BeneHeart R3/BeneHeart R3A Electrocardiograph Service Manual
Contents
1. Check that a network connector is available if the equipment needs to be connected to the wired network Environmental Requirements To avoid explosion hazard do not use the equipment in the presence of flammable anaesthetics vapours or liquids The environment where the equipment will be used should be reasonably free from vibration dust and corrosive substances If these conditions are not met the accuracy of the system may be affected and damage may occur Enviornment Check and make sure that there is no electromagnetic interference source around the equipment especially large medical electrical equipment such as radiological equipment and magnetic resonance imaging equipment etc Switch off these devices when necessary Keep the examination room warm no less than 18 C to avoid muscle action voltages in ECG signal caused by cold 3 1 M Power supply Check that power supply specification is met and the power cord is securely connected if mains power is used Use only power socket that is properly grounded AC mains Input voltage 100 240V 110 Input power Battery When powered by a new fully charged battery and at ambient temperature 2 GH Gs Battery Type 500 auto measurement reports or 2 hours of continuous recording or 6 hours of measurement without recording With equipment power off and at ambient temperature 25 C 5 TC Run time lt 3 h to 90 capacity lt 3 5 h to 100 capacity2. Shutdown delay at least 5 minutes after a low battery message first occurs 3 3 Turning On the Equipment Once the equipment has been installed and checked you can get ready for measurement and recording l Connect the equipment with AC mains If you run the equipment on battery power ensure that the battery is sufficiently charged 2 Press the power on off switch 4 Hardware and Software Upgrade 4 1 Hardware Upgrade Not applicable 4 2 Software Upgrade You can upgrade the system by installing and running the Mindray Patient Monitor Software Upgrade Tool PN 110 000493 00 on a PC with Windows operating system Connect the equipment to be upgraded and the PC running the upgrade tool to the same network or directly connect the equipment and the PC via a crossover network cable Then configure the IP address of the PC You can upgrade the following software System software package Simplified 110 002535 00 l System softwar Chinese package System software package Traditional Chinese 110 002525 0 Power management program M501 ECG module STM32 chip writing Module software 110 002545 00 software 110 001201 00 TR8A recorder drive chip writing software 115 017992 00 Glasgow upgrade pack FRU Chinese Software function l 115 018007 00 Glasgow upgrade pack FRU English upgrade package 115 017996 00 PDF format upgrade pack FRU Note No specific sequence is required for the upgrading of above so
3. English Operator s manual German Operator s manual Czech Operator s manual Italian Operator s manual Portuguese Operator s manual Portuguese for Brazil Operator s manual Russian L 2 L e 2 2 L 53 54 57 040 001584 00 Patient cablem IEC 12 lead Clip 58 0010 10 12304 ECG electrode 10 pcs pack 9 2 59 61 62 63 64 65 67 70 71 72 73 9000 10 07469 ECG electrode 50 pes pack ECG electrode neonate 3M 2258 3 3 900E 10 04880 y y pcs pack PC management software package for 115 017981 00 l international 115 017992 00 Glasgow upgrade pack FRU Chinese 115 018007 00 Glasgow upgrade pack FRU English y 115 017996 00 PDF format upgrade pack FRU 9 3 9 2 Material Change Not Applicable 9 4 A Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program They are a proven means of detecting abnormalities that if undetected could prove dangerous to either the patient or the operator Additional tests may be required according to local regulations All tests can be performed using commercially available safety analyzer test equipment These procedures assume the use of a 601PROXL International Safety Analyzer or equivalent safety analyzer Other popular testers complying with IEC 60601 1 used in Europe such as Fluke Metron or Gerb may require modificatio
4. Then select Start Turn on the equipment to be upgraded Press and hold F1 key and F4 key for 2 to 3 seconds Then the equipment enters upgrade mode and starts software upgrade automatically Corresponding prompt messages are displayed to be upgraded on both the equipment and PC When software upgrade is finished restart the equipment and check if the software is correctly upgraded For details of software upgrade please refer to help and instructions for use of Mindray Patient Monitor Software Upgrade Tool ANCAUTION Discomnect the equipment from the patient and make sure the important data are saved before upgrade Do not shut down or power off the equipment when upgrading the system software Otherwise it may cause the equipment to break down Software upgrade should be performed by qualified service personnel only Crossover network cable is recommended when a PC is connected for software upgrade NOTE Make sure the version of the upgrade package is what you desired To obtain the latest upgrade package please contact Mindray Customer Service Department 4 4 5 Testing and Maintenance 5 1 Introduction To ensure the equipment always functions normally qualified service personnel should perform regular inspection maintenance and test This chapter provides a checklist of the testing procedures for the equipment with recommended test equipments and frequency The service personnel should perform the te
5. 1 aime oro LU Coin CO a essentielle 5 1 MESE tadas 5 1 5 1 2 AMES CIRC DOU en ee see 5 1 5 13 Preventative Maintenance 2 aaa A ine 5 1 5 1 4 Recommended Frequentes 5 2 3 2 Ylsyal Inspection aan ER AN 5 2 ISA OW EL ORTES eier 5 3 SAE CG Performance Test ann a at ed 5 3 3 3 Recorder check ae aa Er a 5 3 OBE Check a nen area ABeeRn ae 5 4 SJ Ma inlchance Mode asien eae eo ee ee 5 4 6 Ir0ubleshootins aus ee 6 1 COVE IE ee ee en ze ee A 6 1 6 2 Paris Replac A a 6 1 6 3 Ounickhy Identity ime Failure ccs eset kee eit 6 1 64 General Problems AAA E OO nn OR 6 2 IMEI SS 5c cael is dct sto E se Gs eared Sec Ga een E E ciel of E ET ORR E E 6 3 O A A A E 6 4 60 2 Prompt Messase o bete ato de rebote ato de a boe a LO dE 6 6 6 6 Troubleshooting GUIAS aaa ma 6 8 6 6 1 Power On OL FAU ni ri 6 8 02 RECO rd Ca US een acid 6 9 6 6 5 WONO SYSE O a cada 6 10 7 Disassemply and RE Pah 3 022 5 ee a Hans slehsileteiihe 7 1 A AAA A EEE NEIERIEIRSUIE 7 1 T 2 PreparaviOns Tor DIS e des e pios 7 1 7 3 Disassembling the Main DU ea aa 7 2 7 3 1 Removing Bottom housing assembly cccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 7 2 7 3 2 REMOVE the Rower DO lat 7 3 71 3 3 Removing the Main Control Board iii 7 3 734 Removns the DA and 7 4 7 3 5 Removing the Parameter Board cccccccnncnnccncnonnnnnnnnnnnnnononnnnnnnnnnnnnnnnnnnnnnnnnnnnnss 7 5 720 0 Removing the Key pad Board se 7 5 1 3 1 Removing the Recorder Drive Bol ER II
6. 7 6 7 3 8 Removing the Thermal Print Head n 7 7 A NA 8 1 8 1 o rn ere sr en ren rr 8 1 8 2 Mam Ut A SS 8 2 A IOC A A A A A IAS 8 2 A A A ee a 8 3 8 3 Top Housing Assembly 115 017634 00 or 115 017 7983 00 0ooocccccccccocooooooooooonnnnnnnnnnnos 8 5 Sl Exploded VIEW anne 8 5 A tue ace E E E E E E E 8 5 8 4 Recorder door assembly 115 01 7633 00 0ooooccoconocononooooooononononononononnnnnnnnonnnnnnononnnnonnnnnos 8 6 Sl Exploded ies 8 6 8 42 Parts Lita areas 8 6 8 5 Bottom housing assembly 115 017792 00 or 115 01838 7 00 0ooooocoocconooooooooonnnnnononnnos 8 7 SEE 0110 A ee Ne Ne ON 8 7 A ve 1a IG secrete eames O 8 7 9 BeneHeart R3 R3A Replacement Partes ccccccccccssssssssssssssssssssssscccccsccccccsssssssssssess 9 1 9 1 BeneHeart R3 R3A BOM V1 0 for Repair Upgrade and Accessories 9 1 92 Maitena CHAS cis 9 4 A Electrical Safety Inspection a uuani uni A 1 AE POW T CSU PINTO aa aA A 1 A 2 Device Enclosure and Accessoris AA AA AAA A AAA A 2 AA A O A te eats A 2 A4 Protective Barth Resistance tetas A 2 IR Earth Lee ak as CGS ies ssssnorasoerversaceansatcacea E E S A 4 2 6 Patient beakace Current ie eet ea aha A 6 Ac Mains on Applied Patt Le kaee en AAA A 7 A 8 Patient Auxiliary Coffent rai RER IRRE A 9 A 9 Scheduled Electrical Safety Inspection esen E RAEE A 11 A 10 Electrical Safety Inspection after Repalr oooccccccccnccnnnnonononononncnnnncnnnnnnnnnnnnnnn
