLOCK mmHg - kPa 



mmHg - kPa mmHg kPa

M

 Use the arrow keys in the alphanumeric

keypad to move the cursor to the desired unit of measure.

(*) (*) 

 Confirm the entry by pressing the button

„RETURN“ . The main menu will then reappear.

  

You may now proceed to other menu items or exit the monitor program by pressing the button „RETURN“ again.

Version: 05/02

35



  

ECG Start Pulse Duration (only for remote start of ECG) The ergometer has a remote start output with which an ECG device can be triggered (provided that the ECG device has a corresponding input). The feature programmed below determines the period during which the remote start signal is applied to the output. Signal duration is fully selectable in 1 second steps within a range of 0 - 99. Signal duration is determined as follows:








MONITOR V.XXX LOAD INT/EXT ADJUST LOAD - INPUT ECG - RECORD

 Using the arrow keys in the alphanumeric

keypad, move the cursor to the menu item „ECG RECORD“.

  Call up this subprogram by pressing the


ECG - RECORD XX sec

M  Enter the period in seconds using the al-

phanumeric keypad. The cursor will automatically advance.   Confirm the entry by pressing the „RE-

TURN“ key. The main menu will then reappear.

  



36

Version: 05/02

   7.3.4


Select Language The language used in the display and on the print-outs may be selected. There are two versions of software available, each with three languages. The available languages are: German (GER), French (FRZ), English (ENG), or Spanish (ESP), Italian (ITA), Dutch (DUT).








MONITOR ECG - TYP TRANSM.SPEED LANGUAGE

 Using the arrow keys in the alphanumeric

V.XXX

keypad, move the cursor to the menu item „LANGUAGE“.



LANGUAGE

M

GER ( * ) FRZ ( * )

ENG ( * ) 


keypad to move the cursor to the desired language.  Confirm the entry by pressing the „RE-


  

Version: 05/02


37


  


RPM Control Sometimes, it may be necessary for the patient to discontinue pedaling for one reason or another. Normally, when the RPM value drops below the minimum value (30 RPM), this will lead to an abort of the load program since a defined load is no more present. Now it is possible to turn off RPM control for these special applications. The load program is then not aborted, but rather continues regardless of the presence of a minimum RPM value or not. Re-entry into the program is therefore possible at any time.




  Using the arrow keys in the alphanumeric

keypad, move the cursor to the menu item „CONTR: RPM“. („CONTR: RPM“ is a main menu option that will appear eventually as the main menu scrolls through the display with repeated pressing of the arrow keys.)



MONITOR V.XXX CONTR. RPM CONTR. INT / EXT RESERVE 



CONTR. RPM ON OFF

MM


keypad to move the cursor to the desired selection.

( * ) (*) 

 Confirm the entry by pressing the „RE-


  


You may now proceed to other menu items or exit the monitor program by pressing the button „RETURN“ again. 38

Version: 05/02

   7.3.6


Other Parameters Numerous other parameters can be specified by using the monitor program, among these are: * analog input/output adjustments, load unit adjustment, etc. Some of these parameters are code protected and should not be modified by the operator due to safety considerations. Notify your authorized dealer or theergoline service department if you wish to alter any one of these protected parameters.

„Appendix B“ contains setup instructions for the following parameters: Setting of ECG-Type Type selection for an attached ECG unit (for data transmission) TRANSM.SPEED ECG specific TRANSM.SPEED selection Toggle between internal and external load control Determines if load is to be controlled internally (by the ergometer) or externally (by the ECG unit) Hardware Tests Determines if the voltages of the system are correct

Parameters that are only to be altered by personnel authorized by ergoline : Blood Pressure Measurement Unit Certification Test routine that is run by the office of certification Torque Adjustment Adjustment of the drive train unit Analog Output Adjustment Adjustment of the analog data outputs Analog Input Adjustment Adjustment of the analog data inputs

Version: 05/02

39



7.4

  

Defining an Ergometry Program The operator may select from 10 different ergometric programs when using the ergometrics er900. Of these 10 programs, eight are fully programmable, one program offers automatic loading and one program is for pulse-steady-state training.

 

Ergometric program definition is only possible when the ergometer is controlled internally, i.e. not controlled by a PC or ECG unit. Mixed control is also possible, that is, normal control is internal and, when needed, control may be transferred to an external device. For mixed control operations one should ensure that program 8 can be used as a buffer for several interface modes. Therefore, for mixed control operations only programs 0 through 7, or 9 may be used since program 8 will be used for switching the control type.

The monitor program can be used to establish a basic stress program. Program creation is done as follows:





button „MONITOR“ once more. 

ACTIVATE PROGRAM M Program No 0 max. HEARTFREQ. HF < XXX max. Syst. S < XXX mmHg    

 Select the program number that you wish

to program by entering the program number with the numeric keypad.  Program the selected stress program as

described in this chapter.  Confirm the entry by pressing the „RE-

TURN“ key. The main menu will then reappear. In order to proceed to other menu items, e.g. defining another program, the monitor program must be called up again. See above. er900 Operation Manual Art-No: 475.037

40

Version: 05/02

   7.4.1


Setup of Automatic Program 0 Automatic program 0 is for the fully automated testing of patients with unknown circulation condition, in particular, weak patients. The ergometer’s control computer uses this program to test the patient’s circulation response across two or three different but specific load increments. The computer then determines three standard load increments within which the pre-set maximum heart rate should be attained. The standard load increments and the corresponding time intervals are taken from the WHO table for stress analysis.   

ACTIVATE PROGRAM M Program No 0 max. HEARTFREQ. HF < XXX max. Syst. S < XXX mmHg 

ACTIVATE PROGRAM M max . Diast . D< XXX START LOAD Po = XXX W max. LOAD Pmax = XXX W 

ACTIVATE PROGRAM M Interv . BPM = XX min . 0 PWC = XXX PWC = XXX TRAININGIND. [ Y / N ] N    

 Call up program creation as described in the

preceding section.  Select program 0 in the field „Program No“.  You can now assign the individual parameters.

