DanMedical D-MAS HyperSat 2540, Instructions For Use Manual

Page 1: ...DM DOC 040 Rev 1 0 DanMedical Analysis System D MAS HyperSat 2540 Instructions for use 2013 DanMedical Ltd 1...

Page 2: ...y DanMedical D MAS System DanMedical Ltd assumes no responsibility for use of D MAS not in accordance with this manual Before using a D MAS please read this guide and become familiar with the contents...

Page 3: ...Monitor mode 41 3 Set up 42 Basic operation 43 Software overview 45 Using the D MAS System 45 Pulse CO OXIMETER 47 Alarms 54 Sensors cleaning reuse 64 Resting ECG 71 Blood pressure 74 Spirometry 77 Mo...

Page 4: ...ening evaluation of a patient to Display non invasive measurements of functional oxygen saturation of arterial hemoglobin SpO2 pulse rate carboxyhemoglobin saturation methemoglobin saturation and tota...

Page 5: ...vasive Blood Pressure measurements when using the appropriate blood pressure cuff D MAS is intended to provide an interpretation of a resting ECG in all situations D MAS is not intended for use in con...

Page 6: ...nify that the device meets all essential requirements of the European Medical Device Directive 93 42 EEC General warning sign Defib protection is within patient cable Type CF Defibrillator proof Addre...

Page 7: ...y described in this manual Refer servicing to DanMedical for repair of this equipment WARNING The D MAS Pulse CO Oximeter function should not be used as a replacement or substitute for ECG based arryt...

Page 8: ...RNING Do not use the D MAS on patients who are also connected to a heart or lung machine WARNING Do not use the D MAS on patients who appear to be experiencing convulsions or tremors WARNING Protectio...

Page 9: ...perfusion at the monitored site the readings may read lower than core arterial oxygen saturation CAUTION Misapplied sensors or sensors that become partially dislodged may cause either over or under re...

Page 10: ...imits for medical devices to the EN 60601 1 2 2002 Medical Device Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful interference in a typical medical insta...

Page 11: ...damage the electrical components potentially leading to harm CAUTION Inaccurate measurements may be caused by incorrect application or use CAUTION All D MAS sensor and accessories listed are to be ava...

Page 12: ...nments D MAS has been designed to be used within the patient environment as detailed in EN 60601 1 1 2001 Medical Electrical Equipment General requirements for safety D MAS will accurately measure and...

Page 13: ...Battery Blade following the instruction labels and slide into the housing tray D MAS HyperSat with twin Battery Blades Ensure the battery locking button locates into tray when inserting the battery A...

Page 14: ...3 hours as the batteries becomes depleted the number of green segments on the capacity gauge will slowly reduce until the indicator will illuminate Red an audible beep will occur every 10 seconds to p...

Page 15: ...without batteries connected the charger LED will initially illuminate Green and then Red for about 5 seconds reverting to Green LED illumination Connect the Battery Blade to the charger the Charger L...

Page 16: ...ion Index PI with trending capability indicates arterial pulse signal strength and may be used as a diagnostic tool during low perfusion Pleth Variability Index PVI captures vital thoracic pressure ch...

Page 17: ...acing a sensor on a patient usually on the fingertip for adults and the hand or foot for infants The sensor connects either directly to the Pulse CO Oximetry instrument or through an instrument patien...

Page 18: ...todiode photodetector Signal data is obtained by passing various visible and infrared lights LED s 500 to 1000nm through a capillary bed for example a fingertip a hand a foot and measuring changes in...

Page 19: ...are usually taken over a period of 20 seconds the time it takes to draw the blood a meaningful comparison can only be achieved if the oxygen saturation carboxyhemoglobin and methemoglobin concentrati...

Page 20: ...blood concentration and perfusion Inaccurate measurements may be caused by Significant levels of methemoglobin Intravascular dyes such as indocyanine green or methylene blue Abnormal hemoglobin level...

Page 21: ...od flow at the monitoring site occurred e g an inflated blood pressure cuff a squeezing motion sampling of an arterial blood specimen from the hand containing the pulse oximetry sensor severe hypotens...

Page 22: ...l condition or enable it to work during periods of low perfusion and or motion They are as follows Normal Sensitivity This is the recommended mode for patients that are experiencing some compromise in...

Page 23: ...te the insides are negatively charged compared to the outsides Membrane pumps act to maintain this electrical polarity negative charge of the cardiac cells Contraction of the heart muscle is triggered...

