background image

56

Appendices

Appendix F  Safety and compliance information

The DocUReader 2 Pro device was designed and manufactured to comply with 

the following international regulations, and left the factory in a safe condition. 

Follow the instructions and pay attention to the warnings in this manual to keep 

the analyzer in a safe condition.
The device complies with the protection requirements of IEC 61010-1:2001, 

IEC 61010-2-101:2002, IEC 61326-1:2005 and IEC 61326-2-6:2005.

Complies with the provisions of the applicable EU regulations.

According to EN 61326-2-6, it is the user’s responsibility to ensure that a com-

patible electromagnetic environment for this instrument is provided and main-

tained in order that the device will perform as intended. Do not use this device in 

close proximity to sources of strong electromagnetic radiation (e.g. unshielded 

intentional RF sources), as these may interfere with the proper operation. The 

electromagnetic environment should be evaluated prior to operation of device.
This equipment has been designed and tested to CISPR 11 Class A. In a domes-

tic environment it may cause radio interference, in which case you may want to 

reduce the interference. 
The analyzer must be operated only with the prescribed power supply unit 

(Class II protection).
Personal computers that are connected to the device must meet the EN 60950, 

UL 60950/CSA C22.2 No. 60950 requirements for data processing equipment.
Only connect the intended external devices with safety low voltages to the cor-

responding interfaces (serial, PS2, USB, Ethernet) to avoid the risk of electrical 

shock or the risk of damaging the devices or the analyzer.
Please note that the instrument may potentially be infectious. Disinfect or steri-

lize all equipment before repair, maintenance or removal from the laboratory (See 

“Appendix E Disposal information”).

F.1  Incident reporting

Inform 77 Elektronika Kft. service representative and your local competent au-

thority about any serious incidents which may occur when using this product.

Содержание DocUReader 2 PRO

Страница 1: ...77 Elektronika Kft H 1116 Budapest Feh rv ri t 98 Hungary sales e77 hu www e77 hu DocUReader 2 PRO Urine chemistry analyzer User Manual Short version...

Страница 2: ...d in any form or by any means electronic mechanical or otherwise for any purpose without the express written permission of 77 Elektronika Kft 77 Elektronika Kft may have patents or pending patent appl...

Страница 3: ...th selected items 24 8 Quality Control Testing 24 8 1 Editing QC LOT Information 25 8 2 Setting QC solution acceptance limits 25 8 3 QC Testing 26 9 The Options menu 27 9 1 Registration Code 27 9 2 St...

Страница 4: ...ntitative measurement of relevant properties of the following urine analytes of the samples Bilirubin Bil Urobilinogen Ubg Ketones Ket Ascorbic Acid Asc Glucose Glu Protein Pro Blood Bld Ery pH Leukoc...

Страница 5: ...be downloaded by the following link or QR Code https www en e77 hu products urine analyzers docureader 2 pro 1 4 1 Symbols and formatting conventions This manual uses the following symbols to highlig...

Страница 6: ...es the same level of testing requirements Indicates that this equipment is classified as Waste Electrical and Electronic Equipment under the European WEEE Directive It must be recycled or disposed of...

Страница 7: ...robiological and Biomedical Laboratories BMBL 6th Edition and the World Health Organisation s Laboratory biosafety manual Fourth edition 1 6 Approvals The DocUReader 2 Pro system meets the requirement...

Страница 8: ...The analogue electrical signals from the detectors are first boosted by an amplifier 4 before they arrive at the microcontroller 5 Here the A D converter in the microcontroller changes the analogue s...

Страница 9: ...cables Use the On Off switch to switch off the device only if the normal power ing down procedure fails The USB ports are compatible with FAT32 ext2 and ext4 file systems but not compatible with the...

Страница 10: ...constant temperature and humidity Do not operate the device in close proximity to sources of intense electromag netic radiation such as unshielded intentional RF sources The device is certified to mee...

Страница 11: ...nd where the test strip channel opens opposite the reference pad Make sure that the test strip channel is fac ing upwards 2 Push the test strip tray into the open ing on the front of the device to the...

Страница 12: ...ected PC must comply with EN 60950 requirements 3 5 4 Switching the device on and off Connect the device to the electric mains via the AC adapter and switch it on by pressing the On Off switch at the...