7. plugged into the 601PRO front outlet If the DUT fails Earth Resistance discontinue tests and label the device defective To Perform the Test 1 From the MAIN MENU or with the outlet unpowered plug the DUT into the 601PRO front panel outlet 2 Attach the 601PRO RED input lead to the device s Protective Earth terminal or an exposed metal area 3 Press shortcut key 3 The Protective Earth Resistance test is displayed 4 Press SOFT KEY 3 to select a test current 25AMP The selected test current is displayed in the upper right corner of the display Prot Earth Resistance Test Current 1A A Ohm Limit 0 000 START TEST CAL LEADS AMPERES ay aw e 5 Press START TEST to start the test The test current is applied while resistance and current readings are taken This takes approximately 5 seconds 6 Press the print data key at any time to generate a printout of the latest measurement s A 3 NOTE When Over is displayed for Ohms this signifies that a valid measurement was not obtained because either an open connection was detected or that the measurement was not within range Readings greater than 9 999 Ohms will be displayed as Over In Case of Failure Once it reaches the limitation stop using and inform the Customer Service Engineer for analysis and disposal LIMITS ALL COUNTRIES R 0 2 Q Maximum A 5 Earth Leakage Test Run an Earth Leakage test on the device being tested before perf
8. to IEC60601 1 SFC 1000uA INSPECTION AND TESTING Power Cord Plug Device Enclosure and Accessories Device Labeling Protective Earth Resistance Q Normal condition NC Earth Leakage Single Fault condition SFC A IL Normal Patient condition NC Leakage Max CF applied part Current Single Fault NC 10uA SFC 50uA condition SFC Max CF applied part SOUA Mains on Applied Part Leakage Normal condition NC Patient Max Auxiliary CF applied part NC 10uA SFC SOUA Current Single Fault condition SFC Note The equipment sold to the United States shall comply with the requirement of UL60601 1 others shall comply with the requirement of IEC60601 1 Name Signature Date FOR YOUR NOTES P N 046 005000 00 1 0
9. two years Refer to A 1 Following any repair or replacement Electric safety ve Electrical Safety 2 After the equipment drops ests Inspection 3 At least once every two years Recorder check Following any repair or replacement of the recorder 1 When first installed 2 Whenever a battery is replaced Battery check Once per year or if the battery run time reduced Performance test oe significantly 5 2 Visual Inspection Functional test Inspect the equipment for obvious signs of damage The test is passed if the equipment has no obvious signs of damage Follow these guidelines when inspecting the equipment NW Carefully inspect the case display screen keys and knob for obvious signs of damage Inspect the power cord wall mount and accessories for obvious signs of damage Inspect all external connections for loose connectors bent pins or frayed cables Inspect all connectors on the equipment for loose connectors or bent pins Make sure that safety labels and data plates on the equipment are clearly legible 5 3 Power on Test This test is to verify that the equipment can power up correctly The test is passed if the equipment starts up by following this procedure 1 Install the battery and connect the equipment to AC power The AC mains indicator and battery indicator are illuminated 2 Press the Power On Off switch to turn on the equipment Then the equipment performs self test as soon as the equip
10. 15 017993 00 FRU y y orr o1eo 00 Power oaainsinor SY fs osioo7 00 TR recontra board ON o orons eana Thermal print head 8 dot mm 72 mm 60 11 024 000134 00 y y mm sec FPC lead E VN rss Bentca RA to housing emy N IN ris osmosis Keypad Bent REAL Chin N o 1s 017693 00 record doraembly SY 20 aran 2 pogo pros N N EMT re EE a 115 017792 00 Bonom housings Sd as 15 018987 00 Bonom housing asemby Berhe man V fas uno er E 9 1 27 043 003451 00 Battery door M501 for bidding 28 009 00323 1 00 Recorder cable Cable between the main control board and 29 009 003325 00 parameter board Connecting cable between main control board 30 009 003326 00 and keypad board Cable between the main control board and 31 009 003327 00 power board 32 33 9211 20 87221 046 004650 00 34 046 004651 00 35 046 004737 00 36 046 004738 00 Operator s manual French 37 046 004739 00 38 046 004740 00 39 Operator s manual Spain 40 046 004742 00 41 046 004743 00 046 004744 00 046 004745 00 Operator s manual Turkish y y 3 046 004817 00 Gago Piscis Guide ng O N so osoz Quick iden O so 02200012200 Lone 1 1V 2500 nab EMSOOLA Y Patient cablem AHA 12 lead 4 banana 51 040 001582 00 y connector Patient cablem IEC 12 lead 4 banana 52 040 001579 00 connector Cable for AC input receptacle Operator s manual Chinese Operator s manual
11. BeneHeart R3 BeneHeart R3A Electrocardiograph Service Manual Intellectual Property Statement SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD hereinafter called Mindray owns the intellectual property rights to this product and this manual This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray nor the rights of others Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties IL mora and MINDRAY are the registered trademarks or trademarks owned mindray by Mindray in China and other countries Revision History This manual has a revision number This revision number changes whenever the manual 1s updated due to software or technical specification change Contents of this manual are subject to change without prior notice NW Version number 1 0 NW Release time April 2013 2013 Shenzhen Mindray Bio Medical Electronics Co Ltd All rights reserved Preface Manual Purpose This manual provides detailed information about the assembling dissembling testing and troubleshooting of the equipment to support effective troubleshooting and repair It is not intended to be a comprehensive in depth explanation of the product architecture or technical implementation Observance of the manual is a prerequisite for proper equipment maintenance and prevents equipment d
12. List 2 Data memory Data memory is unavailable or Contact your service personnel unavailable cannot detect the data memory Data memory error Unable to read or write the data Contact your service personnel memory RT clock need reset The real time clock displays the Contact your service personnel initial value because button cell failed and reset or button cell is not available RT clock error Unable to read the real time clock Contact your service personnel register Battery error Failure is detected when the battery Contact your service personnel 1s being charged Device abnormal The voltage of PCBA power supply Contact your service personnel voltage j 1s abnormal Limb lead off 1 RL lead off or more than one 1 Check corresponding electrodes limb lead off and lead wires Re apply the 2 Patient cable is detached from electrodes or reconnect the lead wires the equipment if necessary 2 Check that patient cable is properly connected to the equipment XX Lead off The referred lead is off Check corresponding electrodes and XX refers to LA F lead wires Re apply the electrodes or LL L V1 C1 V6 C6 reconnect the lead wires if necessary Noise or artifacts from lead I II Check the patient V1 V2 V3 V4 V5 V6 is detected Noise Recording The recorder is working To stop printing press the ECG key for auto measurement recording or Manual key for manual measure
