Custo Med custo cardio 400 BT Operating Manual

Custo Med custo cardio 400 BT Operating Manual

Resting and stress ecg
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Operating Manual
Resting and Stress ECG
1
Safety
Part 2: Hardware, description of device
for custo cardio 400 BT and custo cardio 400 accu
Operating characteristics:
12-channel PC ECG,
Resting & stress ECG
MHW 0012 – DK 1713
Version 004 – 20/04/2020
2
Hardware
3
Software
4
Hygiene

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Summary of Contents for Custo Med custo cardio 400 BT

  • Page 1 Resting and Stress ECG Safety Hardware Software Hygiene Part 2: Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Operating characteristics: 12-channel PC ECG, Resting & stress ECG MHW 0012 – DK 1713 Version 004 – 20/04/2020...
  • Page 2 Internet or from a CD to ensure the Operating Manual is complete. MHW 0012 – DK 1713 | Version 004 – 20/04/2020 | custo med GmbH [2] Resting and Stress ECG Hardware, custo cardio 400 devices |...
  • Page 3: Table Of Contents

    ......... MHW 0012 – DK 1713 | Version 004 – 20/04/2020 | custo med GmbH...
  • Page 4: Symbols On The Devices

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Symbols on the devices Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany Production date (YYYY-MM, e.g. 2018-01) CE mark, notified body...
  • Page 5: Intended Use

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Intended use custo cardio 400 BT / custo cardio 400 accu is a 12-channel electrocardiograph with integrated electrode application system which is used professionally as a rest- ing or stress ECG.
  • Page 6: Part Names, Components For The Recording

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Part names, components for the recording 2.3.1 custo cardio 400 BT custo cardio 400 BT ECG application system 6 thoracic wall leads (1.20 m) and 4 extremity leads (1.45 m)
  • Page 7: Custo Cardio 400 Accu

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu 2.3.2 custo cardio 400 accu custo cardio 400 accu ECG application system 6 thoracic wall leads (1.20 m) and 4 extremity leads (1.45 m) Electrode “hair”, other versions optional...
  • Page 8: Assembly, Preparing The Custo Cardio 400 Device

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Assembly, preparing the custo cardio 400 device 2.4.1 custo cardio 400 BT and telescopic boom Operating elements on the telescopic boom Anti-rotation lock for fixing the boom, open during operation (swivel range 270°)
  • Page 9 Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Insert custo cardio 400 BT into the telescopic boom Push custo cardio 400 BT from above into the bracket on the boom .
  • Page 10: Custo Cardio 400 Accu And Custo Move Extension Arm

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu 2.4.2 custo cardio 400 accu and custo move extension arm custo move operating elements Bracket for custo cardio 400 accu with safety bar Anti-rotation lock for fixing the extension arm, open during operation, swivel range 270°...
  • Page 11 Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Fasten custo move extension arm in the fixture Viewed from above, turn custo move clockwise until the stop of the fixture. Then fasten the inset in the...
  • Page 12: Attaching Patient Leads To The Custo Cardio 400 Bt/Custo Cardio 400 Accu Device

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu 2.4.3 Attaching patient leads to the custo cardio 400 BT/custo cardio 400 accu device Attach the coding labels to the ends of the patient leads.
  • Page 13: Handling The Device

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Handling the device 2.5.1 Charging custo cardio 400 accu The custo cardio 400 accu device type has a lithium polymer battery that is located on the top of the housing.
  • Page 14: Custo Cardio 400 Display And Operating Elements

    Correct installation, configuration and commissioning of the system by your authorised custo med dealer The device types custo cardio 400 BT and custo cardio 400 accu have the same display and operating elements. These are located in the front area of the bottom of the housing.
  • Page 15: Custo Cardio 400 Device States In Standard Operation

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu 2.5.3 custo cardio 400 device states in standard operation Energy saving mode The On/Off button flashes blue and the suction level and status display show the charging status...
  • Page 16: Custo Cardio 400 Further States And Special Functions