Page 24: ...ts Areas are measured in units of millivolts x milliseconds mV x ms Units of measure are not specified when an area measurement appears in the criteria Isoelectric components between the overall QRS o...

Page 25: ...n abnormalities such as bundle branch block Type C An ECG abnormality that is essentially descriptive e g axis deviation moderate ST elevation etc Definitions TRUE POSITIVE TP A correct report of an a...

Page 26: ...72 98 88 96 170 1220 IMI 71 99 93 92 273 1220 MIX 63 98 69 98 73 1220 Total Accuracy 73 7 Partially correct 75 7 both on 1220 cases 1 The CSE database does not allow a meaningful interpretation of st...

Page 27: ...A STATEMENTS PROG TRUTH NORM LVH RVH BVH AMI IMI MIX VH MI OTHER TOTAL PREV NORM 97 1 1 0 0 0 0 0 1 6 0 3 0 0 0 0 0 0 100 382 1220 LVH 29 5 56 8 0 5 2 2 3 6 6 0 0 8 0 0 0 5 100 183 1220 RVH 40 0 7 3 4...

Page 28: ...92 9 2 2 0 7 0 5 1 0 1 2 0 1 1 4 100 0 503 1220 LVH 18 0 72 0 2 8 0 3 4 8 0 7 1 4 100 0 145 1220 RVH 28 3 66 7 1 7 3 3 100 0 30 1220 BVH 3 4 10 3 5 2 70 7 3 4 6 9 100 0 29 1220 AMI 9 4 2 5 1 3 80 2 6...

Page 29: ...le for assessment of type B statements in adults TYPE B STATEMENTS CONDUCTION DEFECTS CONDUCTION DEFECT SENS SPEC PPV NPV PREVALENCE RBBB 96 99 9 96 99 9 24 958 LBBB 100 100 100 100 16 958 RBBB with L...

Page 30: ...99 72 45 2570 Atrial flutter 92 31 100 00 100 00 99 88 39 2570 Possible atrial flutter 100 00 99 96 97 37 100 00 37 2570 Possible ectopic atrial rhythm 96 15 99 92 92 59 99 96 26 2570 Possible ectopic...

Page 31: ...9 96 95 00 100 00 19 2570 with slow ventricular response 100 00 99 96 92 86 100 00 13 2570 with 2 1 A V block 80 00 100 00 100 00 99 92 10 2570 with frequent multifocal PVCs 100 00 100 00 100 00 100 0...

Page 32: ...statements in adults derived from the Glasgow 1000 ECG database less the 73 childrens ECGs ECG FINDINGS SENS SPEC PPV NPV PREV LAD 100 100 100 100 65 927 Leftward axis 100 100 100 100 59 927 RAD 100...

Page 33: ...4 4 71 664 LVH 44 4 95 8 28 9 97 4 27 664 BVH 100 99 1 73 9 100 17 840 Possible right atrial abnormality 100 99 6 96 7 100 89 840 Possible left atrial abnormality 100 99 5 73 3 100 11 840 Possible bia...

Page 34: ...92 5 99 8 94 9 99 6 40 840 LBBB 100 100 100 100 1 840 IVCD 100 99 5 73 3 100 11 840 WPW pattern 50 100 50 99 8 4 840 Incomplete RBBB 100 100 100 100 6 840 rSr V1 probable normal variant 100 100 100 10...

Page 35: ...deviation 100 100 100 100 43 840 Severe right axis deviation 100 100 100 100 8 840 QRS axis leftward for age 100 99 7 97 8 100 46 840 Left axis deviation 100 100 100 100 25 840 Indeterminate axis 100...

Page 36: ...inimum pressure in the arteries which occurs near the beginning of the cardiac cycle when the ventricles are filled with blood An example of normal measured values for a resting healthy adult human is...

Page 37: ...oscillate Oscillometric monitors may produce inaccurate readings in patients with heart and circulation problems which include arterial sclerosis arrhythmia preeclampsia pulsus alternans and pulsus pa...

Page 38: ...w volume loop which graphically depicts the rate of airflow on the Y axis and the total volume inspired or expired on the X axis Generally the patient is asked to take the deepest breath they can and...

Page 39: ...he predicted values for the patients of similar characteristics height age sex and sometimes race and weight Generally speaking results nearest to 100 predicted are the most normal and results over 80...

Page 40: ...or maximal mid expiratory flow and is the peak of expiratory flow as taken from the flow volume curve and measured in litres per second It should theoretically be identical to peak expiratory flow PEF...