Страница 13: ...bottom of the screen to turn green When it does keep gently pressing down on the touch screen until the yellow calibration screen appears Do not use your finger to calibrate the touchscreen Use a poi...

Страница 14: ...with the software update into one of the USB A con nectors at the back of the analyzer Wait for a disk icon to appear in the top right hand corner of the touchscreen The yellow disk icon indicates th...

Страница 15: ...See 10 4 2 System security settings the Measure screen is displayed first In the work area the user can start a measurement switch to the LabStrip U mALB CREA test strip handle the worklist cycle thro...

Страница 16: ...ack Return Forward More Drop modifications and Back Drop Back Apply Modifications and Next Apply Next Confirming changes Any changes on User options or Settings screens can be confirmed by tapping App...

Страница 17: ...e button The cursor can be moved with the left and right buttons To cancel the entry of a character from the current selec tion tap the button marked 4 2 3 Entering data via a barcode reader or a keyb...

Страница 18: ...is to cycle through the onscreen buttons using the Tab key Every time you press Tab a crosshairs pointer will move one button to the right indicating the targeted button Press Shift and Tab together...

Страница 19: ...ease refer to the strip s instructions for use The test strip tray has to be correctly loaded into the reader Prepare the test strip the urine sample and paper towel 1 2 3 1 Dip the test strip into th...

Страница 20: ...conds the pad results will be displayed on the screen and the test strip tray is automatically moved out of the analyzer The buttons remain inactive until the tray is fully moved out If Autostart is O...

Страница 21: ...s not available during the acquisition The Edit button is only active if the result has not yet been printed or transferred Before performing the next measurement remove the used test strip and dis po...

Страница 22: ...List view Key to the screen 1 Results list 2 Actions with selected records Database Select ed screen 3 Tap this button to make continuous selections us ing the up and down buttons on either side of a...

Страница 23: ...rmation Negative positive sed iment recommendation false an error message is returned instead of measurement results with comment including warning messages self measured records measured by the opera...

Страница 24: ...nents the necessity for reconstitution or readiness for use or the type and volume of container 77 Elektronika Kft recommends the use of CombiScreen Dip Check Ref 93010 or Drop Check Ref 93015 control...

Страница 25: ...year and the month with a slash a hyphen a dot or an underscore _ Consult the control solution s instruction of use and enter the acceptance limits for the type of control solution selected in step 2...

Страница 26: ...or Solution 3 for a High positive control solution if a three level control solution kit is used If a LOT number and the acceptance limits for the given solution type are already en tered on the QC Op...

Страница 27: ...u open a new shipment or vial of test strips find the registration calibra tion card in the package The unique registration code is attached to the registra tion card and it is valid for one 1 ten 10...

Страница 28: ...ent settings please refer to the full User Manual See chapter 1 4 How to use this manual 10 1 Output Connectivity Transfer Export The DocUReader 2 Pro device can be connected to other systems or stora...

Страница 29: ...tailed information about the output settings please refer to the full User Manual See chapter 1 4 How to use this manual 10 2 Strip options The main strip options screen shows the available test strip...

Страница 30: ...ible line 10 3 Power management On the Power Management screen the following options can be enabled and set LCD off time the screen saver starts Logout time the active operator is logged out After mea...

Страница 31: ...der of the operators that will be displayed on the Login screen can be changed with the Move button The button will only become active if there is at least one operator listed that has the Display on...

Страница 32: ...perator that has an Administrator operator access level Anonymous usage Logging in is automatic no identification or password is required Tests can be performed but settings cannot be modified Users c...

Страница 33: ...ecessary It is recommended to perform a Log export 255 before a Full clear 10 4 3 Security settings overview 1 Open system 2 Anonymous usage 3 Self add 4 Self add with password 5 Secure auto login On...

Страница 34: ...un inside the case and damage electrical parts Make sure that no liquid enters the device and printer compartment Do not use any type of solvent oil grease silicone spray or lubricant on the analyzer...

Страница 35: ...ease and dirt that can cause non printing white spots or streaks on the printout It is recommended to clean the printer roller at least every six months of device operation 1 Switch off the device and...

Страница 36: ...8 2 Setting up filters to find specific results Please note that this filter will also list results with comments inserted by the user If the result is saved with an error only the error code is visi...

