DanMedical D-MAS HyperSat 2540 Instructions For Use Manual

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DM DOC 040 Rev 1.0
DanMedical Analysis System
D-MAS HyperSat
2540
Instructions for use
© 2013 DanMedical Ltd
1

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  • Page 1 DM DOC 040 Rev 1.0 DanMedical Analysis System D-MAS HyperSat 2540 Instructions for use © 2013 DanMedical Ltd...
  • Page 2 DanMedical Ltd. shall not be liable for errors contained herein, or for damages in connection with the performance or use of this material. DanMedical Ltd. will not be responsible for any injury to the user or other person(s) that may result from accidents during operation or use of any DanMedical D-MAS System.
  • Page 3: Table Of Contents

    Blood pressure Spirometry Monitor mode Alarms and limits Retrieving patient data Printing reports Maintenance Storage & cleaning Battery Device function check Troubleshooting Replacement parts and accessories Specifications & factory defaults Guidance and Manufacturer’s Declarations Warranty & returns © 2013 DanMedical Ltd...
  • Page 4: General Information

    DM DOC 040 Rev 1.0 General Information The DanMedical Analysis System will be referred to as D-MAS throughout this manual. Important! Read this manual before use. About this manual This user manual relates to the DanMedical Analysis System (D-MAS). This manual explains how to set up and use D-MAS and includes important safety information.
  • Page 5: Intended Use

    DM DOC 040 Rev 1.0 Intended use D-MAS HyperSat 2540 is intended for use in a HyperBaric or Diving Saturation chamber. D-MAS is intended for use by medical clinicians on adult patients. D-MAS is not intended for use in environments that are not supervised by a health care practitioner.
  • Page 6: Symbols, Warnings And Cautions

    European Medical Device Directive 93/42/EEC General warning sign. Defib. protection is within patient cable. Type CF Defibrillator proof Address of manufacture These symbols appear in this user manual: Symbols Description Warning symbol Caution symbol © 2013 DanMedical Ltd...
  • Page 7 WARNING! For the safety of patients and to ensure best product performance and accuracy, use only supplies and accessories recommended or supplied by DanMedical Ltd. WARNING! Do not place containers with liquids on or near D-MAS. Liquids spilled on D- MAS may cause it to perform inaccurately or fail.
  • Page 8 WARNING! Refer servicing to authorized and qualified personnel. Important Notice All maintenance, repairs and other technical adjustments to be performed by DanMedical or authorised provider only. Warranties and any maintenance cover will lapse/end if unauthorised providers are used.
  • Page 9 CAUTION! If using Pulse CO-Oximetry during full body irradiation, keep the sensor out of the irradiation field. If the sensor is exposed to the irradiation, the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period. © 2013 DanMedical Ltd...
  • Page 10 EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS. CAUTION! To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilize by irradiation, steam, autoclave, or any method other than ethylene oxide as indicated. © 2013 DanMedical Ltd...
  • Page 11: List Of Components

    General Examination Camera Backpack (option) Protective case (option) User manual (electronic) Unpacking and inspection Inspect packaging for signs of damage in transit. Contact DanMedical Ltd. immediately if any damage is discovered. If possible retain packaging for future use. © 2013 DanMedical Ltd...
  • Page 12 10 lead Resting ECG recordings with interpretation  Non-invasive blood pressure with pulse rate for adult patients  Spirometry (Lung function)  Audiometry HSE & OSHA hearing thresholds  USB scope and general examination digital camera images © 2013 DanMedical Ltd...
  • Page 13: Battery Blades

    A positive click signals the Battery Blade is inserted correctly. Battery Blade On/Off switch Switch on the D-MAS HyperSat Switch ON both Battery Blades using the ON/OFF switch on each Battery Blade then switch on the D-MAS HyperSat © 2013 DanMedical Ltd...
  • Page 14 The twin batteries should be replaced sequentially to prevent power loss from the D-MAS HyperSat. Removing both batteries will result in complete power loss to the D-MAS HyperSat and it will require re-booting once fully charged batteries are inserted. © 2013 DanMedical Ltd...
  • Page 15 LED will remain RED until the battery is fully charged at which point it illuminates Green (2 hours approx.) The Battery Blade is provided with a 10Amp Auto fuse, it is a “when it blows it glows” type and will illuminate if blown. © 2013 DanMedical Ltd...
  • Page 16: Features

     Desat Index Alarm enables clinicians to detect an increasing quantity of smaller desaturations that may precede declining respiratory status.  PI Delta Alarm alerts clinicians to specified changes in perfusion, often a reliable indicator of illness severity. © 2013 DanMedical Ltd...
  • Page 17: Pulse Co-Oximeter

