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ABPM with custo screen 100/200 and custo diagnostic  |  GEB 0141 – DK 0953  |  Version 002 – 05.06.2013  |  custo med GmbH

Introduction

01

01.1

  Symbols on the recorder 

 

CE mark

Safety class designation of a medical electrical device according to 

IEC 60601-1 (type BF)

Suitable for application with XXL blood pressure cuff

Take note of the accompanying documents

Follow the operating manual

Recyclable material

Separate collection of electric and electronic equipment, 

do not dispose with domestic waste

01.2

 Intended 

use

custo screen 100/200 is an ABPM recorder with internal power supply and 

serves for recording and evaluating the blood pressure behaviour of a patient. 

The recording period is 24 hours. custo screen 100/200 can be applied with 

pacemaker patients without any risk.

The system is intended for 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 who are not capa-

ble of understanding and following the instructions given are not allowed to 

use the device. This applies in particular to senile patients or patients suffering 

from dementia.

The device is not suited for small children or newborns as well as for the 

unsupervised use with unconscious patients.

Содержание ABPM

Страница 1: ...Operating Manual ABPM with custo screen 100 200 and custo diagnostic Operating characteristics custo diagnostic 3 8 and higher for Windows GEB 0141 DK 0953 Version 002 05 06 2013...

Страница 2: ......

Страница 3: ...ut 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 can be downloaded from ou...

Страница 4: ...ty checks 12 02 5 Disclaimer 12 02 6 Warranty 13 Device description basics of putting into operation 03 1 Scope of delivery and accessories 14 03 2 Operating the device 15 03 3 custo diagnostic basic...

Страница 5: ...lues 32 06 4 7 Automatic Report 33 06 4 8 Unconfirmed report 34 06 5 Confirming the evaluation 34 06 6 Ending the evaluation 35 06 7 Archiving evaluations 35 Product information 07 1 Measurement and s...

Страница 6: ...internal power supply and serves for recording and evaluating the blood pressure behaviour of a patient The recording period is 24 hours custo screen 100 200 can be applied with pacemaker patients wi...

Страница 7: ...tips ACTIONS THAT ARE PROHIBITED or not allowed under any circumstances WARNING used to indicate situations which if not avoided may result in personal injury and property damage NOTE provides import...

Страница 8: ...ns applicable to the product This system is designed in accordance with Medical Device Directive 93 42 EEC Class IIa and meets the requirements of protection class I or II depending on the power suppl...

Страница 9: ...the maximum permitted load is 3200 VA Slots which are not used in the delivered system portable multiple socket out lets must be provided with covers Ambient conditions For the installation and operat...

Страница 10: ...ed by the system should only be considered as suggestions For diagnosis and therapy purposes it is essential that the results are checked and assessed by a qualified physician Important hints regardin...

Страница 11: ...e for ensuring regular data backups patient databases evaluations etc and system backups We recommend that you backup the data at the latest before new installations updates and far reach ing system c...

Страница 12: ...onnecting the device to other equipment only specially screened cables supplied by custo med must be used 02 4 Maintenance regular safety checks The operator is responsible for maintenance The operato...

Страница 13: ...an authorised custo med dealer or custo med and the Operating Manual has been observed during device operation 02 6 Warranty Our product philosophy is committed to providing you with faultless produc...

Страница 14: ...g into operation 03 1 Scope of delivery and accessories custo screen 100 200 ABPM recorder Blood pressure cuff standard Carrying belt Carrying bag Batteries 3 pieces Mignon 1 5 Volt Type AA custo com...

Страница 15: ...la tors The direction of insertion is shown on the illus trations in the battery case Functional elements on the device Turn on off button for turning on and off the recorder Infrared interface for tr...

Страница 16: ...main menu of the User area is used to create and manage system users The user administration can be used to allocate user rights and control user specific settings e g the creation of a separate patie...

Страница 17: ...COM connection is assigned to custo com IR so that you can enter the COM connection in custo diagnostic afterwards Make a right click on the icon My Computer in your Windows surface on Admi nister in...

Страница 18: ...se and belt Both case and belt can be machine washed with a mild detergent at 40 C but must not be dried in a dryer Light spray application of suitable disinfectants is allowed Blood pressure cuff Aft...

Страница 19: ...agnostic GEB 0141 DK 0953 Version 002 05 06 2013 custo med GmbH 04 2 Recommended cleaning agents and disinfectants Disinfectants custo screen 100 200 carrying case belt All alcohol based disinfectants...

Страница 20: ...ne and the wearing comfort Attach the cuff to the left upper arm two to three centimetres above the crook of the arm Apply the cuff in a way that the marking is situated on the arteria brachialis The...

Страница 21: ...0 minutes during the night The recorder must be protected against extreme cold heat humidity dirt and mechanical impacts e g no shower no use of swimming pool and sauna Avoiding faulty measurements In...