The meaning of these parameters for this special analysis program is described below.  The cursor will automatically skip to the next

field when entry is complete for the current field. Complete entry must be made in each field in accordance with the number of character positions provided. The arrow keys may be used to move to any field desired. The display will scroll automatically when the upper or lower display margins are reached.  Close data entry with the „RETURN“ key.

Now program 0 is configured in accordance with your choices. Any parameter may still be changed at the beginning of ergometry for a specific ergometric run.

The meaning of the various training parameters: max. Heartfreq. = heart rate which is to be attained in three standard load steps. When this goal has been reached the program will stop. (Any one of the alarm conditions described below will also cause program termination.) max. Syst. = alarm parameter, when reached will cause program termination. max. Diast. = alarm parameter, when reached will cause program termination. Start load = load value with which the system begins stressing the patient. max. Load = maximum load value that is not to be exceeded. Interv. BPM = interval at which blood pressure readings are to be made. PWC = heart rate value at which a PWC value is to be determined (see Appendix D.1). TRAININGIND. = see appendix (see Appendix D.2). Version: 05/02

41



  

Definition of Programs 1-8 The operator has the choice of eight stress programs that are freely programmable to specific requirements on the ergometrics er900. In these eight programs, all control and alarm parameters are fully selectable. As with programs 0 and 9, the setup accomplished with the monitor program represents a basic setup that can still be changed for any specific ergometry run at the beginning of that particular ergometry.



Program 8 is an exception to this rule in case the ergometer is operated in mixedcontrol mode. That is, when the ergometer switches back and forth between internal and external (from an ECG or PC) control. Program 8 should not be used in such cases as it is used as an interface buffer for various external control modes which will cause parameters to be lost.    

ACTIVATE PROGRAM M Programm No 0 max. HEARTFREQ. HF < XXX max. Syst. S < XXX mmHg 

ACTIVATE PROGRAM M max . Diast . D< XXX START LOAD Po = XXX W max . LOAD Pmax = XXX W 

ACTIVATE PROGRAM M Interv . BPM = XX min . 0 PWC = XXX PWC = XXX TRAININGIND. [ J / N ] N 

ACTIVATE PROGRAM M LOAD STEP 01 : 12 0 INTERV. LOAD = XX min . LOAD INCREMENT XXX W    


 Call up program definition as described in the

preceding section.

 Select the desired program to be modified

(1-8) in the field „Program No“.

 Now you can set the individual parameters.

The significance of the parameters for this special analysis program are described below. The cursor will automatically skip to the next field when entry is complete for the current field. Complete entry must be made in each field in accordance with the number of character positions provided. (Example: Start Load Po = 3 characters; entry value of 50 Watt would be entered as Po = 050W). The arrow keys may be used to move to any field desired. The display will scroll automatically when the upper or lower display margins are reached.

 Close data entry with button „RETURN“ . The

selected program is now configured according to your choices. Any parameter may still be changed at the beginning of ergometry for a specific ergometric run. 42

Version: 05/02

  


The meaning of the various training parameters : max. Heartfreq max. Systole max. Diastole Start Load

= = = =

max. Load Interv. BPM PWC

= = =

TRAININGSIND. LOAD STEPS

= =

INTERV.LOAD

=

LOAD CHANGE

=

alarm parameter parameter,, when reached will cause cause program program termination termination alarm parameter parameter,, when reached will cause cause program program termination termination alarm parameter parameter,, when reached will cause cause program program termination termination load value value with which the the system system begins begins stressing stressing the patient. The time interval for the initial load is specified by the interval for the first load increment. maximum maximum load load value value that that is not not to be be exceede exceeded d interval interval at which which blood blood pressure pressure readings readings are are to be made made heart rate rate value value at which which a PWC value value is to to be determi determined ned (PWC value see appendix) see see ap appen endi dix x twelve load steps may be programmed programmed individual individually ly.. An entry made into any one of these load steps will cause the same value to be entered into all subsequent load steps. The load settings of the 12. load step are maintained for all subsequent load steps up to the 99. load step. time interva intervall of the load, load, that is elaps elapsed ed time for for the respect respective ive load step. amount amount of load chang change e with respect respect to the the previous previous load load step step Example : In I nitial load = 025 W Load change 1 = 015 W + __________ Load step 1



=

040 W

In Annex C attached to this operator’s manual, you will find programming forms. We recommend that these forms be filled out before actually programming the ergometer. Save these forms as they will be useful if the ergometer should malfunction and these program settings need to be restored.

Version: 05/02

43


Ergometer Type er900 7.4.3 7.4 .3

  

Defini Definitio tion n of of Progr Program am 9 for PulsePulse-Ste Steady ady-St -State ate Trainin raining g Program 9 offers pulse-steady-state training capability. capability. A continuously available heart rate input is prerequisite for this program. program. Heart rate input can be accomplished accomplished in various ways. You can attach an ear/finger clip, a pulse monitor (such as the Polar Pacer) or connect a QRS trigger output from an ECG device being used (see Annex E to this operator’s manual).

   

ACTIVATE PROGRAM M Program No 0 > X< max. HEARTFREQ. HF < XXX max. Syst. S < XXX mmHg 

ACTIVATE PROGRAM M max . Diast . D< XXX START START LOAD Po = XXX W max . LOAD Pmax = XXX W 

ACTIVATE PROGRAM M Interv . BPM = XX min . 0 PWC = XXX PWC = XXX TRAININGIND. [ Y / N ] N 

 Call up program creation as described in the

preceding section. No“. „Program No“.  Select program 9 in the field „Program  Now you can set the individual parameters.

The significance of the parameters for this special analysis program are described below. The cursor will automatically skip to the next field when entry is complete for the current field. Complete entry must be made made in each field in accordance with the number of character positions provided (Example: Start Load Po = 3 characters; entry value of 50 Watt would be entered as P0 = 050W). The arrow keys may be used to move to any field desired. The display will scroll automatically when the upper or lower display margins are reached.

ACTIVATE PROGRAM M LOAD STEP 01 - 12 12 0 INTERV. LOAD = XX min . LOAD CHANGE XXX W    


„RETURN““ key.  Close data entry with the „RETURN Now program 9 is configured in accordance with your choices. Any parameter may still be changed at the beginning of ergometry for a specific ergometric run.