13. amage and personnel injury Intended Audience This manual is for biomedical engineers authorized technicians or service representatives responsible for troubleshooting repairing and maintaining the equipments Passwords A password may be required to access different modes The passwords are listed below NW Maintain Mode 888888 E Demo Mode 2088 II Contents DGC A TN 1 1 A I ORY A teste ti ieee tee 1 1 1 Sale Info is 1 1 ELA DANGER E E aeeeee 1 2 122 WaN iS een 1 2 A A A T 1 2 LS A at otras toe tat 1 3 ELSE Symbol O 1 3 2 Theory of Operation sii adsl 2 1 O E TON ee es 2 1 2 2 Connectors Tor External E en 2 2 23 Main Unit a hes Ba a cae ne ea Het la a Ina 2 4 2 4 lop housins as MD een ehe ueisieheie 2 5 2 42 Mam E00troL Board une ee ee i 2 5 242 Keypad DO nen ern 2 6 243 AQ DE Power Bostd u nun denies an ateros a 2 6 24 4 Recorder DIVE Boar rn en ee an en ee 2 6 PAo Parame er Dosen ran 2 6 3 Unpacking and Installation 3 1 a in 3 1 32 Prepatation Tor Installations idad dabas 3 1 33 Turnins On tne Equipment ie cobos Nd 3 2 A Hardware and Software Upgrade s cisesiscscscsicescseei essen 4 1 41 Hardware Ur bc a 4 1 RS A A A A IA 4 1 4 2 1 Installing Software Upgrade Tool cccccccccnnncnnnnnnnnnnnnnnnnnnnnnnonononnnnnnnnnnnnnnos 4 2 4 2201 Ware pgrade Proceed re mi 4 4 gt Testing and MAINTENANCE ar cscs cs cscceendceciessscecdeeeiveudoscedecDoevivwedoceses bossuerenveceesaveetevstseoseeees 5 1 9
14. and operate it on battery power if possible eo Dispose of the package material observing the applicable waste control regulations and keeping it out of children s reach 1 2 3 Cautions CAUTION Make sure that no electromagnetic radiation interferes with the performance of the equipment when preparing to carry out performance tests Mobile phone X ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation Before connecting the equipment to the power line check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment s label or in this manual Protect the equipment from damage caused by drop impact strong vibration or other mechanical force during servicing 1 2 1 2 4 Notes NOTE o Refer to Operation Manual for detailed operation and other information 1 3 A a Symbols Caution Attention consult ON OFF part accompanying documents equipment EN Battery indicator gt Alternating current AC DEFIBRILLATION PROOF TYPE CF APPLIED PART E remar eK mr DATE OF S N Serial number MANUAFACTURE Equipotentiality Dispose of in accordance to AY General symbol for your country s requirements E recovery recyclable CCC Mark China Chi et ina etrolo Compulsory Certification M GC l 2 Certification mark Environment friendly Used Authorized representative Period per Chinese Stan
15. condition Patient NC LICF uA Max Leakage CF applied part g BF WA ppl ed p Current Single Fault NC 10uA SFC 50uA condition SFC OCF uA LIBF uA Max 7 Mains on Applied Part Leakage OCF uA CF applied part SOUA E BF uA Normal condition Patient NC LICF uA Max Auxilia CF applied part ry u BF mn ppl ed p Current Single Fault condition T NC 10uA SFC 50uA SFC OCF uA Note The equipment sold to the United States shall comply with the requirement of UL60601 1 others shall comply with the requirement of IEC60601 1 Name Signature Date A 10 Electrical Safety Inspection after Repair The following table specifies test items to be performed after the equipment is repaired Repair with main unit not disassembled Test items 1 2 3 Repair with When neither power supply Test items 1 2 3 4 main unit PCBA nor patient disassembled electrically connected PCBA is repaired or replaced When power supply PCBA is Test items 1 2 3 4 5 repaired or replaced When patient Test items 1 2 3 4 6 7 8 electrically connected PCBA is repaired or replaced When both power supply Test items 1 2 3 4 5 6 7 8 PCBA and patient electrically connected PCBA are repaired or replaced ELECTRICAL SAFETY INSPECTION FORM Equipment Control Number Manufacturer Model Measurement equipment SN Date of Calibration Max 0 2 Q Max NC 300uA refer to UL60601 1 NC 500uA refer
16. could be used instead Change another probe to confirm if the fail is caused by console If the leakage current measurement tests fail on a new unit and if situation can not be corrected submit a Safety Failure Report to document the system problem Remove unit from operation If all else fails stop using and inform the Customer Service Engineer for analysis and disposal NW For CF applied parts 50 uA A 8 Patient Auxiliary Current Patient Auxiliary currents are measured between any selected ECG jack and the remaining selected ECG jacks All measurements may have a true RMS only response Preparation l From the MAIN MENU or with the outlet unpowered plug the DUT into the 601 PRO front panel outlet and turn on the device Attach the patient leads to the 601PRO ECG jacks Define the Lead Types from the View Settings Option refer to Lead Type Definitions in Section 5 of this chapter Press shortcut key 8 The Patient Auxiliary Current test is displayed and the test begins immediately Display values are continuously updated until another test is selected Patient Auxiliary Cur RA AII Outlet Norm Pol Earth L2 OuA Limit Inv DUT OFF NO EARTH NOL2 APPLIED PART aD ED AD AD AD ED 5 Press SOFT KEYS 1 4 to select leakage tests 6 Press APPLIED PART SOFT KEY 4 at any time to select the desired applied part leakage current 7 Modify the configuration of the front panel outlet by pressing the ap
17. dard in the European SJ T 11363 2006 Community The product bears CE mark indicating its conformity with the provisions of en the Council Directive 93 42 EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive NOTE Some symbols may not appear on your equipment 1 3 FOR YOUR NOTES 2 Theory of Operation 2 1 Introduction BeneHeart R3 BeneHeart R3A Electrocardiograph hereafter referred to as the equipment or the system is intended to acquire analyze display store and record the patient s electrocardiographic information for clinical diagnosis and study The equipment provides the following functions M Display 12 lead ECG waveforms in real time print manual auto and rhythm measurements NW Perform resting ECG interpretation output measurements and diagnosis in auto measurement mode NW Save ECG data in internal memory and export the data through a USB memory NW Enables program upgrade over the network Mobile Viewer r 2 1 The above figure shows the system consists of the electrocardiograph and its peripheral devices The electrocardiograph NW Acquires processes and reviews 12 lead resting ECG data M Prints ECG reports NW Runs on AC power source or a battery ii Exports data through a USB memory 2 2 Connectors for External Equipment The connectors for external devices are located on the left and rear of the equip
18. e insulator AC input receptacle and cable 7 3 3 Removing the Main Control Board 1 Release the latch locking the flexible PCB connecting the display to the main control board by pushing the latch from Position 1 to Position 2 as shown in the picture below Disconnect the flexible PCB 1 l N Te cee eaten ages a se ral le men MARA AAA A i a aN 1 1 i i NOTE o Make sure to disconnect the flexible PCB between the main control board and the display before removing the main control board 7 3 2 Unscrew the four M36 screws Disconnect the recorder cable the connecting cable between the main control board and the parameter board the connecting cable between the main control board and the keypad board and the connecting cable between the main control board and the power board 7 3 4 Removing the Display Before removing the display remove the main control board as described in 7 3 3 Removing the Main Control Board Then you can remove the display follow this procedure 1 Unscrew the four PT3x6 tapping screws to remove the displayfixing kit 2 Remove the TFT display 7 4 7 3 5 Removing the Parameter Board 1 Unscrew the four M3x6 tapping screws 2 Disconnect the cable between the main control board and the parameter board 7 3 6 Removing the Keypad Board Before removing the keypad board remove the parameter board as described in Secti
