Custo Med Holter ABPM Custo Screen 400, Operating Manual

Page 1: ...ting Manual Holter ABPM Part 2 Hardware description of device for custo screen 400 1 2 3 4 Safety Hardware Software Hygiene Operating characteristics For Holter ABPM MHW 0004 DK 1663 Version 001 12 01...

Page 2: ...nto another language without the prior written consent of custo med GmbH The manufacturer reserves the right to change the information in this Operating Manual without prior notice The current version...

Page 3: ...1 custo screen 400 Holter ABPMrecorder 13 2 5 2 custo guard 3 ECG transmitter with a custo belt electrode belt 14 2 5 3 Adjusting the length of the custo belt electrode belt 15 2 5 4 Fitting the ECG...

Page 4: ...n and older not for newborns and small children Non ionising electromagnetic radiation Device contains a RF transmitter Symbol on the custo screen 400 recorder for the insertion direction of the mini...

Page 5: ...x 72 hours OR Holter recordings max 24 hours The type of recording is defined when the recorder is started in the medical operating system custo diagnostic custo screen 400 is perfectly safe for patie...

Page 6: ...M recorder Cuff with retainer standard Additional cuff sizes Cuff with retainer x large Cuff with retainer xx large Bandage cuff small child Bandage cuff standard Bandage cuff xx large Carrying case f...

Page 7: ...o screen 400 page 7 custo guard 3 ECG transmitter custo belt 3 electrode belt custo belt extender custo charger single custo guard 3 ECG cable Adjustable neck strap Tip custo screen protect hygiene se...

Page 8: ...e battery compartment as depicted and insert three commercially available batteries The direction of insertion is shown on the illustrations in the battery compartment Functional elements of the devic...

Page 9: ...pressure P Pulse Battery Lights up if the batteries are weak If the blood pressure measurement has been carried out successfully systole diastole and plus will be displayed three times in succession...

Page 10: ...r service Disturbed measurement Too many movement artefacts Cuff slipped or not tight enough Attach the cuff carefully and keep the arm steady during the measurement Battery voltage too low Insert new...

Page 11: ...ng Error when determining diastole Cuff attached incorrectly marking is not situated on the artery movement artefacts Attach the cuff carefully and keep the arm steady during the measurement Error whe...

Page 12: ...At a sampling rate of 1 kHz the maximum runtime is approx 3 days in standby approx 100 days The rechargeable battery capacity or the maximum runtime decreases over time 80 of the initial capacity aft...

Page 13: ...f contains information for which arm circumference it is suited e g standard 24 32 cm Lay the cuff tube from the left shoulder over the right shoulder to the right hip There the recorder will be place...

Page 14: ...t but that the patient is not impaired or hindered in breathing The contact surfaces on the inside of the electrode belt must not be soiled Soiling will affect the ECG quality CAUTION The electrode co...

Page 15: ...r is located directly next to the point where the material becomes wider on the custo belt The elastic excess length is completely pulled through the slider so that the slider is directly next to the...

Page 16: ...lastic hook and the wide material point Extension with the custo belt extender If the maximum length is not sufficient use a custo belt extender extension piece The custo belt extender is adjusted to...

Page 17: ...ts of the custo guard 3 ECG cable Attach the neck strap to the hooks on the custo guard 3 ECG cable Adjust the neck strap to the desired length Clean the electrode contact points the skin must be free...

Page 18: ...card must stay together for the whole of the examination and must not be swapped with parts of other custo screen 400 systems Make sure that the device and recording data are always clearly allocated...

Page 19: ...ing pool and sauna The patient is not allowed to remove the batteries or rechargeable batteries or modify the device in any way The custo flash card mini must not be removed from the recorder during r...

Page 20: ...es Discomfort during the recording If the patient experiences discomfort during a recording e g caused by a too high cuff pressure the patient must contact his her physician The patient can stop the m...

Page 21: ...s Measuring intervals Can be set to 5 to 90 minutes in the software Standard every 15 minutes during the day every 30 minutes at night Cuff pressure max 300 mmHg Cuff sizes Cuff with retainer standard...

Page 22: ...F Underlying standards DIN EN 60601 1 DIN EN 60601 1 2 DIN EN 60601 2 47 Technical data of custo belt 3 Length approx 680 mm 1400 mm without stretching Extension with custo belt extender approx 250 45...

Page 23: ...older versions are not supported PC The PC hardware should meet the minimum requirements of the operating system used Provide additional RAM 1 GB for custo diagnostic Please ensure that there is suff...

Page 24: ...le position systems Fanless Dual DVI or DP graphics card for CPET Windows 8 1 x64 PRO version for joining a domain Ports One USB 2 0 port per USB device preferably not USB 3 0 One COM port each for er...

Page 25: ...Magnetic field with supply frequency 50 60 Hz according to IEC 61000 4 8 IEC 60601 test level 6 kV contact discharge 8 kV air discharge 2 kV for net wires 1 kV for input and output wires 1 kV push pu...

Page 26: ...ompliance levels at the location where the device is used the device should be watched in order to prove the intended functions If unusual performance features are observed it may be necessary to take...

Page 27: ...ominal power is not indicated in the above table the recommended protective distance d can be determined in meters m using the equation affiliated with the corresponding column P is the maximum nomina...

Page 28: ...Holter ABPM Hardware description of device for custo screen 400 MHW 0004 DK 1663 Version 001 12 01 2018 custo med GmbH 2 Holter ABPM Hardware custo screen 400 page 28 2 9 EC Declaration of Conformity...

Page 29: ...2 Holter ABPM Hardware description of device for custo screen 400 MHW 0004 DK 1663 Version 001 12 01 2018 custo med GmbH 2 Holter ABPM Hardware custo screen 400 page 29...

Page 30: ...i 2 GB incl adapter 200321 3 Batteries AA LR6 Mignon 1 5 Volt 10310 custo ECG set 3 K 10302 1 custo guard 3 10301 R 2 custo belt 3 red 10118 2 custo belt 1 3 red extender 10103 1 custo charger single...

Page 31: ...pressure recorder ECG accessories 510241 SD card mini 2 GB incl adapter 10121 ECG cable guard 3 55551 Z Adjustable neck strap for custo guard 3 ECG cable and custo flash 5xx 10311 Adapter set for cust...

Page 32: ...Manufacturer s contact details custo med GmbH Maria Merian Stra e 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...