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Ergosana SanaBike 500 User Manual

Bicycle ergometer
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SanaBike 500/1000
Bicycle ergometer
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User Guide

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Summary of Contents for Ergosana SanaBike 500

  • Page 1 SanaBike 500/1000 Bicycle ergometer GANSHORN needs your support! User Guide...
  • Page 2 Sales and Service Information The ergosana sales and service center network is world-wide. Contact your nearest ergosana subsidiary to obtain the address of your local distributor. A complete list of all distributors and subsidiaries is provided on our Inter- net site: www.ergosana.de...

  • Page 3: Table Of Contents

    User Guide Table of Contents Safety Notes ......7 Intended Purpose ......7 1.1.1 Indications and Contraindications .
  • Page 4 Performing an exercise test with the patient ..26 4.2.1 Safety Notes ....... 26 4.2.2 Patient Information .
  • Page 5 User Guide Characteristics for the braking moment control ..53 Manufacturer's Declaration EMC ....54 9.6.1 Electromagnetic emissions ..... 54 9.6.2 Electromagnetic immunity .
  • Page 6 Page 6...

  • Page 7: Safety Notes

    Safety Notes SanaBike 500/1000 ‐- User Guide Intended Purpose 1 Safety Notes Read and follow these safety notes and the intended purpose to  prevent any injuries or damages. Intended Purpose The bicycle ergometer is a device for quantitative measurement of the speed at which a muscle or group of muscles performs work (en- ergy) under controlled conditions.

  • Page 8: Responsibility Of The User

    Safety Notes Responsibility of the User Responsibility of the User The numerical and graphical results and any interpretation given  must be examined with respect to the overall clinical condition of the patient and the quality of the displayed data. The user is responsible for compliance with all applicable acci- ...

  • Page 9: Abort Criteria During Exercise

    Safety Notes SanaBike 500/1000 ‐- User Guide Responsibility of the User 1.2.1 Abort Criteria during Exercise Absolute Abort Criteria: moderate to serious angina pectoris (painful chest tightness),  dyspnoea (shortness of breath), cyanosis (blue coloration of the skin or mucous membrane), dizziness, cold sweat, ataxia or ex- haustion ST depression ≥3 mm or ST elevation ≥1 mm...

  • Page 10: Organisational Measures

    Safety Notes Organisational Measures Organisational Measures Before putting the device into operation, have the features and  necessary safety measures explained by a medical product repre- sentative. This user guide, and especially these safety notes, must be read  and observed. These operating instructions do not override any statutory or lo- ...

  • Page 11: Operation With Other Devices

    SanaBike 500/1000 ‐- User Guide Operation with other Devices Operation with other Devices If the ergometer is combined into a system by the ergosana part-  ner or the operator, the ergosana partner or operator becomes the producer of the system and is therefore responsible for safety and compliance with all applicable standards.

  • Page 12: Safe Use Of Electrical Devices

    Safety Notes Safe Use of Electrical Devices Safe Use of Electrical Devices Danger of injury for the patient or user when using the device  with defective cables or incorrect fuses: – Do not use the device if the protective earth is suspect or if the mains lead, power supply unit or device is damaged or sus- pected of being damaged.

  • Page 13: Safety Symbols And Signs

    Safety Notes SanaBike 500/1000 ‐- User Guide Safety Symbols and Signs Safety Symbols and Signs 1.9.1 Symbols used in this document The safety and warning messages are designed and phrased accord- ing to the applicable standards. For a direct danger which could lead to severe personal injury or ...

  • Page 14: Safety Symbols On The Device

    Safety Notes Safety Symbols and Signs 1.9.2 Safety symbols on the device Reading the user guide before using the device is compulsory Attention: Observe the warning and safety notes given in the user guide Non-ionic electromagnetic environment. The device may cause or be susceptible to electromagnetic disturbances.