Page 41: ...Monitor mode is selected D MAS will present the user with a monitoring screen which continuously displays measurements of patient vital signs parameters D MAS will activate alarms if any of the measur...

Page 42: ...fully charged Shut down procedure Click start shut down Alternatively use the power on off control Initial installation Place D MAS on a stable hard flat surface near the patient Always place D MAS on...

Page 43: ...detector are properly aligned Remove any substances that may interfere with the transmission of light between the sensor s light source and photodetector 4 Refer to the Directions for Use of the senso...

Page 44: ...i e electrosurgical unit Verify the sensor is on correctly and that the measured data is appropriate After monitoring is complete remove the sensor from the patient and store or dispose of the sensor...

Page 45: ...aptured measurements Depending on specification the Dan file can be automatically encrypted The dan file can be opened by the D MAS system or on any other computer with D MAS encryption and decoding s...

Page 46: ...s ID Input the Patient ID Alphanumeric 16 Name Input the Patient Name Alphanumeric 32 Age Input the Patient Age Numeric 4 Gender Select Male or Female Selection Race Select ethnicity Selection Height...

Page 47: ...icator can be shown with or without a slash It flashes when an alarm condition is present When the alarm is silenced using the Alarm Silence Button an alarm status indicator with a slash and a timer i...

Page 48: ...ity and the timing of the pulse A tall vertical line indicates a high quality signal while a small vertical line indicates a low quality signal 10 TIME AND DATE INDICATOR The Time and Date Indicator d...

Page 49: ...ts that include SpMet and SpCO parameters the SpMet and SpCO parameters will be disabled in the display screen if a non Rainbow sensor is being used NOTE The Pulse CO Oximeter display view will be dif...

Page 50: ...lick the Settings menu to select the Normal APOD and Maximum Sensitivity modes Use the Normal Sensitivity setting for typical monitoring purposes Use the APOD setting where there is a high probability...

Page 51: ...e the On Off selections click to enable the required FastSat Mode SmartTone Mode Turn SmartTone On and Off by Clicking Settings and mouse over SmartTone Mode to make the On Off selection PVI Mode Turn...

Page 52: ...ck on Settings and mouse over SpHb Arterial Venous Mode to access the Arterial Venous mode selection SpHb Averaging Mode SpHb Averaging Mode may be selected as Long Default Medium or Short Click on Se...

Page 53: ...d Line Frequency by clicking Settings and mouse over Line Frequency Select 50 Hz or 60 Hz The user can change the default setting depending on location by selecting Change Default Select the required...

Page 54: ...ed Alarm Level label A selection drop down box allows easy adjustment of the selected alarm level Rapid Desat Desat Index 3D and PI Delta 3D alarms are located at the top right hand side of the Alarms...

Page 55: ...The SpMet low alarm limit can be set anywhere between 0 1 to 99 5 Between 0 1 and 2 the step increment is 0 1 Between 2 and 99 5 the step increment is 0 5 In the off setting the alarm can be turned o...

Page 56: ...e audible pulse to continue to beep when the pleth graph shows signs of motion Deselect to turn off SmartTone PVI Select to display the PVI parameter The PVI will display numerically on the main scree...

Page 57: ...decline in the patient s status and the need for more focused monitoring and or a change in treatment To address patient populations at risk for cyclic and moderate desaturations the 3D Alarm System...

Page 58: ...4 Desat Index Time Range of 1 hr to 4 hrs in 1 hr increments default of 1 hr Desat Index Alarm Range of 1 to 25 desaturations default is OFF If the measured Desat Index parameter is greater than the c...

Page 59: ...c RJ The pulse oximeter perfusion index as a predictor for high illness severity in neonates Eur J Pediatr 2002 161 561 562 The 3D Alarm System provides an audible and visual alert to important change...

Page 60: ...will remain on the screen until the Alarm condition is removed Alarm settings PARAMETER MENU ITEM DESCRIPTION DESAT INDEX ALARM DESAT THRESHOLD The Desat Threshold can be set in the range of 2 to 10 i...

Page 61: ...nd selected by the user The y axis of the trend display shows the time scale of the trend graph including the starting date starting time and end time of the data set that is displayed on the screen T...

Page 62: ...ive or faulty cable Replace cable Refer to the Directions for Use of the cable being used INCOMPATIBLE SENSOR Not a proper Masimo sensor Replace with a proper Masimo sensor INVALID SENSOR Oximeter can...

Page 63: ...ect cable into connector Unit is searching for patient s pulse Disconnect and reconnect the sensor into the Patient Cable Connector PULSE SEARCH Unit is searching for patient s pulse If values are not...

Page 64: ...DO NOT USE DAMAGED SENSORS OR PATIENT CABLES DO NOT USE A SENSOR OR PATIENT CABLE WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS DO NOT IMMERSE THE SENSOR OR PATIENT CABLE IN WATER SOLVENTS OR CLEANIN...

Page 65: ...uired Failure to take this precaution in high ambient light conditions may result in inaccurate measurements SENSOR APPLICATION INSTRUCTIONS Unless indicated otherwise in the directions for use reposi...

Page 66: ...3 bpm 5 bpm 2 3 bpm 3 5 1 10 30 kg 60 80 3 70 100 2 3 3 bpm 5 bpm 2 3 bpm 3 5 1 SpO2 Sensors D MAS may use standard Masimo LNOP LNOPv and LNCS SpO2 sensors when used with Red PC Red LNC or Rainbow Pa...

Page 67: ...n Accuracy Pulse Rate Accuracy Low Perfusion Accuracy No Motion Motion No Motion Motion Saturation Pulse Rate LNOP Adt 30 kg 2 3 3 bpm 5 bpm 2 3 bpm LNOP Adtx 30 kg 2 3 3 bpm 5 bpm 2 3 bpm LNOP Pdt 10...

Page 68: ...racy No Motion Motion No Motion Motion Saturation Pulse Rate LNOP Blue 2 5 30 kg 60 80 4 N A 3 bpm N A 3 3 bpm 70 100 3 3 N A 3 bpm N A 3 3 bpm 80 100 3 N A 3 bpm N A 3 3 bpm LNCSTM REUSABLE SENSORS L...

Page 69: ...Pt L 1 kg 3 3 3 bpm 5 bpm 3 3 bpm SENSOR ACCURACY Refer to Section 7 Specifications for SpO2 SpMet SpCO and pulse rate accuracy Unless otherwise specified in the previous tables The sensor accuracy sp...

Page 70: ...ENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS POTENTIALLY LEADING TO PATIENT HARM WARNING ELECTRICAL SHOCK AND FLAMMABILITY HAZARD BEFORE CLEANING THE OXIMETER ALWAY...

Page 71: ...the patient cable make sure that the connectors never come into contact with other conductive parts or with earth In particular make sure that all of the ECG electrodes are attached to the patient to...

Page 72: ...hand side Move your finger down two more intercostal spaces to the fourth intercostal space which is the C1 position Chest lead electrode placement The six pericardial chest leads are placed as follo...

Page 73: ...e results list box on the Welcome Screen and may be reviewed again by double clicking the file name Resting ECG report Note ECG sensitivity settings are 5mm mV 10mm mV and 20mm mV DanMedical recommend...

Page 74: ...easurements commence Do not place the cuff too tightly and avoid restricting circulation Measurement accessory connection NIBP 1 To perform NIBP measurement select and place the appropriately sized NI...

Page 75: ...ay set the target pressure of the cuff Blood Pressure screen To start a Blood Pressure measurement click Start To cancel a Blood Pressure measurement at any time click Cancel Once measurement has star...

Page 76: ...with time and date and are shown graphically as Trend If an error occurs an error message is displayed Possible NIBP error messages Primary overpressure detected cuff pressure has exceeded safe press...

Page 77: ...orm the spirometry manoeuvre When the spirometry maneuver is completed the results and an interpretive statement are presented Spirometry screen Predicted Minimum Mean and Maximum values are calculate...

Page 78: ...never place ECG electrodes near to the grounding plate of the ES device as this can cause a lot of interference on the ECG signal When you are connecting the electrodes or the patient cable make sure...

Page 79: ...s 14 PI Display with alarm limits 15 Pulse rate display with alarm limits Derived from Pulse CO Oximeter sensor 16 Silence button Use to silence alarm for 2 minutes 17 ECG BPM display with alarm limit...

Page 80: ...Setting menu allows the adjustment of alarm limits Adjustment is made by clicking the alarm level box A selection drop down box allows easy adjustment of the selected alarm level Factory default setti...

Page 81: ...print functions To print a summary report of the patient data 1 Viewing the Welcome Screen 2 Click File and then Open then select the required file 3 Once the data is displayed on the screen select F...

Page 82: ...nt solution Cables supplied with the D MAS may be wiped with a damp cloth moistened with mild detergent solution The Pulse CO Oximeter sensor cables and ECG patient cable may be damaged through excess...

