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1. BioZ Dx Operator Service Manual WARNINGS AND PRECAUTIONS e Ensure that the ICG and ECG patient data cables and lead wires are tucked away from the wheels of the cardiograph cart when transporting the cardiograph Ensure that the patient data cables do not present a hazard when pushing the cardiograph cart e When operating the BioZ Dx on AC power ensure that the BioZ Dx and all other electrical equipment connected to or near the patient are effectively grounded e Only qualified personnel may service the cardiograph e Do not touch the patient patient cable ICG PIM or BioZ Dx during defibrillation Death or injury may occur from the electrical shock delivered by the defibrillator e Ensure that the sensor gel sensors or lead wires do not contact any other conductive materials including earth grounded materials during patient monitoring and or when connecting and disconnecting sensors patient cable lead wires to and from the patient Contact with any of these materials may result in incorrect parameter values e Connecting multiple cardiographs and or other medical devices to the same patient may pose a safety hazard due to summation of leakage currents Any potential combination of instruments should be evaluated by local safety personnel prior to being placed into service or applied to a patient e Do not connect any equipment to the BioZ Dx RS 232 USB media keyboard and or RJ 41 port s that do not meet medical safety r
2. ELECTRICAL BIOIMPEDANCE EB A noninvasive technique for converting the measurement of electrical conductivity of a body segment into the blood flow through the segment and the content of fluids within the segment HEART RATE HR beats mint The number of beats performed by the heart in one minute HEATHER INDEX HI Ohms Is Ratio of maximum impedance change to the QC Interval HI dZ dt max 1000 QC HEMODYNAMIC MODULATORS The parameters that affect modulate blood flow and blood pressure HI See HEATHER INDEX HR See HEART RATE HYPERDYNAMIC STATE The supernormal or abnormally high value for a specific condition HYPERTENSION A state where the mean arterial pressure exceeds 100 mmHg supine resting adults HYPODYNAMIC STATE The infranormal or abnormally low value for a specific condition HYPOTENSION A state where the mean arterial pressure is lower than 84 mmHg supine resting adults INOTROPY Myocardial contractility or the force of contraction Normoinotropy is an adequate normal inotropic state hypoinotropy is an inadequate infranormal inotropic state corrected therapeutically through the use of positive inotropic therapy support hyperinotropy is an excessive supranormal level of inotropic state corrected therapeutically through the use of negative inotropic therapy LCW See LEFT CARDIAC WORK LCWI See LEFT CARDIAC WORK INDEX LEFT CARDIAC WORK LCW kg m The measure of work which the
3. Birth Characters Text Box BioZ Dx system date must be set correctly in order to calculate patient s age correctly Height Yes Numeric Feet 1 Character Inches 2 Characters Centimeters 3 Characters All Text Boxes Height Yes Alpha Select English or Metric units Units Weight Yes Numeric Pounds 3 Characters Kilograms 5 Characters Both Text Boxes Weight Yes Alpha Select English or Metric units Units Gender Yes Radio Button Select Male or Female Blood Yes Radio Button Manual or Auto BP Cuff If Manual is selected then the User Pressure will input Numeric values up to 3 Characters in the SBP and DBP fields Physician No Alphanumeric 32 Characters Drop Down Menu Operator No Alphanumeric 32 Characters Drop Down Menu Indicates either one or more of the following fields are required to begin an ICG test Patient ID Last Name or First Name BioZ Dx Operator Service Manual 35 CardioDynamics International Corporation Should the operator enter data on the Patient ID Screen that is outside the Operating Range of the cardiograph the value will be rejected However for values entered which are outside the Recommended Range that value may be accepted upon confirmation by the user Session Start up Behavior When a new patient session is started updates will be displayed according to the selected Data Update rate Until enough beats have been collected data averaging will be based on the ava
4. 1 5 amp 250V time delay the same size and configuration as the original fuse Figure 9 7 Replacing the AC fuse To Replace the AC Fuse Unplug the Cardiograph from AC power Pull out the AC power cord from the AC power connector on the rear of the cardiograph Locate the AC fuse which is directly below the AC power connector Push down on the center tab on the fuse and pull out the fuse from the fuse holder slot Insert the new fuse using the same orientation with the center tab facing up Push the fuse all the way into the fuse holder slot The fuse snaps into place 9 9 Ordering replacement parts To order replacement parts contact the CardioDynamics Technical Service department at 800 778 4825 and select option 3 or outside of the USA at 858 535 0202 option 3 BioZ Dx Operator Service Manual 77 ICG BioZ Dx SUGGESTED MAINTENANCE SCHEDULE 10 ICG BioZ Dx SUGGESTED MAINTENANCE SCHEDULE There are two maintenance checks that should be performed on the Cardiograph an ICG and NIBP check See sections 10 1 and 10 2 for the procedure e ICG Maintenance Test should be performed quarterly or anytime the hemodynamic values are questioned by the Operator e NIBP Maintenance Test should be performed annually or anytime the blood pressure values are questioned by the Operator 10 1 ICG Maintenance Test The BioZ Dx is self calibrating The calibration may be verified via the built in ICG tester located in the
5. 5 Reviewing Patient Information se c ccscccisgssesesenccaiesavsscagavavctaassseausnavesacavsndeaceanvcoddvatebaaecuaenventeses 39 5 6 Archived Patient formatio i a a aa as aaa aad laaan SS 40 5 7 Orders ENUYE aE de AE E EEE AE sae ea E a Aa eee E da ake 42 Se S o Ce Seata nYa i ato AEA EE A EE E E E T 44 6 PRINTING THE ICG REPORT 49 6 1 ICG Status REDOR Heade minsenu reenen na a E EE Oa E E EER ei raia 50 6 2 ICG Status Report Hemodynamic Parameter Value Section s ssseseeeeeeseereesreeresrersrrererreeseee 50 6 3 ICG Status Report Waveform Display Section ssssssssssesssesessseesseeessresseesseessseesssressresseessee 50 GA ICG Stat s R port POGUE 4 4 recs cigceustiess sis aaadwes duis E a a E E Eni 50 7 SYSTEM CONFIGURATION 51 7 1 SCTE amp Rep rt Contig ration Screened ii i dese E a EE E EE E 51 7 2 Options Configuration Screen se ssesssessseessseetsseesseteseessetessttessresstesstessetesseeesstesseesseresseeeseet 52 7 3 Facility Confisurati n Sereemi nesei rae e a ae a ed aie 54 7 4 Password Configuration Screen c ccsssis gssetesscccausvevssieevaseegi te beneaadesadeusdazedeansagaanetp sadeceaunsasanses 55 BioZ Dx Operator Service Manual 1 CardioDynamics International Corporation 7 5 Network Conn stration SCreeniis cccsceesstcadsentaccacdeches ateg taa a sies a ES aias 56 TOn HIPAA Sreem ee E em E EE eR Re Ne SARE 57 8 TROUBLESHOOTING 59 8 1 Blood Pr ssure Errors sissies ene
6. DSP Main PM CRC 0x14B3 Expected DSP Boot Version 1 1 2 2004 Expected DSP Boot PM CRC Ox94c4 Reported DSP Boot Version 1 1 2 2004 Reported DSP Boot PM CRC Ox94c4 Expected FX Program Version 1 3 Expected UI Program CRC Ox3301 Reported FX Program Version 1 3 Reported UI Program CRC 0x3301 Take BP Saye Review Orders Archive Config Help ECG First Figure 10 4 Version Control Check Screen BioZ Dx Operator Service Manual 83 SAFETY TESTS 11 SAFETY TESTS This section explains tests of the cardiograph s electrical safety Use the procedures called out by the manufacturer of the safety analyzer in use e Test both Normal and Reverse polarity line connections for each test and record the worst case value e Ifa ground reference point is needed for the testing use the metal grounding stud on the back of the cardiograph 11 1 Safety Test S1 Earth Leakage To check for leaks in the ground wire for the AC power cord Normal Condition with both AC line connections intact e lt 300 uA UL 120 VAC e lt 500 uA IEC 240 VAC Single Fault Condition with one AC line connection open e lt 1000nA 11 2 Safety Test S2 Protective Earth Resistance Impedance of protective earth ground e lt 200 mQ 11 3 Safety Test S3 Leads Leakage Current Leakage from Source or into Sink patient leads Applied Parts Source Normal Condition with both AC line connections and earth ground intact e lt 10nA Single
7. Fault Condition with separate open neutral and open earth each in turn e lt S50uA BioZ Dx Operator Service Manual 85 CardioDynamics International Corporation Sink Single Fault Condition with AC Mains voltage on Applied Parts both AC line connections and earth ground intact e lt 50uA 86 BioZ Dx Operator Service Manual NOMINAL SPECIFICATIONS 12 NOMINAL SPECIFICATIONS The BioZ Dx has input protection against defibrillators and electro surgical devices The Cardiograph is designed to meet the following specifications Contact Technical Support for information regarding use in conditions other than specified Physical Specifications Technical Information System Storage Temperature and Humidity Range 0 C to 50 C 32 F to ICG BioZ Dx and 122 F 15 to 90 Relative Humidity RH non condensing PIM Storage Altitude 15 000 ft 4550 m Operating Temperature and Humidity Range 10 C to 40 C 50 F to 104 F 15 to 80 Relative Humidity RH non condensing Operating Altitude Range 650 ft 198 m to 5 350 ft 1 631 m Cardiograph Physical Dimensions 12 2 x 15 3 x 6 9 in 31 0 x 38 8 x 17 6 cm Weight 16 3 Ibs 7 4 kg Display 640 x 480 pixel resolution color TFT display Printer Type High resolution digital array printer using thermal sensitive paper Printer Resolution 200 dpi voltage axis by 500 dpi time axis Battery Type Rechargeable Lead acid Battery Capacit
8. Licensee hereby agrees not to export or re export any Licensed Program or any direct product thereof directly or indirectly to or for use in any country other than the United States without the prior written authorization of Licensor and the United States Government 94 BioZ Dx Operator Service Manual Appendix A HEMODYNAMIC PARAMETERS 15 Appendix A HEMODYNAMIC PARAMETERS Note 1 The normal mid ranges defined in the BioZ are derived and or obtained from one or more sources 1 from the mean CI HR and MAP 2 SD as published by Milnor William R M D Hemodynamics 1982 Baltimore Williams amp Wilkins 2 Darovic G O Hemodynamic Monitoring Invasive and Noninvasive Clinical Application 2 Ed 1995 W B Saunders Company 3 Historical based on predicate ICG devices Therefore values lying within the normal mid range are not necessarily indicative of the optimal hemodynamic state for a given patient physiologic state Patients must be assessed based on their individual Note 2 Displayed and printed parameter values that fall outside of the maximum and minimum limits will be displayed at their respective limits as defined in the table below under the column headings MIN and MAX Parameter Abbrev Units Normal Mid Range MIN MAX Note 1 Note 2 Note 2 Heart Rate HR beats min 58 86 40 250 Systolic Blood Pressure SBP mm Hg 100 140 40 260 Diastolic Blood Pressure DBP mm H
9. Manual Entry Female Auto BP Cuff Physician DR SMITH v Operator v a R 54 3Pe He Take BP Saye Review Orders Archive Config Help ECG First Blood Pressure SBP Figure 5 2 Patient ID Screen Patient ID Screen All required patient information must be entered by the User via the Patient ID screen if monitoring a patient for the first time To navigate through the Patient ID screen rotate the trim knob or press the Tab key to move the cursor to the desired entry field Use the keyboard to enter information If an incorrect entry is made press the Backspace key and re enter the correct value Press down on the Trim knob to make a selection within a Radio Button Field for example to select Male or Female Press Enter when all selections 34 BioZ Dx Operator Service Manual PATIENT MONITORING are complete Pressing Esc will cause the ID screen to be closed and none of the entered data will be retained NOTE It is important to enter accurate height and weight in order to obtain accurate hemodynamic information Be sure to take these measurements prior to beginning the ICG test Field Description Size Patient ID All Characters Except for space 40 Characters Last Yes All Characters 40 Characters Name First Yes All Characters 40 Characters Name Add No All Characters 40 Characters Name Date of Yes Numeric Month amp Day 2 Characters Drop Down Menu Year 4
10. Printing Archived ICG Reports Once the desired ICG Report has been selected press the Auto Print Control key to print the Archived ICG Report Deleting Archived ICG Reports Once the desired ICG Report s have been selected press the Delete button on the Archive Screen to delete the selected ICG Report s Transferring Archived ICG Reports ICG Reports may be transferred to and from another ICG BioZ Dx via a PCMCIA Card e Load is used to transfer ICG Reports into the Cardiograph s ICG Patient database from the external PCMCIA media e Send is used to transfer ICG Reports from the Cardiograph s ICG Patient database and onto the external PCMCIA media NOTE Removing the PCMCIA Card while data transfer is in progress may corrupt the database Contact Technical Support should you have questions on transferring archived ICG reports BioZ Dx Operator Service Manual 41 CardioDynamics International Corporation 5 7 Orders Entry Selecting the Orders Command provides the User with the ability to schedule tests for specific patients for upcoming sessions Orders The user may add up to 150 orders to the desired list The Orders page can be accessed by using the Trim Knob and navigating to the Orders icon and pressing down Once the Orders page has been selected press Alt amp O simultaneously to select the Orders tab and then navigate using the Trim Knob or the Up Down Arrow keys to the desired field Data
11. Report Should the operator exceed the maximum number of displayed parameters a message will automatically appear to alert them Rotate Trim Knob or press the Tab key to move cursor to the desired parameter Screen or Report field and press the Trim Knob to either include or remove a parameter from the Screen or Report Press Enter to save and exit Data Average Data Update Signal Status 08 17 2007 BEREE occa ol e 9 51 01 AM Configuration Screen amp Report S Options O Facility F Password P Network N Parameters Screen Report Parameters Screen Report HR E K VI L L BP SBP DEP MAP Iv ACI E L SBP STR DBP oral STRI Iv Iv SV E lv QC E E SI Iv lv HI E L co Iv TFC Iv Iv cl Iv Iv TFCI SSRI Zo SVR Iv LCWI SVRI Iv Iv LSWI TAC TACI ICG Waveform ICG DeltaZ Waveform ICG d2 dt Waveform RESTORE DEFAULT PARAMETERS Print TFC TFCI and Zo Bar Graphs vy Display Pacer Spikes on ECG Waveform Od SHoaD et He Take BP Saye Review Orders Archive Config Help ECG First Figure 7 1 Screen amp Report Screen BioZ Dx Operator Service Manual 51 7 2 CardioDynamics International Corporation Options Configuration Screen The Options Configuration Screen provides the User with the ability to set the default formats units and or values for Date Time Height Weight CVP PAOP Standby I
12. Resistance Index D 10G 3 7 mmjohm s 25 mm sec Data Avg 5 beats Data Update 10 beats CardioDynamics ICG Status Report Ic Diagwostics Figure 6 1 ICG Status Report The ICG Status Report consists of four main sections The Header A ICG Values B Waveforms C and Footer D areas Note For an explanation of parameters and their respective normal ranges refer to Appendix A Hemodynamic Parameters and Appendix B Glossary of Terms Note Values that fall outside of the maximum and minimum limits will be displayed at their respective limits per Appendix A BioZ Dx Operator Service Manual 49 CardioDynamics International Corporation 6 1 ICG Status Report Header The Header contains all of the Patient Physician and Facility information entered in the Patient ID and Facility screens for the particular ICG test Also included is an area for the Physician to write their interpretation and list the status of any medication adjustments 6 2 ICG Status Report Hemodynamic Parameter Value Section The ICG Hemodynamic Parameter Section displays up to 13 of the current and most recent previously saved User defined ICG parameters in both numerical and Bar Graph format as related to their respective Low Normal and High ranges The current data are indicated via the bar graph while the most recent previous saved data are indicated via a tick mark thus providing the clinician with a visual indication of visit to visit chan
13. SVR See SYSTEMIC VASCULAR RESISTANCE SVRI See SYSTEMIC VASCULAR RESISTANCE INDEX SYSTEMIC VASCULAR RESISTANCE SVR dyne sec cm The vascular resistance of the systemic vasculature as seen by the left ventricle afterload Normal range for a supine resting adult is 770 1500 dyne sec cm SVR 80 MAP CVP CO BioZ Dx Operator Service Manual 99 CardioDynamics International Corporation SYSTEMIC VASCULAR RESISTANCE INDEX SVRJ dyne sec cm m SVRI represents the primary component of afterload The normal range of SVRI for a supine resting adult is 1680 to 2580 dyne sec cm m SVRI 80 MAP CVP CI SYSTOLIC BLOOD PRESSURE SBP mmHg The highest level of arterial blood pressure reached with each heart beat SYSTOLIC TIME RATIO STR Calculated by the systolic time intervals STT of PRE EJECTION PERIOD PEP and LEFT VENTRICULAR EJECTION TIME LVET STR PEP LVET SYSTOLIC TIME RATIO INDEX STRI sec The ratio of the STR to R R Interval STRI STR R R interval TAC See TOTAL ARTERIAL COMPLIANCE TACI See TOTAL ARTERIAL COMPLIANCE INDEX TEB See THORACIC ELECTRICAL BIOIMPEDANCE TFC See THORACIC FLUID CONTENT TFCI See THORACIC FLUID CONTENT INDEX TFI See THORACIC FLUID INDEX THORACIC ELECTRICAL BIOIMPEDANCE TEB The special utilization of Electrical Bioimpedance for thoracic measurements producing a measurement of global blood flow CO CI SV SI Thoracic Fluid Con