  • Page 15: Introduction

    Introduction SanaBike 500/1000 ‐- User Guide Accessories 2 Introduction The bicycle ergometer is a device for quantitative measurement of the speed at which a muscle or group of muscles performs work (en- ergy) under controlled conditions. The bicycle ergometer can be operated in three different modes. With the optional device functions blood pressure and oxygen saturation can be measured.

  • Page 16: Device Components

    Introduction Device components Device components (1) Handler bar and clamp for handlebar adjustment (2) Saddle and clamp for saddle height adjustment (manual) (3) On/Off switch, mains connector, potential equalisa- tion (accessible from the back) (4) Base adjuster for height adjustment (5) RS-232 connector (underneath left-hand side cover) (6) Pedal cranks with pedals and safety straps (7) Running gear with lockable heavy rollers...

  • Page 17: Mains, Potential Equalisation And Rs-232 Connectors

    Introduction SanaBike 500/1000 ‐- User Guide Device components 2.2.3 Mains, potential equalisation and RS-232 connectors Danger to the patient due to modifications of the electrical sys-  tem: – Only connect accessories approved by the manufacturer to the device. •...

  • Page 18: Console (Probe)

    Introduction Console (probe) Console (probe) During normal operation, the console is turned towards the physi- cian/therapist. For special purposes such as individual patient train- ing, however, the unit can be rotated by 180 degrees, so that the pa- tient can easily see the display and reach the control elements. Display indicating the number of pedal rev- olutions per minute Display with touch func-...

  • Page 19: Touchscreen

    Introduction SanaBike 500/1000 ‐- User Guide Console (probe) 2.3.1 Touchscreen In remote mode, a fully equipped ergometer has the following dis- plays and functions: Speed: Ergometry featuring the patient's most important ergometry data • Speed/Cadence (If the speed exceeds the defined range, the number is dis- Load: played in red.)

  • Page 20: Start-Up And Initial Preparation

    Start-up and Initial Preparation Location 3 Start-up and Initial Preparation Serious injury caused by an electrical shock:  – Do not use the device if the protective earth is suspect or if the mains lead/power supply unit is damaged or suspected of be- ing damaged.
  • Page 21 Start-up and Initial Preparation SanaBike 500/1000 ‐- User Guide Unpacking and assembling • Combination spanner 17 The device is securely fastened to the pallet with two screws and should only be lifted from the pallet by two people. 1. Loosen the two hex screws under the pallet and have two people lift the device from the pallet.

  • Page 22: Connecting Cables/Accessories

    Start-up and Initial Preparation Connecting cables/accessories Connecting cables/accessories (see paragraph 2.2.3, p. 17). • Mains cable • Potential equalisation cable • Interface cable • Accessories 1. Check the device's power supply voltage (see nameplate 115/ 240) against the mains voltage. 2.

  • Page 23: Power Supply

    Start-up and Initial Preparation SanaBike 500/1000 ‐- User Guide Power supply Power supply 3.4.1 Isolating from the mains supply • Cable damage: – Unplug the cable by pulling the plug, not the cord. Position the device so that it can quickly and easily be isolated from the power supply.

  • Page 24: Language Selection

    Start-up and Initial Preparation Language selection Language selection The ergometer is set to the desired language upon delivery. However, you can easily change it at any time via the configuration menu, with the following languages available for selection: • German •...

  • Page 25: Operation

    Operation SanaBike 500/1000 ‐- User Guide Setting the height and position of saddle and handlebar 4 Operation Before the start of each training session, the sitting position must be individually adjusted to the patient. The saddle height and handlebar position can be adjusted.

  • Page 26: Electrical Saddle Height Adjustment (Optional)

    Operation Setting the height and position of saddle and handlebar 4.1.1 Electrical saddle height adjustment (optional) Speed: Motorised adjustment of saddle height (optional) with saddle height indication IMPORTANT Before making the adjustment, the patient must relieve the  saddle by supporting their weight on the pedals. 1.