19. ectly loaded Set Paper Type correctly 6 6 3 Wrong system time Displayed system time is wrong Message RT clock error is presented Replace main control board Y Reset system time yo OK gt No cell button or cell button failed Y Replace button cell N y Replace main control board gt 6 10 F Disassembly and Repair 7 1 Tools Required To disassemble and replace the parts and components the following tools may be required Philips screwdrivers Tweezers Sharp nose pliers Clamp 7 2 Preparations for Disassembly Before disassembling the equipment finish the following preparations NW Stop measuring turn off the equipment and disconnect all the accessories and peripheral devices EW Disconnect the AC power source and remove the battery N WARNING o Before disassembling the equipment be sure to eliminate the static charges first When disassembling the parts labeled with static sensitive symbols make sure you are wearing electrostatic discharge protection such as antistatic wristband or gloves to avoid damaging the equipment e Properly connect and route the cables and wires when reassembling the equipment to avoid short circuit o Select appropriate screws to assemble the equipment If unfit screws are tightened by force the equipment may be damaged and the screws or part may fall off during use causing un
20. ent system status Some messages see Message List 1 are more important and urgent and need you to acknowledge or take actions in time The system pops up a dialog box when these messages happen In this case you cannot operate the equipment unless you press any key to clear the messages or wait till the triggers disappear Some messages see Message List 2 are less important These messages are shown in the message area They disappear automatically when the triggers disappear The equipment can give a notification tone when a message is presented The notification tone is switched off by default You can enable it by accessing the System Setup menu However the equipment always gives a notification tone when some messages occur regardless of the setting of Notification tone Refer to the messages followed by an asterisk in the Messages Lists below 6 3 6 5 1 Message List 1 Battery depleted Recorder unavailable 1 When recording is needed or a measurement is started In this case a dialog box pops up You can press any key to close the dialog box It does not affect the function 2 Recorder communication error or does not work ECG module error failure causes ECG communication error or communication stops Paper type error i different with the used paper type The battery is too low Damaged ECG board or software The setting of Paper Type is Connect the equipment to AC mains t
21. er or owner to correct any deviations As a work around check the other outlets to see if they could be used instead NW Change another probe to confirm if the fail is caused by console m Ifthe leakage current measurement tests fail on a new unit and if situation can not be corrected submit a Safety Failure Report to document the system problem Remove unit from operation NW If all else fails stop using and inform the Customer Service Engineer for analysis and disposal LIMITS For UL60601 1 300 uA in Normal Condition 1000 uA in Single Fault Condition For IEC60601 1 500 uA in Normal Condition 9 1000 uA in Single Fault Condition A 6 Patient Leakage Current Patient leakage currents are measured between a selected applied part and mains earth All measurements have a true RMS only response Preparation Perform a calibration from the Mains on Applied Part menu The following outlet conditions apply when performing this test NW Normal Polarity Earth Open Outlet ON Normal Polarity Outlet ON WE Normal Polarity L2 Open Outlet ON Reversed Polarity Outlet ON NW Reversed Polarity Earth Open Outlet ON Reversed Polarity L2 Open Outlet ON NWARNING o Ifall of the applied parts correspond to the instrument type the applied parts will be tied together and one reading will be taken If any of the applied parts differ from the instrument type all applied parts will be tested individually based on the type
22. ftware For detailed information please refer to 4 2 2 Software Upgrade Procedure 4 2 1 Installing Software Upgrade Tool 1 Find the installation program Ef SystemUpdateTool exe and double click it to start installation 2 Select language 3 Click Ok and the following screen 1s displayed Click Next to go to the next step Welcome Welcome to Mindray Patient Monitor System Update Tool install program This program install Mindray Patient Monitor System Update Tool into your computer Click Cancel to Exit the install program Click Next to continue the install program The program can Upgrade the Patient Monitor of Mindray Co Ltd If you don t have Patient Monitor of Mindray the program can t work If you want purchase patient monitor of mindray please contact with us Authorization The program need license if you haven t now please contact with us to ask for one cnoe 4 Enter User Name Company name and Serial Number 26582640 Then click Next Customer Information Please enter your information Please enter your name the name of the company for whom you work and the product serial number User Name ities Company Name o oo Serial Number cos 4 2 5 Specify the destination folder for installing this program Then select Next Choose Destination Location Select folder where Setup will install files Setup will install Mindray Patient Monit
23. h voltage is present at applied part terminals while measurements are being taken To Perform the Test l From the MAIN MENU or with the outlet unpowered plug the DUT into the 601 2 Attach the applied parts to the 601PRO applied part terminals 3 Attach the red terminal lead to a conductive part on the DUT enclosure 4 Press shortcut key 7 The Mains on Applied Part test is displayed Mains on Applied Part All Earth Outlet Norm Pol Earth L2 Norm uA Rev UA Limit Inv START TEST CAL DUT OFF APPLIED PART ED AD as eas AD aD 5 Select the desired outlet configuration and applied part to test using the appropriate SOFT KEYS 6 Press START TEST SOFT KEY 1 to begin the test 7 Press the print data key to generate a printout of the latest measurement NOTE If all of the applied parts correspond to the instrument type the applied parts will be tied together and one reading will be taken If any of the applied parts differ from the instrument type all applied parts will be tested individually based on the type of applied part This applies to Auto and Step modes only In Case of Failure LIMITS Check any broken of the enclosure Replace any defective part Inspect wiring for bad crimps poor connections or damage Test the wall outlet verify it is grounded and 1s free of other wiring abnormalities Notify the user or owner to correct any deviations As a work around check the other outlets to see if they
24. k whether the USB memory is file s are being exported properly plugged If yes the file system might be damaged Format the USB E ES and try again Data export completed Patient data 1s successfully exported Export configuration Configuration is successfully successfully exported Export failed Exporting patient data failed 1 Check that the settings are correct and a correct option is select 2 Check that USB memory is properly inserted and file system is not damaged 3 Check that the USB memory has sufficient File s are being deleted Deleted successfully A single file or all files are successfully deleted Deleting failed Deleting file s failed Check that deleting option is selected You can format the internal memory 1f you want to delete all the files USB memory low The USB memory has insufficient Delete useless files stored in the space when patient data or USB memory to release the configuration is to be exported to the memory space USB memory Formatting failed Formatting memory failed Internal memory might be damaged Contact your service mz Formatting completed The memory is successfully Formatting Please wait Please wait The memory is The memory is being formatted formatted Shutting down The system is shutting down BO Note means that the equipment always gives a notification tone when the message occurs 6 5 2 Prompt Message