14. Tein aTa EE E cedetstesvasseostesetadstessbesetrsoiates 8 M Maintenance ICG Maintenance Test 00 0 0 ee eeeeeeeeeereeeeenees 79 NIBP Maintenance Test 0 0 0 0 ee eeeeeteeeeeeeeees 81 Preventive Maintenance Schedule ccece 79 N Nominal Specifications csccescececsceeseeereeeeeeeseeeeees 87 P Patient ID Sereen reier RER 34 Patient Preparation soinri oneen niaii 29 TOG Sensors iranran datiawietivess 29 Skin Preparation eeeeeee 30 PLECAUTIONS eenn E oul E 6 Printer Changing Printer Papet 71 Pulmonary Artery Occluded Pressure PAOP 99 R printed report red stripe appears troubleshooting red stripe on printed report printer paper replacing 71 Retrieve Archived Patient ID Information 36 Reviewing Patient Information cee eeeeeeeeeeeeee 39 S Saving Patient Information cecceeceeseeeteeeeeeneeees 38 SOFTWARE LICENSE AGREEMENT eee 93 T Theoretical Concepts cecceeesceeneecsseceeeeecsseceeeeecnseeeees 1 Thoracic Fluid Index TFI cescesseesseeeeeeeeeeeeees 100 TROUBLESHOOTING cece ceeeeceeeeceeeeeeeseeneeeeene 59 WwW WARNINGS AND PRECAUTIONS 3 Warranty serisine asr ea i eea Ea E 91 BioZ Dx Operator Service Manual
15. This term dates back to times before the introduction of the occlusive balloon At that time the catheter was actually wedged into a small pulmonary artery in order to measure the filling pressure of the left heart Zo See BASE IMPEDANCE BioZ Dx Operator Service Manual 101 CardioDynamics International Corporation 17 INDEX A JaN ACA d OYTO MNENE AE EE EE nests 97 Apply the Blood Pressure Cuff 32 Archived Patient Information ccccccccesseceereeeseees 40 B Base Impedance Zo ceseceesseceeeeeesseceereeeneeceeeeeeeeeeee 97 Batteries B ttery Care peni i eae eed a ees 73 Charging the Batteries 20 00 0000 eeeseeeeeeeeeeeee 74 Replacing the Batteries ee ceeeecseeseeeecnereeeeeees 76 Begin the Patient Monitoring Session eeeeeeeeee 34 Body Surface Area BSA ccccecceesseeseessceseeeteeeeenteeeee 97 C Central Venous Pressure CVP csccecessseeeesseeeeeneees 97 Cleaning Cleaning Materials cccccccseesceesceeeceeeceeeeeseenseenee 69 Cleaning the Paper Sensor Lens ceeeeeeeeee 70 Cleaning the Print Head ccceeceesceeeeeeeeteeeeeeeee 70 Contractility ie a a dn E 97 Contraindications ccccccecsssceescecssecesscecsseceseeecsseeesees 8 D A T IO E E ESEE 97 Delta Z Impedance Waveform se seseseseseesseeeseeeeee 97 ZI A EEEE SEAE E 97 F Figure 4 1 ICG Sensor Placement Diagram 31 G GETTI
16. Update Signal Status 10 24 2006 A Data Average i Enana 30 Beats w SBeas w 12 32 25 PM Patient ID Patient ID P Retrieve Records R Orders Use up and down arrows to select an Orders entry Press Enter to load order Patient ID LastName First Name Add IName Gender Physician FIELDS Female DR SMITH KEIL Male DR PATTERS ROLAND Female DR JONES Pending Orders List Loaded 3 Available 147 O Jowa de He Take BP Saye Review Orders Archive Config Help ECG First Figure 5 7 Orders Entry 42 BioZ Dx Operator Service Manual PATIENT MONITORING The user may use the Trim Knob or the Up Down Arrow keys to Add Edit or Delete patients from the pending orders list When the Add button is selected a dialogue window will appear for input of patient information e Rotate Trim Knob or use the Up Down Arrow keys to the desired field and use the keyboard to enter the patient information Press the Trim knob or the Enter key when done to automatically save the information and close the window Data Average Data Update Signal Status 10 24 2006 Orders Entry Patient ID Last Name First Name Add l Name Date Of Birth Physician Operator Take BP Saye Review Orders Archive Config Help ECG First Figure 5 8 Orders Entry BioZ Dx Operator Service Manual 43 CardioDynamics International Corporation 5 8 Help Command The Help Command button opens screens that offer info
17. WR DH S 8 2 5 Safety Symbols Marked on the Cardiograph ssssssssesssesesssesssesserssessseressseesseessersseresseesssees 9 3 GETTING STARTED 11 3 1 The BioZ Dx Impedance Cardio er apy ise asics ciere e a a eae a 11 3 2 The BidZ Dx Control Keys i nesssinssronieane nti e a n need a 13 33 The BigA Dx Rey Board ss eent a a E E EEEa a AEE IEE DES 14 3 4 Impedance Cardiography Patient Interface Module ICG PIM ssssssssssesssessssssessressessesssee 15 3 5 GG ASC ad WATS isas aces oe vad es cate dee dase toca ber tase Ne ite eis ole a fet Oe Sot entrance 16 3 6 ICG PIM With ACCESSOrlES oaiae aaa does a shes tease a e teed ose steseauelens 16 3 7 PCMCIA CA ic seactswiiht nnna na sacs uisicn wied odedy sig ARR N aS 17 3 8 HG TIOZ AD AIS DAW o acces s oad ides sectnee 3s zaspe eta rcede Canaan a a a E N E 18 4 OPTIONAL ECG FEATURE 25 4 1 Intended Ws nearr hea ceacedavsgesdectecaes Hastusaaseeetaceiasedeudestacecetadavbag stash EINE E ROSAE 25 4 2 T dicatio sessen e E a A AS 25 4 3 ICG ECG Launch SCre esi annenin a a E ONSA RES 25 5 PATIENT MONITORING 29 5 1 Patient Preparations nteni yeeie i e a a oe buss aae a ee reoat 29 5 2 Apply the Bl od Pressure Curt cs ssccaicssdaacsesseacavavoseansadeycaeds saguaasaeeydaacisasead es Gegeaas a sins 32 5 3 Begin the Patient Monitoring Session asc ss ccs isp cadedougeas al doceaateeasta iad dora age See ea see 34 5 4 Savins Patient Informations esanen toned ce iey a E A den em E teonaneh 38 5
18. a dh A aoa 44 Figure 5 10 Help Screener ansann a a in Nona e i aaa aiia 45 Figure 5 h Help Sreem e a a A A E A A edna ha A A E aa ee anaes 46 Fig re 5 12 HelpSereen rome res ioa EE AE E E E e e a a Ea E aata 47 Figure 5 13 Help Screen iocta aeie e i r i e n tli Roe st Bae SE ds 48 Figure 6 ICG Ora ReO e a a a a a a a E Er aa aaae RATA 49 Figure 7 1 Screen amp Report Screen is ce cotvecdinaeateai inca ii a ede a haere 51 Figure 7 2 Options Serene ne erin e a E A A A Ai E A E E E ein 52 Figure 7 3 Facility Sree da badinc ated ane ed a acetaeas sis uses cates uuadacdtuuaiaatawesocatsuesstcataelansed 54 Figure 7 4 Password Sretni ancini aeeiiaii iee iiaa e i i a a ie 55 Figure 7 5 Network Sereen ginaren n R E EA Le 56 Figure 7 6 HIPAA Screenin a e E E E AEE E E A a a E a 58 Figure Cod System Reset button oossessssesssssssessessesesssseseesssseesssseesssseresssreeessoeosssstessssereesseeeesseresssseessset 67 Figure 9 Cleaning the Print TA COO ia aiees irr coe taediucd deat natansiaas in suaeshaeseucddnedsdebsatid dessin tdaesbatssusdabcataebsatens 70 Figure 922 Inserting Paperissa eieo e n a loads i a at aa i aka aiad 71 Figure 9 3 Paper Sensor Holes a cna eee aa nena aE 71 Fig te 9 4 Lower Paper DiGi sac rac ean a E EE a EO N AET ETa 72 Figure 9 5 Tearing Off the Paper oonnneennnennnnneeensseseesseseesssseeessseressssereessesessssseesssseressseseessesesssseesssee 72 Figure 9 6 Replacing the Battery 2 OCKS vicsict his bcs otek kt etn
19. aS aiT 77 10 ICG BIOZ DX SUGGESTED MAINTENANCE SCHEDULE 79 MOST ICG Maintenance Testine nnne E E e O ea senna a 79 10 2 INIBE P Maintenance eS a E A E EE 81 10 3 Version Control Ch ck i s ori Ae a A a Maal e tered 83 11 SAFETY TESTS 85 leh Satety Pests l Edrthi Leaks eani r a qed cele E E 85 11 2 Safety Test S2 Protective Earth Resistance cj cise cadscess sansesosgeeyscadvendavossaddassecpasendgesecdareoss 85 11 3 Safety Test S3 Leads Leakage urrentsss csdssscterdoapsiutedasianestetssgete d sadsssnitbeeadineastgeeadiaaadtans 85 12 NOMINAL SPECIFICATIONS 87 12 1 Electromagnetic Compatibility EMC ssssessseesessesssessessessresressessresresseestesreesteseeseeeseeseeseresee 90 13 Z CARE STANDARD WARRANTY 91 14 SOFTWARE LICENSE AGREEMENT 93 15 APPENDIX A HEMODYNAMIC PARAMETERS 95 16 APPENDIX B GLOSSARY OF TERMS 97 17 INDEX 102 ii BioZ Dx Operator Service Manual TABLE OF FIGURES TABLE OF FIGURES Figur 3 1 BioZ Dx and GALE raatrcas Recta tite Sindh salads aces tata asniea A e Vanna diy aad E ae Il Figure 3 2 ICAI TA cas cane cans a teeta g sitar a getaiaa gus E OEREO get oslsade a ses A ebtaase essen oa Oe 12 Fig re 3 3 BioZ Dx Gontro Keys arriten iiinn aet ea a i a dectdcseetadanbtses 13 Figure 3 4 PIM Front and Rear nesia genes ce ed ca R 15 Fig re 3 9 LCG Lega WANE 8a ca i a a ea Oa aa a A aO ERER 16 Figure 3 6 ICG PIM with accessoriesS nneneennnnenneseeeosssseesssseesssseressseressssseosssseesssseres
20. button will not select the Radio button only give it focus Radio buttons can only be selected by the space bar or Trim Knob press BioZ Dx Operator Service Manual 23 OPTIONAL ECG FEATURE 4 OPTIONAL ECG FEATURE 4 1 Intended Use The intended use of the ECG Patient Interface Module PIM is to acquire multi channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record display analyze and store these ECG signals for review by the user The cardiograph is to be used in healthcare facilities by trained healthcare professionals Analysis of the ECG signals is accomplished with algorithms that provide measurements data presentations graphical presentations and interpretations for review by the user The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only It is to be used in conjunction with the clinician s knowledge of the patient the results of the physical examination the ECG tracings and other clinical findings A qualified physician is asked to review and validate or change the computer generated ECG interpretation 4 2 Indications The ECG is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis potential treatment effectiveness of treatment or to rule out causes for symptoms 4 3 ICG ECG Launch Screen For De
21. depending on the version currently in use on your BioZ Dx and the version that is going to be installed For this reason it is important to follow the installation instructions that are included in the software upgrade kit CardioDynamics includes installation instructions with every software upgrade kit that is sent out If you experience difficulties or have questions regarding any of the steps please contact Technical Support at 800 778 4825 option 3 USA or if outside the USA 1 858 535 0202 option 3 8 7 Power Management The system host processor controls several functions of the power system These include e Activating sleep mode if the unit is on battery power and has been left on the launch screen for 5 minutes e Battery power saving modes refer to section 7 2 e Restricting the user from printing when the charge capacity reaches preset levels e Alerting the user when maintenance is needed for the battery BioZ Dx Operator Service Manual 67 CardioDynamics International Corporation Battery Discharging When the battery is discharged to the 30 level the Cardiograph disables printing and continues to allow the battery to be discharged to a 20 level When the 20 level is reached the Cardiograph beeps to warn the user to plug in the AC power cord If the AC power cord is not plugged in within three minutes the Cardiograph automatically shuts down Accidental discharging of the battery may be avoided through the
22. en as arenes 76 Fig re 9 7 Replacing the AG JURE sieles aeo i eaa towesrlerieatiouioretes tase datencesesekortaretelaavanctis 77 Fig re10 LICG Check Screen irienn n iia i DR Bins a a TES Oo ea GS 79 Figure 10 2 Example NIBP Test Set up iis tensnsccatiidis dees ie teutiinana ans Leela amp 1 Figure 10 3 Blood Pressure Check Screen a ses ecateeds vtasitalenastsd iteriastiletae votlaslansns eve tas aue ieee tea es 82 Figure 10 4 Version Control Check Screen eosseesessesenssssssessseseesseresssseseosssseesssseresssereesseseesssseesssee 83 BioZ Dx Operator Service Manual iii iv CardioDynamics International Corporation BioZ Dx Operator Service Manual INTRODUCTION NOTE Before using the BioZ Dx carefully and completely read the instructions in this manual If you do not understand the instructions or need additional information contact CardioDynamics International Corporation CDIC at the address listed on the cover of this manual 1 INTRODUCTION The BioZ Dx cardiograph is an innovative noninvasive impedance cardiography ICG device that provides hemodynamic parameters based on the measurement of thoracic electrical bioimpedance Specifically the BioZ Dx allows for assessment of a patient s hemodynamic status and ventricular function by determining 24 hemodynamic parameters some of which areindexed In addition the BioZ Dx allows the operator to e Observe trends in the patient s status e Measure Blood Pr
23. fibrillation Afib e Wolff Parkinson White WPW Syndrome e Sustained bigeminy e Aortic valve regurgitation e AV valve insufficiency e Severe hypertension MAP gt 130 mmHg e Patient heights below 48 120 cm or above 90 230 cm e Patient weights less than 67 lbs 30 kg or greater than 341 Ibs 155 kg e Patient Movement e Aortic Balloon Pump BioZ Dx Operator Service Manual 7 CardioDynamics International Corporation Observe the following considerations when using the BioZ Dx 2 3 2 4 During open chest surgery the BioZ Dx may produce inaccurate values because of the change in the normal pattern of blood flow and or the electrical current flow through the chest cavity In addition during post operative recovery monitoring patient shivering and motion may produce excessive artifacts that may affect the accuracy of the BioZ Dx Do not pull on the paper when printing the report This can cause the waveform to be distorted on the report and lead to misinterpretation by the clinician Signal interference caused by other equipment may occur if cables and or power cords of the BioZ Dx and other equipment cross over each other The BioZ Dx should not be used concurrently on patients with Minute Ventilation pacemakers when the MV sensor function is activated Indications The BioZ Dx is designed for use with an adult in a supine position The BioZ Dx and its components are not designed sold or intende
24. full recharge every 3 months Charge the battery for at least 16 hours This will ensure that the battery does not completely discharge while in storage A fully depleted battery will require replacement The battery life will be prolonged when stored in cooler temperatures but will be damaged if stored below freezing 0 C 32 F Store the battery at a temperature of 40 C 104 F or lower To Store the Battery Charge the battery for 16 hours before removing it from the cardiograph Ensure that the AC power cord is connected to the BioZ Dx and is plugged into a grounded AC power outlet Check that the green AC power indicator light on the front of the Cardiograph is lit Remove the battery from the BioZ Dx and store it in a cool dry location For information about removing or replacing the battery refer to Replacing the Battery Recharge the battery for 16 hours every 3 months that the battery is in storage Charging the Batteries Charge the batteries whenever the Cardiograph is not in use The batteries will charge when the BioZ Dx is in use and is connected to AC power but will charge at a slower rate 74 BioZ Dx Operator Service Manual ICG BioZ Dx CARE AND MAINTENANCE Battery Charge Rates If the BioZ Dx is Time to fully charge batteries Power off 480 minutes Standby 575 minutes Active Use Variable Check the battery level indicator on the Status Bar to verify that the batteries are full
25. label should be positioned closest to the heart For the neck use the root of the neck as a reference for vertically locating the rectangular shaped heart labeled detecting sensor with the corresponding circular shaped transmitting sensor being positioned directly superior and inline with the ear lobe For the thorax use the xiphoid process as a reference for vertically locating the rectangular shaped heart labeled detecting sensor with the corresponding circular shaped transmitting sensor being positioned directly inferior and along the mid axillary line Connect the right and left with respect to the patient s right and left lead wires as indicated on the patient cable yoke and individual lead wire connectors to their respective dual sensor sites The lead wires must be attached as follows 30 Blue left and right lead wire connectors labeled as a 1 inside a circle to the respective circular shaped transmitting sensors on the neck Purple left and right lead wire connectors labeled as a 2 inside a heart to the respective rectangular shaped detecting sensors on the neck Green left and right lead wire connectors labeled as a 3 inside a heart to the respective rectangular shaped detecting sensors on the thorax BioZ Dx Operator Service Manual PATIENT MONITORING e Orange left and right lead wire connectors labeled as a 4 inside a circle to the respective circular shaped transmitting sensors on the thorax NOTE
26. not in use e Operate the cardiograph charge batteries and store at room temperature 25 C 77 F Higher temperatures reduce battery life and degrade performance e Ifthe BioZ Dx is not in use for more than six months fully charge batteries prior to using the cardiograph e Repeated undercharging of the battery will damage the battery and reduce battery life BioZ Dx Operator Service Manual Ms foe CardioDynamics International Corporation e If the battery has been fully charged and requires recharging after a few ICG tests consider replacing it e The battery should be removed from the unit and placed in storage if the Cardiograph will not be used for more than one month e The use of cardiograph accessories bar code reader magnetic card reader PC card modem will deplete battery power at a faster rate The battery will require more frequent charging if these accessories are used with the cardiograph e A fully charged battery stored outside the cardiograph will need to be recharged every three months If the battery is not charged every three months it will be damaged A depleted battery will not perform as expected after a full recharge and will eventually require replacement See Storing and Charging the Battery for more information 9 6 Storing and Charging the Battery Remove the battery from the Cardiograph if it will be stored for more than 30 days without use While in storage the battery will require a