Страница 22: ...gnostic and log on with your user name and password if required Click on Examina tion ABPM New ABPM Selecting the patient Select a patient for the recording To do this enter the patient s name in full...

Страница 23: ...ent Print diary After having clicked on Start a form for the patient is being printed which can be used to document events during measurements You can save the modified profile under a new name with S...

Страница 24: ...unction key in order to carry out a sample measurement Take care that the patient keeps steady during the measurement In the event of a faulty measurement improve the fitting of cuff and tube If the s...

Страница 25: ...ulty measurements have occurred Click on Options Faulty Measure You can see from the error codes which kind of disorder has occurred In the menu Options under Recorder Info you can check the accumulat...

Страница 26: ...ABPM In the Properties area you can define more search criteria If you set the confirmed property to No you will receive a list of all the evaluations which have not yet been confirmed a type of to d...

Страница 27: ...t whose re cording you want to open Enter the patient s name or parts of it into the input fields in the search screen Select the patient from the list below the input fields and confirm your selectio...

Страница 28: ...e overview table Fade in and out of the heart rate curve Fade in and out of limit values for the blood pressure curve Buttons for opening various viewing modes Button for printing the evaluation Butto...

Страница 29: ...initial screen to another view mode you can return to the original view mode by clicking on the same button Example You click on Table in the evaluation You access the tabular overview of all measure...

Страница 30: ...des 06 4 1 Graphic Hourly Values Evaluation Hourly Values Simplified heart frequency and blood pressure curve with the mean hour values Benefit Better overview thanks to a more smooth measurement curv...

Страница 31: ...3 Comparison Evaluation Comparison Comparison of the current evaluation with an additional one Use the arrow buttons to select other evaluations of the patient for a comparison 06 4 4 Comparison with...

Страница 32: ...ents shows the portion of successfully performed measurements 06 4 6 Table with Hourly Values Evaluation Table Hourly Values Simplified measurement table with mean hour values Tips for working in the...

Страница 33: ...matic report is created from the mean values day night drop and the por tion of the measurements which exceed the limit values Click on Accept report to transfer the results into the unconfirmed repor...

Страница 34: ...u can create report modules for confirming an evaluation The report modules are called during the confirmation via keyboard commands F5 to F12 In total you can create four categories each with eight r...

Страница 35: ...indicates that the work on an evaluation is complete and it acts as a write protection when the evaluation is opened again Click on Confirm to close the examination 06 7 Archiving evaluations Archivin...

Страница 36: ...up if batteries are weak If the blood pressure measurement has been carried out successfully systole diastole and pulse will be displayed three times one after the other During data transfer between...

Страница 37: ...service if multiple occurrences during a recording Error when determining diastole Cause Cuff has been attached incorrectly insufficient oscillation marking on the cuff is not situated on the artery...

Страница 38: ...Examination ABPM Settings Diagnostic Limit values to change the limit values permanently In the ABPM graphic initial screen you can fade in auxiliary lines at the level of the fixed limit values by cl...

Страница 39: ...eased with the function key R Repeat measurement e g if the limit values have been exceeded before they can be set individually at the start Average Average value of the corresponding measured value o...

Страница 40: ...5 min during the day every 30 min during the night Intervals can be set between 5 and 90 min Individual adaptation of all phases day night additional possible Cuff pressure max 300 mmHg Cuff sizes Chi...

Страница 41: ...ed dealer and forward your queries System Requirements Operating system Windows XP x64 Windows Vista x64 Windows 7 x64 Windows Server 2003 x64 Windows Server 2008 x64 Windows Server 2008 R2 older vers...

Страница 42: ...ull voltage 2 kV push push voltage 5 UT for 0 5 period 95 drop 40 UT for 5 periods 60 drop 70 UT for 25 periods 30 drop 5 UT for 5s 95 drop 3 A m Compliance Level 6 kV contact discharge 8 kV air disch...

Страница 43: ...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 being observed it may be necessary to take ad...

Страница 44: ...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 correspon ding column P is the maximum nominal powe...

Страница 45: ...s Graz PMG Technische Universit t Graz Kopernikusgasse 24 A 8010 Graz Austria ID number 0636 Certificate registration no EGII 130001 002 1 Date of issue Graz 2013 04 30 Certificate expiry date Graz 20...

Страница 46: ...sensitive piece of electronic equipment If unavailable pack the custo screen 100 200 such that the device is protected against impact moisture and dust The device must meet operation conditions when...

Страница 47: ...47 ABPM with custo screen 100 200 and custo diagnostic GEB 0141 DK 0953 Version 002 05 06 2013 custo med GmbH...

Страница 48: ...custo med GmbH Leibnizstrasse 7 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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