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Ergosana SanaComfort 1000 User Manual

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SanaComfort 1000
Seat Ergometer
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User Guide

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Summary of Contents for Ergosana SanaComfort 1000

  • Page 1 SanaComfort 1000 Seat Ergometer GANSHORN needs your support! User Guide...
  • Page 2 Sales and Service Information ergosana has a worldwide sales and service centre network. 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 ..54 Manufacturer's Declaration EMC ....55 9.6.1 Electromagnetic emissions ..... 55 9.6.2 Electromagnetic immunity .
  • Page 6 Page 6...

  • Page 7: Safety Notes

    Safety Notes SanaComfort 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 seat ergometer is a device for quantitative measurement of the speed at which a muscle or group of muscles performs work (energy) 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 SanaComfort 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

    SanaComfort 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 SanaComfort 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 SanaComfort 1000 ‐- User Guide Accessories 2 Introduction The seat ergometer is a device for quantitative measurement of the speed at which a muscle or group of muscles performs work (energy) under controlled conditions. The seat 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) Handlebar and clamp for handlebar adjustment (2) Console with touchscreen (rotatable by 180°) with option to adjust the sitting position and speed in- dication (rpm) (3) Power button, mains connector, potential equilisa- tion, RS-232 interface (4) Running gear with lockable heavy-duty wheels (5) Pedal cranks with pedals and safety straps (6) Locking lever for adjusting the backrest...

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

    Introduction SanaComfort 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. The two arrow keys can be used to adjust the sitting position accord- ing to the patient's height.

  • Page 19: Touchscreen

    Introduction SanaComfort 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: Connecting Cables/Accessories

    Start-up and initial preparation SanaComfort 1000 ‐- User Guide 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.

  • Page 22: Power Supply

    Start-up and initial preparation 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 23: Language Selection

    Start-up and initial preparation SanaComfort 1000 ‐- User Guide 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: •...

  • Page 24: Operation

    Operation Adjusting seat, backrest, 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. Adjusting seat, backrest, and handlebar Before the patient takes a seat on the ergometer, check if the ...

  • Page 25: Adjusting Handlebar

    Operation SanaComfort 1000 ‐- User Guide Adjusting seat, backrest, and handlebar 4.1.3 Adjusting Handlebar The handlebar can be adjusted using the clamp. Note: The clamp can be brought to the desired position by pulling it out to facilitate the loosening/tightening of the clamping.

  • Page 26: Connecting Spo2 Sensor (Optional)

    Operation Performing an exercise test with the patient 4.1.5 Connecting 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 Safety Notes An exercise test may only be initiated, if the patient has been in- ...

  • Page 27: Modes Of Operation

    Modes of operation SanaComfort 1000 ‐- User Guide 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.

  • Page 28: Manual Operation And Performance Adjustment

    Modes of operation 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  the menu bar. Menu for setting the manual load control 0 rpm Speed...

  • Page 29: Setting And Starting The Automatic Mode

    Modes of operation SanaComfort 1000 ‐- User Guide 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 30 Modes of operation 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. In this case, the active Ergometry display manual operating mode is designated by the red triangle symbol in the bottom right corner of the menu bar.

  • Page 31: During The Training

    Modes of operation SanaComfort 1000 ‐- User Guide 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 32 Modes of operation 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 32...

  • Page 33: Blood Pressure Measurement (Optional)

    Modes of operation SanaComfort 1000 ‐- User Guide 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 34: Cuff Application

    Modes of operation 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.) 4.

  • Page 35: Performing Manual Blood Pressure Measurement

    Modes of operation SanaComfort 1000 ‐- User Guide 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 36: Spo2

    Modes of operation 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. The information in this manual does not overrule any instructions ...

  • Page 37: Applying Sensor

    Modes of operation SanaComfort 1000 ‐- User Guide SpO2 5.5.2 Applying 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 38: Cleaning And Disinfecting

    Cleaning and disinfecting 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 39: Cleaning

    Cleaning and disinfecting SanaComfort 1000 ‐- User Guide Procedure overview 6.1.1 Cleaning Before each use. Interval • 50 % Isopropyl alcohol Approved Cleaning Solutions • Neutral, mild detergent solution • All products designed for cleaning plastic Do not use detergents containing the following:...

  • Page 40: Cleaning The Blood Pressure Cuff

    Cleaning and disinfecting 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 41: Cuff Preparation

    Cleaning and disinfecting SanaComfort 1000 ‐- User Guide 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.
  • Page 42 Cleaning and disinfecting 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). Remove the bladder from the cuff. After washing re-insert the bladder in the cuff.
  • Page 43 Cleaning and disinfecting SanaComfort 1000 ‐- User Guide Cleaning the blood pressure cuff Bladder tube and microphone connector – downward outlet Page 43...

  • Page 44: Cleaning The Spo2 Sensor

    Cleaning and disinfecting 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 44...

  • Page 45: Maintenance

    Maintenance SanaComfort 1000 ‐- User Guide Measurement and Safety Checks 7 Maintenance MTKs and STKs as well as any recalibrating work necessary must  only be performed by authorised and trained personnel with the special tools required for this purpose.

  • Page 46: Checking And Setting The Supply Voltage

    Maintenance 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. On delivery, the unit is set for the local supply voltage (115 VAC or 230 VAC).

  • Page 47: Trouble Shooting

    Maintenance SanaComfort 1000 ‐- User Guide Trouble Shooting Trouble Shooting Fault Cause/note Remedies 1. Power cord plugged in? Unit does not switch No power supply 2. Mains switch ON? (see paragraph 3.5, p. on, blank screen 3. Checking the Device`s Fuses (see paragraph 7.3, p.

  • Page 48: Preventing Electromagnetic Interferences

    Maintenance 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 49: Disposal

    Maintenance SanaComfort 1000 ‐- User Guide 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 •...

  • Page 50: 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 51: Technical Data

    Technical Data SanaComfort 1000 ‐- User Guide Device 9 Technical Data Device Feature Value/description Base dimensions 40 x 130 cm Weight 75 kg Allowed patient weight 200 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 52: Drive Mechanism

    Technical Data Blood pressure module 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 Performance/ 1 to 20 watts (range is dependent of revolutions per minute) Load range 20 to 999 watts (range is independent of revolutions per minute) Continuous operation up to 100 watts...

  • Page 53: Spo2 Module

    Technical Data SanaComfort 1000 ‐- User Guide SpO2 module Feature Value/description Measurement Range 50 ...270 mmHg ( ± 3mmHg) Systolic 20 ...150 mmHg ( ± 3mmHg) Diastolic 40 ...250 bpm (40 ...100 bpm < ± 2%) Pulse (100 ...200 bpm < ± 4%) (200 ...250 bpm <...

  • Page 54: Wi-Fi Connection Box

    Technical Data 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 Max.

  • Page 55: Manufacturer's Declaration Emc

    Technical Data SanaComfort 1000 ‐- User Guide 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.
  • Page 56 Technical Data 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- mended separation distance (d) calculated from the equation applicable to the fre- quency of the transmitter Recommended separation distance:...

  • Page 57: Immunity To Proximity Fields From Rf Wireless Communications Equipment

    Technical Data SanaComfort 1000 ‐- User Guide 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...

  • Page 58: Revision History

    Technical Data Revision History Revision History Rev. 01 2023-09-25 Initial version Page 58...

  • Page 59: Index

    Index User Guide 10 Index Accessories ......11 Accessories and Disposables ..57 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 60 Index Page 60...

  • Page 61: 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 62 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 63 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 64 Appendix - Symbols...

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