25. ll else fails stop using and inform the Customer Service Engineer for analysis and disposal LIMITS For CF applied parts 9 10uA in Normal Condition 50uA in Single Fault Condition A 7 Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage which is 110 of the mains voltage through a limiting resistance to selected applied part terminals Current measurements are then taken between the selected applied part and earth Measurements are taken with the test voltage 110 of mains to applied parts in the normal and reverse polarity conditions as indicated on the display The following outlet conditions apply when performing the Mains on Applied Part test M Normal Polarity NW Reversed Polarity Preparation To perform a calibration from the Mains on Applied Part test press CAL SOFT KEY 2 1 Disconnect ALL patient leads test leads and DUT outlet connections 2 Press CAL to begin calibration as shown Disconnect All Patient Leads and OUTLET connections CAL PREVIOUS dG Tr wo DD If the calibration fails the previously stored readings will be used until a passing calibration has occurred Also the esc stop key has no effect during calibration 3 When the calibration is finished the Mains on Applied Part test will reappear NWARNING A 2 beep per second signal indicates high voltage present at the applied part terminals while a calibration is being performed o Hig
26. ment Side View l Patient cable connector connects the patient cable for ECG acquisition 2 Recorder door latch opens the recorder door 1 Network connector connects the equipment to the network for software upgrade 2 USB connector connects USB disc for data transfer Back View 1 AC power input 2 Equipotential Grounding Terminal When the equipment and other devices are to be used together their equipotential grounding terminals should be connected together to eliminate the potential difference between them Bottom View 1 Battery compartment 2 3 Main Unit The equipment consists of the following parts M Top housing assembly consists of main control board keyboard assembly display power switch power board AC DC recorder and parameter board M Lower housing includes a battery compartment The following figure shows the main unit architecture Thermal head module W7 Damen hoard Recorder drive Keypad board board Wil W3 W2 USB T RJ45 Main control board W4 Parameter Board 9 WS W6 B Wi Fi En LCD reserved 2 4 Top housing assembly Bosses for screwing top and bottom housings together Recorder drive board Power board Bosses for screwing top and bottom housings together Keypad board Parameter board Main control board 2 4 1 Main C
27. ment is powered on 5 4 ECG Performance Test Tool required Patient simulator eg Medsim300B or equivalent equipment Test Method 1 Connect the patient cable to the equipment under test and the lead wires to the patient simulator 2 Set the patient simulator as follows ECG sinus rhythm HR 80 bpm with the amplitude as 1 mV default setting 3 Check that the displayed ECG waveforms are clear and complete without obvious noise 4 Press the ECG key to start automatic ECG measurement Print out the waveforms and diagnosis 5 Check that the displayed ECG waveforms are clear and complete with the amplitude of lead II waveform about 10 mm assumed the Gain is set to 10mm mV and diagnosis indicating sinus rhythm and HR 80 bpm 6 Disconnect each of the leads in turn and observe the corresponding lead off message displayed on the screen 5 5 Recorder check Tool required E None 1 Print ECG waveforms The recorder should print correctly and the printout should be clear 2 Simulate some recorder problems such as out of paper paper jam and etc and then the equipment should present the message Check Recorder After the problem is removed the recorder should be able to work correctly 5 3 5 6 Battery Check Tool required E None Functional Test 1 Ifthe equipment is installed with a battery remove the battery first i Verify that the equipment works correctly when running powered f
28. ment recording or the Rhythm key for rhythm measurement recording Analyzing The algorithm is analyzing acquired ECG data Analyzing Failed The algorithm fails to analyze Refer to 12 Lead ECG Interpretive acquired ECG data and is unable to Program Physician s Guide PN give disagnoses 046 004817 00 ECG data insufficient In the situation that pre acquisition Wait till sufficient data is acquired is enabled the equipment has not acquired 10 seconds of ECG data when auto measurement is started Acquiring The equipment is acquiring Wait till 60 seconds of countdown 1s 60 second ECG data when rhythm reached To stop acquisition press measurement is started the Rhythm key Please check recorder 1 Recording paper is not loaded or 1 Verify that recording paper is runs out loaded and sufficient 2 Recorder door is not properly 2 Verify recorder door is properly closed closed Recorder head hot Print head has heated up do to Stop printing and wait till the aie tale OO use aa disappears IP IP address conflict conflict IP IP address conflict conflict Contact your service Contact your service personnel The memory space Left memory space is less than 10 Delete useless historic files insufficient files Low battery Battery charge is low Connect the equipment to AC mains to run the equipment and charge the battery Note means that the equipment always gives a no
29. nnanos A 12 FOR YOUR NOTES 1 General 1 1 Revision History Manual Version Description of Changes Change Time SN Since Premios 1 2 Safety Information NDANGER o Indicates an imminent hazard that if not avoided will result in death or serious injury N WARNING eo Indicates a potential hazard or unsafe practice that if not avoided could result in death or serious injury NCAUTION eo Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage NOTE Provides application tips or other useful information to ensure that you get the most from your product 1 1 1 2 1 DANGER There are no dangers that refer to the product in general Specific Danger statements may be given in the respective sections of this manual 1 2 2 Warnings NWARNING eo All installation operations expansions changes modifications and repairs of this product are conducted by authorized personnel eo Disconnect the equipment from external power source and remove the battery before disassembling the equipment eo When you disassemble reassemble the equipment a patient leakage current test must be performed before it is put in use o The equipment must be connected to a properly installed power outlet with protective earth contacts only If the installation does not provide for a protective earth conductor disconnect it from the power line
30. ns to the procedure Please follow the instructions of the analyzer manufacturer The consistent use of a safety analyzer as a routine step in closing a repair or upgrade is emphasized as a mandatory step if an approved agency status is to be maintained The safety analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line voltage and grounding as well as total current loads A 1 Power Cord Plug Test Item Acceptance Criteria The power plug pins No broken or bent pin No discolored pins The plug body No physical damage to the plug body The power plug l No physical damage to the strain relief No plug The strain relief 8 warmth for device in use No physical damage to the cord No deterioration to the cord For devices with detachable power cords inspect The power cord the connection at the device For devices with non detachable power cords inspect the strain relief at the device A 2 Device Enclosure and Accessories A 2 1 Visual Inspection Test Item Acceptance Criteria No physical damage to the enclosure and accessories No physical damage to meters switches connectors etc The enclosure and accessories No residue of fluid spillage e g water coffee chemicals etc No loose or missing parts e g knobs dials terminals etc A 2 2 Contextual Inspection Test Item Acceptance Criteria No unusual noises e g a rattle inside the case No unusual