44

Version: 05/02

  


The meaning of the various training parameters: max. Heartfreq.

=

This This is is the the pulse pulse-st -stead eady-s y-stat tate e limi limitt for for hea heart rt rate rate tha thatt is to be used used in this training. When this limit is reached, reached, the ergometer ergometer will take over complete load control to ensure that the patient’s heart rate remains stable at this level (by lowering l owering and raising the load automatically).

max. Systole

=

Alarm Alarm pa para rame meter ter,, whe when n rea reach ched ed will will cau cause se progra program m term termina inatio tion n

max. Diastole

=

Alarm Alarm pa para rame meter ter,, whe when n rea reach ched ed will will cau cause se progra program m term termina inatio tion n

Start Load

=

Load valu Load value e with with wh whic ich h the the syst system em be begin gins s stre stress ssing ing the pa patie tient. nt. The time interval for the initial load is specified by the interval for the first load increment.

max. Load

=

Maxi Ma ximu mum m loa load d val value ue that that is no nott to to be be exc excee eede ded d

Interv. BPM

=

Inte Interv rval al a att whic which h blo blood od pres pressu sure re rea readi ding ngs s are are to to be be mad made. e.

PWC

=

Heartt rat Hear rate e val value ue at wh whic ich h a PWC PWC val value ue is to be de dete term rmin ined ed (see ANNEX D.1)

TRAININGIND.

=

see ANNEX D.2

LOAD STEP

=

Twe welve lve load load steps steps ma may y be indiv individu idual ally ly progra programm mmed ed.. An en entry try made into any one of these load steps will cause the same value to be entered into all subsequent load steps. The load settings of the 12. load step are maintained for all subsequent load steps up to the 99. load step.

Interv. LOAD

=

Time interv interval al of the load, load, tha thatt is is elap elapse sed d time time for the respec respectiv tive e load step.

LOAD CHANGE

=

Amou Amount nt of of load load chan change ge with with res respe pect ct to to the the pre previ viou ous s load load s ste tep p Example : Initial load Load change 1 LOAD step 1



= 025W = 015W + -----------= 040 W

When running pulse-steady-state training, the significance of the load increments and load changes is limited to the preliminary training prior to reaching the desired maximum heart rate (Pulse-Steady-State limit). Load control is dependent upon heart rate response after this limit is reached. Pulse-Steady-State training may only be carried out when the heart rate is continuously provided to the system.

Version: 05/02

45



    

8.

Structure of Programs

8.1 8.1

Gener era al St Struct ucture of of Pr Program grams s 11-8

8.1.1

Factory Setti ttings The programs 1-8 can be individually programmed for the testing of various patient groups such that at the push of a button the right program is at hand. Programs 1-4 have been pre-programmed with sample programs by ergoline prior to delivery delivery.. These programs are only exemplary and can, of course, be changed.

y l g l a n i o c r t e s p y s l e e t ( ) s n a t r n e e e d i m t o o a m p w

c ) i t n e g l e n h t m o a d r t y s l l n y a a l l t s i c n a n e e e m m r i t p s o a e o n p ( w

s r e n r , e o b s m t a n t s l e r y i t o v a p a p s e g e h n i v o t d r t c n s a a

1

2

3

4

max. heart rate

150

150

150

170

max. systolic pressure

230

230

230

240

max. diastolic pressure

130

130

120

100

Start load Po

25

50

50

50

max. Load Pmax

999

999

999

999

Interval BP in min.

1

1

2

2

PWC

110

130

130

150

PWC

130

150

150

170

Training index

N

J

J

J

Load steps

01 02 . . .

01 02 . . .

01 02 . . .

01 02 03 . .

Interval load in min

01 01 . . .

01 01 . . .

01 02 . . .

01 02 02 . .

Load change in Watts

010 010 . . .

010 010 . . .

025 025 . . .

025 025 025 . .

g ) s k t t n 5 h e 4 i g i t . a x e p o w k r y a p d e p o a w ( b

Program No.


46

Version: 05/02

     8.1.2


Creating Your Own Load Program Programs 1-8 were intended to be programmed from the monitor program, as described in this manual, for various pre-defined patient groups. This allows you to select the appropriate program for a patient at the touch of a button. This gives you basic settings with which the stress test of the patient can be performed. You may still change any of the parameters prior to starting ergometry. Such a parameter change, that is not accomplished within the monitor program, is only temporary and effective for this specific one ergometry. Such changes are voided at the end of the ergometry. This is why, when you use the monitor program to program the load programs, you need to proceed such that only the absolute limits for an entire patient group be pre-set as alarm parameters. The patient specific alarm parameter should be entered when the program is called up. In general eight programs with differing load characteristics are adequate to serve various types of patient groups if patients are grouped by their load requirement patterns. The flowchart below serves to clarify the process of an ergometry.

Determine the correct patient group for the patient.

Select the appropriate program for the patient.

If necessary, change circulation alarm parameters

Start the program (blood pressure measurement at rest) Print-out of the resulting data Start load program at Po Print-out of the loaded data with every load change and/or every blood pressure measurement Load increments 1...12 as programmed

Load program termination (caused by reaching an alarm parameter, dropping below the minimum RPM rating of 30 RPM or because the „END“ key was pressed); transition to the recovery phase Print-out of measurement results for the on-going blood pressure measurements Terminate ergometry by again pressing the „END“ key Output of the summary protocol Version: 05/02

47



    

8.2

Systematic Setup of Programs

8.2.1

Setup of Automatic Load Program 0 Program 0 does not permit any load settings from the operator. The initial load is set to 25 Watt, the maximum load is set to 999 Watt, and the blood pressure interval is set to 1 minute. Individual load increments are not programmable. The loading process is determined automatically by the ergometer during the ergometry process and is only dependent upon the circulation response of the patient. Program 0 is intended for critical patients whose circulatory condition is unknown. It is therefore necessary that the parameters are accordingly conservative. Establish alarm parameter values such that even very weak patients will not be over-stressed. The program will calculate three standard load increments of 5, 10 or 25 Watt within which the patient can reach the pre-set heart rate. The resulting protocol data will enable you to subsequently classify the patient into one of the patient groups for which you have a specific program (1-8).