27. produce instability in the waveform Perform ICG Maintenance Test to verify integrity of lead wires replace any lead sets that fail the check ECG These error messages advise the Prep the patient s skin with soap and water Amplitude is operator that the BioZ Dx can before applying sensors too low not display data due to the poor quality of a specific signal Make sure patient s head is straightforward not ECG has turned to the left or right excessive artifact Be sure patient is lying still motion such as coughing and talking will produce instability in ICG the waveform Amplitude is too low Remove any jewelry that may interfere with the leadwires ICG has excessive Perform ICG Maintenance Test to verify artifact integrity of lead wires replace any lead sets that fail the check Intermittent leads failure If the problem persists contact CardioDynamics detected Technical Services 800 778 4825 opt 3 for additional assistance HR is out of The patient s heart rate is either The patient s heart rate must be in a range the system below 40 or above 250 beats per between 40 and 250 beats per minute range 40 250 minute 64 BioZ Dx Operator Service Manual 8 4 Problem s Message is displayed stating Not enough space on the media Please insert a new disk and TROUBLESHOOTING Communication and Data Errors Possible Causes This m
28. pulsatile changes in blood volume occur in the thoracic arterial system predominantly in the aorta as a result of ventricular function This change in blood volume results in a change in the electrical conductivity and thus the impedance of the thorax to electrical current Changes in the electrical impedance of the thorax are primarily due to changes in the velocity and volume of the blood in the aorta The BioZ Dx measures this change in impedance by injecting a high frequency 60 kHz Minimum low amplitude 4 0 mA rms Maximum alternating electrical current through the thorax between a pair BioZ Dx Operator Service Manual 1 CardioDynamics International Corporation of sensors placed on the neck and another pair placed on the mid axillary line at the xiphoid process level Use of a high frequency current eliminates the possibility of interference with bioelectrical activity of the heart and brain Additionally as the skin to sensor impedance is very low at high frequency there are no thermal effects to tissue thus no sensation to the patient By detecting and measuring the change in thoracic impedance as a function of time the BioZ Dx is able to non invasively calculate stroke volume cardiac output and many other hemodynamic parameters 2 BioZ Dx Operator Service Manual WARNINGS AND PRECAUTIONS 2 WARNINGS AND PRECAUTIONS 2 1 General Warnings and Patient Safety Information The BioZ Dx and the ICG Patient Interface M
29. the battery even if it is plugged into AC power The Cardiograph has one lead acid battery that supplies power to the BioZ Dx during mobile use and to power the Cardiograph printer while it is connected to AC power With the batteries fully charged the BioZ Dx can print up to 10 ICG Status Reports every 30 minutes Use of the blood pressure feature which draws power from the battery as well may have an impact on the number of status reports that can be printed in this period of time Battery life varies depending on frequency of use and maintenance For improved battery life keep the Cardiograph plugged in when not in use If the battery has been fully charged and requires recharging after a few Status reports consider replacing it For Optimal Battery Performance e Fully charge batteries before AC or mobile use e Check the battery power indicator on the Status Bar e Configure the battery power saving modes as described in section 7 2 e Put the BioZ Dx into Standby mode when not in use e Always charge the batteries when the Cardiograph is not in use Connect the BioZ Dx to an AC power source and make sure that the power switch is turned to the ON position with the green AC light on e The batteries automatically charge whenever the Cardiograph is connected to AC power The batteries will charge while the BioZ Dx is in use on AC power but will charge at a slower rate It is recommended to charge the batteries while the Cardiograph is
30. this software license agreement if Licensor has given Licensee written notice of such breach and request that Licensee promptly cure such breach and Licensee has failed to cure such breach within thirty 30 days after receipt of Licensor s written notice of breach C Within ten 10 business days after the effective date of termination of this software license agreement Licensee shall return to Licensor all Licensed Program and User documentation without asserting any right of detention it being understood that Licensee hereby expressly waives any such right D Upon termination of this software licensee agreement for any reason whatsoever Licensor shall have no further obligation to Licensee GOVERNING LAW This software license agreement shall be governed by and interpreted in accordance with the laws of the State of California COMPLIANCE WITH GOVERNMENTAL REGULATION Licensee agrees to comply with all rules and regulations of any governmental or administrative authority which may from time to time restrict or impose conditions concerning its use of the Licensed Program Licensee specifically acknowledges that the Licensed Program and the User documentation supplied to Licensee in accordance with the terms of this Software License Agreement are subject to the United States Export Controls pursuant to the Administration Act of L979 as amended 50 U S C App 2401 ET SEQ and the Export Administration Regulations 15 C F R Parts 368 399
31. ABEL1 145 95 112 12 17 25 PM 145 95 112 12 17 20 PM 145 95 112 12 17 15 PM 145 95 112 Use up down arrow keys to scroll through records Press Enter to save highlighted record or press Auto Print to start printing ABP AS ID DEMOPATIENT na Y 3 m gt Last PATIENT Take BP Save Review Orders Archive Config Help ECG First DEMO Figure 5 5 Review Screen BioZ Dx Operator Service Manual 39 CardioDynamics International Corporation 5 6 Archived Patient Information Selecting the Archive Command provides the User with the ability to Print Delete or Ga Export files from the ICG Cardiograph s database The Archive is a database of all saved patient ICG Reports The reports are sorted and retrievable by Date Last Name Archive Patient ID Date of Birth or Physician o Data Average Data Update Signal Status 08 21 2007 ij ARREN 30 Beats x E Beats v T 12 23 00 PM Te Highlight saved ICG Status Report s to Print Delete Load Send or Export Press spacebar to view Sort By Fast Name Load Select All Find Session Date Session Time Last Name First Name Addl Name Patient 1D Date 08 21 2007 12 17 30 PM PATIENT DEMO DEMOPATIENT 01 297 08 17 2007 09 13 22 AM PATIENT DEMO DEMOPATIENT 01 29 08 17 2007 09 13 07 AM PATIENT DEMO DEMOPATIENT 01 29 Total Sessions 19 Total Sessions Last 30 days 8 15 P iA Ka a p 5 i ee Take BP Saye Revie
32. AINTENANCE SCHEDULE NIBP Maintenance Test The NIBP module should be tested on an annual basis at minimum There are four 4 separate tests that require testing Over Pressure Test Leak Rate Test Transducer Accuracy Test and Blood Pressure Test In addition to a blood pressure cuff the following equipment NOT supplied with the BioZ Dx is required in order to perform the tests An external pressure tester such as a BioTek NIBP Analyzer calibrated pressure gauge such as a mercury manometer hoses and Tee fittings Assemble the NIBP Diagnostic Test Set up as indicated in the following diagram NOTE NIBP MOOULE i 1 1 1 4 LUER i t INFLATION BULB MALE LUER PLUG MERCURY MANOMETER Figure 10 2 Example NIBP Test Set up BioZ Dx Operator Service Manual The setup and procedures in this section represents only one way of performing the recommended maintenance checks of the blood pressure module There are other automated testing devices and procedures that may be substituted for the equipment and or procedures indicated in this manual 81 CardioDynamics International Corporation To Perform a BP Check e Press the Alt and S keys simultaneously to access the System Check Screen Select the BP Check tab by pressing Alt and B keys simultaneously Data Update Signal Status 10 24 2006 i a Data Average a wW CERE 30 Beats E Beats x T 12 45 42PM_ ICG Check 1 BP Check B Vers
33. BioZ px ICG DIAGNOSTICS Operator Service Manual Part 1103087 Revision G August 2009 CardioDynamics RG oe LO G Cc O M PANY 6175 Nancy Ridge Drive San Diego California 92121 USA 800 778 4825 858 535 0202 Fax 858 535 0055 European Representative medis A division of CardioDynamics Medizinische Messtechnik GmbH Werner von Siemens Str 8 98693 Ilmenau Germany CE on CardioDynamics International Corporation This document contains confidential information that belongs to CardioDynamics International Corporation No part of this document may be transmitted reproduced used or disclosed outside of the receiving organization without the written consent of CardioDynamics International Corporation Cardio Dynamics BioZ BioZ Dx BioZtect BioZ ADvaSENSE ZMARC and Z Care are trademarked names protected by law This product is manufactured and sold under U S Patent No D468 433 6 636 754 D471 281 and Patent Pending TABLE OF CONTENTS TABLE OF CONTENTS 1 INTRODUCTION 1 1 1 Theoretical Concepts 4 27 acuenian aed aaa ee ee eee 1 2 WARNINGS AND PRECAUTIONS 3 2 1 General Warnings and Patient Safety Information sseessesseeseesesesesseseresrersessresressersresreeseesese 3 2 2 Precautionsne sr ann E ea acs a S E E A E E oR OR RR 7 2 3 Indications neea EEEE os Ra Todo aad eS LG ts BORON BAR as Be ev edb ous 8 2 4 ContrairidiC ating ssn a hace wesc Wea ess Ta AE es ds
34. ICG PIM Data Average Data Update Signal Status 10 24 2006 ae i URUNE fo Beats E Beats x 0 12 44 59 PM System Check ICG Check 1 BP Check B Patient s Right Patient s Left STEPS 1 Connect Patient Cable to ICG Simulator 2 Press Test to Perform ICG Check 3 Verify Parameters are Within Target Ranges 4 Press Auto Print to Print this Window Parameter Value Target 69 71 a VE 70 51 0 FC EE 34 0 F 260 vE 7 1D 1234 ae Last FIELDS First DEBBY HEA P Take BP Save Review Orders Archive Config Help EGG Figure 10 1 ICG Check Screen BioZ Dx Operator Service Manual 79 CardioDynamics International Corporation To Verify System Calibration Connect Patient Lead Wires to corresponding ICG PIM snap connectors i e left lead wire array to left sided snaps with the corresponding proper colored and numbered lead wire connector Connect to AC power source and turn Cardiograph ON Press the lt Alt gt and S keys simultaneously The ICG Check Screen will be displayed See Figure 10 1 ICG Check Rotate Trim Knob to select TEST and press Enter or the Trim Knob to begin the test Verify that the values are within the Target Range as indicated on the screen Select Print button to print an ICG Test Report If values are out of target range contact Technical Support 80 BioZ Dx Operator Service Manual 10 2 ICG BioZ Dx SUGGESTED M
35. ING A patient monitoring session is initiated from the Main Screen The Patient ID Control Key located on the front panel is used to begin a live monitoring session The following sections will explain the steps necessary to monitor a patient 5 1 Patient Preparation Instructing the Patient The first step in beginning a monitoring session is to explain the test to the patient It is important that the patient is calm and in a relaxed state e Reassure the patient that the test is painless e Ensure that the patient is comfortable and in a supine position NOTE Hemodynamic normal ranges are established for a patient in the supine position only Mean Arterial Pressure MAP related parameters are based on the assumption that MAP is constant throughout the arterial system Due to gravitational forces this assumption is only valid when the arterial system is at the same level i e when a patient is supine Therefore the MAP and MAP related parameters for SVR SVRI SSRI TAC TACI LSWI and LCWI are invalid when the patient is not in the supine position Once the Sensors Cable and Blood Pressure cuff have been properly applied to the patient instruct the patient to e Not move or talk e Breathe normally e Relax all muscles ICG Sensors To obtain accurate results with the BioZ Dx it is important to e Properly prepare the skin e Use high quality ICG sensors with low skin to electrode impedance e Ensure proper spacing b
36. Index Systolic Time Ratio Systolic Time Ratio Index Pre Ejection Period Left Ventricular Ejection Time Thoracic Fluid Content Thoracic Fluid Content Index Systemic Stroke Resistance Index Left Stroke Work Index Base Impedence See Appendix A HEMODYNAMIC PARAMETERS and Appendix B GLOSSARY OF TERMS 20 BioZ Dx Operator Service Manual Waveform Area GETTING STARTED The BioZ Dx provides three waveforms of which two may be displayed at any given time The User may select the waveforms for display via the Config button on the Command Bar Waveform Description ECG ECG Displays the system selected optimum ECG vector The ECG vector amplitude is auto scaled to fill the display and therefore may not be indicative of actual ECG amplitude and or morphology Note The BioZ Dx ECG is non diagnostic and is used only for the purpose of R and Q point detection It is NOT intended to be used by the clinician to evaluate and or make decisions regarding possible diagnosis treatment or causes for symptoms Pacer Spikes are simulated and do not reflect actual and or relative amplitude as related to the ECG signal They are intended as a point of reference for timing purposes only ICG ICG Displays the inverted Delta Z waveform The Delta Z waveform is the dynamic change of impedance due to pulsatile changes in thoracic blood volume that occurs with each heartbeat dZ dt dZ dt Displays the firs
37. NG STARTED ccccccccccessceescecessceeseeceteeesseees 11 GLOSSARY dsc bese aE i A NE AEREE iE oes 97 H Help Command serrara err E ae 44 Hemodynamic Parameters Acceleration Index ACD oo ccecsccsssseesseceeeeeseeees 97 Cardiac Index Curunen EE 97 Cardiac Output CO eeeceeeeeeceseceeeeeeeeeeeeeeeeeees 97 Heart Rate HR sieer eere eree ere ri eree 98 Left Cardiac Work Index LCWI cccccecceesseeees 98 Left Ventricular Ejection Time LVET 98 Mean Arterial Pressure MAP cscecsseceseeeseees 99 Normal Ranges 0 cece cee eseeeeeeeeeeeeeeeeeeseeeeensees 95 Pre Ejection Period PEP ccscesseeseeeseeteeeeeees 99 Stroke Index SD ecececceececssseceessececssneeeeeseeeeeneees 99 Stroke Volume SV ccccccecsssseceessececseseeeeeseeeeeneees 99 Systemic Vascular Resistance SVR esceeeeeee 99 Systemic Vascular Resistance Index SVRI 100 102 Systolic Time Ratio STR cescesseesseeteeeeeeeeees 100 Thoracic Fluid Content TFC 00 0 ceeeeesseceeeees 100 Velocity Index VI cecceesceescesseeseeeseeeseeeeeeteeeaes 101 I TC C E EE cee asd E A TEE ees 1 ICG Cardiograph Care and Maintenance 0 69 ICG Display sind aiina erele sabe aes 17 Command Barreira constechsetevstecspeeests 22 Hemodynamic Values cee eecseeceseeeetecseeeeenees 20 Status BAT eeens sana a ra tes EERI 19 Waveform ATEA aee ea apaa e Reira raTa 21 Jeata
38. P as well as different MAPs for the same systolic and diastolic pressures To Use the NIBP Cuff e Wrap the cuff around the patient s upper arm observe the precautions listed below Ensure that the cuff is positioned so that the arrow aligns with the patient s Brachial artery e Connect the inflation tube to the NIBP Port on the front panel of the ICG PIM Once the monitoring session begins the Cardiograph will automatically operate the blood pressure cuff to obtain the measurement In order to obtain an accurate blood pressure measurement and to ensure the safety of the patient it is essential that the following precautions be observed e Use only the blood pressure cuff provided with the device e Use the proper size cuff for the patient s arm e Ensure that the cuff is evenly and snugly wrapped around the patient s arm e Ensure that the bladder within the cuff is not folded e Ensure that all connections are tight so as to prevent leakage e While making blood pressure measurements be sure to avoid any compression or restriction of the pressure tube leading to the cuff e The operator is advised to observe directly that inflation of the cuff does not result in prolonged impairment to the patient s circulation e The patient s arm should remain relaxed and still while the blood pressure cuff is inflating and deflating 32 BioZ Dx Operator Service Manual PATIENT MONITORING To Enter a Manual Blood Pressu