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu 2.5.4 custo cardio 400 further states and special functions Change of operating mode If a USB connection is available, this will be prioritized over the wireless connection due to the higher data rate.
  • Page 17: Custo Cardio 400 Troubleshooting (Both Device Variants)

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu 2.5.5 custo cardio 400 troubleshooting (both device variants) In the event of an error, the custo cardio 400 suction level display lights up yellow or red.
  • Page 18: Examination Procedure

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Examination procedure IMPORTANT - Prerequisite for the use of the device: Correct installation, configuration and commissioning of the system by your authorised custo med dealer...
  • Page 19: Attaching The Device To The Patient

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Attaching the device to the patient 2.7.1 Electrode application Thoracic wall resting and stress ECG, standard according to Wilson V1 (C1) 4. Intercostal space at the right sternal border...
  • Page 20: Instructions For The Stress Ecg With Treadmill

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu 2.7.2 Instructions for stress ECG with treadmill The patient should ideally be wearing running shoes or trainers. The patient should not hold onto the handles of the treadmill during the recording process.
  • Page 21: Technical Data And System Requirements

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Technical data and system requirements Technical data custo cardio 400 BT / custo cardio 400 accu Number of ECG channels Frequency response 0 to 0.262 * sampling frequency [HZ]...
  • Page 22 Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Operating conditions Temperature +10°C ... +40°C Air humidity 30 ... 75 % rH Air pressure 700 ... 1060 hPa Transport and Temperature -20°C ...
  • Page 23 Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Recommended system requirements Computer Intel Core i3-CPU with HD graphics 4400 4 GB RAM 256 GB SSD or SSHD (for single-position systems 2TB HDD)
  • Page 24: Manufacturer's Declaration Regarding Emc (Electromagnetic Compatibility) According To Din En 60601-1-2:2016

    Manufacturer's declaration – electromagnetic emissions The custo cardio 400 BT/custo cardio 400 accu ECG application system is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 400 BT/custo cardio 400 accu ECG application system should make sure that it is used in such an environment.
  • Page 25 Manufacturer’s declaration – electromagnetic immunity The custo cardio 400 BT/custo cardio 400 accu ECG application system is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 400 BT/custo cardio 400 accu ECG application system should make sure that it is used in such an environment.
  • Page 26 RF telecommunication devices and custo cardio 400 BT/custo cardio 400 accu custo cardio 400 BT/custo cardio 400 accu is designed for use in an electromagnetic environment in which the RF transients can be controlled. The user can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile RF telecommunication devices (transmitters) and the device –...
  • Page 27: Ec Declaration Of Conformity

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu 2.10 EC Declaration of Conformity MHW 0012 – DK 1713 | Version 004 – 20/04/2020 | custo med GmbH [2] Resting and Stress ECG Hardware, custo cardio 400 devices |...
  • Page 28 Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu MHW 0012 – DK 1713 | Version 004 – 20/04/2020 | custo med GmbH [2] Resting and Stress ECG Hardware, custo cardio 400 devices |...
  • Page 29: List Of Product Components And Accessories

    Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu 2.11 List of product components and accessories Set no. Set name Part no. Qty. Set/product designation 85130 custo cardio 400 BT 84024...
  • Page 30 Resting and Stress ECG Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu Accessories Part no. Set/product designation 85027/Z Electrode “hair” (bag of 10 pieces) 85064/Z Electrode “standard” (bag of 10 pieces) 85065/Z Electrode “small” (bag of 10 pieces) 85035/z Extremity lead (1.45 m)
  • Page 31 Manufacturer's contact details: custo med GmbH Maria-Merian-Straße 6 85521 Ottobrunn Germany Phone: +49 (0) 89 710 98 - 00 Fax: +49 (0) 89 710 98 - 10 E-mail: info@customed.de Internet: www.customed.de...

This manual is also suitable for:

Custo cardio 400 accu

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