Continuous doctor’s attention is also required for patients who are stressed with automatic program 0 since the circulatory response is not continuously monitored. Parameters can change abruptly between individual blood pressure measurements without the system being able to counteract appropriately.


48

Version: 05/02

    


Program flowchart:

Patients with unknown circulatory conditions select program 0

If necessary, change circulation alarm parameters Start program (blood pressure measurement at rest) Print-out of resulting data Load program start at Po Print-out of the loaded data with every blood pressure measurement Calculation of standard increments via 2-3 free load increments, subsequently stressing with 3 standard load increments to reach the max. heart rate

Load program termination (caused by reaching an alarm parameter, dropping below the minimum RPM rating of 30 RPM or because the „END“ key was pressed); then transition to the recovery phase Print-out of measurement results for the on-going blood pressure measurements Terminate ergometry by again pressing the „END“ key Output of the summary protocol

Version: 05/02

49



    

Pay attention to the execution of the program when programming. The base values that were entered via the monitor program are not necessarily those that are appropriate for a given patient. When programming you should only enter upper limit values that apply to the largest possible group of patients. Any parameter can still be changed for any specific ergometric run such that the parameters are tailored to the patient. You should also select alarm values that will prevent over stressing even weaker patients but still allow for a meaningful test. Select an initial load that will not overburden the weaker patients. If you do not the circulation condition will show false results and automatic ergometry is then impossible. In general, automatic ergometry is only used for acute, mostly weak, patients. Accordingly, you should set the parameters at relatively low levels. Heart rate is one exception in these parameters. It should only be entered via the monitor program as a nominal value. Adapt this value however, to each individual patient, prior to ergometry. The ergometer works toward attaining this maximum heart rate. Program 0 will try to reach the maximum heart rate by using three standard load increments. You should, therefore, set the maximum heart rate in accordance with the capabilities of the individual patient so as to avoid excessive stress. It is also astute to provide the ergometer with a continuous heart rate. This can be done with an ear/finger clip, a pulse monitor or with a heart rate feedback from an ECG unit (see appendix).



Enter the maximum heart rate via the monitor program only as a nominal value but adapt this value to each individual patient prior to ergometry.



Write your programs on the program forms (as found in the appendix of this manual) before entering them in the console of the ergometer. This contributes to clarity and proper record keeping.

You should write your program on one of the programming forms before entering the program on the console of the ergometer. The programming form is an aid that helps the operator to maintain an overview of the various parameters. The program forms also represent a permanent record of the programs that are available if the unit should malfunction. You will find blank programming forms in the appendix to this manual. An example of a programming form already filled out can be found in this chapter.


50

Version: 05/02

    


Program Listing Program No.: 0

maximum heart rate

HR

=

14 0 140

1/min.

maximum Systole

S

=

23 0 230

mmHg (kPa)

maximum Diastole

D

=

13 0 130

mmHg (kPa)

initial load

Po

=

25

watt

maximum load

Pmax

=

99 9 999

watt

blood press. measurement interv.

INTERV.BDM =

01

min.

desired PWC value

PWC

=

Training index.

J

N

13 0 130

PWC

=

150 15 0

Load increments: Step 1

Step 2

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Step 3

Step 4

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Step 5

Step 6

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Step 7

Step 8

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Step 9

Step 10

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Step 11

Step 12

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Version: 05/02

51


    


Setup of the Fully Programmable Load Programs 1-8 Programs 1-8 serve to provide the user with a stress program spectrum that will accommodate the patient groups that are to undergo ergometry. Every parameter in these eight programs is freely definable and will be upheld by the ergometer unless an alarm parameter is exceeded or a manual change is made to ergometry by the operator. In this manual you will find examples of such patient group oriented programs. These example programs are the same as those that are factory pre-programmed prior to shipment. Naturally, these programs can also be overwritten and individually adapted to the wishes and needs of the user. Program Flow: Classify the patient as belonging to a particular patient group. Select the appropriate program (1-8).

If necessary, change circulation alarm parameters

Start program (blood pressure measurement at rest) Print-out of resulting data Load program start at Po Print-out of the loaded data with every blood pressure measurement Increasing the load according to the pre-programmed load increments at the pre-programmed intervals

Load program termination (caused by reaching an alarm parameter, dropping below the minimum RPM rating of 30 RPM or because the „END“ key was pressed); transition to the recovery phase Print-out of measurement results for the on-going blood pressure measurements Terminate ergometry by again pressing the „END“ key Output of the summary protocol


52

Version: 05/02

    


Pay attention to the execution of the program when programming. Determine the parameters for the various patient groups before you begin to program. Select alarm and load parameters according to average strength characteristics of patient groups. Select parameter values such that most individuals in the group require no parameter changes and those that may become necessary are minor. Reserve a program, preferably program 8, for special patients that require an individualized program. Here, you can create experimental programs suited to the patient’s specific requirements. To make such an experimental program, set all of the parameters for the selected program (e.g. program 8) to minimum or maximum values, i.e. 0 or 999, so that all automatic control functions are turned off. Then you can enter the actually desired values for this specific ergometry just before starting the session.



For special ergometrics, setup one program (e.g. program 8) as experimental with all maximum or minimum parameter values.

You should write your program on one of the programming forms before entering the program on the console of the ergometer. The programming form is an aid that helps the operator maintain an overview of the various parameters. The program forms also represent a permanent record of the programs that are available if the unit should malfunction. You will find blank programming forms in the appendix to this manual.



Version: 05/02

Write your programs on the program forms (as found in the appendix to this manual) before entering them in the console of the ergometer. This contributes to clarity and proper record keeping.