39. Page Stop C I J Figure 3 3 BioZ Dx Control Keys A On Standby Turn ON Off E Auto Print Print an ICG Report Cardiograph or set to Standby B Standby Indicator When lit the F Rhythm Not enabled on ICG only devices cardiograph is in Standby power save See Philips Getting Started Guide M4992 mode and the screen is black 91120 for ECG application C AC Power Indicator When lit the G Copy Print a copy of the latest ICG report cardiograph is plugged into AC power D Patient ID Allows User to input view H Page Advance the paper to the beginning of or edit patient information such as height the next page weight DOB etc Also initiates a monitoring session I Stop Stop monitoring session BioZ Dx Operator Service Manual 13 CardioDynamics International Corporation 3 2 The BioZ Dx Keyboard The Cardiograph keyboard is equipped with symbolically labeled keys TAB Moves cursor from SHIFT IT field to field lt _ ENTER Exits a Screen and saves information BACKSPACE DELETE TRIM KNOB Rotating allows the User to navigate through various Dialog boxes the Status and Command Bars Pressing allows the User to accept entered information and advance to the next field and or command as applicable 14 BioZ Dx Operator Service Manual GETTING STARTED 3 3 Impedance Cardiography Patient Interface Module ICG PIM A Noninvasive Blood Pressure C System test lead wire c
40. Placing the ICG Sensors incorrectly will adversely affect the ability of the BioZ Dx to measure and process the bioimpedance signal which can lead to inaccuracies in the hemodynamic parameters e Both the neck and thorax ICG sensors must be positioned so that they are 180 degrees opposite each other Should the patient have an invasive line chest tube etc at the recommended locations the ICG sensors may be rotated slightly as long as they remain 180 degrees opposite of each other Figure 5 1 ICG Sensor Placement Diagram BioZ Dx Operator Service Manual 31 CardioDynamics International Corporation 5 2 Apply the Blood Pressure Cuff The BioZ Dx NIBP module utilizes the oscillometric method in determining blood pressure values The oscillometric method measures the pressure pulse within the cuff in incremental steps This pressure pulse has a maximum value of approximately 1 mmHg that occurs at the MAP A sophisticated algorithm is then applied to plot the oscillometric envelope of pulse pressure measurements vs cuff pressure measurements The cuff pressure at which the peak pressure pulse occurs is the MAP The diastolic and systolic values are determined by the shape of the oscillometric envelope The shape of an actual patient oscillometric envelope varies from measurement to measurement and from individual to individual Therefore it is quite possible to have different systolic and diastolic pressures for the same measured MA
41. al CDIC invoice date If during the warranty period Buyer uses the Products as directed in the Operators Manual but the Products fail to conform to their specifications CDIC will repair or replace the Products at CDIC s sole election CDIC MAKES NO OTHER REPRESENTATIONS OR WARRANTY WHETHER EXPRESS OR IMPLIED AS TO MERCHANT ABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ARISING FROM COURSE OF DEALING OR USAGE OF TRADE CDIC SHALL NOT BE LIABLE TO BUYER OR ANY OTHER INDIVIDUAL OR ENTITY FOR ACTS OF GOD PROPERTY DAMAGE LOSS OF USE INTERRUPTION OF BUSINESS LOST PROFITS LOST DATA OR ANY OTHER SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RELATING TO USE OF THE PRODUCTS HOWEVER CAUSED WHETHER FOR BREACH OF WARRANTY CONTRACT TORT INCLUDING NEGLIGENCE STRICT LIABILITY OR OTHERWISE IN NO EVENT SHALL CDIC S LIABILITY IN CONNECTION WITH THE PRODUCTS EXCEED THE PRICE PAID THEREFOR BY THE BUYER Warranty is made on original product purchase only and is not transferable CDIC products are designed tested and warranted as complete systems consisting of integrated hardware and consumables As a result CDIC cannot guarantee or warrant the accuracy or results of tests done with CDIC hardware products when third party consumables such as sensors are used to perform tests with such products Any attempt to modify any CDIC product from its original condition as delivered to Buyer or any use or integration with or into a CDIC product of parts or compone
42. al blood flow level for a specific condition NORMOTENSION A state where mean arterial pressure MAP is within a normal range The normal MAP range for supine resting adults is 84 100 mmHg PAOP See PULMONARY ARTERY OCCLUDED PRESSURE PEP See PRE EJECTION PERIOD PRE EJECTION PERIOD PEP msec The period of isovolumetric ventricular contraction PULMONARY ARTERY OCCLUDED PRESSURE PAOP mmHg The filling pressure of the left heart Normal mean value is 10 mmHg Q C INTERVAL QC msec The interval from start of left ventricular depolarization to the point of maximum impedance change QC q_time c_time 1000 process_rate QC See Q C INTERVAL SI See STROKE INDEX SSRI See STROKE SYSTEMIC RESISTANCE INDEX SSVRI See STROKE SYSTEMIC RESISTANCE INDEX Same as SSRI STRI See SYSTOLIC TIME RATIO INDEX STROKE INDEX SI ml m STROKE VOLUME indexed by BODY SURFACE AREA SI SV BSA STROKE SYSTEMIC RESISTANCE INDEX SSRI dyne sec cm L min m A measure of afterload on a per beat basis It is calculated by substituting SI for CI in the SVRI equation MAP CVP SI x 80 The normal range for SSRI based on the ideal hemodynamic state where SI 50 ml m MAP 92 mmHg CVP 6 mmHg is 110 165 Note Also referred to as Stroke Systemic Vascular Resistance Index SSVRI STROKE VOLUME SV ml The volume of blood delivered by the heart into the vasculature in one beat SV See STROKE VOLUME
43. any output of the System will meet the standards or requirements of the End User s medical practice End User expressly acknowledges that End User is solely responsible for verifying that any results produced by the System are free from error and suitable for the applications for which they are to be used 92 BioZ Dx Operator Service Manual SOFTWARE LICENSE AGREEMENT 14 SOFTWARE LICENSE AGREEMENT By this agreement CardioDynamics International Corporation a California Corporation Hereinafter referred to as Licensor in this agreement agrees to grant and the end User hereafter referred to as Licensee in this agreement agrees to accept the following terms and conditions described in this agreement including User documentation NON EXCLUSIVE LICENSE LICENSOR HEREBY GRANTS TO LICENSEE A LIMITED PERSONAL NONTRANSFERABLE AND NON EXCLUSIVE LICENSE TO USE THE LICENSED PROGRAM IN OBJECT CODE FORMAT ONLY LICENSEE EXPRESSLY UNDERSTANDS AND AGREES THAT IT WILL NOT 1 LICENSE OR SUBLICENSE TO ANY THIRD PARTY OR OTHERWISE DISTRIBUTE RELEASE SELL RENT OR PUBLISH THE LICENSED PROGRAM OR THE USER DOCUMENTATION II MODIFY ADAPT TRANSLATE REVERSE ENGINEER DECOMPILE OR DISASSEMBLE THE LICENSED PROGRAM LICENSEE EXPRESSLY UNDERSTANDS AND AGREES THAT IT HAS NOT BEEN GRANTED HEREUNDER ANY LICENSE OR RIGHT TO USE OR RECEIVE ANY SOURCE CODE CONFIDENTIAL DISCLOSURE Licensee agrees that the Licensed Program includes trade se
44. ardioDynamics International Corporation 3 7 The BioZ Dx Display The Cardiograph consists of a color display screen with four distinct areas A System Status Bar C Waveform Area B Patient Values D Command Bar Data Update 10 24 2006 KES Data Average Signal Status A U BERBE 20 Beats 5 Beats x 0 12 26 23PM BP ant mmHg SI 35 mtean 2 CI 2 5 L min m SVRI 2800 dyme sec min 0 35 31 6 ohms g 0 E Ka a 23 Q gt a ees Take BP Save Review Orders Archive Config Help ECG First Abe Figure 3 9 Monitoring Screen 18 BioZ Dx Operator Service Manual Status Bar Button Indicator KE 20 a Data Average GETTING STARTED Description Battery Signal Status Indicator Indicates Battery Level Cycling progress Bar indicates Charging Green battery icon indicates full charge Data Average Indicator and Button Provides Drop Down Menu to set and indicator to display the number of beats to use when calculating Hemodynamic Patient values Data Update jo__ Data Update Indicator and Button Provides Drop Down Menu to set and indicator to display the number of beats to use when updating the Hemodynamic Patient values on the screen Signal Status Signal Status Indicator Green indicates that a sufficient number of acceptable ICG beats 5 out of 40 are present to display Hemodynamic values Yellow indicates an insufficient number of acceptable ICG beats are available and Hemody
45. asive Method of Measurement Oscillometric Diastolic values correspond Integrated Blood to Phase 5 Korotkoff sounds Pressure Module Systolic Range 40 260 mm Hg Diastolic Range 20 200 mm Hg Mean Arterial Range 27 220 mm Hg HR Range 40 250 BPM beats per minute Cuff Deflate Rate Deflation Step Rate varies with HR cuff pressure and cuff volume Initial Inflation Pressure 160 mm Hg default Variable from 120 to 280 mm Hg Transducer Accuracy 3 mm Hg under normal operating conditions Possible slight reduction in accuracy for temperatures above 50 C up to 60 C Patient Safety e Maximum cuff inflation time is limited to 50 seconds e Duration of blood pressure reading is limited to 130 seconds Additional redundant safety circuitry oversees normal operation and will override to abort a reading if e Cuff pressure exceeds 300 mm Hg e The cuff has been inflated for 180 seconds The Module meets all relevant parts of the following safety standards ITEC 60601 1 IEC 60601 2 30 AAMI SP10 EN1060 1 EN1060 3 UL 2601 CAN CSA C22 2 No 601 1 BioZ Dx Operator Service Manual CardioDynamics International Corporation 12 1 Electromagnetic Compatibility EMC Electromagnetic compatibility with surrounding devices should be assessed when using the cardiograph An electronic device can either generate or receive electromagnetic interference Testing for electromagnetic compatibility EMC has been
46. ce manual and or instructions for use provided with the System at time of sale e CDIC will provide free shipping and freight charges for original and loaner replacement unit exchanges UPS Ground or equivalent e CDIC will provide subsequent operational software upgrade disks and installation instructions at no charge to the customer Warranty Coverage is void if e The System and or Software has been maintained repaired modified or altered by any person other than an authorized CDIC representative or without prior approval from an authorized CDIC representative e The System and or Software has not been properly operated or maintained in accordance with CDIC s then applicable written operating and maintenance manuals e The configuration of the System and or Software has been altered by but not limited to the addition of any other computer software to the System e The failure of the System and or Software has resulted from acts of God accident abuse misapplication or negligence Note There are no user serviceable components in the BioZ Dx All units must be returned to CDIC for repair or replacement during the warranty period CDIC does not warrant either expressed or implied the correctness or validity of any output information or data provided by the System including but not limited to any information relating to any medical diagnosis treatment or to the health and safety needs of patients CDIC does not warrant that
47. chnical Support Printed data is garbled dark on one side but faint on other If error persists contact Technical Support BioZ Dx Operator Service Manual 61 CardioDynamics International Corporation Problem Potential Solutions Paper does not tear off cleanly or paper stops at the wrong spot Wrong paper size setting Wrong method is being used to tear off paper Ensure that paper is torn horizontally in a steady left to right motion Do not tear paper in a rapid up or down motion If error persists contact Technical Support Blank pages printed after report Wrong paper size setting Verify that the correct paper for the Paper size setting is properly loaded in the paper drawer If error persists contact Technical Support 62 BioZ Dx Operator Service Manual TROUBLESHOOTING 8 3 Monitoring Errors ICG Problem s There are no values to save or print Please wait until the first update message is displayed Possible Causes Communicates to the user they have attempted to print or save prior to values being displayed or while the signal status is bad Potential Solutions Wait until values are displayed Verify sensor and lead placement are correct Be sure patient is lying still Motion such as coughing and talking will produce instability in the waveform Replace sensors with new set Perform ICG Maintenance Test to verify integrity o
48. crets and proprietary know how belonging to Licensor and is being made available to Licensee in confidence and solely on the basis of a confidential relationship to Licensor Licensee agrees to hold the Licensed Program in trust and agrees not to use print copy provide or otherwise make available in whole or in part any portion of the Licensed Program or modifications thereof or any material related to the Licensed Program except as expressed in this agreement Licensee agrees that it will not reconstruct in whole or in part the code or algorithms contained in the Licensed Programs COPYRIGHTS TRADEMARKS LEGENDS AND LOOSE LOGOS A The Licensed Program its package and the User documentation contain certain copyright and proprietary notices Licensee agrees that these notices shall not be removed or altered No rights of any kind under any trade name s trademark s or service mark s owned by Licensor are granted under this agreement nor is Licensee authorized to use any trade name s trademark s or service mark s owned by Licensor B Licensee agrees to reproduce the following notice on any copies of the Licensed Program This computer program includes proprietary trade secrets owned by CardioDynamics International Corporation Possession and use of this program must conform strictly to the User s License Agreement Receipt or possession does not convey any rights to divulge reproduce or allow others to use this program without the specif
49. d for use except as described in this document For hygienic purposes single use patient sensors are specified when using this device The device classification for BioZ Dx is Class II US FDA Class Ila European Medical Device Directive and Class II Canadian Medical Device Regulations The blood pressure cuff provided with the BioZ Dx is non conductive thus assuring no risk of burning the patient during radio surgical procedures such as electrocautery The patient cable circuitry affords a high degree of patient isolation from potential ground faults Contraindications None known BioZ Dx Operator Service Manual WARNINGS AND PRECAUTIONS 2 5 Safety Symbols Marked on the Cardiograph Attention A See BioZ Dx Instructions for Use Mouse Not Used DD The receptacle marked by this icon is not being used at this time USB Connector mS The USB connection on the back of the cardiograph is used to connect to the PIM On Standby O Pressing the button with this symbol turns on the cardiograph or puts the cardiograph into Standby power saving mode BioZ Dx Operator Service Manual Equipotential grounding post Vv Equipotential grounding post used for establishing common ground between instruments Fuse E34 Cardiograph contains a 1 5 amp 250V time delay fuse Input 2 The connector near this symbol receives an incoming signal 3 GETTING STARTED GETTING STARTED Pr
50. e Power Supply Hardware Failure Safety Override Fitted or Auto zero Out of Range Transducer Out of Range ADC Out of Range EEPROM Calibration Data Failure Damaged Equipment Service Required Contact Technical Support 60 BioZ Dx Operator Service Manual TROUBLESHOOTING 8 2 Problem Printer Printing Errors Paper doesn t advance Paper jam detected Error Message is Displayed Potential Solutions Replace Paper or clear paper jam If error persists contact Technical Support Paper moves then stops and displays error message Paper jam detected Make sure BioZ Dx is loaded properly with approved thermal paper Clean paper sensor lens If error persists contact Technical Support Printer does not feed paper Battery power too low for good printing error message is displayed Charge batteries Replace battery packs If error persists contact Technical Support Printer does not feed paper Printer drawer is open error message is displayed Close drawer If error persists contact Technical Support Paper moves but printing is faint or blank Ensure approved thermal paper is being used Clean paper sensor lens If error persists contact Technical Support Paper stops in the wrong place after pressing Page or Print control keys Ensure approved thermal paper is being used Clean paper sensor lens If error persists contact Te
51. ec NA 120 450 Total Arterial Compliance TAC mL mmHg 13 0 28 0 0 1 80 0 Total Arterial Compliance Index TACT mL m mmHg 8 0 14 0 0 1 40 0 Left Stroke Work Index LSWI gm In 47 2 70 8 1 0 270 0 Heather Index HI Ohms s NA 0 2 30 0 Q C Interval QC msec NA 100 350 Base Impedance Zo Ohms Female 27 0 48 0 7 0 67 0 Male 20 0 33 0 96 BioZ Dx Operator Service Manual Appendix B GLOSSARY OF TERMS 16 Appendix B GLOSSARY OF TERMS ACCELERATION INDEX ACI 100 sec An index of the peak acceleration of aortic blood flow The peak acceleration takes place approximately 15 30 msec after the opening of the aortic valve ACI is a measure of the true inotropic state of the heart and is fairly independent of AFTERLOAD The normal ranges for supine resting adults are 70 150 x 1007 sec for males and 90 170 x 100 sec for females ACI 100 d Z dt Zo ACI See ACCELERATION INDEX AFTERLOAD Represents the forces that the ventricle must overcome to deliver blood into the systemic vasculature during contraction The primary component of afterload is vasoactivity represented by Systemic Vascular Resistance SVR The secondary component of AFTERLOAD is blood viscosity AFTERLOAD is a systolic phenomenon BASE IMPEDANCE Zo Ohm The mean electrical impedance of the thoracic cavity Also known as THORACIC FLUID INDEX TFI BODY SURFACE AREA BSA m BSA is est