  • Page 27: Connecting The Spo2 Sensor (Optional)

    Operation SanaBike 500/1000 ‐- User Guide Performing an exercise test with the patient 4.1.3 Connecting the SpO sensor (optional) Insert the SpO SpO2 finger sensor (or ear sensor as per cus-  tomer preference) into the SpO2 connector. Performing an exercise test with the patient 4.2.1...

  • Page 28: Modes Of Operation

    Modes of Operation Remote Operation Requirements 5 Modes of Operation In remote mode, the ergometer is controlled by the ergometry/exer- Remote operation cise program of an external system such as a PC or EKG device. Operation mode detection: Remote mode = no triangle symbol Manual/automatic mode = white, red, or green triangle symbol –...

  • Page 29: Manual Operation And Performance Adjustment

    Modes of Operation SanaBike 500/1000 ‐- User Guide Requirements for Manual/Automatic Operation 5.2.1 Manual Operation and Performance Adjustment This mode enables gradual load increment (in 5-watt steps) by the us- Open the settings menu by clicking on the triangle symbol in ...

  • Page 30: Setting And Starting The Automatic Mode

    Modes of Operation Requirements for Manual/Automatic Operation 5.2.2 Setting and Starting the automatic Mode • This mode enables stepwise load increment by the ergometer as specified by the operator. • In automatic mode, load is incremented continuously at the de- fined rate.
  • Page 31 Modes of Operation SanaBike 500/1000 ‐- User Guide Requirements for Manual/Automatic Operation 4. Confirm the settings with 5. Start the training with . The program switches to the ergom- etry display to show the current ergometry parameters or to per- form a blood pressure measurement.

  • Page 32: During The Training

    Modes of Operation During the Training During the Training For self-monitoring of the pedaling cadence, the speed value is dis- played in different colours to provide the user the following informa- tion: • White speed value = cadence is ok (ideal range) •...
  • Page 33 Modes of Operation SanaBike 500/1000 ‐- User Guide During the Training Characteristics for the braking moment control Load verso speed - characteristic diagram DIN VDE 0750-2387 Speed Speed too high Speed OK Speed too low Load Page 33...

  • Page 34: Blood Pressure Measurement (Optional)

    Modes of Operation Blood pressure measurement (optional) Blood pressure measurement (optional) It must be certain that, according to the patient’s health, the de-  vice will not damage blood circulation in the arm. To prevent extensive pressure on the extremity, it is very impor- ...

  • Page 35: Cuff Application

    Modes of Operation SanaBike 500/1000 ‐- User Guide Blood pressure measurement (optional) 5.4.1 Cuff application 1. Instruct the patient to remove upper clothing. 2. Select the appropriate cuff size according to the patient's upper arm. 3. Uncover the left upper arm of the patient. (The cuff is designed to fit the left upper arm, but can be placed on the right arm if re- quired.)

  • Page 36: Performing Manual Blood Pressure Measurement

    Modes of Operation Blood pressure measurement (optional) Please note that the cuff's air pressure hose must be fixed in a  way that prevents it from dashing against the ergometer. This is to prevent unnecessary artefacts that might affect the measure- ment's accuracy.

  • Page 37: Spo2

    Modes of Operation SanaBike 500/1000 ‐- User Guide SpO2 SpO2 5.5.1 Safety Notes Before using the sensor, carefully read the sensor directions for  use. The ear sensor is designed for use with adults and children over  30 kg and should not be used with neonates.

  • Page 38: Applying The Sensor

    Modes of Operation SpO2 5.5.2 Applying the Sensor For pulse oximetry, a reusable ear-clip sensor or finger sensor is used. If the measurement is performed during an exercise ECG, loop the Ear-clip sensor cable and secure it to the patient's clothing with a crocodile clip or medical tape (strain relief).

  • Page 39: Cleaning And Disinfecting

    Cleaning and Disinfecting SanaBike 500/1000 ‐- User Guide Procedure Overview 6 Cleaning and Disinfecting Danger of electric shock due to ingress of liquid:  – Switch the device off before cleaning and disconnect the plug – Do not immerse the device or accessories in liquid –...