31. nts Cr O Er SS Dr Dr OO OO Equipment under test EUT Hardware version Software version J PO O PO E IO E IO AO HE PE E PS E A 5 5 Test Result Test Contents Test Record Pass Fail Visual Inspection The housing display screen keys power cord and accessories have no obvious signs of damage The external connecting cables are not frayed and the connector pins aoa AS Tnsemlomnesmwenstkosseriir mama i The safety labels and data plate are clearly legible S Power on Test The power on self test is passed The power indicator works correctly and the equipment starts up properly Performance test ECG performance test and calibration The ECG waveforms displayed and printed out should be clear and complete without obvious noise The amplitude of lead II waveform is about 10 mm and diagnosis indicate sinus rhythm and HR 80 ECG Lead Off prompt behaves correctly a Recorder check The recorder can print ECG waves correctly and the printout is clear Simulate recorder problems such as out of pater and paper jam the message Check Recorder shall be presented Battery Check The equipment can operates correctly from battery power when an AC power failure accidentally occurs The equipment can operate independently on a single battery Test conclusion Tested by Test date 5 6 6 Troubleshooting 6 1 Overview In this chapter equipment problems are li
32. o run the equipment and charge the battery 1 Verify that recording paper is properly loaded 2 Verify the platen of the print head is in position 3 Verify that the recorder does not stop due to hot print head 4 If the message persists after above actions have taken contact your service personnel Contact your service personnel Verify the setting of Paper Type is correct by selecting Menu System Setup Configuration loaded The configuration is successfully successfully loaded Configuration restored Default configuration 1s successfully successfully i restored Loading configuration Main control software or hardware Contact your service personnel failed fails USB memory not found The system fails to find the USB memory Configuration file not Configuration file is not found in the found USB memory when Load Configuration is selected Exporting data Please The system 1s exporting patient data wait X Y X refers to the number of files having been exported while Y refers the total number of files to be exported 1 Verify the USB memory is properly plugged 2 If the message persists format the USB memory and try again 1 Verify that correct configuration file is stored in the USB memory 2 Check whether the file system is damaged If yes contact your service personnel Failed to create file s The system failed to create files when Chec
33. of applied part This applies to Auto and Step modes only To Perform the Test l From the MAIN MENU or with the outlet unpowered plug the DUT into the 601PRO front panel outlet and turn on the device 2 Attach the applied parts to the 601PRO s applied part terminals 3 Press shortcut key 6 The Patient Leakage test is displayed and the test begins immediately Patient Leakage All Earth Outlet Rev Pol Earth No L2 OuA Limit Inv DUT OFF NO EARTH L2 APPLIED PART m aw ep ee awe Gp 4 Press APPLIED PART SOFT KEY 4 at any time to select the desired applied part leakage current 5 Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the 601PRO 6 Press the print data key at any time to generate a printout of the latest measurement A 6 In Case of Failure M Check any broken of the enclosure Replace any defective part NW Inspect wiring for bad crimps poor connections or damage M Test the wall outlet verify it is grounded and is free of other wiring abnormalities Notify the user or owner to correct any deviations As a work around check the other outlets to see if they could be used instead NW Change another probe to confirm if the fail is caused by console m Ifthe leakage current measurement tests fail on a new unit and if situation can not be corrected submit a Safety Failure Report to document the system problem Remove unit from operation NW fa
34. om housing assembly assembly Masa Bottom housing assembly a BeneHeart R3A 15 022 000122 00 000122 00 Li ion battery 11 1V 2500 mAh 8 3 SN PN Description FRU part Remarks number ar GE HE BE 16 o43 003114 00 Battery door 043 003451 00 _ Battery door M501 forbidding 17 043 002861 00 Z fold paper jam protector 18 115 017633 00 Recorder door assembly 19 043 00311200 Recorder tink o AAA AAA BEE EEE EEE EEE BEE EEE mm 60 mm sec FPC lead 2 2 2 2 2 8 3 Top Housing Assembly 115 017634 00 or 115 017793 00 8 3 1 Exploded View 8 3 2 Parts List OT 047 010209 00 Display lens a E 043 003107 00 Upper housing Display dust proof strip short Display dust proof strip long 9211 20 87221 AC input receptacle and cable 8 5 8 4 Recorder door assembly 115 017633 00 8 4 1 Exploded View 8 4 2 Parts List S 1 j Z fold paper jam protector ing rn 8 6 8 5 Bottom housing assembly 115 017792 00 or 115 018387 00 8 5 1 Exploded View O 8 5 2 Parts List FRU part SN PN Description Remarks number a Recorder instruction labelling rm apoo O VE VE a Device Iabelling Chinese CA DEE 8 7 FOR YOUR NOTES 8 8 9 BeneHeart R3 R3A Replacement Partes 9 1 BeneHeart R3 R3A BOM V1 0 for Repair Upgrade and Accessories 051 001353 01 Main control board 512MB y Main control board 512M Glasgow PDF 2 1
35. on 7 3 5 Removing the Parameter Board Then follow this procedure to remove the keypad board 1 Unscrew the four PT3x6 tapping screws 2 Disconnect the cable between the main control board and the keypad board Then remove the keypad board j i 8 F d r y k y e a TTT TE i a AAA a A A O I a 7 3 Removing the Recorder Drive Board 1 Unscrew the two M3x6 screws Disconnect the recorder cable NOTE o Make sure to the flexible PCB which is located under the TR8A recorder and connects the thermal print head before disassembling the recorder drive board 2 Release the latch locking the flexible PCB connecting thermal print head to the recorder drive board by pushing the latch from Position 1 to Position 2 as shown in the picture below Disconnect the flexible PCB and remove the recorder drive board 7 3 8 Removing the Thermal Print Head Before removing the thermal print head remove the recorder drive board as described in Section 7 3 7 Removing the Recorder Drive Board Then follow this procedure to remove the thermal print head 1 Unscrew the two M3x6 screws and the take out the thermal print head NOTE e Open the recorder door before removing and installing the thermal print head FOR YOUR NOTES 7 8 O Parts 8 1 Introduction This chapter contains the exploded views and parts lists of the main unit It helps the engineer to identify the parts during disassembling the equi
36. ontrol Board The main control board provides the following functions Drive display and control back light Store data Process printing Implement serial port communication Drive buzzer Provide USB and wired network connection Process data Implement power supply conversion Charge the battery Implement power management 2 4 2 Keypad Board The keypad board drives the keys The power on off switch AC indicator and battery indicator are also located on the keypad board 2 4 3 AC DC Power Board The power board transforms AC power to DC power 2 4 4 Recorder Drive Board The recorder drive board drives the recorder module 2 4 5 Parameter Board Parameter board is responsible for ECG data acquisition 2 6 3 Unpacking and Installation 3 1 Unpacking the Equipment Open the package and take out the packing list Check that all the articles included in the packing list are available and the quantity and specification are correct All the optional parts purchased by the customer shall also be checked Notify the supplier 1f provided components are not correct as compared to the packing list In case of damage during transportation keep the packing material and notify the supplier immediately Keep the packing material till the equipment is accepted 3 2 Preparation for Installation Ensure that the site meets all safety environmental and power requirements Check that required power sockets are available