52. eee sen ie RA ee ee ae 59 8 2 Printers Printing ErrOrS semoirs nisni E e us EI EE nE ni EEAS 61 8 3 Monitoring Errors CG i000 ere ee ee deg ee 63 8 4 Communication and Data Errors yoscccccstecsssceasaaseneahcssascsnegsecawiat sa sanseasusaecans ecules edn oqnauianeaess 65 8 5 System RESET iecucauicaca cs cuca A dune cae cua pens aioya waa duns Satay E gedaan taeetete dass ET REDEE 67 8 6 Software Installation Instructions 12 cc01scissiddees decider dee eee eee see 67 Dols WPOWer MANA O i re secthccs edu ea Wess ccune e A A e a a T 67 9 ICG BIOZ DX CARE AND MAINTENANCE 69 Gilt WC learning Fx ternal S Wi aCe s 4c nooi tices ec Neth Nl te tiie ah edt nee O E Net set cada 69 92 Cleaning the Print Head s5 s 2cccreswcsseessnsccbdaseasaasasausneiansces satis duancessasadaasccvedeaneesaee seeders bucbaennens 70 9 3 Cleaning the Paper Sensor Lensi iiin p ahah ed Se Gee AG 70 9 4 Replacing Printet Paper Accson Bil eel eee be a ha ee Uo Bhi 71 9 5 Battery Maintenance and Caresse aaa sueudedads seeeanse lusdadasusede reas 13 9 6 Storing and Charging the Battery eeeeseseseeeeesessssssessessrssressersresreeseestesstesesrrssresseseresresseseresees 14 9 7 Replacing the Batterie sinin ha R A a ete EEES 76 9 8 Removing and Replacing the AC Fuse sseessssessessseseseresssersseessersseesseressseessressresseesseeesssees 71 9 9 Ordering replacement PAarisssa csseccescszacehnadinevetansverdondessdexaaseagadaaanecmteod O E a
53. equirements and that has not been evaluated by local safety personnel e Do not connect any equipment other than authorized by CDIC to the BioZ Dx RS 232 media keyboard and or RJ 41 port s if a patient is connected to the BioZ Dx via the ICG PIM when properly connected to the USB port e Unauthorized equipment connected to the BioZ Dx RS 232 USB media keyboard and or RJ 41 port can cause ground leakage currents exceeding the maximum specified IEC 60601 1 safety standards e Do not connect any device to the RS 232 port on the rear of the cardiograph when the patient data cable is connected to a patient e As a Class II Type BF device under the International Electrotechnical Commission IEC the BioZ Dx is not specifically intended to monitor variations in cardiac performance that could result in immediate danger to the patient e Caution In the U S Federal law restricts this device to sale by or on the order of a physician e Explosive Hazard Do not use in the presence of flammable anesthetics or gases e ICG Sensors are to be placed externally on the skin only and are not for direct cardiac application BioZ Dx Operator Service Manual 5 CardioDynamics International Corporation DO NOT ALLOW patients to wear ICG Sensors when undergoing Magnetic Resonance Imaging MRI due to risk of second and third degree burns ICG Sensors are single time use devices and should be replaced after a maximum of 24 hours of use While
54. erference between the BioZ Dx and any existing RF transmitting or receiving equipment at the installation site including electrosurgical equipment should be evaluated carefully and any limitations noted before the equipment is placed in service Radio frequency generation from electrosurgical equipment at close proximity to transmitters may seriously degrade performance Like all electronic devices this BioZ Dx is susceptible to electrostatic discharge ESD Electrostatic discharge typically occurs when electrostatic energy is transferred to the patient the sensors or the cardiograph ESD may result in ECG and or ICG artifact that may appear as narrow spikes on the BioZ Dx display and or printed report When ESD occurs the BioZ Dx ECG and or ICG interpretation may be inconsistent with the physician interpretation CardioDynamics assumes no liability for failures resulting from RF interference between the BioZ Dx and any radio frequency generating equipment Use of accessories other than those recommended by CardioDynamics may compromise product performance Impedance Cardiography ICG is a theoretical model of blood flow movement and is subject to inaccuracies in cases where the model does not fit a particular patient s clinical circumstances Conditions that may limit the accuracy of the data and or result in the inability to obtain hemodynamic measurements are listed below e Septic shock e Left bundle branch block LBBB e Atrial
55. essage is displayed when the PCMCIA Card is full but there is still more information to be transferred Potential Solutions Insert a new PCMCIA Card and press the OK button in the message box When OK is pressed the information shall continue to be transferred until all the selected reports have been copied or until the storage media is filled and the message is redisplayed press Send again ICG The BioZ Dx is unable to Check the USB cable connecting the Communications communicate with the Patient cardiograph to the PIM verify the connector Failure interface module ends are fully inserted in the receptacle Replace the USB cable if any damage is noted on the connector ends or they will not lock into the receptacle Perform the Version Control Check to verify the CRC If the problem persists contact CardioDynamics Technical Services 800 778 4825 opt 3 for additional assistance The BioZ Dx The USB cable plugs into the Verify the USB cable is plugged into the has detected a rear of the cardiograph and cardiograph and the ICG PIM problem with the connects the monitor with the USB ICG PIM If the problem persists contact CardioDynamics connection Technical Services 800 778 4825 opt 3 for additional assistance Cannot access database Your database might be damaged A problem exists where the system can no longer read the information in the database The system will automa
56. essure with the integrated Blood Pressure monitor e View store and review the collected data and or waveforms e Print reports of hemodynamic parameters with date and time annotations e Download files toa PCMCIA Card e Utilize security precautions Password protection for system configuration e Networking capabilities 1 1 Theoretical Concepts Note The initial use of thoracic electrical bioimpedance was supported by impedance cardiography and plethysmography assessments Today many terms are used interchangeably when discussing impedance cardiography Thoracic electrical bioimpedance TEB thoracic electrical impedance and electrical bioimpedance In this manual the term impedance cardiography or ICG will be used ICG is a technology that quantifies the mechanical activity of the heart blood flow as opposed to its electrical activity ECG The fundamental theoretical basis of ICG involves direct measurement of base impedance velocity index acceleration index pre ejection period ventricular ejection time and heart rate These measurements are then used to calculate additional hemodynamic parameters The application of ICG to determine hemodynamic parameters is based on the following principles Biological tissues such as muscle bone fat and blood all have different electrical properties Of these tissues blood is the most electrically conductive Since arterial blood flow is pulsatile and arterial vessel walls are compliant
57. etter key in parenthesis Figure 5 12 Help Screen BioZ Dx Operator Service Manual 47 CardioDynamics International Corporation Help screen for useful Tips CardioDynamics BO Zip Tips for Tips for Taking Blood Pressure Obtaining Good Signal Quality 1 Use correct size cuff 1 Prep patient s skin e Shave if necessary 2 Place cuff 1 above elbow with e Clean with soap and water arrow over the brachial artery Dry thoroughly with gauze 3 Ensure the patient is relaxed 2 Ensure lead wires are connected not talking and motionless during properly and sensors are making cuff inflation an deflation good contact with patient s skin 3 Ensure patient is relaxed not talking and motionless during ICG test Turn Trim Knob to go back Press ESC key to exit Figure 5 13 Help Screen 48 BioZ Dx Operator Service Manual PRINTING THE ICG REPORT 6 PRINTING THE ICG REPORT The BioZ Dx has an integrated printer Pressing the Print Control Key during a live ICG test Review or Archive function will Print the ICG Status Report and Save a copy to the Archive for later review printing and or transfer to external media dalton thelma CardioDynamics MEDICATIONS 1D 1137 Female 6175 Nancy Ridge Or DOB 08 08 1931 Age 74 5ft4in 155 Ibs San Diego CA 92121 BSA 1 76 Operator Barbara Label Interpretation Signature Physican Dr Fenton Systemic Vasculat
58. etween transmitting and receiving sensors e Ensure good adhesive properties e Only use sensors that have been recently removed from the sealed package Sensors are single use disposable items Check the package expiration date before use BioZ Dx Operator Service Manual 29 CardioDynamics International Corporation The ICG sensors distributed by CardioDynamics meet these requirements NOTE The algorithm used to determine the stroke volume by Impedance Cardiography is dependent on proper skin preparation the ICG Sensor conductive gel electrode type spatial relationship between snaps and site placement on the patient Use of non CardioDynamics approved ICG sensors will affect the ability of the BioZ Dx to determine the patient s hemodynamic parameters Skin Preparation Proper skin preparation is very important in order to prevent artifact and obtain a strong ICG signal Shave the hair over the sensor sites if necessary Wash thoroughly with soap amp water Dry prep the sensor sites by mildly abrading the skin ICG Sensor Application Check the expiration date on the sealed pouch prior to opening Open the sealed pouch and remove the four dual sensors Prep the skin as listed above Remove the four dual sensors from the backing material and apply each sensor adhesive side down to the proper sites as indicated on the diagram Figure 5 1 and the package label The wide rectangular shaped end with the heart
59. f lead wires replace any lead sets that fail the check If problem persists it is likely a patient related issue such as a bundle branch block Unable to learn ECG message is displayed There may be a problem with one of the lead sets sensor application or patient related issue Verify the lead sets are from CardioDynamics the BioZ Dx will only operate with CardioDynamics leads Prep the patient s skin with soap and water before applying sensors Make sure patient s head is straightforward not turned to the left or right Be sure patient is lying still Motion such as coughing and talking will produce instability in the waveform Remove any jewelry that may interfere with the leadwires Perform ICG Maintenance Test to verify integrity of lead wires replace any lead sets that fail the check If the problem persists contact CardioDynamics Technical Services 800 778 4825 opt 3 for additional assistance BioZ Dx Operator Service Manual 63 CardioDynamics International Corporation Problem s Possible Causes Potential Solutions Learning ECG The cardiograph is programmed If the message continues to appear perform the Vector to automatically identify the best following message is ECG vector no input is required displayed from the operator Verify sensor and lead placement are correct Be sure patient is lying still motion such as coughing and talking will
60. filled in e Enter the current weight Update the height if necessary Select BP method and enter BP if necessary e After the required Patient ID fields have been entered press the Enter key The blood pressure cuff will inflate if Auto BP is selected and the Main Screen will be displayed The Cardiograph will automatically perform a Leads Check to determine patient cable and sensor integrity Once proper lead connection has been established the system will begin looking for an ECG R wave After the system has identified an ECG vector with acceptable R waves it will evaluate the corresponding ICG beat After a minimum number of ICG beats has been accepted as determined by the Data Average setting hemodynamic values will be displayed NOTE Please refer to the Troubleshooting Section of this manual if unable to obtain hemodynamic values BioZ Dx Operator Service Manual 37 CardioDynamics International Corporation 5 4 Saving Patient Information Selecting the Save Command provides the User with the ability to save a patient a ICG Report that may later be retrieved via the Retrieve Command When the Save L command is selected a Save Dialog Box will be displayed The User may then Save define a label to be appended to the data via an alphanumeric text entry up to 125 characters Pressing Enter will then Save the ICG Report to the BioZ Dx Archive In addition to the Save Command the Print Command also saves an ICG Rep
61. g 60 90 20 200 Mean Arterial Blood Pressure MAP mm Hg 70 105 27 220 Stroke Index SI mL m 35 65 5 125 Stroke Volume SV mL Variable depending on 5 250 Body Surface Area BSA Cardiac Index CI L min m 2 5 4 2 1 4 15 0 Cardiac Output CO L min Variable depending on 1 4 15 0 Body Surface Area BSA Systemic Vascular Resistance SVR dynes sec cm 770 1 500 1 3500 l Qoctamir Vacecuiar RPacictanca Indas URT dunsee cap ham o ne IERD DRAG I I O a I I UOTA Systemic Vascular Resistance Index SVRI dynes seccm m 1 680 2 580 1 11000 Left Cardiac Work Index LCWI kg m m 3 0 5 5 0 1 25 0 Acceleration Index ACI 100 sec Female 90 170 0 400 Male 70 150 Velocity Index VI 1000 sec 33 65 6 200 BioZ Dx Operator Service Manual 95 CardioDynamics International Corporation Parameter Abbrev Units Normal Mid Range MIN MAX Note 1 Note 2 Note 2 Thoracic Fluid Content TFC kOhms Female 21 0 37 0 15 0 143 0 Male 30 0 50 0 Thoracic Fluid Content Index TFCD kOhms m Female 12 0 21 0 5 0 150 0 Male 15 0 25 0 Systolic Time Ratio STR no units 0 30 0 50 0 10 1 50 Systolic Time Ratio Index STRDI sec 0 3 0 5 0 1 1 5 Systemic Stroke Resistance Index SSRI dyne Bee cm L 110 1 165 1 1 0 1250 0 Pre Ejection Period PEP E NA 70 300 Left Ventricular Ejection Time LVET ms
62. ges in ICG parameters 6 3 ICG Status Report Waveform Display Section The ICG Waveform Section displays two of the three available waveforms displayed by the BioZ Dx as defined by the User via the Config Command function NOTE These waveforms are auto scaled to vertically fill the waveform section Please refer to the scale in the footer section in order to determine actual waveform amplitude 6 4 ICG Status Report Footer The Footer Section displays the scale of the ECG and ICG Waveform amplitude and speed ICG Data Average Period Display Update and Signal Status NOTE The BioZ Dx ECG is non diagnostic and is used only for the purpose of R and Q point detection It is NOT intended to be used by the clinician to evaluate and or make decisions regarding possible diagnosis treatment or causes for symptoms 50 BioZ Dx Operator Service Manual SYSTEM CONFIGURATION 7 SYSTEM CONFIGURATION The Config Command Button provides the User with the ability to configure various system defaults There are three main areas for User Configurability Screen amp Report Options and Facility 7 1 Screen amp Report Configuration Screen The Screen amp Report Dialog Screen provides the User with the ability to configure which waveforms and parameters will be to displayed on the ICG Main Screen and ICG Status Report The user may choose one of two ICG waveforms six parameters for the Main Screen and 13 parameters for the ICG Status
63. ic authorization of CardioDynamics International Corporation Copyright 2004 all rights reserved CardioDynamics International Corporation TITLE Licensee acknowledges and agrees that title to all copyright trade secrets or any other intellectual and or proprietary rights in the Licensed Program are the property of Licensor Licensee agrees that during and after termination of this agreement Licensee shall not raise or cause to be raised any questions or objections concerning any of the rights held by Licensor in the Licensed Program Licensee further acknowledges and agrees that except for the nonexclusive license granted hereunder Licensee shall acquire no right title or interest in the Licensed Program Acceptance by Licensee of any Licensed Program or User documentation from Licensor shall by deemed conclusive evidence of Licensee s agreement that the license for those Licensed Programs and User documentation is governed by this agreement BioZ Dx Operator Service Manual 93 CardioDynamics International Corporation TERMS AND TERMINATION A This software license agreement and the license hereby granted to Licensee shall remain in full force and effect for a period of fifteen 15 years unless terminated earlier in accordance with this clause B Licensor may terminate this software license agreement effective immediately or as of the date specified by giving written notice of termination upon 1 any breach by Licensee of
64. ilable beats Once enough beats have been collected data averaging will be based on the newest beats based on the selected Data Average period Re Monitoring a Patient If the patient has been monitored previously and their record was Archived then the User may recall the previously stored Patient ID information via the Auto Patient ID The user simply types the desired patient s ID into the Patient ID field when the user moves the cursor out of the Pt ID field the BioZ Dx will search its internal database for a patient with the same Pt ID If a patient is found the BioZ Dx will automatically populate the Last Name First Name Add Name Date of Birth Height Physician and Operator fields with the data found in the most recent database record and the Weight field will be put into focus If the Pt ID field is blank or no match can be found the fields will not be populated Additionally the user may recall the previously stored Patient ID information via the Retrieve Records tab a Data Average Data Update Signal Status 05 09 2007 ERANA 60 Beats w w i 9 14 53 AM Patient ID P Retrieve Records R orders o Highlight patient record and press ENTER to retrieve patient information Sort By Last Name v Find Jack Add I Name Patient D Date Of Birth Jackson Patrick J 413 05 15 1949 Eoff Jackson Patrick J 414 05 15 1949 Eoff Jackson Patrick J 415 05 15 1949 Eoff Jac