  • Page 40: Cleaning

    Cleaning and Disinfecting Procedure Overview General procedure: 1. Wipe the device, accessories and cables on the surface with a slightly moistened (not wet) cloth. The saddle and handlebars can, as an exception, be sprayed with a spray bottle and wiped dry with a soft cloth after an exposure time of approximately 5 minutes.

  • Page 41: Cleaning The Blood Pressure Cuff

    Cleaning and Disinfecting SanaBike 500/1000 ‐- User Guide Cleaning the blood pressure cuff Cleaning the blood pressure cuff The blood pressure cuff should be cleaned regularly. It is made of a polyamide fabric (blue) or a plastic film (gray), which can be washed with soapy water and a cleaning cloth at a temperature of up to 40 °C.

  • Page 42: Cuff Preparation

    Cleaning and Disinfecting Cleaning the blood pressure cuff 6.2.1 Cuff Preparation Two types of cuff are available: Cuff type with a D-ring and cuff type without a D-ring. Both are available in various sizes. The cuff prepa- ration procedure for cleaning is the same for both type and all sizes. Disconnecting the Pressure Hose Before cleaning, the microphone and the bladder must be removed and Removing the Microphone...
  • Page 43 Cleaning and Disinfecting SanaBike 500/1000 ‐- User Guide Cleaning the blood pressure cuff Bladder tube and microphone connector – upward outlet Gently push the microphone out of the cuff and disconnect the pressure hose from the bladder (connector quarter twist).
  • Page 44 Cleaning and Disinfecting Cleaning the blood pressure cuff Bladder tube and microphone connector – downward outlet Page 44...

  • Page 45: Cleaning The Spo2 Sensor

    Cleaning and Disinfecting SanaBike 500/1000 ‐- User Guide Cleaning the SpO2 sensor Cleaning the SpO2 sensor Disconnect the sensor from the monitor before cleaning or  disinfection. For cleaning and disinfection information, consult the user manual of the SpO2 sensor.

  • Page 46: Maintenance

    Maintenance Measurement and Safety Checks 7 Maintenance MTKs and STKs (Measurement and Technical Safety Checks) as  well as any recalibrating work necessary must only be performed by authorised and trained personnel with the special tools re- quired for this purpose. The settings should only be carried out by trained service person- ...

  • Page 47: Checking And Setting The Supply Voltage

    Maintenance SanaBike 500/1000 ‐- User Guide Checking and Setting the Supply Voltage Checking and Setting the Supply Voltage The device may only be opened by the manufacturer's customer  service. If any ambiguities should arise, promptly contact the manufacturer's customer service.
  • Page 48 Maintenance Trouble Shooting Page 48...

  • Page 49: Preventing Electromagnetic Interferences

    Maintenance SanaBike 500/1000 ‐- User Guide Preventing electromagnetic interferences Preventing electromagnetic interferences Interference caused by radiated high-frequency electromagnetic  energy: – Use the device in accordance with the user guide – Use portable high-frequency telecommunication devices in a distance of at least 0.3 meters to the ergometer including ca- bles –...

  • Page 50: Disposal

    Maintenance Disposal Measures to prevent interferences • Switch off the device • Stop data transmission • Increase distance to the source of interference (see above) • Turn the device to change the angle of radiation • Connect the device to a different mains connector •...

  • Page 51: Accessories And Disposables

    – Only use accessories and disposables approved by the manu- facturer. Accessories and disposables area available from the local ergosana representative or directly from ergosana (see page 2). Mains lead/power supply unit Part No.

  • Page 52: Technical Data

    Technical Data Device 9 Technical Data Device Feature Value/Description Base dimensions 45 x 83 cm Sana Bike 1000 approx. Weight Sana Bike 500 approx. Allowed patient weight 160 kg Screen LCD Touch display (57x43 mm) Power supply device 230 VAC with 50 Hz, or 115 VAC with 60 Hz Power Consumption max.