    The sensor connects either directly to the Pulse CO-Oximetry instrument or through an instrument patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as percentage value for the SpMet. © 2013 DanMedical Ltd...
  • Page 18: Principle Of Operation

    The maximum of the skin surface temperature is measured at an ambient temperature of less than 106º F (41º C). This is verified by sensor skin temperature test procedures © 2013 DanMedical Ltd...
  • Page 19 The D-MAS displays measurements of SpMet and SpCO during patient motion. However, because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion, the accuracy of such measurements may not be readable during excessive motion. © 2013 DanMedical Ltd...
  • Page 20 With motion, the plethysmographic waveform is often distorted and may be obscured by artifact. The Signal IQ, shown as a vertical line, coincides with the peak of an arterial pulsation. © 2013 DanMedical Ltd...
  • Page 21 IF THE LOW PERFUSION MESSAGE IS FREQUENTLY DISPLAYED, FIND A BETTER-PERFUSED MONITORING SITE. IN THE INTERIM, ASSESS THE PATIENT AND, IF INDICATED, VERIFY OXYGENATION STATUS THROUGH OTHER MEANS. Severinghaus JW, Spellman MJ. Pulse Oximeter Failure Thresholds in Hypotension and Vasoconstriction. Anesthesiology 1990; 73:532-537 © 2013 DanMedical Ltd...
  • Page 22 OF THE SENSOR OFF DETECTION MAY BE COMPROMISED. IF THE UNIT IS IN THIS SETTING AND THE SENSOR BECOMES DISLODGED FROM THE PATIENT, THE POTENTIAL FOR FALSE READINGS MAY OCCUR DUE TO ENVIRONMENTAL ‘NOISE’ SUCH AS LIGHT, VIBRATION AND EXCESSIVE AIR MOVEMENT. © 2013 DanMedical Ltd...
  • Page 23: Resting Ecg

    The ECG signals are acquired via electrodes attached to the ECG patient cable. The signals are digitized, displayed and stored electronically. The recorded signal is measured and an ECG interpretation algorithm is applied to the recording providing the user with displayed measurements and interpretation statements. © 2013 DanMedical Ltd...
  • Page 24 QRS Duration Line frequency (60Hz) -0.400 2.797 QRS Duration Base-line 0.200 3.048 QT Interval High frequency -2.200 3.048 QT Interval Line frequency (50Hz) -0.200 0.632 QT Interval Line frequency (60Hz) -0.200 1.476 QT Interval Base-line -0.800 1.398 © 2013 DanMedical Ltd...
  • Page 25 SPECIFICITY (SPEC) =    POSITIVE PREDICTIVE VALUE (PPV)    NEGATIVE PREDICTIVE VALUE (NPV)    Number occurrence abnormalit PREVALENCE Total number cases data base Total number cases correctly classified TOTAL ACCURACY 1220 © 2013 DanMedical Ltd...
  • Page 26 ‘NORMAL’ (even though the ECG may appear ‘NORMAL’). In the CSE study, an ECG report stating only ‘MYOCARDIAL ISCHEMIA’ was mapped to ‘NORMAL’ even if the true answer was ‘INFARCTION’, thereby also contributing to decreased specificity for ‘NORMAL’. © 2013 DanMedical Ltd...
  • Page 27 100% 55/1220 13.2 46.7 30.7 100% 53/1220 15.9 71.8 100% 170/1220 25.6 70.5 100% 273/1220 63.4 22.9 100% 73/1220 VH+MI 25.8 46.8 27.4 100% 31/1220 Total accuracy: 73.7 % Partially correct: 75.7 % (both on 1220) © 2013 DanMedical Ltd...
  • Page 28 100.0 30/1220 10.3 70.7 100.0 29/1220 80.2 100.0 159/1220 14.0 82.9 100.0 228/1220 11.8 71.5 100.0 72/1220 VH+MI 20.5 61.4 100.0 22/1220 OTHER 70.3 100.0 32/1220 TOTAL 46.3 10.4 11.4 17.0 100.0 1220 Total agreement 81.48% © 2013 DanMedical Ltd...
  • Page 29 33/958 (Possible) LAFB 100% 100% 100% 100% 15/958 RBBB = Right bundle branch block LBBB = Left bundle branch block LAFB = Left anterior fascicular block IVCD = Intra ventricular conduction defect = Wolf Parkinson White © 2013 DanMedical Ltd...
  • Page 30 100.00 100.00 100.00 1/2570 Probable atrial tachycardia 100.00 100.00 100.00 100.00 1/2570 Marked sinus bradycardia 100.00 100.00 100.00 100.00 1/2570 Possible junctional rhythm 100.00 99.96 50.00 100.00 1/2570 Regular supraventricular rhythm 100.00 99.88 25.00 100.00 1/2570 © 2013 DanMedical Ltd...
  • Page 31 100.00 100.00 100.00 1/2570 ~ with complete A-V block 0.00 100.00 0.00 99.96 1/2570 ~ with bigeminal PVCs 100.00 100.00 100.00 100.00 1/2570 ~ with 2nd degree (Mobitz II) SA block 0.00 99.96 0.00 100.00 0/2570 © 2013 DanMedical Ltd...
  • Page 32 100% 99.8% 97.3% 100% 71/927 T changes rSr' – probable 100% 99.9% 94.4% 100% 17/927 normal variant Poor R wave 92.8% 99.9% 96.3% 99.8% 26/927 progression LAD = Left axis deviation RAD = Right axis deviation © 2013 DanMedical Ltd...
  • Page 33 92.8% 99.9% 96.3% 99.8% 26/840 (Q waves) Borderline high QRS voltage – probable 100% 100% 100% 100% 24/840 normal variant RVH = Right ventricular hypertrophy LVH = Left ventricular hypertrophy BVH = Biventricular hypertrophy © 2013 DanMedical Ltd...
  • Page 34 (V1) – probable 100% 100% 100% 100% 14/840 normal variant RBBB = Right bundle branch block LBBB = Left bundle branch block LAFB = Left anterior fascicular block IVCD = Intra ventricular conduction defect = Wolf Parkinson White © 2013 DanMedical Ltd...
  • Page 35 Note: Computer assisted interpretation is a valuable tool when used properly. However, no automated analysis system is completely reliable, therefore interpretations should be reviewed by a qualified Healthcare Professional before treatment, or non-treatment, of any patient. © 2013 DanMedical Ltd...
  • Page 36: Blood Pressure