65. imated by the DuBois and DuBois formula to be BSA W x H x 0 007184 where H is the patient s height in cm and W is their weight in kg BSA See BODY SURFACE AREA CARDIAC INDEX CI 1 min m The value of CARDIAC OUTPUT CO indexed by the BODY SURFACE AREA BSA The normal range for supine resting adults is 2 5 4 2 1 min m CI CO BSA CARDIAC OUTPUT CO l min The total volume of blood pumped by the heart in one minute CO SV HR CENTRAL VENOUS PRESSURE CVP mmHg The pressure at the output of the systemic vasculature filling pressure of the right heart Normal mean value is 6 mmHg CI See CARDIAC INDEX CO See CARDIAC OUTPUT CONTRACTILITY The rate of shortening of the myocardial muscle fibers in time Contractility is a systolic phenomenon CVP See CENTRAL VENOUS PRESSURE DIASTOLIC BLOOD PRESSURE DBP mmHg The minimum arterial pressure at the end of diastole DELTA Z IMPEDANCE WAVEFORM deltaZ The change in the thoracic base impedance due to the cardiac cycle dZ dt Ohms sec The first derivative of the deltaZ waveform with respect to time dZ dtmax corresponds to the peak blood velocity in the aorta during systole d Z dt Ohms sec The second derivative of the deltaZ waveform with respect to time WZ dt max corresponds to the peak blood acceleration in the aorta during systole BioZ Dx Operator Service Manual 97 CardioDynamics International Corporation
66. ion Contral Press the desired command to perform ower Pressure Test the selected function Refer to the Service Manual for NIBP Test Leak Rate Test Procedures Transducer Accuracy Test BP values are shown in units of mmHg Blood Pressure Test see bee ap a i ee Transducer Pressure A BP i a SA x ID 1234 a j Be gt p Q gt Last FIELDS Take BP Save Review Grice Archive Config Help ECG First DEBBY Figure 10 3 Blood Pressure Check Screen e Specifications for these Blood Pressure Tests vary depending on the model Cardiograph and PIM your facility has Contact CardioDynamics Technical Services 800 778 4825 opt 3 to obtain specifications for your specific model 82 BioZ Dx Operator Service Manual ICG BioZ Dx SUGGESTED MAINTENANCE SCHEDULE 10 3 Version Control Check It is recommended that the Version Control Check be performed after a software upgrade or if the operator is unable to resolve a PIM communication error No input is required by the operator simply pressing the Version Control V tab will initiate the check Data Average Data Update Signal Status 08 21 2007 NENNE 30 Beats x E Beats x o 12 19 50 PM ICG Check 1 BP Check B Version Control v ICG Application Version UI 4 0 b20 Subsystem Yersions Expected DSP Main Version 1 0 2c 0627 Expected DSP Main PM CRC 0x14B3 Reported DSP Main Version 1 0 2c 0627 Reported
67. ior to monitoring a patient it is recommended that the User become familiar with the BioZ Dx through the use of this Manual Please pay close attention to all of the Warnings and Cautions included in this Manual After review of this manual the User should feel competent to begin a live monitoring session on a patient 3 1 The BioZ Dx Impedance Cardiograph ICG Patient Cable Yoke On Standby button Display Printer Paper Report Storage Slot Storage Shelf A I a BS p ICG Patient Cable BioZ Dx Operator Service Manual Figure 3 1 and Cart O KF oS ICG Lead Wires Wheel Brake Control Keys Keyboard Trim Knob Printer Paper Drawer 11 sz a J a CardioDynamics International Corporation SS T630 f 250v Reset Button Pinhole PCMCIA Card Eject Button PCMCIA Card Slot AC Power Connector Equipotential Ground Post Serial Connector Not Supported Figure 3 2 Rear Panel lt Barcode Reader or Magnetic Card Reader Connector ECG Application Only ICG PIM Connector ICG Application SmartCard Reader ECG Application ECG PIM Connector ECG Application Battery Door Fuse Door BioZ Dx Operator Service Manual GETTING STARTED The BioZ Dx Control Keys The Cardiograph has seven Control Keys located on the left and to the right of the display respectively M 7 Patient ID D 6 Auto Print E B O ECG Rhythm Standby F c 2 S ee
68. kson Patrick J 416 05 15 1949 Eoff Jackson Patrick J 417 05 15 1949 Eoff Jackson Patrick J 418 05 15 1949 Eoff Jackson Patrick J 419 05 15 1949 Eoff Jackson Jim al 273 07 26 1949 Kilcullen Jackson Jim J 274 07 26 1949 Kilcullen Jackson Jim J 275 07 26 1949 _ Kilcullen Bis gt 2 Soa eS He Take BP Save Review Orders Archive Config Help EcG First Figure 5 3 Retrieve Records Screen 36 BioZ Dx Operator Service Manual PATIENT MONITORING e Press Alt amp R simultaneously to access the Retrieve Records Menu The cursor will be placed in the Sort By field e Press the Trim knob to display the Sort By Drop Down Menu Rotate Trim Knob or use the Up Down Arrow keys to highlight the desired Sort by method Press the Trim knob to Select desired Sort By method e Type in the Patient ID Last Name or Date of Birth of the person to test The Retrieve Records page shall dynamically search as characters are typed into the Find field when the selected Sort By is Last Name or Patient ID The applicable Archived patient record will be displayed If multiple records exist for the same Patient ID Name or DOB the records will be sorted by the date and time of the archived patient record Use the Up Down arrows to scroll through the list and to highlight the desired patient record e Press the Trim Knob to retrieve the Patient ID information The screen will revert to the Patient ID screen and all fields except weight and SBP DBP will be
69. lease confirm new password Signal Status 10 24 2006 A 12 43 56 PM Data Average ae ee 0 Beats wl Configuration Screen amp Report S Options O Facility F Confirm Password Select CHANGE PASSWORD button and press the Trim Knob to confirm change Screensaver timeout CHANGE PASSWORD OFF BR A Bowe o Take BP Saye Review Orders Archive Config Help EcG First DEBBY Figure 7 4 Password Screen BioZ Dx Operator Service Manual 55 CardioDynamics International Corporation 7 5 Network Configuration Screen The Network Configuration Screen provides the User with the ability to change TCP IP settings to either static or a fixed IP configuration Pressing Alt amp N simultaneously will access the Network screen The cursor will be displayed in the Network ID field by Rotating the Trim Knob the cursor will move to the desired field and the user can either select to Obtain an IP Address Automatically or Specify an IP Address To Specify an IP Address rotate the Trim Knob between fields for IP Address Subnet Mask and Default Gateway and use the keyboard to enter the applicable domain information Data Average Data Update Signal Status 10 24 2006 E 30 Beats v 5 Beats w 12 44 27 PM Configuration Screen amp Repart S Options O Faciity F Password P Network N Setting changes will take affect after the network card is re
70. left ventricle must expend to pump blood it is a product of the ventricular pressure contribution MAP PAOP CO and a constant unit conversion factor LCW is proportional to the myocardial oxygen consumption The normal range for supine resting adults is 5 4 10 0 kg m LCW MAP PAOP CO 0 0144 LEFT CARDIAC WORK INDEX LCW kg m m A value of LEFT CARDIAC WORK LCW indexed by the BODY SURFACE AREA BSA LCWI is a product of the ventricular pressure contribution MAP PAOP CI and a constant The normal range for supine resting adults 3 0 5 5 kg m m LCWI MAP PAOP CI 0 0144 LEFT STROKE WORK INDEX LSWI g m m The measure of work which the left ventricle must expend to pump blood per heart beat it is a product of the ventricular pressure contribution MAP PAOP SI and a constant The normal range for LSWI based on the ideal hemodynamic state where SI 50 ml m MAP 92 mmHg PAOP 10 mmHg is 47 2 70 8 g m m LEFT VENTRICULAR EJECTION TIME LVET msec The time between the opening and closing of the aortic valve 98 BioZ Dx Operator Service Manual Appendix B GLOSSARY OF TERMS LSWI See LEFT STROKE WORK INDEX MEAN ARTERIAL PRESSURE MAP mmHg A measure of the average arterial perfusion pressure which determines blood flow to the tissues NORMODYNAMIC STATE When the CARDIAC INDEX CI is within its respective normal range normodynamic adequate glob
71. moved and re inserted Network ID Cardiograph Name Obtain IP Address Automatically Specify IP Address Network Information IP Address 192 168 0 152 Subnet Mask Default Gateway eg ID 1234 B gt Last FIELDS Config Help eca First DEBBY a Take BP Saye Review Orders Archive Figure 7 5 Network Screen 56 BioZ Dx Operator Service Manual SYSTEM CONFIGURATION CardioDynamics suggests that a network professional assists in the setup when selecting a specific IP configuration NOTE To use XML files in an EMR system the EMR developer MUST use the correct CDIC XML schema to extract data from the files Transfer of data from the BioZ Dx into the EMR system must be fully validated by the EMR developer 7 6 HIPAA Screen This screen is designed to assist customers in their compliance with the Health Insurance Portability and Accountability Act of 1996 HIPAA HIPAA included provisions designed to encourage electronic transactions and also required new safeguards to protect the security and confidentiality of health information Whenever the Cardiograph is left idle for a User defined period of time the HIPAA screen will be activated locking out access to patient information The User can easily return to the operating mode by entering the User defined password and pressing the Enter key BioZ Dx Operator Service Manual 57 CardioDynamics International Co
72. n Battery Power in ICG mode the BioZ Dx will go to Standby and then complete Shutdown after a User configurable time interval when no keys commands have been operated Standby and or Shutdown will not occur while printing or during an active monitoring session When the unit enters Standby mode power to the LCD screen is turned off but the cardiograph itself remains on Any key press will bring the system back from standby mode When returning from standby the screen shown will be the HIPAA screen if the HIPAA timeout was set and was exceeded If the HIPAA timeout was not set or was not exceeded then the screen shown will be the last screen before entering Standby Shutdown differs from Standby in that the Cardiograph will actually shut itself off The user must press the power button to turn the unit back on The system will go into Standby when the Standby idle time drop down list is set to a value between 5 and 30 minutes Options available in the drop down list are OFF 5 10 15 20 25 and 30 minutes The default for Standby is set to a timeout interval of 5 minutes and if the user selects OFF the system will not go into Standby mode The system will shut down when the Shutdown idle time drop down list is set to a value between 5 and 30 minutes Options available in the drop down list are OFF 5 10 15 20 25 and 30 minutes The default for Shutdown is set to a timeout interval of 10 minutes and if the user selects OFF the system will not go in
73. namic values are not calculated and or updated See Troubleshooting section for what to do when indicator is yellow 11 03 03 20 03 01 System Date and Time Displays current date and time Date and Time may be formatted through the Config function BioZ Dx Operator Service Manual Network Status Indicator Indicates when a network card is installed in the PCMCIA card slot in the back of the Cardiograph Network functions may be accessed through the Config function 19 CardioDynamics International Corporation Hemodynamic Values The Main Screen displays up to six User Defined parameters at any given time The User can define which parameters to display via the Config button on the Command Bar See Section 7 1 Screen amp Report Configuration Screen During a Patient monitoring session the User may also view the remaining Parameters via the Review button on the Command Bar The Hemodynamic Parameters are HR SV SI CO CI SVR SVRI BP TAC TACI QC HI Heart Rate Stroke Volume Stroke Index Cardiac Output Cardiac Index Systemic Vascular Resistance Systemic Vascular Resistance Index Systolic SBP Diastolic DBP and Mean Arterial MAP Blood Pressure Total Arterial Compliance Total Arterial Compliance Index Q C Interval Heather Index LCWI VI ACI STR STRI PEP LVET TFC TFCI SSRI LSWI Zo Left Cardiac Work Index Velocity Index Acceleration
74. nterval Shutdown Interval and Paper size Pressing Alt amp O simultaneously will access the Options screen Rotate the Trim Knob to move the cursor to the desired field for fields containing radio buttons press down on the Trim Knob to make a selection The fields for CVP PAOP Standby Interval and Shutdown Interval contain a drop down menu of choices after accessing the field press down on the Trim Knob to display the drop down menu Rotate the Trim Knob or use the Up Down arrow keys make a selection within the drop down menu press down on the Trim Knob to accept the selection and close the drop down menu Press Enter to save and exit 52 Data Average Data Update S Beats vl Options O Faciity F Password P Network N Signal Status 05 09 2007 9 18 56 AM Domm YYYY Time Format 12 hr AM PM OFF 24 hr Every data update Height Units us Clock times Metric Idle Timeout Weight Units us Metric Shutdown OFF CYP 20 x mmHg PAOP fiz mmHg Automatically Save Reports At intervals of 1 to 60 Minutes Battery Power Saving Modes Standby 5 minutes x Paper Size 81 2x11 44 Take BP Saye Review Orders Archive Config Help Figure 7 2 Options Screen Last First BioZ Dx Operator Service Manual SYSTEM CONFIGURATION Battery Power Saving Modes When o
75. nts not approved by CDIC will void the warranty for that product CDIC s and or its Distributors liability and obligation and the End User s sole remedy shall be at CDIC s option to either repair or replace software and or System or any part thereof It is the responsibility of the End User to notify CDIC or CDIC s Distributor if CDIC requests the End User to notify its Distributor by telephone or in writing of any problem experienced by the End User within the Warranty Period and no later than thirty 30 days after the expiration of the warranty period This Warranty does NOT apply to fuses and or cardiograph paper used in conjunction with the System Warranty Coverage e Customer Technical Support is available Monday through Friday 7 a m to 4 p m Pacific Time at 800 778 4825 or 858 535 0202 option 3 e CDIC will provide a loaner or replacement unit equivalent or similar to purchased unit within two 2 business days U S Customers only after it has been determined that the purchased unit needs repair This determination needs to be made before 3 00 p m Pacific Time in order for the BioZ Dx Operator Service Manual CardioDynamics International Corporation two 2 day loaner replacement unit provision and is dependent upon delivery services available to End User s location e CDIC will repair or replace any components of the System that cause the System to not function in accordance with the Operators Servi
76. odule PIM isolates all connections to the patient from electrical ground and all other conductive circuits in the Cardiograph and or ICG PIM This reduces the possibility of hazardous currents passing from the Cardiograph and ICG PIM through the patient s heart to ground Observe the following to ensure patient and operator safety A i Symbol for CAUTION CONSULT ACCOMPANYING DOCUMENTS Symbol for DEFIBRILLATOR PROOF TYPE BF APPLIED PARTS e TYPE BF is generally for devices that have conductive contact with the patient or have applied parts that are fixed in medium or long term contact with the patient e g ICG electrodes e The use of equipment that applies high frequency voltages to the patient including electrosurgical equipment and some respiration transducers is not supported and may produce undesired results Disconnect the ECG Patient Interface Module PIM data cable from the cardiograph or detach the ECG leads from the patient prior to performing any procedure that uses high frequency surgical equipment e Do not perform ST analysis on the Real Time ECG screen display or on ECG Rhythm reports when the 0 5 Hz Baseline Wander filter is applied e If abnormal ECG data appears on the printed ECG report and the abnormal data does not have a physiological origin perform the printer diagnostic test to assess printer performance e When printing an ECG Rhythm report there may be a slight delay before the Rhythm re
77. one Number f e00 778 4825 Ordering Physician Add Operator v Add Label z BP E ID 1234 05 F D gt Gy Last FIELDS Take BP Save Review Orders Archive Config Help EcG First DEBBY Figure 7 3 Facility Screen 54 BioZ Dx Operator Service Manual SYSTEM CONFIGURATION 7 4 Password Configuration Screen The Password Configuration Screen provides the User with the ability to set a unique password as well as adjusting the Screensaver timeout Pressing Alt amp P simultaneously will access the Password screen The cursor will automatically be placed in the Please enter current password field and the user is prompted for the current password Rotate Trim Knob to move cursor to the Please enter new password field and type in the desired password Rotate Trim Knob to move cursor to the Please confirm new password field and type in the new password Rotate Trim Knob to move to the Change Password button and press down on the Trim Knob a pop up window will confirm your password has been changed press Enter to close the window Press Enter to save and exit Data Update 5Beats v Password P Network N Please enter current password If you do not remember your password please contact Technical Support for assistance Please enter new password Enter a new password from 4 to 32 characters long It is recommended to use a combination of numbers and letters P