53


    


Setup of Program 9, Steady-Pulse (Cardiovascular Training) Program 9 is for pulse-steady-state training. The ergometer increases the load from the outset of the training according to your parameters. Upon reaching the maximum heart rate setting, instead of causing program termination, the unit switches over to pulse-steady-state control. That means that load changes are calculated to maintain this heart rate. It is absolutely necessary to provide the ergometer with a continuous heart rate signal when running the pulse-steady-state program. This can be accomplished with an ear/finger clip, a pulse monitor or a heart rate feedback from an ECG unit. Once reached, the ergometer will hold the maximum heart rate value stable until an additional alarm parameter is exceeded or the training session is manually ended by the operator. Program Flow: Patient for pulse-steady-state training select program 9 Possible change of the maximum heart rate Start program (blood pressure measurement at rest ) Print-out of resulting data Load program start at Po Print-out of the loaded data with every blood pressure measurement Increasing the load according to the pre-programmed load increments at the pre-programmed intervals until the max. heart rate value is reached

Transition to pulse-steady-state control. Load will be automatically altered in response to the heart rate. Load program termination (caused by reaching an alarm parameter, dropping below the minimum RPM rating of 30 RPM or because the „END“ key was pressed); transition to the recovery phase Print-out of measurement results for the on-going blood pressure measurements Terminate ergometry by again pressing the „END“ key Output of the summary protocol er900 Operation Manual Art-No: 475.037

54

Version: 05/02

    


Pay attention to the execution of the program when programming. Since program 9 is a pure training program, alarm parameters (except for heart rate) should be chosen so that any danger to the patient is remote. Select a warm-up load parameter (used until reaching the max. heart rate value set) such that reaching the heart rate value will not go too quickly or take too long. When the warm-up phase is too short, reasonable pulsesteady-state training is not possible as the circulatory system has not yet adjusted to the load. When the warm-up phase is too long, the patient is already tired before the actual training phase has been reached.



Program 9 is purely a training program. Parameters must be selected that reflect the requirements of this mode of operation (as opposed to programs 0-8).

You should write your program on one of the programming forms before entering the program on the console of the ergometer. The programming form is an aid that helps the operator maintain an overview of the various parameters. The program forms also represent a permanent record of the programs that are available if the unit should malfunction. You will find blank programming forms in the appendix to this Operation Manual.



Write your programs on the program forms (as found in the appendix to this manual) before entering them in the console of the ergometer. This contributes to clarity and proper record keeping.

Version: 05/02

55




 

56

Version: 05/02

  

9.

Cleaning

 9.1


The unit, blood pressure cuff and related accessories should be regularly cleaned, if required, daily. Important !! Be sure to disconnect the power cord prior to cleaning the unit.

Cleaning the Unit



Use a soft cloth moistened with a mild cleanser to wipe off the unit as needed. Ensure that the cloth is not fully saturated. A fully saturated cloth may allow liquid to enter the unit and cause a defect.

Do not use strong household cleaners or disinfectants to clean the unit. This may damage the unit’s finish and lead to defects. Recommended are disinfectants like Fugaten spray, Lysoform or Promanum N. 9.2

Cleaning the Blood Pressure Cuff

 

The blood pressure cuff may also be cleaned with mild soapsuds. Only alcohol may be used to disinfect the cuff. Other disinfectants or the use of strong cleansers may damage the cuff and lead to defects. The microphone should also be cleaned at regular intervals. To clean the microphone, remove it from its pocket in the cuff (pay attention to its position in the cuff, it must be replaced in the same position after cleaning - the level side of the microphone has to be pointing towards the arteria). Clean it with a mild detergent or alcohol. Defects caused by improper detergent and disinfectants as well as defects originating from insufficient cleaning of the unit are excluded from the guarantee.

Version: 05/02

57




 

58

Version: 05/02

    


Appendix A: Interfaces The bicycle ergometer er900 features a number of interfaces. Data can be transmitted or received by the ergometer in analog or digital modes. Complete external control of the ergometer from a PC or ECG is possible via these interfaces. These interfaces are also capable of transferring information to external devices (PC or ECG). ergoline provides a wide range of control variations using a variety of control protocols with a combination of analog and digital signals. These protocols permit the ergometer’s connection to practically all ECG units on the market that have an ergometric program. You will find the interface protocols in this appendix.

A.1

Input and Output Pin Specifications

Pin1 Pin2 Pin3 Pin4 Pin5

= = = = =

TxD GND RTS CTS RxD

Inputs = Kursiv Version: 05/02

Pin1 Pin2 Pin3 Pin4 Pin5 Pin6 Pin7 Pin8 Housing

= = = = = = = = =

External Load Remote Start BPM Remote Start ECG Pulse output Load output Diastole output ECG input Systole output GND

Pin1 Pin2 Pin3 Pin4 Pin5 Pin6

= = = = = =

+5VAnalog ECG input. NC NC Opto input GND Analog

Outputs = Normal

59


    


ergometrics er900 Interface ECG Type P1 Software Version V.243 Interface for digital data transfer from er900 to PC or ECG with internal control of er900 Voltages: logic low

logic high

Transmit Output (Pin 1)

>+7 V

<-7 V

Receive Input (Pin 5)

>+3 V

<-3 V

Baud rate: 2400/4800 Baud

Protocol: Format Start bit Data bits Stop bit Parity Handshake

ASCII 1 8 1 None None

Hardware Connection :

Pin 1 Pin 2 Pin 3 Pin 4 Pin 5 er900 Operation Manual Art-No: 475.037

60

Transmit (Output) GND NC NC Receive (Input) Version: 05/02

    


Transmission Protocol : DATE 14.06.91 LOAD (watt) 000 SYSTOLE(mmHg) XXX

TIME 08.23 HR (pulse/min) XXX DIASTOLE(mmHg) XXX

Protocol of measurement at rest

TORQUE (n/min) LOAD (watt) SYSTOLE(mmHg)


Protocol of first load step

XXX XXX XXX  • •


XXX XXX XXX


Protocol of fourth load step

TORQUE (n/min) LOAD (watt)

XXX XXX

TIME 08.27 HR (pulse/min) XXX

Protocol of load program termination

DATE 14.06.91 SYSTOLE(mmHg) XXX HR (pulse/min) XXX

TIME 08.28 DIASTOLE(mmHg) XXX

Protocol of first recovery measurement



Protocol of second recovery measurement

DATE 14.06.94 P max (watt) XXX PWC110 (watt) XXX PWC130 (watt) XXX PWCXXX (watt) XXX

TIME 0829 HR (pulse/min) PWC110 (watt/kg) PWC130 (watt/kg) PWCXXX (watt/kg)

Summary protocol at the end of the complete ergometry

XXX XXX XXX XXX

TRAINING IND. = XXXXX

A protocol will automatically be produced at every blood pressure measurement and at every load increment. This data will be sent to the RS-232 interface without a prompt, command, or service request from the external device. Control of load and blood pressure measurements as well as the monitoring of alarm parameters is handled internally from the console of the ergometer.

