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Summary of Contents for ergoline ERS 2
- Page 1 2 ergoline Rehabilitation System Operator‘s Manual 201000414000 • Version 2014-04-15 / Rev 00 • English...
- Page 2 No part of this manual may be reprinted, translated, or reproduced without the manufacturer's written permission. This manual is not subject to any change order service. Please contact the manufacturer for the most recent version. ergoline GmbH Lindenstrasse 5 72475 Bitz Germany...
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Page 3: Table Of Contents
Ers 2 System ........ - Page 4 Patient Data > Protocols Treadmill........... 32 Creating a Protocol .
- Page 5 Training ........... 49 Monitoring .
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Page 7: Introduction
Council Directive 93/42/EEC about medical devices and fulfills the essential requirements of Annex I of this directive. The product ERS 2 system has been assigned to class IIa in accordance with Annex IX of the Directive 93/42/EEC. -
Page 8: Revision History
The warranty does not cover damage resulting from the use of unsuitable acces- sories and consumables from other manufacturers. Always consult with Ergoline GmbH if you intend to connect equipment not men- tioned in this manual. Parts and accessories must comply with the applicable IEC 60601 safety stan- dards and/or the configured system must comply with the collateral standard IEC 60601-1-1 "Safety requirements for medical electrical systems". -
Page 9: Definitions
Safety Notices Explosion Hazard The ERS 2 system is not designed for use in areas of rooms used for medical purpos- es where an explosion hazard may occur. Potentially explosive atmospheres may result from the use of flammable anesthetics, skin cleansing agents or disinfec- tants. - Page 10 Liquids must not be allowed to enter the devices. If liquids have entered the devices, the ERS 2 system must be checked by a service technician before being used again Do not open any of the devices. There are no user-replaceable components inside the devices.
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Page 11: System Requirements
RF Interference — Known RF sources, such as cell phones, radio or TV stations, and two-way radios, may cause unexpected or adverse operation of the ERS 2 system. Check the performance before each use. Caution Equipment Damage —... -
Page 12: Equipment Symbols
It is intended for use in rehabilitation centers, cardiology offices and fitness centers with medical cardiac programs. The ERS 2 system is intended to be used only by trained operators under the direct supervision of a licensed health care practitioner on adult and pediatric patients. -
Page 13: An Overview Of The Key Performance Features Of The Software
The development of the new ergoline ERS 2 rehabilitation system was able to draw on the experience of more than 250 installed ergoline rehabilitation sys- tems. -
Page 14: System Configuration
(the ECGs of all patients and all training sessions are stored) System Configuration The central component of the ERS 2 system is a PC with an MS Windows operat- ing system and special software which runs the training programs. The training ergometers are connected to the PC system via control lines. - Page 16 16 |...
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Page 17: Starting The Program
tarting tHE rograM Start the program by double-clicking the icon. The initial screen is displayed. anagEMEnt raining naLysis onfiguration anagEMEnt In the Management window, you will find the patient database with these tabs: atiEnts roups rotoCoLs From some of the tabs you can access further sub-categories which will be ex- plained in detail on the following pages. - Page 18 anagEMEnt atiEnts This is a list of all patients stored in the database with their name, ID, and SSN (social security number). The Find function allows you to conve- niently access any patient in the data- base. Entering the first characters of a patient name or of the ID (highlighted yellow) is sufficient.
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Page 19: Patient Data > General
> g atiEnt EnEraL ErsonaL · Patient Data At this point in the program, patients are added to the database. Type the patient's personal data such as last name and first name in the appropriate text boxes. Mandatory fields are identified with an asterisk *. - Page 20 > g atiEnt EnEraL ErsonaL · Chip Card Via Standard you save the data [ Write ] to the chip card. Via Extended [ View ] can review the entered data once more. With you prepare data for their [ Format ] first use or delete the data on the chip card.