78. onnectors NIBP module connector B ICG Patient cable connector D ICG PIM data cable connects to USB port on cardiograph C Figure 3 4 PIM Front and Rear CAUTION To ensure safety and prevent damage to the system connect the ICG PIM data cable ONLY to the USB port on the cardiograph BioZ Dx Operator Service Manual 15 CardioDynamics International Corporation 3 4 ICG Lead Wires Figure 3 5 ICG Lead Wires 3 5 ICG PIM with Accessories Figure 3 6 ICG PIM with accessories The patient cable yoke and lead wires included with your unit may be different than those pictured above Please consult the accompanying documentation or call CDIC Technical Support if you need further assistance BioZ Dx Operator Service Manual 16 GETTING STARTED 3 6 PCMCIA Card The PCMCIA Card is an optional accessory available with the BioZ Dx The PCMCIA Card contains a removable memory Card that can be used to transfer ICG Status Reports to and from the cardiograph A PCMCIA Card Adapter B Removable Memory Card A B Figure 3 7 PCMCIA Card Assembly To Insert or Remove a Card from the Cardiograph 1 Insert the PCMCIA Card into the Card slot rear of cardiograph and firmly push it in 2 Push the eject button to the left of the Card slot to eject the PCMCIA Card 3 Pull out the Card A Eject Button Figure 3 8 PCMCIA Card Eject Button BioZ Dx Operator Service Manual 17 C
79. ort for later retrieval Should the operator attempt to shut down the cardiograph or monitor the next patient without saving a status report a message will automatically be displayed giving them the option to continue or to go back and save the status report Maximum storage capacity is 15 000 ICG Reports The User should use the Archive function for instructions on deleting and transferring archived ICG Reports see section 5 6 Archived Patient Information Pressing Esc will return the User to the Main Screen Press Enter to print and save the status report Label Optional Figure 5 4 Save Dialog 38 BioZ Dx Operator Service Manual PATIENT MONITORING 5 5 Reviewing Patient Information Selecting the Review Command provides the User with the ability to review all of the data sets that were displayed saved and or printed during the last 20 minutes of the most _ recent ICG session The User may highlight a data set and then print and or save to Review Archive should they desire Press Ese to return to the ICG main screen The Review Command is active only after the Stop Control Key has been selected and the patient data will remain available only until the next time the Patient ID Screen is opened or power is turned off a Data Average Data Update Signal Status 08 21 2007 i ITT TL fso Beats x E Beats v m 12 18 10 PM Face eee Eas Re ae Se es ES Dea ae EES 145 95 112 145 95 112 12 17 30 PM L
80. p the paper bar Insert a new pack of printer paper with the printed side facing up Ensure that no more than 100 sheets are being inserted into the paper tray Figure 9 2 Inserting Paper 3 Ensure that the paper sensor hole A is positioned as shown Figure 9 3 Paper Sensor Hole BioZ Dx Operator Service Manual 71 CardioDynamics International Corporation 4 Lower the paper bar Drape the entire first sheet over the roller Ensure that the perforated edge of the paper aligns with the edge of the paper drawer Figure 9 4 Lower Paper Bar 5 Close the paper drawer 6 Press the Page button on the right side of the cardiograph 7 Tear off the page a Steady left to right motion Do not tear A TA ZA Figure 9 5 Tearing Off the Paper ry 72 BioZ Dx Operator Service Manual ICG BioZ Dx CARE AND MAINTENANCE 9 5 Battery Maintenance and Care The sealed lead acid battery used in the cardiograph will provide optimum life when the unit is continuously connected to AC power and fully charged after each use A depleted battery requires 16 hours of continuous charge time to fully charge Because it is not always possible to allow a full charge cycle between uses the Cardiograph was designed to charge a depleted battery to 90 of its capacity in approximately eight hours The battery must be installed for proper operation of the cardiograph The BioZ Dx cannot print an ICG Status report without
81. performed on the Cardiograph according to the international standard for EMC for medical devices IEC 60601 1 2 This IEC standard has been adopted in Europe as the European Norm EN 60601 1 2 The BioZ Dx should not be used adjacent to or stacked on top of other equipment If the Cardiograph must be used adjacent to or stacked on top of other equipment verify that the BioZ Dx operates in an acceptable manner in the configuration in which it will be used Fixed portable and mobile radio frequency communications equipment can affect the performance of medical equipment 90 BioZ Dx Operator Service Manual Z Care STANDARD WARRANTY 13 Z Care STANDARD WARRANTY CardioDynamics International Corporation CDIC warrants that the BioZ Dx System System and the System Software Software shall be free from errors defects in materials workmanship and programming that cause the System not to function in accordance with the accompanying written specifications provided with the System at the time of installation CDIC will provide this Warranty for a period of sixty 60 months from the original CDIC date of shipment This Warranty shall include all options and accessories purchased with the System except the external patient cable s power cords data cables PCMCIA memory cards removable battery the external inflatable blood pressure cuff s and hose s which shall be covered for ninety 90 days from the origin
82. port begins to print on the cardiograph Rhythm printing is not completed in real time e Pace pulse tick marks will not print on an ECG Auto report that uses simultaneous acquisition e Periodically inspect the ECG PIM data cable lead wires and AC power cord for any worn or cracked insulation to ensure that no inner conductive material is exposed Discard worn accessories and replace them only with CardioDynamics authorized accessories BioZ Dx Operator Service Manual 3 CardioDynamics International Corporation The ECG PIM data cable supplied with cardiograph is an integral part of the cardiograph safety features Use of any other patient data cable not authorized by CardioDynamics may compromise defibrillation protection degrade cardiograph performance and may result in distorted ECG data Ensure that the ECG electrodes or lead wires do not come in contact with any other conductive materials including earth grounded materials especially when connecting or disconnecting ECG electrodes to or from a patient Portable medical equipment such as X rays and MRI may produce electromagnetic interference that produces noise in the ECG signal Move the cardiograph away from these potential sources of electromagnetic interference When using additional peripheral equipment powered from an electrical source other than the cardiograph the combination is considered to be a medical system It is the responsibility of the operator to comply
83. r CardioDynamics B Ke Wd Dx Command Toolbar A B c D E F G H tS Fe tH at F rt re tr Et ai lt ID oo Take BP Save nate Orders Archive Config Help ECG Name Button Select this Button to A Start or stop a blood pressure measurement Save an ICG Status Report to the Archive Review the most recently monitored patient s hemodynamic data Enter ICG Orders using the keyboard Print an ICG Status report of a previously monitored patient Transfer ICG Status reports to and from the cardiograph Change the Configuration settings on the cardiograph Get help with using the cardiograph to take an ICG To perform a 12 Lead ECG Zrigini mio lola Turn Trim Knob to go back Turn Trim Knob to go forward Press ESC key to exit Figure 5 11 Help Screen 46 BioZ Dx Operator Service Manual PATIENT MONITORING Help screen for Basic Navigation CardioDynamics B lO FA Dx Basic Navigation eN 1 Turn the Trim Knob to scroll through buttons 2 Press the Trim Knob to select a button 3 Press the Enter key to accept changes and exit any screen Tab 4 Press the Esc key to exit any screen without saving changes m To select a Dialog Screen Tab Screen amp Report S Parameters Screen Report HR B K BP SBP DBP MAP V L Turn Trim Knob to go back Turn Trim Knob to go forward Press ESC key to exit 1 Press and hold the Alt key 2 Press the l
84. re When Manual Entry is the source for entering the systolic blood pressure SBP and diastolic blood pressure DBP the Cardiograph will estimate the mean arterial pressure MAP using the following equation MAP DBP SBP DBP 3 Note SBP and DBP may be obtained by any method available to the clinician For example the auscultatory method via a sphygmomanometer may be used to obtain the SBP and DBP and then manually entered into the respective fields on the Patient ID screen BioZ Dx Operator Service Manual 33 CardioDynamics International Corporation 5 3 Begin the Patient Monitoring Session After the Lead Wires Sensors and Blood Pressure Cuff have been properly connected to the patient there is required demographic information that must be entered into the ICG BioZ Dx in order to begin the ICG test There are two methods for entering this data Enter new patient data or retrieve previously archived patient data New Patient Data When performing an ICG test the first time To begin Press the Patient ID Control Key The Patient ID Screen will be displayed Data Average Data Update Signal Status 10 24 2006 ae es 12 32 55 PM Patient ID P Retrieve Records R Orders Patient ID Pae Last Name Feos oo First Name BEBB Add I Name Date Of Birth Month o7 Day fog Year fic67 YYYY Height P e in Weight fis Gender BP Method Male
85. rmation for Taking an ICG Q Test Button Identification Command Toolbar Basic Navigation and useful Tips Help Once in the help screen use the Trim Knob to scroll between screens Use the ESC key to exit from the help menu CardioDynamics To Take an ICG Test 1 Prepare patient and attach sensors and lead wires 2 Place NIBP Cuff if using automatic BP method patient should be supine 3 Press Patient 10 button to enter required Patient ID information 4 Press qj Enter to begin monitoring 5 Press 4xto Print button once values appear and signal status is green 6 Press after report has finished printing Turn Trim Knob to go forward Press ESC key to exit Figure 5 9 Help Screen 44 BioZ Dx Operator Service Manual PATIENT MONITORING Help screen for Button Identification BIOA CardioDynamics s Button Press Button to A 1 Turn the cardiograph on off or place in Standby B Patient ID Enter Patient ID information C Auto Print Print ICG Status Report D ECG Rhythm Not used for ICG E Copy Print a copy of the last ICG Status Report F Page Advance the printer paper to the top of the next page G Stop Stop the ICG test Turn Trim Knob to go back Turn Trim Knob i to go forward Press ESC key to exit Figure 5 10 Help Screen BioZ Dx Operator Service Manual 45 CardioDynamics International Corporation Help screen for the Command Toolba
86. rporation CardioDynamics THE I1CG COMPANY BioZ p aes ICG DIAGNOSTICS Figure 7 6 HIPAA Screen 58 BioZ Dx Operator Service Manual TROUBLESHOOTING 8 TROUBLESHOOTING The ICG Cardiograph is designed for reliable operation If you experience any problems with the cardiograph ICG PIM or performing an ICG there are several things that you should verify prior to calling for service If you have any problems that you are unable to solve please contact CardioDynamic s Technical Service Department at 800 778 4825 option 3 or outside of the USA at 858 535 0202 option 3 or by e mail at tech service cdic com Emergency After Hours Technical Support is available 7 days a week between the hours of 6 a m and 9 p m Pacific Time by cell phone at 866 880 6674 8 1 Blood Pressure Errors Problem s Possible Causes Potential Solutions Weak or No Cuff is in wrong position Reapply Cuff and retake BP ensuring that Oscillometric Signal Cuff is loose on patient s arm The arrow on the cuff is located over the patient s artery just above the elbow joint Artifact Erratic Excessive clothing between cuff Oscillometric and patient s arm The cuff is wrapped snugly Signal j Cuff is the wrong size There isn t excess clothing between the cuff and Exceeded Retry arm Count Patient is not motionless and relaxing their arm The size is correct for the patient s arm Exceeded circumference Measurement Patient ha
87. s displayed Help When button is pressed the cardiograph exits from the ICG monitoring mode and enters the ECG ID monitoring mode For additional information on the ECG application refers to section 4 OPTIONAL ECG FEATURE Name NOTE The cardiograph cannot perform both ICG and ECG monitoring simultaneously See Philips Getting Started Guide M4992 91120 and ECG Learning Kit M4992 91905 for ECG application instructions ID Displays the current patient ID Last and First name Last First 22 BioZ Dx Operator Service Manual GETTING STARTED Navigation Inactive toolbar buttons will all make the inactive beep when the user presses the Trim Knob Arrow Keys The arrow keys will act like the default Windows action of the Tab and Shift Tab key presses when navigating GUI items In other words the Down arrow and the Right arrow acts as the Tab key press does and the Up arrow and the Left arrow acts as the Shift Tab key press does Exceptions If a drop list is expanded the arrow keys will retain their default Windows actions Also if the cursor is in an edit field the Left and Right arrows will retain their default Windows actions as well Radio Buttons The Arrow keys the Trim Knob and Tab and Shift Tab key presses will cycle focus through all Radio button items instead of the normal Windows action for Tab and Shift Tab of cycling focus through only one Radio button in a group Arrowing trimming or tabbing through a Radio
88. s weak and or low Time Limit pulse The patient is motionless with their arm relaxed during the measurement cycle If error persists contact Technical Support Pneumatic Hose Cuff and or Fittings are Clear Hose Cuff or Fittings of any blockage Blockage blocked Replace Hose and or Cuff Hose or Cuff is crimped and or folded If error persists contact Technical Support Cuff Hose Cuff and or Fittings are Clear Hose Cuff or Fittings of any blockage Overpressure blocked Hose or Cuff is crimped and or folded BioZ Dx Operator Service Manual Replace Hose and or Cuff If error persists contact Technical Support 59 Problem Inflate Timeout CardioDynamics International Corporation Possible Causes Hose Cuff and or Fittings have Potential Solutions Replace Hose Cuff and or fittings Air leak or a leak Loose Cuff If error persists contact Technical Support Cuff is loose Hose Cuff or fittings are not connected properly BP reading Wait ICG PIM Does not have enough Wait at least four minutes for sufficient power to message stored power to initiate Cuff be restored inflation If error persists contact Technical Support Following msg is displayed No BP values Are you sure you want to continue Communicates to the user they have attempted to print or save without valid BP parameters Correct the missing or invalid BP parameters and retry BP Cuff Communications Failur
89. sseeossoseessssseessese 16 Figure 3 7 PCMCIA Gard Assembly oorr eE K E AR E O RE 17 Figure 3 8 PCMCIA Card Eject Button eesssseesesseseesssseesssseesssseresssereesssseossssecssssteeessseeeesseoeesssseessssees 17 Figure 3 9 Monitoring Screen sseesseseessssesesssesesssereesssseessssresssseresssereessoreesssseessssrressseeeessereesssseessssrt 18 Figure 4 1 ICG ECG Launch Screen sitvascrcsteas ssactsain do iaiceadenadites a sdutederade tbl vaabs sei deceihsdedenaiaet nadie 25 Figure AD VO TC TCO ati Gia esl vse naka ease E AA E la she E kara E A e andes 26 Figure 3 ICG Launch Screen sn re a E E E ni Gu aK aint ed 27 Figure 5 1 ICG Sensor Placement DiGi obssdicuaccse tice bactdavecadssuscscs tocsbaak ben dice cbadbsadessescsesicelastidunsdsedias 31 Figure 5 2 Patient ID Screen cis 5 alts coh AS teed hse AI iad ae a ih Nalin ed ts Atle 34 Figure 5 3 Retrieve Records Screen ss ccos aang cessacicr ulna dee auisalinieaeints na eaten i ek 36 Figure 5 4 SAVE Diglo gsi galan eien a E E E R castes Wola ica acaba aL Caden ee bee Ae aude 38 Fig re 5 35 Review Sereen sais ea cata ob aS oe aia ade nie Sa a calla a aai 39 Figure DAO Archive Sereen sagas cet acd saben escicadssc ceded gore sa ueds cu aidenle Sunuagson dyes stats E ad peesea E e etaatiee 40 Figure Dod Orders ENUY eanes e eet ae e dls sulbsteidad acniaasiutiauscensbisd a a aaae iiaiai 42 Figure 5 8 Orders ENY nrima a E I tea aaa ine ee 43 Fic re 3 9 HelpScreen cet sacs teint Dict a a a aa E a