Version: 05/02

61


    


ergometrics er900 Interface ECG Type P2 Software Version V.243 Interface for digital data transfer from er900 to PC or ECG with internal control of er900 Voltages: logic low

logic high


>+7 V

<-7 V


>+3 V

<-3 V





Pin Pin Pin Pin Pin er900 Operation Manual Art-No: 475.037

62

1 2 3 4 5

Transmit (Output) GND Receive (Input) Version: 05/02

    


Transmission Protocol DATE 14.06.91 LOAD (watt) 000 SYSTOLE(mmHg) XXX



LOAD (watt)

XXX

Load rep., begin increm.

LOAD (watt)

XXX

Load rep., end increm.

TORQUE (n(min) LOAD (watt) SYSTOLE(mmHg)

XXX XXX XXX

LOAD (watt)

XXX


LOAD (watt)

XXX



XXX XXX XXX

LOAD (watt)

XXX


LOAD (watt)

XXX



XXX XXX XXX

LOAD (watt)

XXX


LOAD (watt)

XXX













DATE 14.06.94 P max (watt) XXX PWC110 (watt) XXX PWC130 (watt) XXX PWCXXX (watt) XXX TRAINING IND. = XXXXX



Version: 05/02

63

XXX XXX XXX XXX



    


ergometrics er900 Interface ECG Type P4 Software Version V.243 Interface for digital data transfer from er900 to an ECG, with analog control via the ECG Voltages:

Digital

logic low logic high


>+7V


>+3V

Analog

Baud rate :

<-7V <-3V

minimal maximal

resolution

Load argument (input)

0V

5V

adjustable

Load return (output)

0V

6V

adjustable

RPM return (output)

0V

6V

1V = 50 1 / min

2400 or 4800 Baud



Hardware Connections :

Remark: Applies only to the RS-232 digital interface

Pin 1 Pin 2 Pin 3 Pin 4 Pin 5

Transmit (Output) GND NC CTS Receive (Input)

Pin 1 = Load argument (input) Pin 2 = Remote Start BPM (input) Pin 3 = Remote Start ECG (output) Pin 4 = Pulse frequency (output) Pin 5 = Current load (output) Pin 6 = Current diastole (output) Pin 7 = QRS signal (input) Pin 8 = Systole (output) Case = GND


64

Version: 05/02

    


Transmission Protocol: In contrast to purely digital transmission, ECG type P4 protocol always responds, upon demand, with a standardized data record. The string consists of 54 alphanumeric characters with „Carriage Return“ and „Line Feed“ as line delimiters. The RS-232 will only accept the „S“ command. All other characters will be ignored. Ergometry cannot be terminated with an interface command. The ergometry will automatically terminate, at the latest, six minutes after the test subject ceases to pedal. Error measurements of the blood pressure unit are discernible in that all values in the data string are set to „000“. Control flow with P4 :

Start command sent from controlling device (e.g. ECG) S

The ergometer will begin the ergometry by taking the blood pressure measurement at rest. After the blood pressure measurement is completed, the following string will be sent from the ergometer. NR.01,SYST:xxxmmHg,DIAST:xxxmmHg,Pulse:xxx/min

The pre-set load will be applied after the data record has been sent.

Every subsequent blood pressure measurement must be triggered with the „S“ command.

After every new start command a new blood pressure measurement will be taken and then the data record (as below) reported. NR.xx,SYST:xxxmmHg,DIAST:xxxmmHg,Pulse:xxx/min

Remark: NR.xx, SYST: xxx mmHg , DIAST: xxx mmHg ,PULSE: xxx/min measurement no.

diastolic value systolic value

Version: 05/02

heart rate value

65


    


ergometrics er900 Interface ECG Type P5 Software Version V.243 Interface for digital data transfer from er900 to PC or ECG (for Cardiosunny / Polymed) Voltages : logic low

logic high


>+7 V

<-7 V


>+3 V

<-3 V


Protocol: Format Start bit Data bits Stop bits Parity Handshake




66

1 2 3 4 5

Transmit (Output) GND NC CTS Receive (Input) Version: 05/02

    


Transmission Protocol: DATE 14.06.91 LOAD (watt) 000 SYSTOLE(mmHg) XXX

TIME 08.23 HR ((pulse/min) XXX DIASTOLE(mmHg) XXX





XXX XXX XXX   


XXX XXX XXX



TORQUE (n/min) LOAD (watt)

XXX XXX

TIME 08.27 HR (pulse/min) XXX







DATE 14.06.94 P max (watt) XXX PWC110 (watt) XXX PWC130 (watt) XXX PWCXXX (watt) XXX



XXX XXX XXX XXX


TRAININGSIND. = XXXXX

A protocol will automatically be produced at every blood pressure measurement and at every load increment. This data will be sent to the RS232 interface without a request from the external device. Control of load and blood pressure measurements as well as the monitoring of alarm parameters is handled internally from the console of the ergometer.

Version: 05/02

67


    


ergometrics er900 Interface ECG Type P10 Software Version V.243 Interface for digital data transfer from er900 to PC or ECG. The ergometer control is done via PC or ECG Voltages:

logic low

logic high


>+7 V

<-7 V


>+3 V

<-3 V




Hardware connection:


68

1 2 3 4 5

Transmit (Output) GND Receive (Input) Version: 05/02

    


Transmission Protocol : Command from PC (ECG)

Response from er900

Description

W xxx

---

Sets a load target of xxx Watts.

L xxx

---

Sets load increment to xxx Watts per minute. (The load will be increased in 1 Watt steps over the period of one minute.)

A xxx

---

Sets the initial load Po (load value to start of ergometry ) to xxx in Watts.