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Page 21: Contact Data
> g atiEnt EnEraL ontaCt · Patient Contact Data · Emergency Contact Data Enter address, names, etc. on this screen. These inputs are optional. State, Country, or Relation are added via button. Type a name and save it with . The new entries will be added [ OK ] to the drop-down list. -
Page 22: Patient Data > Medical
> M atiEnt EdiCaL HErapy · Diagnoses · Medications · Remark This screen accommodates all fields for entry of the diagnosis, the medications, and any remarks. This information is es- sential for the therapist. Existing medical findings and / or instructions for the use of medications are adopted with [ Create ] The Create/edit diagnosis or Create/edit... -
Page 23: Examinations
> M atiEnt EdiCaL xaMinations · Exercise ECG · Echocardiogram · Ergospirometry · Remark You will find a number of different en- try fields. Enter values for HR at rest, BP at rest, etc. Use the arrow buttons [ ] [ ] on the keyboard to change values. -
Page 24: Alarms
> M atiEnt EdiCaL LarMs · Heart Rate · Blood Pressure · SpO2 · Bicycle · Treadmill It is recommended to enter all values concerning the patient's condition at the beginning of the physical therapy. The settings for bicycle and treadmill entered here override the settings in the different protocols. -
Page 25: Findings
> M atiEnt EdiCaL indings Use this space to document findings or results concerning the patients. Frequently used phrases can be assigned to the buttons on the right with [ Edit ] The Findings text samples dialog opens. Use the buttons [ Insert before ] to define the position of [ Insert after ]... -
Page 26: Patient Data > Protocols
> p atiEnt rotoCoLs iCyCLE The graphic shows relevant information such as: - training heart rate - warmup phase - training duration - blood-pressure measurement - load control - recovery phase The Protocol drop-down list that you open with the arrow button shows all protocols that you configured. -
Page 27: Selecting The Protocol Type
> p atiEnt rotoCoLs iCyCLE Selecting the Protocol Type You can choose from various protocol types: · Constant Workload · HR-controlled · SpO2-controlled · Interval · Interval (HR-controlled) · Custom · Constant Workload permanent load without interruptions at a constant intensity ·... -
Page 28: Protocol Type 'Interval Hr-Controlled
> p atiEnt rotoCoLs iCyCLE Protocol Type ‘SpO2-controlled’ Click to open the SpO2 con- [ Extended ] trol window. In this window you define the parameters for the SpO2-controlled exercise. The settings under Workload Reduction define how the current SpO2 value will be controlled. -
Page 29: Protocol Type 'Custom
> p atiEnt rotoCoLs iCyCLE Protocol Type 'Custom' Additional entries are mandatory for custom protocols. With [ Insert before ] you define the first step [ Insert after ] type. Your choices are: · constant (absolute), the training workload is kept at a con- stant level for the specified duration ·... -
Page 30: Editing A Protocol
> p atiEnt rotoCoLs iCyCLE Protocol Type ‘Custom’ Repeat under allows you to [ Extended ] copy one step or multiple steps. The cop- ied steps will be appended to the existing steps. With you can change the duration [ Edit ] and load of individual or of all steps. -
Page 31: Saving A Protocol As Default
> p atiEnt rotoCoLs iCyCLE Saving a Protocol as Default At this point you can define one of the protocols as the Default. Having entered the protocol name, protocol type, etc, you click and choose Save [ Extended ] def.. The default protocols can be viewed and edited ·... -
Page 32: Treadmill
> p atiEnt rotoCoLs rEadMiLL The illustration shows relevant informa- tion such as: - training heart rate - warmup phase - training duration - blood-pressure measurement - speed and slope - recovery phase Under Protocols, you will find the Tread- mill Default* protocol. -
Page 33: Selecting The Protocol Type
> p atiEnt rotoCoLs rEadMiLL Selecting the Protocol Type These are the protocol type choices: · Constant Workload · HR-controlled (Speed) · HR-controlled (Slope) · HR-controlled · Custom · Constant Workload permanent load without interruptions at a constant intensity · HR-controlled (Speed) the predefined training heart rate is achieved via the speed ·... -
Page 34: Protocol Type 'Custom
> p atiEnt rotoCoLs rEadMiLL Protocol Type 'Custom' Additional entries are mandatory for custom protocols. Define the first step with [ Insert before ] [ Insert after ] choose the step type: · constant (absolute), the training workload is kept at a con- stant level for the specified duration ·... -
Page 35: Editing A Protocol
> p atiEnt rotoCoLs rEadMiLL Protocol Type ‘Custom’ With you can modify the duration [ Edit ] (abs. [s]/rel. [%]), the speed (abs. [km/h]/ rel. [%]) as well as the slope (abs. [%]/ rel. [%]) of the steps. Highlight the steps you want to modify and enter a value in the appropriate field using the keyboard or the arrow keys... -
