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ABPM with custo screen 300 and custo diagnostic  |  GEB 0154 – DK 1055  |  Version 002 – 05.06.2013  |  custo med GmbH

Patient instructions

In order to receive optimum results, inform your patient of the recording 

procedure and about the correct handling of the recorder:

Handling of the recorder

The day on which the recording is made should be planned as normally as pos-

sible (no day off, no exceptional events).

The switched-on recorder and the cuff must also be worn during the night.

On the day of recording no X-ray recordings are allowed to be made. Sources of 

interference, such as stimulation current devices, are to be avoided.

Each measurement is announced with a beep (unless this function is deac-

tivated in custo diagnostic). Using default settings, the measurements are 

performed every 15 minutes during the day and every 30 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 or sauna).

Avoiding faulty measurements

In order to avoid faulty measurements, the patient must keep his/her arm still 

during a measurement – physical activities must be stopped.

A repeat measurement is automatically performed two minutes after a failed 

measurement. If several measurements fail during recording (especially E6, 

E21-24 and E25-28) it should be checked if the cuff is still positioned correctly. 

The marker should be located on the brachial artery and the cuff should be 

positioned so that approximately two fingers fit between the cuff and the 

arm.

In case of disorders during the recording

If during the recording process disorders occur, e. g. caused by a too high cuff 

pressure, the patient must contact the doctor. The patient is able to stop the 

measurements at any time by pressing the function key or by opening the 

cuff’s hook and loop fastener.

Summary of Contents for custo screen 300

Page 1: ...Operating Manual ABPM with custo screen 300 and custo diagnostic Operating characteristics custo diagnostic 3 8 and higher for Windows GEB 0154 DK 1055 Version 002 05 06 2013...

Page 2: ......

Page 3: ...thout 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...

Page 4: ...13 02 5 Warranty 13 Device description basics of putting into operation 03 1 Scope of delivery and accessories 14 03 2 Device operation 15 03 3 custo diagnostic basic program structure 16 03 4 Device...

Page 5: ...report 33 06 4 8 Unconfirmed report 34 06 5 Confirm the evaluation 34 06 6 End the evaluation 35 06 7 Archive evaluations optional 35 Product information 07 1 Measurement and status indication on the...

Page 6: ...se with domestic waste 01 2 Intended use custo screen 300 is an ABPM recorder with an internal power supply which is used to record and evaluate the blood pressure behaviour of a patient The recording...

Page 7: ...d 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 impor...

Page 8: ...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 supply unit used the r...

Page 9: ...et 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 ope...

Page 10: ...duced 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 notes when...

Page 11: ...If custo screen 300 is not to be used for a prolonged period of time remove the batteries If liquid has been spilled on the device remove the batteries or the accumula tors immediately and send the d...

Page 12: ...grate additional medical devices in the custo med system for automatic PDF printouts from the connected medi cal device check whether the PDF file belongs to the current patient Do not trigger any PDF...

Page 13: ...bility for the safety and reliability of the custo screen 300 when all changes enhancements repairs and other work to the device and or system have been performed by an authorised custo med dealer or...

Page 14: ...elivery and accessories custo screen 300 ABPM recorder Blood pressure cuff standard Carrying belt Carrying case Batteries set of 3 Mignon 1 5 Volt type AA Starter kit custo com IR including USB connec...

Page 15: ...ies The direction of insertion is shown on the illustrations in the battery compartment Functional elements of the device On off switch for switching the recorder on and off Infrared interface for tra...

Page 16: ...the User main menu the users of the system can be created and managed The user administration can be used to allocate user rights and control user specific settings e g the creation of a separate pati...

Page 17: ...n Ports COM and LTP and make a note of the port assigned to custo com IR e g COM2 In custo diagnostic click on Examination Settings Connection Device Select custo com USB as the device and the corresp...

Page 18: ...th 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 After each use th...

Page 19: ...agnostic GEB 0154 DK 1055 Version 002 05 06 2013 custo med GmbH 04 2 Recommended cleaning agents and disinfectants Disinfectants custo screen 300 carrying case belt All alcohol based disinfectants e g...

Page 20: ...h arm circumference it is suited e g standard 24 32 cm Attach the cuff to the left upper arm two to three centimetres above the crook of the arm Apply the cuff in such a way that the marking is situat...

Page 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 or sauna Avoiding faulty measurements In...

Page 22: ...and log on with your user name and password if required Click on Examination ABPM New ABPM Select Patient Select a patient for the recording Enter the patient s name or the first letters of the name i...

Page 23: ...ted which can be used to document events during measurements You can save the modified profile under a new name with Save as and thus make it available for further recordings Click on Save to overwrit...

Page 24: ...a sample measurement Take care that the patient keeps still during the measurement In the event of a faulty measurement improve the fitting of the cuff and the tube If the sample measurement has been...

Page 25: ...download the evaluation is displayed automatically 05 6 Check the evaluation Check if and how many faulty measurements have occurred In the Options menu click on Faulty Meas ure You can see from the e...

Page 26: ...onfirmed a type of to do list To start the search click on Search Evaluation or activate Search automati cally This option triggers an automatic search in your database whenever the search criteria ar...

Page 27: ...recording you want to open Enter the patient s name or the first letters of the name into the input fields of the search screen Select the patient from the list below the input fields and confirm your...

Page 28: ...erview 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 additional view modes Button for printing the evaluation Button fo...

Page 29: ...ur 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 measu...

Page 30: ...ng modes in the evaluation 06 4 1 Chart hourly values Hourly Values Simplified HR and blood pressure curve with hourly mean values Benefit improved overview thanks to a more smooth measurement curve w...

Page 31: ...mparison 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 hour...

Page 32: ...s the portion of successfully performed measurements 06 4 6 Table with hourly values Evaluation Hourly Values Table Simplified measurement table with the hourly mean values Tips for working in the tab...

Page 33: ...atic report is created from the mean values day night drop and the portion of the measurements which exceed the limit values Click on Apply report to transfer the results into the unconfirmed report 0...

Page 34: ...n create report modules for confirming an evaluation The text modules are called during the confirmation via keyboard com mands F5 to F12 It is possible to create up to four groups with eight text mod...

Page 35: ...ompleted by an authorised person set the status of the evaluation to Locked After that the evaluation can still be viewed but no longer changed Click on Confirm to close the examination 06 7 Archive e...

Page 36: ...atteries 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 the data transfer between the...

Page 37: ...st Cause cuff tube is kinked valve system is clogged Align the cuff tube Otherwise contact customer service Discharge period is too long Cause cuff tube is kinked valve is defective Customer service i...

Page 38: ...enter the required values under Examination ABPM Settings Diagnostic Limit Values In the ABPM chart initial screen you can fade in auxiliary lines at the level of the fixed limit values by clicking o...

Page 39: ...ggered 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...

Page 40: ...he 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 Small Children 20...

Page 41: ...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 version...

Page 42: ...arge 8 kV air discharge 2 kV for net wires 1 kV for input and output wires 1 kV push pull 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...

Page 43: ...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 additional meas...

Page 44: ...is not indicated in the above table the recommended protective distance d can be determined in meters m using the equation affiliated with the correspond ing column P is the maximum nominal power of t...

Page 45: ...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 2018...

Page 46: ...ent If the original packaging is unavailable pack the custo screen 300 such that the device is protected against impact moisture and dust The device must meet operation conditions when put back into o...

Page 47: ...aster data All patient s evaluations Patient master data Evaluation last displayed Examination main menu of this examination Tip keyboard navigation When you press the Alt key the initial letter of al...

Page 48: ...custo med GmbH Leibnizstr 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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