37. or System Update Tool in the following folder To install to this folder click Next To install to a different folder click Browse and select another folder CA AMindray Patient Monitor System Update Tool Browse Destination Folder InstallShield lt Back Next gt Cancel 6 Select Program Folder Then select Next Select Program Folder Please select a program folder Setup will add program icons to the Program Folder listed below You may type a new folder name or select one from the existing folders list Click Next to continue Program Folders s ystem Update Tool Existing Folders Accessories Administrative Tools Cisco InstallShield lt Back Cancel 7 Click Finish to complete installation Mindray Patient Monitor System Update Tool install sucessfully Thank you for selecting Mindray product we will provide more service and surport for you Bact Cancel 4 2 2 Software Upgrade Procedure l Connect the equipment to be upgraded and the PC running the upgrade tool to the same network or directly connect the equipment and the PC via a crossover network cable Set the IP address of the PC to 77 77 1 XX and subnet mask to 255 255 255 0 Run Mindray Patient Monitor Software Upgrade Tool on the PC and set Machine to On the Mindray Patient Monitor Software Upgrade Tool screen select Select Package and then the packages you want to upgrade
38. orm an AC source W Verify that battery s installed If not install the battery 4 Remove the AC power cord and verify that the equipment still works correctly Performance Test Perform the test by referring to the chapter 9 Battery in the Operator s Manual and verify the operating time of the battery meets the product specification 5 7 Maintenance Mode The equipment includes maintenance mode for you to check the equipment conveniently To enter the maintenance mode select Menu System Setup gt Maintain Mode enter required password The password for the maintenance mode is 332888 when the equipment left the factory You cannot change this password If you have problem to enter the maintenance mode please contact your service personnel You can perform the following tests in the maintenance mode Display test Sound test Keypad test Lead wire check Internal communication test E E al a M Recorder test A NW USB test Mm Internal storage Test Select a test item you want to perform and follow the on screen prompt 5 4 In the maintenance mode you can also M View device information Check work log Set the frequency of AC filter Format the internal memory Input the equipment s serial number Import hospital and department name To exit the maintenance mode turn off the equipment Maintenance and Test Report See the above sections for detailed test procedures and conte
39. orming any other leakage tests Leakage current is measured the following ways NW Earth Leakage Current leakage current measured through DUT outlet Earth NW Earth Leakage Current AP EARTH ALL Applied Parts connected to Earth leakage current measured through DUT outlet Earth There is no need to attach a test lead the 601PRO automatically connects the measuring device internally To Perform the Test l From the MAIN MENU or with the outlet unpowered plug the DUT into the 601PRO front panel outlet and turn on the device 2 Attach the device s applied parts to the 601PRO applied part terminals if applicable 3 Press shortcut key 4 The Earth Leakage test appears on the display and the test begins immediately Earth Leakage Outlet Rev Pol No Earth L2 No AP Earth OuA Limit Inv DUT OFF EARTH NO L2 AP EARTH A O O OD O C SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse SOFT KEY 2 toggles the DUT outlet from Earth to No Earth SOFT KEY 3 toggles the DUT outlet from L2 to No L2 SOFT KEY 4 toggles the AP to Earth to No AP to Earth gt E E E E Press the print data key at any time to generate a printout of the latest measurement In Case of Failure M Check any broken of the enclosure Replace any defective part NW Inspect wiring for bad crimps poor connections or damage M Test the wall outlet verify it is grounded and is free of other wiring abnormalities Notify the us
40. pment and replacing the parts This manual is based on the maximum configuration Your equipment may not have same parts and the quantity of the screws or stacking sleeves etc may be different with those included in the parts lists NOTE o The part number listed in the Parts List is only for checking the FRU part number which is also included in the Parts List Please provide the FRU parts number if you want to purchase the spare parts 8 1 8 2 Main Unit 8 2 1 Exploded View 8 2 8 2 2 Parts List SN PN Description FRU part Remarks number en 021 000108 00 Display EEE EEE 051 001353 01 1 001353 01 Main control board 512MB N 115 017993 00 Main control board 512M Glasgow PDF FRU 115 017994 00 Main control board 512M PDF FRU 115 017995 00 Main control board 512M Glasgow FRU 049 000542 00 Keypad BeneHeart R3 Chinese a 049 000543 00 Keypad BeneHeart a A Chinese 0051500 Keypa Benito 3 ormon Damien s ponos ac impreso SSS 115 017634 00 BeneHeat R3 top housing assembly 115 017793 00 BeneHeart R3A top housing aca Y Erre 17 051 001354 01 1 001354 01 Keypad board board 009 003326 00 Cable between main board IN BEN keypad board EXISTEN rro O A 047 010840 00 Power board insulator M501 OA 11 009 003327 00 Cable between the main control board and power board 12 115 018611 00 Parameter Board FRU aa ee e a board and parameter board 115 017792 00 Bottom Bott
41. predictable equipment damage or human injury e Follow correct sequence to disassembly the equipment Otherwise the equipment may be damaged permanently o Be sure to disconnect all the cables before disassembling any parts Be sure not to damage any cables or connectors o Be sure to place removed screws and disassembled parts properly preventing them from being lost or contaminated Place the screws and parts from the same module together to facilitate reassembling o To reassemble the equipment first assemble the assemblies and then the main unit Carefully route the cables 7 3 Disassembling the Main Unit NOTE eo To disassemble the equipment place the equipment on a work bench free from foreign material avoiding damaging the screen e All the operations should be performed by qualified service personnel only When disassembling the PCBAs and parts labeled with static sensitive symbols make sure you are wearing electrostatic discharge protection such as antistatic wristband or gloves to avoid damaging the equipment 7 3 1 Removing Bottom housing assembly 1 Lay the equipment on the work bench Unscrew the M3x6 screw to open the battery compartment door Then remove the battery Ze 7 3 2 Remove the Power Board Unscrew the four M36 screws Disconnect the AC input receptacle and the cable Disconnect the connection cable between the main control board and the power board Then take out the power board and th
42. propriate SOFT KEY on the 601PRO 8 Press the print data key at any time to generate a printout of the latest measurement In Case of Failure M Check any broken of the enclosure Replace any defective part NW Inspect wiring for bad crimps poor connections or damage m Test the wall outlet verify it is grounded and is free of other wiring abnormalities Notify the user or owner to correct any deviations As a work around check the other outlets to see if they could be used instead NW Change another probe to confirm if the fail is caused by console m Ifthe leakage current measurement tests fail on a new unit and if situation can not be corrected submit a Safety Failure Report to document the system problem Remove unit from operation NW fall else fails stop using and inform the Customer Service Engineer for analysis and disposal LIMITS For CF amp applied parts 9 10uA in Normal Condition 9 50uA in Single Fault Condition A 10 A 9 Scheduled Electrical Safety Inspection For scheduled electrical safety inspection test items 1 2 3 4 5 6 7 and 8 included in the ELECTRICAL SAFETY INSPECTION FORM shall be performed ELECTRICAL SAFETY INSPECTION FORM Device Enclosure and Accessories A Protective Earth Resistance EE Max 0 2 Q Normal condition uA Max NC NC 300uA refer to Earth UL60601 1 Leakage NC 500uA refer to Single Fault LA 1EC60601 1 condition SFC SFC 10001 A LIBF uA Normal