  • Page 53: Drive Mechanism

    Technical Data SanaBike 500/1000 ‐- User Guide Device 9.1.1 Drive mechanism Feature Value/Description Length of pedal crank 172.5 mm (double length of pedal crank: 345 mm) Drive With Poly-V belt 1 to 20 watts (range is dependent of revolutions per minute)

  • Page 54: Blood Pressure Module

    Technical Data Blood pressure module Blood pressure module Feature Value/description Methods of measurement Auscultatoric (Korotkoff/Riva-Rocci) with or without QRS trigger Measurement Range 50 ...270 mmHg ( ± 3mmHg) Systolic 20 ...150 mmHg ( ± 3mmHg) Diastolic 40 ...250 bpm (40 ...100 bpm < ± 2%) Pulse (100 ...200 bpm <...

  • Page 55: Wi-Fi Connection Box

    Technical Data SanaBike 500/1000 ‐- User Guide Wi-Fi connection box Wi-Fi connection box Feature Value/description Modules ESP-WROOM-32 FCC ID 2AC7Z- ESPWROOM32 Transmission standards IEEE 802.11 b,g,n WPA™ Enterprise, Personal, WPA2™ Enterprise, Personal with secu- Security/encryption rity EAP-TLS, EAP-TTLS, MSCHAPv2, PEAPv0/EAP-MSCHAPv2 Frequency range Dual-band 2.4 GHz and 5 GHz...

  • Page 56: Manufacturer's Declaration Emc

    Technical Data Manufacturer's Declaration EMC Manufacturer's Declaration EMC 9.6.1 Electromagnetic emissions The device is intended for use in an electromagnetic environment as described below. The customer or user of the device should ensure that the device is used in such an environment. Emission measurement Compliance Electromagnetic environment - guid-...
  • Page 57 Technical Data SanaBike 500/1000 ‐- User Guide Manufacturer's Declaration EMC Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic environment - guidance Portable and mobile communications equipment should be used no closer to any part of this device, including cable, than the recom-...

  • Page 58: Immunity To Proximity Fields From Rf Wireless

    Technical Data Manufacturer's Declaration EMC 9.6.3 Immunity to proximity fields from RF wireless communications equipment Test Max. Modulation Distance d Immunity Area frequency Service power P level [V/m] [MHz] [MHz] Various radio services (TETRA 400) Pulse modulation 380–390 18 Hz - Walkie-talkie (FRS) 430–470 –...

  • Page 59: Revision History

    Technical Data SanaBike 500/1000 ‐- User Guide Revision History Maximum Power Output Separation distance according frequency of the transmitter [m] [watts] For transmitters rated at a maximum output power not listed above, the recommended separation distance d in me- ters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts [W] according to the transmitter manufacturer.
  • Page 60 Technical Data Revision History Page 60...

  • Page 61: Index

    Index User Guide 10 Index Accessories ......11 Accessories and Disposables ..56 CE marking ..........2 Cleaning Solutions ......39 Disinfectants ........39 Disposal ..........14 ..........11 Hardware ..........17 Headquarters Address ......2 Indications ..........7 IP protection class ......14 Isolating from the mains supply ...22 Kensington lock ........16...
  • Page 62 Index Page 60...

  • Page 63: Appendix - Symbols

    Appendix - Symbols 11 Appendix - Symbols This appendix lists all general symbols that may be present on the device, label and accessories. Not all of those symbols are necessarily present on your device. Identification of the manufacturer Identification of the manufacturing date Identification of the distributor Identification of the importer Medical device...
  • Page 64 Appendix - Symbols UK Conformity Assessed The regulatory compliance mark for the Australian Standards The device is recyclable The symbol for the recognition of electrical and electronic equip- ment. The device must not be disposed of in the household waste. The symbol for the recognition of a battery.
  • Page 65 Appendix - Symbols Transport the device upwards (this way up) Do not use hooks kg max Maximum stack load weight Do not stack EIP = electronic information product (does not contain any toxic and hazardous substances or elements above the maximum concentra- tion values (the product can be recycled and re-used).
  • Page 66 Appendix - Symbols...

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