Custo Med custo watch Operating Manual
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Custo Med custo watch Operating Manual

Custo Med custo watch Operating Manual

Holter
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Operating Manual
Holter
1
Safety
Part 2: Hardware, description of device for custo watch
Operating characteristics:
For 3-channel holter,
up to 72 hours
MHW 0008 – DK 1695
Version 002 – 21/08/2019
2
Hardware
3
Software
4
Hygiene

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Summary of Contents for Custo Med custo watch

  • Page 1 Operating Manual Holter Safety Hardware Software Hygiene Part 2: Hardware, description of device for custo watch Operating characteristics: For 3-channel holter, up to 72 hours MHW 0008 – DK 1695 Version 002 – 21/08/2019...
  • Page 2 Internet or from a CD to ensure the Operating Manual is complete. MHW 0008 – DK 1695 | Version 002 – 21/08/2019 | custo med GmbH [2] Holter hardware, custo watch | page 2...

  • Page 3: Table Of Contents

    Hardware Software Hygiene Part 2: Hardware, description of device for custo watch Table of contents Symbols on the devices ............... .

  • Page 4: Symbols On The Devices

    Holter Hardware, description of device for custo watch Symbols on the devices (custo watch, custo guard, custo docking station, custo belt) Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany CE mark Medical electrical equipment classification according to DIN EN 60601-1 (Type BF)

  • Page 5: Intended Use

    Hardware, description of device for custo watch Intended use The custo watch is a portable Holter recorder with an internal power supply for recording a 3-channel ECG signal lasting up to 72 hours. The 3-channel ECG signal is taken via the custo guard 3 ECG transmitter (includes the custo belt 3 electrode belt) in accordance with the Holter standard.

  • Page 6: Part Names, Components For The Recording

    1/3 extender, extension piece for the electrode belt Washing net for custo belt custo docking station, charger for custo watch and custo guard, connection to the PC Micro USB cable 2.0 1.5 m, for connecting the custo docking station to the PC...

  • Page 7: Charging Custo Watch And Custo Guard

    “Performing a holter recording”). guard 3 (i.e. one which is not connected to the custo watch), the display shows It is only possible to display guard: ---. Place the correct custo guard 3 onto the custo docking station.

  • Page 8: Device Operation Custo Watch And Custo Guard

    Repeat the process for the remaining strap. To attach the other strap set, hold the custo watch so that the top of the housing can be seen. Place the strap from above on the corresponding parts on the housing and press the strap down until it clicks into place.

  • Page 9: Custo Watch Information Elements During Recording

    Hardware, description of device for custo watch 2.5.3 custo watch information elements during recording The custo watch shows the following elements during a recording: Radio symbol: appears when the connection to the ECG transmitter is successful ECG symbol: appears when QRS complexes are detected...

  • Page 10: Operating The Custo Watch Display

    Operating the custo watch display Standby The custo watch is in idle mode, no recording is in progress. If the custo watch is not connected to the PC, the time and date can be displayed by briefly pressing the grey button.
  • Page 11 ECG transmitter is in radio range and sufficiently charged. Establish a line of sight between the custo watch and custo guard, for example, by holding the custo watch in “reading position” in front of your body. The custo guard ECG transmitter must not be covered by body parts, such as crossed arms or the chest.
  • Page 12 Hardware, description of device for custo watch Memory full!: The memory card in the custo watch is full. The custo watch must be downloaded into custo diagnostic before a new recording can be performed. The data are stored in the custo diagnostic evaluation directory.

  • Page 13: Attaching The Holter Recorder To The Patient

    Hardware, description of device for custo watch Attaching the holter recorder to the patient 2.6.1 Fitting the custo watch The custo watch is worn like a wristwatch, see figure. The custo watch saves the ECG signal from the custo guard ECG transmitter. IMPORTANT: Before attaching...
  • Page 14 Holter Hardware, description of device for custo watch 2.6.3 Length adjustment of the custo belt 3 Opening and closing the custo belt To open the custo belt, pull the material loop off the black plastic hook. To close the custo belt, pull the material loop back over the black plastic hook. Then adjust the belt length with the length adjustment to the circumference of the patient’s chest.
  • Page 15 Holter Hardware, description of device for custo watch Adjustment from maximum length to medium length Hold the slider with your right hand, grasp the lower layer of material to the left of the slider and pull it through the slider up to the wide point.

  • Page 16: Attaching Custo Guard With Ecg Cable Custo Guard 3

    Holter Hardware, description of device for custo watch 2.6.4 Attaching custo guard 3 with ECG cable custo guard 3 If it is not possible to use an electrode belt, the ECG transmitter can be worn with the ECG cable custo guard 3: Press the custo guard 3 ECG transmitter firmly onto the four contact points of the ECG cable custo guard 3 .

  • Page 17: Patient Instructions, Handling Of The Device

    The recording period selected should be as normal as possible (not a holiday, no out-of-the-ordinary events). The devices must also be worn during the night. If the custo watch is taken off, ensure that it is always in radio range of the ECG transmitter. An active connection exists when the radio symbol is shown on the custo watch display.

  • Page 18: Technical Data And System Requirements

    Transport and storage Temperature -20°C ... +45°C conditions Air humidity 10 ... 95 % rH 2) If the custo watch is to be stored for a longer period of time, Air pressure 700 ... 1060 hPa it should be recharged regularly. Recommendation:...
  • Page 19 Holter Hardware, description of device for custo watch Technical data custo guard 3 Number of ECG channels 1 – 3 Sampling rate 125 / 250 / 500 / 1000 Hz Resolution 10 bit 3-dB band width ECG amplifier 0.5 Hz - 150 Hz...
  • Page 20 Holter Hardware, description of device for custo watch General system requirements Operating system Windows 7 SP1 – with current updates (32 bit and 64 bit operating system) Windows 8 (32 bit and 64 bit operating system) Windows 8.1 (32 bit and 64 bit operating system)
  • Page 21 Holter Hardware, description of device for custo watch 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) 1 GBit network connection (not for single-position systems) Fanless Dual-DVI (or DP) graphics card (for CPET) Windows 8.1 x64 (PRO version for joining a domain)

  • Page 22: Manufacturer's Declaration Regarding Emc

    Manufacturer's declaration – electromagnetic emissions The custo watch holter recorder (consisting of custo watch and ECG transmitter)) is designed for use in the elec- tromagnetic environment stated below. The customer or user of the custo watch holter recorder should make sure that it is used in such an environment.
  • Page 23 Manufacturer’s declaration – electromagnetic immunity The custo watch holter recorder (consisting of custo watch and ECG transmitter)) is designed for use in the elec- tromagnetic environment stated below. The customer or user of the custo watch holter recorder should make sure that it is used in such an environment.
  • Page 24 RF telecommunication devices and custo watch custo watch 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 25: Ec Declaration Of Conformity

    Holter Hardware, description of device for custo watch 2.10 EC Declaration of Conformity MHW 0008 – DK 1695 | Version 002 – 21/08/2019 | custo med GmbH [2] Holter hardware, custo watch | page 25...
  • Page 26 Holter Hardware, description of device for custo watch MHW 0008 – DK 1695 | Version 002 – 21/08/2019 | custo med GmbH [2] Holter hardware, custo watch | page 26...

  • Page 27: List Of Product Components And Accessories

    10320 custo watch 10305 custo watch incl. strap set grey 10306 Strap set for custo watch, colour green, circumference 160 – 200 mm 10308/Z Strap set for custo watch, large, circumference 180 – 260 mm 10302 custo guard 3 10301/R...
  • Page 28 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 beltCusto guard 3Custo guard 1

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