Page 36: Saving A Protocol As Default
> p atiEnt rotoCoLs rEadMiLL Saving a Protocol as Default Frequently used protocols can be saved as the Default protocol. Select [ Extended ] Save Def. The default protocols can be edited · on the Management Protocols tab, see “Treadmill Saving the Default Pro- tocol”... -
Page 37: Management
anagEMEnt roups On this tab you configure different train- ing groups for your patients. The illustration shows an overview of existing groups with these group details: - Name - Type - Number of patients (Pat. Cnt.) - Maximum number of patients (Pat. -
Page 38: Creating Groups
roup EnEraL Creating Groups To configure a new group, go to Man- agement - Groups and click the [ Create ] button. First enter the name (e.g., Group 1), the type and, if needed, the patient limit. Selecting the Group Type You can choose between: ·... -
Page 39: Deleting Patients From A Group
roup EnEraL Deleting Patients from a Group To delete a patient, click the patient name (highlighted blue) and then click . As an alternative you can dou- [ Remove ] ble-click the name of a group patient to delete it. To remove all patients of a group at once, click the button. -
Page 40: Management > Protocols
> p anagEMEnt rotoCoLs iCyCLE On the Management - Protocols - Bicy- cle tab, you define protocols for bicycle exercise tests for multiple uses. The win- dow shows the exercise test parameters, such as: · Warmup · Increase · Training ·... -
Page 41: Protocol Type 'Spo2-Controlled
> p anagEMEnt rotoCoLs iCyCLE Selecting the Protocol Type · Constant Workload permanent load at a constant intensity without interruptions · HR-controlled the load controls the predefined train- ing heart rate · SpO2-controlled the training workload is controlled to ensure that the SpO2 value will not permanently drop below the lower limit ·... -
Page 42: Protocol Type 'Interval Hr-Controlled
> p anagEMEnt rotoCoLs iCyCLE Protocol Type ‘SpO2-controlled‘ Subsequently, the SpO2 value is checked on the basis of the Workload Control pa- rameters. If another deviation is detect- ed, the training load will automatically be adjusted. Entries can be made as absolute or rel- ative values with respect to the training load. -
Page 43: Protocol Type 'Custom
> p anagEMEnt rotoCoLs iCyCLE Protocol Type 'Custom' Various training steps can be configured for this protocol type. With [ Insert before ] you define the first step [ Insert after ] and choose a step type: · constant (absolute), the training workload is kept at a con- stant level for the specified duration ·... -
Page 44: Editing The Default Protocol
> p anagEMEnt rotoCoLs iCyCLE Protocol Type ‘Custom’ With you can change the duration [ Edit ] and load of the steps. Mark individual or consecutive steps (highlighted blue) and enter the values for Duration (abs. [s]/ rel. [%]) or Load (abs. [W]/rel. [%]) us- ing the keyboard or the arrow buttons . -
Page 45: Treadmill
> p anagEMEnt rotoCoLs rEadMiLL On the Management - Protocols - Treadmill tab, you define general Default Protocols. The following parameters are presented for configuration: · Warmup · Increase · Training · Decrease · Recovery Saving the Default Protocol The program allows you to create and save Default Protocols (as templates) ·... -
Page 46: Protocol Type 'Hr-Controlled
> p anagEMEnt rotoCoLs rEadMiLL Selecting the Protocol Type · Constant Workload permanent load without interruptions at a constant intensity · HR-controlled (Speed) the predefined training heart rate is achieved via the speed · HR-controlled (Slope) the predefined training heart rate is achieved via the slope ·... -
Page 47: Protocol Type 'Custom
> p anagEMEnt rotoCoLs rEadMiLL Protocol Type 'Custom' This protocol type allows you to con- figure your own training steps. With you define [ Insert before ] [ Insert after ] the first step and choose a step type: · constant (absolute), the training workload is kept at a con- stant level for the specified duration ·... -
Page 48: Editing The Default Protocol
> p anagEMEnt rotoCoLs rEadMiLL Protocol Type ‘Custom’ and Repeat you can eas- [ Extended ] ily copy the step types. With you can modify the dura- [ Edit ] tion, speed, and slope of individual or of all steps. Highlight the steps you want to modify (they turn blue) and enter a value for Duration (abs. -
Page 49: Training
raining onitoring The overview presents the different areas in the form of tabs: onitoring Training station anagEMEnt atiEnts raining From this screen you start training ses- sions, assign patients, and review train- Area 1 Area 2 Area 3 ing data. If the measured values exceed or drop below the preset limits, the system emits an audible and visual alarm (in the illustration: training station 01) to allow... -
Page 50: Removing A Patient
raining onitoring Removing a Patient To remove a patient, right-click the com- mand Remove Patient: the patient will immediately be deleted. Please note that it is not possible to remove a patient while a training is in progress! Assigning a Device To assign a monitoring / training device to a training station, right-click and select the Assign Mon. -