    D-MAS uses a sphygmomanometer cuff with an electronic pressure sensor (transducer) to observe cuff pressure oscillations, electronics to automatically interpret them, and automatic inflation and deflation of the cuff. The pressure sensor should be calibrated annually to maintain accuracy. © 2013 DanMedical Ltd...
  • Page 37 3. Cuff stepped deflation: The cuff will be deflated and oscillation detected until the patient blood pressure has been determined and displayed. 4. Rapid cuff deflation: The cuff pressure is rapidly deflated. © 2013 DanMedical Ltd...
  • Page 38: Spirometry

    Another major limitation is the fact that many intermittent or mild asthmatics have normal spirometry between acute exacerbation, limiting spirometry's usefulness as a diagnostic. © 2013 DanMedical Ltd...
  • Page 39 This generates a reduced value (<80%, often ~45%). In restrictive diseases (such as pulmonary fibrosis) the FEV1 and FVC are both reduced proportionally and the value may be normal or even increased as a result of decreased lung compliance. © 2013 DanMedical Ltd...
  • Page 40 Tidal volume (TV) Tidal volume is the amount of air inhaled and exhaled normally at rest Total lung capacity (TLC) is the maximum volume of air present in the lungs © 2013 DanMedical Ltd...
  • Page 41: Monitor Mode

    D-MAS will activate alarms if any of the measured parameters fall outside of the user settable alarm limits. Refer to the Pulse CO-Oximeter, ECG and Blood Pressure principles of operation for a detailed description of each parameter. © 2013 DanMedical Ltd...
  • Page 42: Set Up

    Configure the unit for your regional power line frequency (50 or 60 hz). CAUTION: THE UNIT MUST BE CONFIGURED TO MATCH YOUR LOCAL POWER LINE FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE INTRODUCED BY FLUORESCENT LIGHTS AND OTHER SOURCES. © 2013 DanMedical Ltd...
  • Page 43: Basic Operation

    Create an alarm condition by lowering the SpO2 or pulse rate high alarm limits beyond the patient readings.  Press the Alarm Silence button.  The alarm tone ceases for the displayed amount of time.  Perform the above steps for the SpMet and SpCO alarm limits. © 2013 DanMedical Ltd...
  • Page 44 Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping the sensor too tightly. Inspect the sensor site regularly to ensure skin integrity and correct positioning of the sensor. Inaccurate results may be caused by incorrect application or use. © 2013 DanMedical Ltd...
  • Page 45: Software Overview

    At program launch the screen below is shown where patient details may be entered. Diagnostic test screen are accessed by clicking on the buttons for Pulse CO-Oximetry, Resting ECG, Blood Pressure, Spirometry, Imaging and Monitor mode. © 2013 DanMedical Ltd...
  • Page 46 D-MAS will automatically calculate BMI when the patient’s height is entered into the height field in metres (m) and the patient’s weight is entered into the weight field in kilograms (kg) The BMI is calculated from the equation: Patient weight (Patient height © 2013 DanMedical Ltd...
  • Page 47: Pulse Co-Oximeter