Страница 37: ...ut the touchscreen does not light up The touchscreen is not connected properly to the Mainboard or the touchscreen is defective Contact your certified service personnel 3 The touchscreen is very dim 3...

Страница 38: ...ction with the Interface board Contact your certified service personnel 8 2 The Interface board is defective 9 The green LED under the test strip tray does not light up or it is very faint 9 1 The LED...

Страница 39: ...lthough normal operation is possible some functionality of the system is lost Information messages I Provide feedback or additional information The system displays these messages in the following ways...

Страница 40: ...ice W65 W S Output memory Not enough memory for output Please restart the system Restart the device W64 W S Output write Cannot write output Please change file name or re insert USB flash drive Use al...

Страница 41: ...ar If the error persists check and verify output settings W56 W S Output connect Output port cannot connect to server Please check Ethernet cable Ethernet configuration in settings and server IP addre...

Страница 42: ...cannot write new item Contact your certified service personnel E194 E P Worklist DB failure cannot insert or modify item Contact your certified service personnel E193 E P Worklist DB failure cannot d...

Страница 43: ...nter another Operator ID E166 E T Password check failed please try again Enter the valid password E165 E T Password is too short please try again minimum length is 3 characters Enter a new password th...

Страница 44: ...rive does not exist Please insert it Make sure that the USB flash drive is connected properly and that the system detects it If required re initialize the USB port by tapping the 77 Elektronika logo i...

Страница 45: ...reased to X day s The QC lockout time was restarted because of the successful QC measurement I116 I T Reminder Last day before lockout There is only one day left to perform a successful QC measurement...

Страница 46: ...e database with the measure ment results and will also be printed ID C T Full text Testing Error Source Corrective Action E299 E R Head HW error some LEDs may be defective Please call Service Contact...

Страница 47: ...267 E R Home position error Step failure detected after measurement Position count check failed after testing Check if the test strip tray is properly inserted and remove any obstacles from its path D...

Страница 48: ...ve action I502 I U The system is already up to date N A I503 I U SW update is not found Please insert USB drive with SW package Follow the message text instructions I504 I U Software update package wa...

Страница 49: ...A Results table The DocUReader 2 Pro analyzer prints the results in the following gradation of concentration using LabStrip urine test strips Parameter Conventional Units Conv SI Units SI Arbitrary BI...

Страница 50: ...e 5 10 Ery l 50 Ery l 300 Ery l negative 1 2 3 pH 5 5 5 6 6 5 7 7 5 8 8 5 9 NIT Nitrite negative positive negative positive negative 1 LEU Leukocytes negative 25 Leu l 75 Leu l 500 Leu l negative 25 L...

Страница 51: ...ary ACR 30 mg g 31 299 mg g 300 mg g 3 4 mg mmol 3 5 33 8 mg mmol 33 9 mg mmol norm ACR Recollect sample Normal Abnormal High abnormal Recollect sample Normal Abnormal High abnormal Recollect sample N...

Страница 52: ...inches Height 77 mm 3 inches Weight 1255 grams 2 767 pounds including the AC adapter the power cord and a new roll of printer paper Power supply 100 240V AC 10 15 50 60Hz 5 external mains adapter Envi...

Страница 53: ...ghtness 100 Measurement color OFF clarity OFF Set Sample ID OFF Set Patient ID OFF Display units conv arbitr Strip LabStrip U11 PLUS Bil 0 Ubg 0 Ket 0 Asc 0 Glu 0 Pro 0 Ery 0 pH 0 Nit 0 Leu 0 SG 0 Pri...

Страница 54: ...time min 5 Logout time min 10 Power off time min 60 Database management options Circular memory OFF Warning at circ mem limit OFF Prewarning 30 Authent general settings Auto login OFF Self add operato...

Страница 55: ...supply adapter S 1AGTM911 1 Appendix E Disposal information Do not dispose of an used DocUReader 2 Pro device or any of its parts as municipal solid waste Without disinfection or sterilization the de...

Страница 56: ...roper operation The electromagnetic environment should be evaluated prior to operation of device This equipment has been designed and tested to CISPR 11 Class A In a domes tic environment it may cause...

Страница 57: ...ation history Version Software Modification UD2 920102 1 2 2 3 First version Short manual according to IVDR requirements Due to software changes some screens on the instrument may appear slight ly dif...

Отзывы: