Custo Med custo screen pediatric Operating Manual
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Custo Med custo screen pediatric Operating Manual

Custo Med custo screen pediatric Operating Manual

Abpm
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Operating Manual
ABPM
1
Safety
Part 2: Hardware, description of device for custo screen 300/310/400/pediatric
Operating characteristics:
For automatic
ABPM measurements
lasting up to 72 hours
MHW 0005 – DK 1664
Version 004 – 30/03/2020
2
Hardware
3
Software
4
Hygiene

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  • Page 1 Operating Manual ABPM Safety Hardware Software Hygiene Part 2: Hardware, description of device for custo screen 300/310/400/pediatric Operating characteristics: For automatic ABPM measurements lasting up to 72 hours MHW 0005 – DK 1664 Version 004 – 30/03/2020...
  • Page 2 Internet or from a CD to ensure the Operating Manual is complete. MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices |...

  • Page 3: Table Of Contents

    ......... MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH...

  • Page 4: Symbols On The Devices

    Safety class classification of medical electrical equipment according to DIN EN 60601-1 (Type BF) custo screen 300/310/400: The device is suitable for children aged ten and older (not for new-borns and small children). custo screen pediatric: The device is suitable for children aged between three and twelve years (not for new-borns and small children).

  • Page 5: Intended Use

    2.2.1 custo screen 300/310/400 custo screen 300/310/400 is an ABPM recorder with an internal power supply which is used to record and evaluate the blood pressure behaviour of a patient (from age of 10 years on). The recording time can last for up to 72 hours. The recorder types 300/310/400 are characterised by different functions, see chapter 2.2.3 Functional...

  • Page 6: Functional Features Of Custo Screen Recorder Types

    Diagnosis with phenotypes (optional, from 19 y.)     Risk stratification (optional, from 16 y.) MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 6...

  • Page 7: Part Names, Components For The Recording

    USB extension cable 2.0, type B mini, 2.0 m 1) Applies to devices from serial number CG2019 00885. Older versions with mini SD card. MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices |...
  • Page 8 Worn underneath the cuff with the soft side on the skin. MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices |...

  • Page 9: Device Operation, For All Types Of Recorders

    1) Applies to devices from serial number CG2019 00885. Older versions with mini SD card. MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 9...

  • Page 10: Elements In The Display

    In the event of erroneous measurements... an error code is shown on the display, e.g. "E06" MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 10...

  • Page 11: Error Codes And Their Causes

    Connect cuff if necessary Check cuff (sealing ring in connection present/OK?) If the error persists, call customer service MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 11...
  • Page 12 If errors occur that are not listed here, switch the device off and back on again. Repeat the desired step. If the error persists, contact your authorised custo med dealer. MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 12...

  • Page 13: Attaching The Recorder To The Patient

    If the sample measurement is successful, patient and recorder are ready for recording. MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 13...

  • Page 14: Patient Instructions

    Pregnant women should consider their individual physical endurance and contact their physician, if necessary. MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices |...

  • Page 15: Technical Data And System Requirements

    Cuff Wrap standard 24 – 32 cm    Cuff Wrap xx-large 38 – 50 cm MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 15...
  • Page 16 DIN EN 60601-1-2, IEC 80601-2-30, DIN EN 60601-2-47 (only applies to custo screen 400), Directive 93/42/EEC MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 16...
  • Page 17 6 MB (for approx. 45 min. of exercise) Hardware & ports DVD or CD-ROM drive, USB port MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 17...
  • Page 18 Monochrome (colour recommended for CPET) USB 2.0 port or network connection PCL-enabled (increases printing speed with the suitable driver) MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 18...

  • Page 19: Manufacturer's Declaration Regarding Emc

    Manufacturer's declaration – electromagnetic emissions The custo screen 300/310/400/pediatric ABPM recorder is designed for use in the electromagnetic environment stated below. The customer or user of the custo screen 300/310/400/pediatric should make sure that it is used in such an environment.
  • Page 20 Manufacturer’s declaration – electromagnetic immunity The custo screen 300/310/400/pediatric ABPM recorder is designed for use in the electromagnetic environment stated below. The customer or user of custo screen 300/310/400/pediatric should make sure that it is used in such an environment.
  • Page 21 Recommended protective distances between portable and mobile RF telecommunication devices and custo screen 300/310/400/pediatric custo screen 300/310/400/pediatric 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 22: Ec Declaration Of Conformity

    ABPM Hardware, description of device for custo screen 300/310/400/pediatric EC Declaration of Conformity MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 22...
  • Page 23 ABPM Hardware, description of device for custo screen 300/310/400/pediatric MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 23...

  • Page 24: List Of Product Components And Accessories

    Batteries AA LR6 Mignon 1.5 Volt 1) The part numbers of the IT accessories or consumables may change. MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices |...
  • Page 25 USB cable 2.0, A-plug, 1.5 m for custo kybe, watch, charger 1) The part numbers of the IT accessories or consumables may change. MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices |...
  • Page 26 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...

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