Page 51: Ending A Training Session
raining onitoring Starting a Training Session The difference between HR and THR is graphically represented by three ele- ments. A minor deviation is indicated yellow, no deviation is indicated by a green symbol, a major deviation is indi- cated red. The colored symbols appear on the left if the value is too low and on the right if the value is too high. -
Page 52: Patient Data
raining onitoring Patient Data Via the shortcut menu (in area 1), you go to the Patient Data, while all training stations and ECGs remain displayed on the right side. , Patient Data and se- With [ Patients ] lection of a patient, you also reach the Patient Data window. -
Page 53: Ecg Display
raining onitoring ECG Display The parameters currently displayed are the ECG, the HR, and the THR. If your training device supports the required functions, you will also see the most recent BP value and the SpO2 value. From the ECG Display shortcut menu (in area 2), you go to the Patient Training ECG. -
Page 54: Marking The Ecg
raining onitoring Marking the ECG To highlight artifacts in the ECG, right- click in area 2 and select Mark ECG. Turning the ECG Pump On To turn on the ECG pump from the short- cut menu in area 2, select Turn on ECG Pump. -
Page 55: Selecting The Training Protocol
raining onitoring Selecting the Training Protocol With a right click in area 3 and by choos- ing Select Training Protocol you access the protocols (this is not possible while a training is in progress). The new window shows all Protocols created in Patient Data or Management. -
Page 56: Management
raining anagEMEnt you display the tabs [ Management ] atiEnts roups rotoCoLs The pane on the right shows all training stations with the most important data. Frequently used commands are easily ac- cessible via shortcut menus. Area 1 Area 2 Area 3 atiEnts With the... -
Page 57: Analysis
naLysis atiEnts The Analysis - Patients view provides an organized overview of all patients in the system. The Group list comprises all groups that were created. If you select a group, the patients of that group will be displayed. With Find you can quickly access the pa- tient data. -
Page 58: Overview - Trend
atiEnt naLysis vErviEw rEnd This screen provides an overview of all analyzed parameters, such as: - HR - BP - SpO2 - METs - W/kg - Load - RPM - Spd. - Slp. - Energy - Distance - Weight When you move the mouse cursor over the curves, the values will be updated and displayed. -
Page 59: Editing / Deleting A Training Session
atiEnt naLysis vErviEw rEnd Analyzing the Training Sessions With the command, you create [ Export ] a CSV file (comma separated values, default storage path C: \ ers2 \ ers2ex- change) of the training session. By double-clicking a training session (data point) you change to the Training - Single tab. -
Page 60: Overview - Compare
atiEnt naLysis vErviEw oMparE In this overview, two training sessions are compared. The illustration shows measured values for: - HR - BP - SpO2 - METs - W/kg - Load - RPM - Spd. - Slp. - Energy - Distance - Weight From the drop-down lists, select the pe- riod of time of the training sessions and... -
Page 61: Training - Single
atiEnt naLysis raining ingLE The diagram presents the parameter val- ues obtained during the training: - HR - BP - SpO2 - METs - W/kg - Load - RPM - Spd. - Slp. Next to the diagram you see the full-dis- closure ECG. - Page 62 atiEnt naLysis raining ingLE Analyzing the Training Sessions In the new window you can enter a writ- ten comment. With you exit the [ OK ] window, with no marker will be [ Cancel ] set. All markers are listed in the Marker drop- down list, annotated with the time of [ l <...
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Page 63: Training - Compare
atiEnt naLysis raining oMparE This view allows two training sessions to be compared. The following parameter values are shown: - HR - BP - SpO2 - METs - W/kg - Load - RPM - Spd. - Slp. As you move the mouse cursor over a diagram, the corresponding measured values will be displayed. -
Page 64: Tools
ooLs Karvonen Formula menu is available on all tabs [ Tools ] of the ers. 2 software. Via you can [ Tools ] configure the Karvonen formula. The Karvonen formula is used to de- termine the optimal heart rate (HR) for different forms of exercise. -
Page 65: Abbreviations
bbrevIAtIons Bc. const bicycle constant blood pressure in beats per minute Ctrl. control ctrld. controlled heart rate identification number Load abs. absolute load Load rel. relative load Mon. Device monitoring device Pat. Cnt. patient count Pat. Lim. patient limit Rev. recovery phase Slope abs. - Page 68 GmbH Lindenstrasse 5 72475 Bitz Germany Phone: +49-(0) 7431 98 94 - 0 Fax: +49-(0) 7431 98 94 - 128 e-mail: info@ergoline.com http: www.ergoline.com...
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