P xxx

---

Sets the maximum pulse rate to xxx per min. (Only makes sense for pulse steady state training.)

S

---

Start of blood pressure measurement at rest with subsequent start of ergometry with initial load Po.

s

---

Start of ergometer with the initial load Po without a prior Po blood pressure measurement at rest.

B

B xxx

Query for current load. Output of current load in W.

D

n xxx

Query for current rpm value. Output of current rpm value in 1/min.

H xxx

Query for current heart rate. Output of current heart rate in 1/min.

O xxx

Query for current systolic value. Output of current systolic value in mmHg.

U

U xxx

Query for current diastolic value. Output of current diastolic value in mmHg.

F

---

I

0900P10VXXX

H

O

End of ergometry process (should be sent three times ).

Identification string of the ergometer. The string contains the device type 0900-, ECG interface protocol - P10 - and software version number VXXX

Remark: W xxx command Version: 05/02

value (e.g. load value)

carriage return (end of line)

69




 

70

Version: 05/02

     


B.1 Additional Settings in the Monitor Program B.1.1 Setting the ECG Type Setting the ECG type determines the manner in which the interface is handled. Descriptions of the various possible modes can be found in appendix C.





Press the „MONITOR“ key. The monitor main menu will appear in the display.

MONITOR V.XXX ACTIVATE PROGRAM ADJUST CLOCK mmHg - kPa 



Use the arrow keys in the alphanumeric keypad to move the cursor to the menu item „ECGTYPE“.



Call up this sub-program by pressing the „MONITOR“ key again.



Move the cursor with the arrow keys in the alphanumeric keypad to the correct ECGTYPE.



Confirm your programming entries by pressing the „RETURN“ key. The unit will then automatically reset and return to the starting state once again.




V.XXX





P1 P2 P3 P4

P5 P6 P7 P8

P9 P10 P11 P12

M



  

You may now continue with other settings or exit the monitor program by pressing the „RETURN“ key again.

Version: 05/02

71



     

B.1.2 Setting the Baud Rate Use of the RS-232 interface requires that the transmission rate of data sent and received (baud rate) be established. For some modes of operation this baud rate is fixed and with others it must be selected. If you have selected a particular ECG device, the baud rate is already fixed. The baud rate is 4800 for interface modes P1, P2 and P10. You only need to alter the baud rate when a value of 2400 is required (instead of 4800).






MONITOR V.XXX ACTIVATE PROGRAM ADJUST CLOCK mmHg - kPa  

Use the arrow keys in the alphanumeric keypad to move the cursor to the menu item „TRANSM.SPEED“.



Call up this subprogram by pressing the „MONITOR“ key again.



Move the cursor with the arrow keys in the alphanumeric keypad to the desired baud rate.



Confirm your programming entries by pressing the „RETURN“ key. The main menu will appear again.




V.XXX





TRANSM.SPEED 2400 Baud 4800 Baud

Press the „MONITOR“ key.

M (*) (*)



  

You may now continue with other settings or exit the monitor program by pressing the „RETURN“ key again.


72

Version: 05/02

     


B.1.2 Switching Between Internal and External Load Control This setting is concerns the load control. Internal control means that the ergometer’s internal program will determine the load. External means that the load will be controlled by the device connected to the analog interface. When the load is controlled externally, the ergometer controls only the blood pressure measurements and data transfer over the RS-232 interface. Some interface modes are based upon external load control and others do not permit external load control. (see Appendix A). 






 

Use the arrow keys in the alphanumeric keypad to move the cursor to the menu item „LOAD INT/EXT“.






Move the cursor with the arrow keys in the alphanumeric keypad to the desired selection.



Confirm your programming entries by pressing the „RETURN“ key. The main menu will appear again.



MONITOR V.XXX LOAD INT/EXT ADJUST LOAD - INPUT ECG - RECORD 



LOAD INT-EXT INT EXT

M

(*) (*) 

  

Version: 05/02

You may now continue with other settings or exit the monitor program by pressing the „RETURN“ key again. If external control has been selected, the display will now show P=ext instead of P=000 in the upper left-hand corner. 73



     

B.1.4 Hardware Diagnostics This program can check the hardware in the event that an error in the system should occur. You can check for operating voltages being within their tolerances and, when necessary, check to see if the blood pressure measurement system has a leak, and also check it for correct display.







MONITOR V.XXX ACTIVATE PROGRAM ADJUST CLOCK mmHg - kPa 



Use the arrow keys in the alphanumeric keypad to move the cursor to the menu item „TEST“.






MONITOR TEST ADJUST TORQUE ADJUST OUTPUT

V.XXX





TEST +-5Va = +5Vd = +24V =

The display will now show the current operating voltages. To the right of each voltage the allowable tolerance will be displayed. The next test display is reached by pressing the down arrow-key in the alphanumeric keypad.

M X.XXV X.XXV XX.XV

[0.2] [0.3] [6V]

 

The current setting for external load will now be displayed along with the current values for null voltages on the blood pressure unit’s transducer (C-BPT) and on the expansion strip of the drive unit (C-ES). The air system on the blood pressure measurement unit can also be pressurized to test for a leak and to see that it displays correctly.



Pressing the „RETURN“ key will cause an exit from the test program at any time.



BEL-EXT = 000W TEST M U-TD = XXX [020 - 150] U-DMS = XXX [050 - 250] S = 000 mmHg D = 000 mmHg 


74

Version: 05/02

     


Program Listing Program No.: ____

maximum heart rate

HR

=

1/min.

maximum Systole

S

=

mmHg (kPa)

maximum Diastole

D

=

mmHg (kPa)

initial load

Po

=

watt

maximum load

Pmax

=

watt

blood press. measurement interv.

INTERV.BDM =

min.

desired PWC value

PWC

=

Trainingsind.

J

N

PWC

=

Load increments: Step 1

Step 2

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Step 3

Step 4

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Step 5

Step 6

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Step 7

Step 8

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Step 9

Step 10

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Step 11

Step 12

Load interval

=

min.

Load interval

=

min.