90. t derivative of the inverted Delta Z waveform BioZ Dx Operator Service Manual 21 CardioDynamics International Corporation Command Bar Button Description a When button is pressed the NIBP module inflates the cuff and takes a blood pressure measurement De IBP selecting the button interrupts the blood pressure measurement and deflates the cuff Take BP When button is pressed the current displayed patient data is saved in Archive as an ICG report A Dialog box is displayed providing the User with the option of appending a label to the dataset i Save Review Orders When button is pressed all of the datasets from the last twenty minutes of the current monitoring session are displayed The User may then select any of the datasets to print and or save to Archive NOTE Any datasets not Saved or Printed during the session will be lost once the Patient ID button is pressed or the power is turned off When button is pressed displays any orders that have been entered into the system User may Add Edit or Delete any order When button is pressed all of the Config Screen is displayed The User may then print delete send to 4 a PCMCIA Card or load patient records into the memory of the cardiograph Archive 3 When button is pressed the Config Screen is displayed Sa ee Config When button is pressed a Screen listing the basic steps required to perform an ICG test i
91. tent TFC base impedance and the parameters of left ventricular performance VI and ACI Velocity Index Acceleration Index THORACIC FLUID CONTENT TFC kOhm The total conductivity of the thorax representing parallel conductivity contributions of three compartments intravascular intra alveolar and interstitial The normal ranges are 30 50 for males and 21 37 for females Excessive TFC value indicates an excess in thoracic fluids however it does not specify if the fluids are in the intravascular intra alveolar or interstitial compartment s TFC 1000 Zo THORACIC FLUID CONTENT INDEX TFCD kOhm m TFCI 1000 TFI BSA THORACIC FLUID INDEX TF Ohm See BASE IMPEDANCE TOTAL ARTERIAL COMPLIANCE TAC mL mmHg TAC 10 SV SBP DBP TOTAL ARTERIAL COMPLIANCE INDEX TACI mL m mmHg TACI 10 SI SBP DBP VASOACTIVITY Vasoactivity is a change in vessel diameter controlling vascular resistance of the vessel s blood flow rate 100 BioZ Dx Operator Service Manual Appendix B GLOSSARY OF TERMS VELOCITY INDEX VI 1000 sec Is a measurement of normalized peak aortic flow VI is a preload volume dependent measure of contractility The normal range for supine resting adults is 33 65 x 1000 sec VI 1000 dZ dt Zo VI See VELOCITY INDEX WEDGE PRESSURE A term that is often used simultaneously although incorrectly for Pulmonary Artery Occluded Pressure PAOP
92. the patient contact materials have been fully evaluated to the guidelines of ISO 10993 1 Biological Evaluation of Medical Devices for biocompatibility skin irritation may occur at the sites of sensor placement If local skin irritation occurs beneath or around any of the sensor sites discontinue product use and remove the sensors Persistent use of the device in the presence of skin irritation may be harmful For safe and proper operation this device is to be connected to a grounded receptacle via a grounded power cord three wire power cords with grounded plugs Never adapt a grounded plug to fit an ungrounded outlet If an ungrounded plug adapter is required use the Equipotential Bonding Receptacle per DIN 42801 to connect the BioZ Dx to the institution s equipotential system The patient data cables and sensors specified and included with the BioZ Dx are designed specifically for protection against the effects of cardiac defibrillators and radio surgery equipment Do not use any other type of patient cable or sensors with this device Disposal of this product and or any of its accessories shall be in accordance with any and all local regulations Do not allow fluid of any kind to penetrate the device enclosure or come into direct contact with any cables and or power cord connectors Contact with fluid may result in either incorrect parameter values or damage to the device or may result in injury to operator or patient Always store pa
93. tically move the corrupt database to a storage location and create a new database The creation of the new database will allow the operator to continue using the cardiograph however the new database will not contain any previous patient data BioZ Dx Operator Service Manual 65 Problem s Cannot access database Your load database might be damaged Cannot access database Your send database CardioDynamics International Corporation Possible Causes These messages may occur when an attempt to load or send the database fails Potential Solutions Shut down the cardiograph restart the system and retry the procedure The external compact flash card may be faulty The PCMCIA adapter may be faulty If the problem persists contact CardioDynamics Technical Services 800 778 4825 opt 3 for might be additional assistance damaged 66 BioZ Dx Operator Service Manual TROUBLESHOOTING 8 5 System Reset In the event the cardiograph does not respond to key presses and the display remains frozen for an extended period of time follow the steps below to initiate a system reset e Gently press and release the system reset button using an ordinary paper clip or other slender object refer to Figure 8 1 gt Gem 2 OE a eS D Figure 8 1 System Reset button 8 6 Software Installation Instructions The process for installing software may vary
94. tient cables and or power cords properly to avoid potential injury due to tripping Do not place additional equipment on BioZ Dx cart as it may increase the risk for tipping and potential injury if BioZ Dx strikes the user or patient The BioZ Dx device applies low level AC current to the thorax of a patient during a monitoring session Implanted devices with electrical sensors such as Minute Ventilation based pacemakers may detect the BioZ s current and exhibit erratic sensor operation It is recommended that electrical sensors of implanted devices be disabled prior to starting a BioZ monitoring session Keep the patient data cables away from power cords and any other electrical equipment Warranty is made on original product purchase only and is not transferable CDIC products are designed tested and warranted as complete systems consisting of integrated hardware and consumables As a result CDIC cannot guarantee or warrant the accuracy or results of tests done with CDIC hardware products when third party consumables such as sensors are used to perform tests with such products Any attempt to modify any CDIC product from its original condition as delivered to Buyer or any use or integration with or into a CDIC product of parts or components not approved by CDIC will void the warranty for that product BioZ Dx Operator Service Manual WARNINGS AND PRECAUTIONS 2 2 Precautions As with electronic equipment Radio Frequency RF int
95. to Shutdown mode unless the battery power drops to a critical level BioZ Dx Operator Service Manual 53 CardioDynamics International Corporation 7 3 Facility Configuration Screen The Facility Configuration Screen provides the User with the ability to enter the ICG Report Header Facility information to include Name Address Ordering Physician Operator and Predefined Report Labels Pressing Alt amp F simultaneously will access the Facility screen Rotate Trim Knob to move cursor to the desired field and enter the information via the keyboard Press Tab or the Trim Knob to move to the next field To enter a list of Ordering Physician s Operator s and Label Field s rotate the Trim Knob to select the Add button and press the Trim Knob to accept The steps are identical to remove an entry via the Remove button Press Enter to save and exit h Data Average Data Update Signal Status 10 24 2006 ne METEM 30 Beats w 5Beats v i 12 43 27 PM Configuration Screen amp Repart S Options o Facility F Password P Network N Institution Name CardioDynamicss ss S Facility Name Home ofie S Dept Name Technical Services S O at dsplayed Cardiograph Location First Floor on status report Street Address 1 6175 Nancy Ridge D tt i S S S S S Street Address 2 ET City an Dego a State or Province CA Postal Code fez 121 Country USA Ph
96. use of the battery power saving modes refer to section 7 2 Battery Charging When the AC power cord is plugged in the battery begins to charge Check the charging status on the System Status Bar When the unit is in operating mode the charge current is 530mA When the unit is in sleep mode the charge current depends on the battery The initial charge current is approximately 580mA in bulk charger status When the voltage is up to approximately 14 6V the current is slowly reduced to approximately 100mA over time as it enters floating charging 68 BioZ Dx Operator Service Manual 9 9 1 ICG BioZ Dx CARE AND MAINTENANCE ICG BioZ Dx CARE AND MAINTENANCE Cleaning External Surfaces Note Infection could occur from cross contamination of blood products Use caution when disinfecting equipment that may come into contact with blood products Approved Cleaning Solutions Mild soap and water Lysol Disinfectant Lysol Deodorizing Cleaner may discolor the cable and or lead wires Dial liquid antibacterial soap Do Not Do Use Isopropyl Alcohol Acetone Iodine Phenol Chlorine or Ammonia based cleaners Autoclave use ultrasonic cleaners or ethylene oxide sterilization Immerse in any cleaning agents and or apply cleaning agents directly to surfaces Use abrasive cleaners or cloths Wet the connectors Unplug the AC power cord Avoid the lead wire connectors and patient data cable connectors Wipe all e
97. vices configured to run the optional Philips PageWriter Trim III ECG application the following Launch Screen will appear at system boot up Figure 4 1 Select application enter password and press Enter to begin ICG O ECG SRR RRR UI 2 0x2 Copyright 2005 CardioDynamics All Rights Reserved Telephone 800 778 4825 Figure 4 1 ICG ECG Launch Screen Select the desired application enter password and press the Enter key to continue BioZ Dx Operator Service Manual 25 CardioDynamics International Corporation This manual provides information for the ICG application only for information regarding the ECG application refer to the User documentation provided with the Philips PageWriter Trim III ECG system NOTE The cardiograph cannot perform both ICG and ECG monitoring simultaneously Cardiographs configured to run both ICG and ECG also contain an additional command enabling the User to exit to ICG when operating the ECG application Figure 4 2 ICG Launch Icon ICG Figure 4 2 ICG Launch Icon 26 BioZ Dx Operator Service Manual OPTIONAL ECG FEATURE For systems that are configured for ICG only the Launch Screen will only display the ICG application CardioDynamics TEE ICG COMPANY ICG DIAGNOSTICS Figure 4 3 ICG Launch Screen To start the BioZ Dx application enter the password and press the Enter Key BioZ Dx Operator Service Manual 27 PATIENT MONITORING 5 PATIENT MONITOR
98. w Orders Archive Config Help EcG First Figure 5 6 Archive Screen 40 BioZ Dx Operator Service Manual PATIENT MONITORING Total Number of Patient Sessions The total cumulative number of patient monitoring sessions is displayed in the lower left of the Archive Screen Additionally the number of sessions performed within the last 30 days is also provided immediately to the right of the total sessions listing Sorting to Retrieve Patient ICG Reports When the Archive Screen is displayed the cursor will be in the Sort By field Press down on the Trim Knob to display a list of sort methods Last Name Patient ID DOB Date and Physician The sort method can be selected by rotating the Trim Knob or using the Up Down Arrow keys Once the desired sort method has been selected press down on the Trim Knob to accept it Move the cursor to the Find field by rotating the Trim Knob and type in the appropriate information i e Last Name Patient ID DOB Date or Physician and move cursor to the table of reports The closest matching record of the ICG Report will be highlighted The archive dialog will dynamically search as characters are typed into the Find field when the selected Sort method is Last Name Patient ID or Physician Selecting Multiple Records Multiple records may be highlighted by holding down the Ctrl button move to the next desired record using the Up Down arrow keys while still pressing the Ctrl button press the Spacebar
99. with IEC 60601 1 1 and test the medical system according to the requirements Do not use non medical peripherals within 1 83 meters or 6 feet of a patient unless the non medical peripherals receive power from the cardiograph or from an isolation transformer that meets medical safety standards Only install CardioDynamics authorized software on the cardiograph The installation or use of software not authorized by CardioDynamics is strictly prohibited and cardiograph safety and performance are not guaranteed Only use CardioDynamics authorized replacement parts and supplies with the cardiograph The use of non approved replacement parts and supplies with the cardiograph is strictly prohibited Cardiograph safety and performance are not guaranteed when non approved replacement parts and supplies are used with the cardiograph Manual measurements of the 12 Lead ECG intervals and magnitudes should be performed on printed ECG reports only Do not make manual measurements of ECG intervals and magnitudes on the R T ECG display since these ECG representations are scaled There are no cardiograph parts that can be sterilized The cardiograph is not intended for direct or invasive cardiac monitoring purposes The physician should not base patient clinical assessments solely on the output of the BioZ Dx device Excessive repetitive use of the cardiograph keyboard and the cardiograph Trim Knob may result in a risk of developing carpal tunnel syndrome
100. xternal surfaces with a soft nonabrasive cloth dampened with any of the approved cleaning agents Let all components dry completely before using Disconnect power cord prior to cleaning Turn power switch to off standby BioZ Dx Operator Service Manual 69 CardioDynamics International Corporation 9 2 Cleaning the Print Head To Clean the Print Head e Open the paper door on front of cardiograph e Wipe print head A lightly with a foam swab dipped in 90 alcohol e Allow the print head to dry completely A Figure 9 1 Cleaning the Print Head 9 3 Cleaning the Paper Sensor Lens To clean the Paper Sensor e Open the paper door on front of cardiograph The paper sensor lens is above and to the right of the print head e Wipe the paper sensor lens lightly with a DRY foam swab Do NOT use alcohol 70 BioZ Dx Operator Service Manual ICG BioZ Dx CARE AND MAINTENANCE 9 4 Replacing Printer Paper Replace the printer paper when a red stripe appears on the printed ECG report Always load less than 100 sheets of printer paper into the paper tray e Ensure that the entire first page of the new paper roll is fully draped over the roller before closing the printer door e Ensure that the paper size configured for the cardiograph is the same size paper being loaded into the paper drawer To Change the Printer Paper 1 Open the paper drawer on the front of the cardiograph and remove any remaining sheets 2 Lift u
101. y Typically 30 ICG report capacity Battery Charge time 480 minutes eight hours to full capacity Power Requirements 100 240 VAC 50 60 Hz 65 VA max Meets the following requirements for safety and performance IEC 60601 1 Class I Type BF IEC 60601 1 2 CISPR 11 Group 1 Class A IEC 60601 2 25 UL 2601 CAN CSA C22 2 No 601 1 JIST 1202 AAMI EC11 BioZ Dx Operator Service Manual CardioDynamics International Corporation Physical Specifications Technical Information ICG PIM Physical Dimensions 7 638 x 4 528 x 2 677 in 19 4 x 11 5 x 6 8 cm Weight 1 8 lbs 0 82Kg Measurement Current 2 5mA rms 10 70 kHz 10 Meets the applicable sections of the following requirements for safety and performance IEC 60601 1 Defibrillation proof Type BF applied parts IEC 60601 1 2 CISPR 11 Group I Class A TEC 60601 2 25 UL 2601 CAN CSA C22 2 No 601 1 ICG Patient Cable Patient Cable Length 8 ft 2 44 m and Lead Wires T ead Wire s Length 27 48 in 69 122 cm Integrated Patient Cable Defibrillation Protection Meets the applicable sections of AAMI EC 53 The cart has been tested for stability using the IEC 60601 1 test protocol Dimensions 16 37 inches width x 23 6 inches depth x 36 6 inches height 416 x 600 x 930 mm Cart Weight 46 29 pounds 21 Kilograms 88 BioZ Dx Operator Service Manual NOMINAL SPECIFICATIONS Physical Specifications Technical Information Noninv
102. y charged BioZ Dx Operator Service Manual 75 CardioDynamics International Corporation 9 7 Replacing the Batteries How often the batteries need to be replaced depends on how well the battery is maintained and how much it is used If the batteries are fully charged but lose significant power after only a few ICGs consider replacement Only use batteries supplied by CardioDynamics sd Mee as SRA ALT Be EE SSE Figure 9 6 Replacing the Battery Packs To Replace the Battery Packs e Disconnect the Cardiograph from AC power and turn the power switch to the OFF position e Lift the battery access panel e Pull on the batteries to remove e Insert the new batteries and replace the battery door e Connect the BioZ Dx to an AC power source and turn the power switch to ON Verify that the green AC indicator is on e Set the correct date and time on the cardiograph e Charge for at least 24 hours prior to mobile use of the cardiograph WARNING Properly dispose of or recycle depleted batteries according to local regulations Do not disassemble puncture or incinerate the disposed batteries 76 BioZ Dx Operator Service Manual ICG BioZ Dx CARE AND MAINTENANCE 9 8 Removing and Replacing the AC Fuse The AC fuse needs to be replaced when the Cardiograph is plugged into AC power but the green AC power indicator light on the front of the BioZ Dx does not illuminate Only use replacement AC fuses with a

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