Page 83: ...he included battery ILLUMINATION OF THE BACKLIT LCD SCREEN TO CONSERVE BATTERY POWER KEEP THE BACKLIT LCD SCREEN AT MINIMUM ILLUMINATION VOLUME OF THE ALARM TONES TO CONSERVE BATTERY POWER KEEP THE FR...

Page 84: ...on the Saturation Alarm Limit Display next to the SpO2 or pulse rate measurement display 4 Return the High Saturation Alarm parameter to its original setting 5 Repeat steps 2 to 4 for the following a...

Page 85: ...g Apparatus required 1 Calibrated manometer 2 Tubing T connectors and inflation bulb 3 An arm sized cylindrical object to wrap the cuff around Method 1 Connect the apparatus 2 From the Welcome Screen...

Page 86: ...4 Click Start and observe audible beep from Spirometer 5 Secureley connect a calibrated 3Litre syringe and push the maximum amount of air through the Spirometer 6 Observe graphic loop and measurement...

Page 87: ...e of the D MAS may be observed Separate the D MAS from any interference as far as reasonably possible refer to EMC information The following chart describes what to do if D MAS system does not operate...

Page 88: ...apply sensor or move to a different site SpO2 VALUES DO NOT CORRELATE WITH CLINICAL ASSESSMENT OR ABGs Low perfusion or sensor displacement Check for error messages See section 5 System Messages for...

Page 89: ...and try again No cuff inflation with inflation pump running Check cuff and all NIBP connections for leak Cuff inflation and deflation with no results displayed Check cuff and all NIBP connections for...

Page 90: ...connected The D MAS instrument has Remote viewer software installed and is launched from the Welcome Screen by selecting Help from the menu and selecting Remote Assistance Communicate the Identificati...

Page 91: ...t DMPN 2013 V2 1002 BP Cuff adult DMPN 2013 V2 1003 BP Cuff large adult DMPN 2013 V2 1004 BP Cuff large adult long DMPN 2013 V2 1005 BP hose DMPN 2013 V2 1006 Electrode clips DMPN 2013 V2 1007 D MAS R...

Page 92: ...I 76 96WH Accessory ANTENNA WLAN MIMO CCD 2 0M FHD COMBO WLAN 802 11BGN 1X1 B T4 0 HALF CARD VGA OPTION AMD VGA WIMBLEDON 2G Performance Specifications Category Description Model Specification Power s...

Page 93: ...el I II III aVR aVL aVf V1 V6 Frequency response 75Hz 3dB IEC 100Hz 3dB AHA Input impedance 5M Common mode rejection 96dB Signal bandwidth 3dB 0 05 250Hz Resolution 3 75 V Gain accuracy 2 5 per lead D...

Page 94: ...ng motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 100 SpO2 against a laborat...

Page 95: ...rics Neonate 5 digits Low Perfusion4 Adults Pediatrics Neonate 3 digits Resolution Saturation SpO2 1 Carboxyhemoglobin saturation SpCO digital display 1 Methemoglobin saturation SpMet digital display...

Page 96: ...may be changed by the user ECG settings Parameter Setting Sensitivity 10mm mV Trace speed 25mm s Filter On Alarm parameter High limit Low limit Heart rate 140 bpm 45 bpm NIBP settings Parameter Setti...

Page 97: ...HIGH Level LOW MED HIGH TREND DISPLAY Set to SpO2 BPM See Section 4 Display for all settings TREND PERIOD Set to Autoscale See Section 4 Trend Setup for all settings LOW SpO2 ALARM LIMIT Set to 90 SpM...

Page 98: ...ould assure it is used in such an environment Emissions Test Compliance Electromagnetic environment RF Emissions CISPR 11 Group 1 The D MAS uses RF energy only for its internal function Therefore its...

Page 99: ...electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note1 At 80 MHz an...

Page 100: ...of a typical commercial and or hospital environment Surge IEC 61000 4 5 1 kV line to line 2 kV line to earth 1 kV line to line 2 kV line to earth Mains power quality should be that of a typical commer...

Page 101: ...distance according to frequency of transmitter in meter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For trans...

Page 102: ...NCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE DANMEDICAL SHALL NOT BE LIABLE FOR ANY INCIDENTAL SPECIAL OR CONSEQUENTIAL LOSS DAMAGE OR EXPENS...

Page 103: ...DanMedical Ltd is a Beneficiary of this Agreement and has the right to enforce its provisions 8 U S Government Rights If you are acquiring software including the related documentation on behalf of any...