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MHW 0007 – DK 1694  |  Version 002 – 15/07/2019  |  custo med GmbH

2

[2] Holter hardware, custo fl ash  500 / 510 / 510V / 501/ 501L  | 

page 12

Holter

 Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L

2.7

 Patient 

instructions

Handling the recorder

The recording period selected should be as normal as possible (not a holiday, no 

out-of-the-ordinary events).

Protect the recorder against humidity and spray water. Do not immerse the recorder 

in liquids. Do not wear the recorder in the shower, bath, sauna or similar wet envi-

ronments. Protect the recorder against extreme cold, heat, excessive dust develop-

ment and impact or being dropped.

The patient is not allowed to remove the rechargeable battery, or modify the device 

in any way.

During the recording no radiological examinations must be performed. The quality 

of the recording may be influenced by other electrical devices (e.g. mobile phones).

Do not leave small children unattended with the device. Risk of strangulation with 

provided cables and belts, risk of suffocation from small parts that could be swal-

lowed.

The LED display flashes green during recording (approximately once every 2 sec-

onds). If this is not the case, contact the medical practice. To avoid incorrect record-

ings the LED display should be checked regularly.

Notes on applying the electrodes

In the case of known allergies, e.g. against substances in the adhesive electrodes, 

the further procedure must be agreed with the physician before the commencement 

of recording.

In the case of multi-day recordings, the electrodes and the hygiene case must be 

replaced daily. To achieve correct measuring results, the electrodes must be applied 

according to the specified electrode positions.

If electrodes become detached during the recording, they must be attached again. 

Otherwise the ECG recording will not be possible. Patients should contact their 

medical practice for assistance with reattaching the electrodes.

The electrodes must not be applied to moist skin. The application positions for the 

electrodes must be dry and free of grease. The application positions must be free of 

personal care products.

If patients experience physical problems (e.g. severe skin irritations) or any other 

form of discomfort during the recording, the recorder can be taken off and they 

should contact their physician.

Summary of Contents for flash 501L

Page 1: ...are Hygiene Operating characteristics for 3 channel holter recordings 24 hours to 7 days MHW 0007 DK 1694 Version 002 15 07 2019 Operating Manual Holter Part 2 Hardware description of device for custo...

Page 2: ...ted into 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 ve...

Page 3: ...tery operating the charger 9 2 6 Starting the recorder and applying it to the patient 10 2 7 Patient instructions 12 2 8 Technical data and system requirements 14 2 9 Manufacturer s declaration regard...

Page 4: ...d GmbH Maria Merian Str 6 85521 Ottobrunn Germany CE mark Observe the Operating Manual Separate collection of electrical and electronic equipment do not dispose with domestic waste Recyclable material...

Page 5: ...r use by trained specialist staff or physicians in clinics and medical practices Patients are only allowed to use the recording device after receiving instruction by trained specialist staff Patients...

Page 6: ...p Chest belt for carrying case standard 60 110 cm custo flash 5xx protect custo sensive disposable electrodes Starterkit for custo flash 500 510 510V Charger for custo flash 5xx rechargeable battery R...

Page 7: ...be pressed to mark events during the recording The patient should make a note of the reason for pressing this key in his recording diary e g health problems stress agitation or similar Release key lo...

Page 8: ...cted The custo multiday card configuration is in progress the process may take several minutes The custo multiday card configuration is complete The device is in recording mode The rechargeable batter...

Page 9: ...rechargeable battery must only be charged at an ambient temperature between 10 45 C The rechargeable battery must not be charged when exposed to direct sunlight or on the radiator Charging the rechar...

Page 10: ...sition as shown Insert the programmed custo multiday card into the recorder Make sure that the direction of insertion is correct see the label in the recorder Assemble the rechargeable battery and the...

Page 11: ...e electrodes of other manufacturers can also be used provided that they are approved by the respective manufacturer for this purpose Remove the protective films from the electrodes Apply the top two e...

Page 12: ...lowed The LED display flashes green during recording approximately once every 2 sec onds If this is not the case contact the medical practice To avoid incorrect record ings the LED display should be c...

Page 13: ...Detach the ECG leads from the electrodes do not pull on the cables Remove the neck strap together with the recorder over the head Store the recorder in a safe and dry place Remove the electrodes from...

Page 14: ...on mode rejection at 50 Hz 80 dB Power supply Rechargeable lithium ion battery 3 7 V 1800 mAh Rechargeable battery lifespan approx 500 charging cycles Dimensions approx 95 65 17 mm L W H Patient leads...

Page 15: ...er 2012 Windows Server 2012 R 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 Ple...

Page 16: ...ion not for single 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...

Page 17: ...ge fluctuations flickers according to IEC61000 3 3 Compliance Group 1 Class B Not applicable Not applicable Electromagnetic environment guidelines custo flash 500 510 510V 501 501L uses RF energy only...

Page 18: ...0 15 MHz and 80 MHz are 6 765 to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The amateur radio bands between 0 15 MHz and 80 MHz are 1 8 MHz to 2 0 MHz 3 5 M...

Page 19: ...s or stacked together with other devices should be avoided as this could result in fault operation If the devices must nonetheless be used as described above this device and the other devices should b...

Page 20: ...1694 Version 002 15 07 2019 custo med GmbH 2 2 Holter hardware custo ash 500 510 510V 501 501L page 20 Holter Hardware description of device for custo flash 500 510 510V 501 501L 2 10 EC Declaration o...

Page 21: ...MHW 0007 DK 1694 Version 002 15 07 2019 custo med GmbH 2 2 Holter hardware custo ash 500 510 510V 501 501L page 21 Holter Hardware description of device for custo flash 500 510 510V 501 501L...

Page 22: ...or custo flash 5xx 55536 2 SD card for custo flash 5xx 256 MB 55543 1 Carrying case for custo flash 5xx 55551 1 Neck strap for custo flash 5xx adjustable 55553 1 Chest belt for carrying case standard...

Page 23: ...to flash 5xx 55551 1 Neck strap for custo flash 5xx adjustable 55553 1 Chest belt for carrying case standard 60 110 cm 55541 7 custo flash 5xx protect 40007 1 PCK30 custo sensive disposable electrodes...

Page 24: ...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...

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