Load change

=

watt

Load change

=

watt

Version: 05/02

75


    


D.1

PWC Values

D.1.1 What is a PWC Value? The PWC (Physical Work Capacity) value is an index of the physical power of a patient at a given heart rate. Empirically derived values for men and women in various age groups are used as objectives. Various authors have established PWC tables. Naturally there are minor performance variations in these assorted tables. To arrive at a standard, PWC values for the following heart rates were calculated: HR = 130/min. HR = 150/min. HR = 170/min. These values establish what performance a patient in the assorted age groups should have at a heart rate of 130, 150 or 170 beats per minute to be considered normal for his/her respective patient group. If only heart rate is considered with regard to a particular performance, the resulting absolute value is of little significance (e.g. 200 Watt at HR=150/min.). The patient’s weight must receive consideration with regard to the performance factor in order for the results to be relevant and comparative. Continuing the same example, for a patient with a weight of 100kg this means: Performance at HR 150/min. = 200 Watt the resulting PWC value is: PWC150 = 200 Watt/100kg = 2 Watt/kg body weight The following tables from the book „Stress Analysis in Practice“ from Rost and Hollmann can be used as a standard for performance characteristics. Table 5.3, Pulse relevant performance characteristics PWC130 PWC150 and PWC170, recorded in our institute, that are based upon non-conditioned men between ages 30 and 70 given in, Watt/kg.

agegroup

n

A (years)

weight (kg)

height (cm)

20 -30

14

24,7

77,6

182

30 - 40

39

35,2

80,6

179

40 - 50

28

45,0

79,8

176

50 - 60

21

54,1

75,8

172

60 - 70

21

65,2

76,3

172

PWC 130 1,45 ± 0,38 1,52 ± 0,40 1,51 ± 0,34 1,56 ± 0,25 1,49 ± 0,33

PWC 150

± ± ± ± ±

1,98 0,38 2,05 0,41 1,96 0,37 2,05 0,30 1,94 0,33

PWC 170

± ± ± ± ±

2,51 0,48 2,53 0,45 2,48 0,42 2,64 0,40 2,37 0,38

Standard values for PWC in Watt/kg body weight. The mean deviation is ±0.4 Watt PWC130 PWC150 PWC170


men 1,50 2,00 2,50

women 1,25 1,60 2,00

76

Version: 05/02

    

D.2


Training Indicator

The system can calculate and print a training indicator when ergometry is complete. These training indicators are reflective of the entire circulation response to the performance invoked by ergometry. This value however only has relevance when it is compared to values from multiple ergometry sessions of the patient over a period of time. These values are very good indicators of the patient’s training progress. The training indicator is calculated by the computer as follows: training indicator

=

S - D * HR * M P

S = maximum systole D = maximum diastole HR = maximum heart rate M = patient’s weight P = maximum performance



The training indicator serves to compare multiple ergometric sessions of a single patient. This value is not applicable for the comparison of different patients. Basically, a drop in the value on a patient’s chronologically consecutive ergometric sessions is a positive indication of good training progress.

Version: 05/02

77


     


E.1

Heart Rate Feedback from ECG

When an ECG device is connected to the ergometer it is advantageous to supply the ergometer with a feedback of the recorded heart rate. This allows the heart rate to be continuously monitored as an alarm parameter. When performing pulse-steady-state training a continuous heart rate input is indeed absolutely necessary. If the ECG device used supports a QRS trigger output, this can be connected to the ergometer. There are two possible connections (see appendix C), either the analog interface (J13, Pin 7) or over the opto-input (J11, Pin 2).

E.2

Pulse Monitor

Ergoline offers a pulse monitor, type Polar, that can be used for heart rate input to the ergometer without an ECG. The receiver of the pulse monitor is connected to the opto-input of the ergometer. The QRS impulse is then radio transmitted from the chest strap to the ergometer.

chest strap

receiver

Polar-Pacer on a seat type ergometer


78

Version: 05/02

    


F.1 Technical Data Type :

ergometrics 900

Operation mode:

continuous operation

Power supply:

115 V / 230 V ~/ 50 Hz / 60 Hz

Power rating:

90 VA

Braking principal:

computer controlled eddy current brakes with torque regulation (RPM independent in accordance with DIN 13405)

Load range:

20 . . . 999 Watt

RPM range:

30 . . . 130 n/min-1

Deviation of load :

acc. to DIN 13405: however: acc. to manufacturer: however:

max. ± 5% in the range ot 25 and 400 W max. ± 3 W in the range of 25 and 100 Watt max. ± 5% in the range of 20 and 900 W max. ± 3 W in the range of 20 and 100 W

Load increments:

manual setting: 5W

programmable: 5W or multiple thereof

Time interval:

1 min. ... 99 min

Load programs:

8 programs freely programmable 1 automatic program (dependent from circulatory condition) 1 program for Pulse-Steady-State training

Max. admissable patient weight:

120 kg

Seat adjustment:

continuously adjustable for body sizes 1.20 m to 2.10 m

Handle bar adjustment:

continuously adjustable for body sizes 1.20 m to 2.10 m

Display:

1x LCD-Display : 4 lines @ 20 char. 1 x LED 10 mm: rpm display for patient

Blood pressure measurement :

RR indirect with automatic artefact suppression separate time interval in range 1 min to 99 min switchover between mmHg and kPa possible

Pulse measurement : Measurement range:

priority principal: 35 to 230 bpm

Alarm settings:

load, pulse, systole, diastole as limit values

Printer:

thermal printer with 40 columns, paper width 80 mm

Electrical inputs: Analog:

Digital control: RS232 Opto, ECG 1V

Electrical outputs: Digital: Analog: Weight:

1. ECG, 2. Opto, 3. RR

RS232, load, pulse, systole, diastole remote start ECG (1 to 99 sec) 64 kg

Dimensions (W x L):

min: 400 x 900 mm, width of handle bar: approx. 540 mm height: min: 950 mm; max: 1330 mm

Calibration:

performed with switches and keypad

Protection of calibration:

Code

Safety standard:

BF according to IEC 60601-1

Device class:

I according to IEC 60601

Classification MDD:

class IIa according to 93/42 ECC

Version: 05/02

79


Operating Manual Ergometrics ER 900 (English)

Recommend Documents