43. rsists after corrective actions have been taken please contact your service personnel The equipment does 1 The equipment is not connected 1 Check that the power cord is securely not power up to AC mains connected 2 Battery is not installed or has 2 Check that the battery is installed and has no charge sufficient charge Otherwise connect the equipment to AC mains to run the equipment and charge the battery ECG data displays 1 Patient movement 1 Tell the patient not to move during ECG unacceptable noise 2 Improper filter setting acquisition 3 Poor skin preparation 2 Check the settings of the filters are 4 Electrode problem appropriate 5 Patient cable problem 3 Prepare the patient before ECG isition 6 Wrong accessories are used or ae mix electrode types and brands 4 Verify the electrodes are applied correctly Check for defective or expired electrodes 5 Check for defective broken or disconnected patient cable 6 Use specified accessories Do not mix electrode types or brands The recorder does 1 Paperless recording is enabled 1 Select Menu Record Setup and set not work 2 Recording paper is not loaded Paperless Recording to Off 3 Recorder door is not properly 2 Verify recording paper is properly loaded closed 3 Verify recorder door is properly closed 4 Print head is too hot 4 Wait till the print head cools down 5 Recorder is disabled due to 5 Connect the equipmen
44. smells e g burning or smoky smells The enclosure and accessories particularly from ventilation holes No taped notes that may suggest device deficiencies or operator concerns A 3 Device Labeling Check the labels provided by the manufacturer or the healthcare facility are present and legible NW Main unit label E Integrated warning labels A 4 Protective Earth Resistance Protective Earth Resistance is measured using the RED test lead attached to the DUT Protective Earth terminal or enclosure Select the test current by pressing SOFT KEY 3 to toggle 25AMP The front panel outlet power is turned off for this test The following conditions apply L1 and L2 Open Preparation 1 First select the test current that will be used for performing the Protective Earth Resistance test by pressing AMPERES SOFT KEY 3 2 Connect the test lead s between the RED input jack and the GREEN input jack 3 Press CAL LEADS The 601PRO will measure the lead resistance and if less than 0 150 Ohms it will store the reading and subtract it from all earth resistance readings taken at the calibrated current Calibration in Progress Iscale 1 004 Lead Resistance Too High Connect test lead from RED input jack To GREEN input jack SEED E ep p GD If the calibration fails the previously stored readings will be used until a passing calibration has occurred NWARNING o During Earth Resistance testing the DUT must be
45. sted along with possible causes and recommended corrective actions Refer to the tables to check the equipment identify and eliminate the troubles The troubles we list here are frequently arisen difficulties and the actions we recommend can correct most problems but not all of them For more information on troubleshooting contact our Customer Service Department 6 2 Parts Replacement The equipment s PCBs major parts and components are replaceable Once you isolate a PCB you suspect defective follow the instructions in Chapter 7 Disassembly and Repairto replace the PCB with a known good one and check that the trouble disappears or the equipment passes all performance tests Defective PCB can be sent to us for repair If the trouble remains exchange the replacement PCB with the original suspicious PCB and continue troubleshooting as directed in this chapter To obtain information on replacement parts or order them refer to 9 BeneHeart R3 R3A Replacement Partes 6 3 Quickly Identifying Failure Some troubleshooting tasks may require you to identify the hardware version and status of your equipment To check equipment information Select Menu System Setup Maintain Mode Enter the required password to enter the maintenance mode In the maintenance mode you can perform related tests to primarily identify the failure 6 4 General Problems This chapter lists the problems that are likely to occur If the problem pe
46. sting and maintenance procedures as required and use appropriate test equipments The testing procedures provided in this chapter are intended to verify that the equipment meets the performance specifications If the equipment or a module fails to perform as specified in any test repairs or replacements must be done to correct the problem If you have any question contact our Customer Service Department CAUTION eo All tests should be performed by qualified service personnel only Oo Service personnel should acquaint themselves with the test tools and make sure that test tools and cables are applicable 5 1 1 Test Equipment See the following sections 5 1 2 Test Report Upon the completion of the tests the table of preventative maintenance test reports and the table of maintenance test reports in this chapter should be kept properly 5 1 3 Preventative Maintenance Below are preventative maintenance tests which need to be performed on the equipment See the following sections for detailed maintenance procedures 5 1 5 1 4 Recommended Frequency Visual inspection 1 When first installed or reinstalled 1 When first installed or reinstalled Power on test 2 Following any repairs or replacement of any main unit parts Performance Test 1 If the user suspects that the measurement is incorrect 2 Following any repairs or replacement of relevant ECG test Module module Calibration 3 At least once every
47. t to AC mains to depleted battery run the equipment and charge the battery Paper jammed or 1 Unapproved paper is used 1 Use approved recording paper misaligned 2 Recording paper is not properly 2 Take out the paper and tear off the loaded jammed part Reload the paper as described in 3 2 3 Loading Paper of the Operator s Manual Partially missing 1 Dirty print head 1 Clean the print head printout or printout 2 Some thermal points on print 2 If the problem persists contact your not clear head are damaged service personnel The equipment 1 Auto shutdown is enabled 1 Check the setting of Auto Shut Down automatically shuts 2 The battery is depleted when by selecting Menu System Setup In down the equipment runs on battery the case that any of limb leads is off the power equipment automatically shut down if there is no operation when the defined time is reached 2 Connect the equipment to AC mains to run the equipment and charge the battery The display is Auto Standby is enabled In the case that any of limb leads 1s off the completely blank equipment automatically turns off the display to save power if there is no operation when the defined time is reached To exit the standby mode press any key The screen display The setting of brightness 1s low Adjust screen brightness is too dark to be seen clearly 6 5 Messages The equipment prompts messages to indicate the curr
48. tification tone when the message occurs 6 6 Troubleshooting Guide 6 6 1 Power On Off Failure System not power on by pressing power switch AC indicator on N Check if AC power is OK as power N problem disconnecting recorder drive board or arameter board Replace power Y board ar recorder eplace main drive board or board parameter board Power switch indicator on A beep is heard within 10 after system powered on Display back lighted Black screen replace main N board or replace display Y y White screen replace the display 6 8 6 6 2 Recorder Failures Recorder not work D Message Cable between recorder and main board loose or failed Reconnect or replace cable Recorder unavailable presented Ok after recorder drive board replaced 1 Check platen in position Ssage Ple 2 Check paper correctly loaded AY 3 Close battery door check recorder resented N y Message Please check recorder presented N Replace main board erform keypad test in maintenance mode Replace keypad board if failed Recorder runs by pressing Manual key End Replace print head N Message Paper type error presented Recording paper incorr
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