    SENSOR OFF will appear at the top of the display screen. When the measured value is outside of the alarm limits, the SpMet measurement display flashes and an alarm will sound. The methemoglobin is calculated and the display is updated once per second. © 2013 DanMedical Ltd...
  • Page 48 14. PULSE RATE ALARM LIMITS DISPLAY The Pulse Rate Alarm Limits Display shows the upper and lower pulse rate alarm limits. When an alarm limit is reached or exceeded, the pulse rate value and the violated limit flashes. © 2013 DanMedical Ltd...
  • Page 49 Trend menu. Once the parameter is selected, the parameter is displayed in the trend graph. The bottom line of the trend graph display shows the selected parameter followed by the time scale of the trend graph. © 2013 DanMedical Ltd...
  • Page 50 OF THE SENSOR OFF DETECTION MAY BE COMPROMISED. NOTE: In “Custom” mode the unit will remain in Normal or APOD setting after a power cycle. Maximum Sensitivity will automatically reset to Normal Sensitivity after a power cycle. © 2013 DanMedical Ltd...
  • Page 51 Turn SmartTone On and Off by Clicking 'Settings' and mouse over SmartTone Mode to make the On/ Off selection. PVI Mode Turn PVI mode On and Off by Clicking 'Settings' and mouse over PVI to make the On/ Off selection. © 2013 DanMedical Ltd...
  • Page 52 SpHb Units SpHb Units may be displayed as g/dL (default) or as mmol/L depending on regional preference. Click on 'Settings' and mouse over 'SpHb Units' to access the SpHb Units selection. © 2013 DanMedical Ltd...
  • Page 53 “2222” then click OK to confirm the change. Reset Restore default settings by clicking 'Settings' and selecting 'Reset' to enable the Default settings selection. This action will reset all previous settings back to factory default. © 2013 DanMedical Ltd...
  • Page 54: Alarms

    Check alarm limits each time D-MAS is used to ensure that they are appropriate. An audible alarm and a flashing alarm icon will occur when an alarm limit is exceeded. The operator should be within a minimum of 2metres/10 feet from the unit. © 2013 DanMedical Ltd...
  • Page 55 Alarm Status Indicator is shown as a bell with a slash through it. A timer is shown next to the bell indicating the remaining alarm silence duration. NOTE: The alarm silence period is reset to 120 seconds upon power cycle. © 2013 DanMedical Ltd...
  • Page 56 -5: The Alarm Delay setting is ignored if the desaturation is 5% (meaning 5 saturation units) below the Low SpO2 alarm threshold. -10: The Alarm Delay setting is ignored if the desaturation is 10% (meaning 10 saturation units) below the Low SpO2 alarm threshold. © 2013 DanMedical Ltd...
  • Page 57 3D Alarm System Option This section applies only if you have purchased the optional 3D Alarm System. Contact DanMedical to purchase this option. D-MAS includes user-selectable High and Low alarm limits for SpO2 and pulse rate. This provides specific, audible and visual levels of these vital signs that the clinician has determined merits their attention as described in this manual.
  • Page 58 Desat Index alarm, the tone is silenced and will not return when the Alarm Suspend time expires unless the condition is removed and then returns. The message will remain on the screen until the Alarm condition is removed. © 2013 DanMedical Ltd...
  • Page 59 48 hr and NONE. Default is NONE. PI Delta Baseline Displays OFF, the current PI baseline or TIMEOUT. If the baseline is activated and then turned off, TIMEOUT will display. NOTE: This is a Read Only display and not user interactive. © 2013 DanMedical Ltd...
  • Page 60 1 hr. 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48 hr and NONE. Default is NONE. PI DELTA The PI Delta Baseline displays OFF, the BASELINE current PI baseline or TIMEOUT. NOTE: This is a Read Only display and not user interactive © 2013 DanMedical Ltd...
  • Page 61 Trend Data. Select a location for storage and to name the file. The stored trend data file may be used for further analysis and printing. Help Click 'Help' followed with 'About' to see the software version. © 2013 DanMedical Ltd...
  • Page 62 • Refer to Chapter 3, Low Perfusion. LOW SIGNAL IQ • Low signal quality. • Ensure proper sensor application. • Move sensor to a better perfused site. • Refer to Chapter 3, Signal IQ. © 2013 DanMedical Ltd...
  • Page 63 • Internal Failure • Unit requires service. UNRECOGNIZED CABLE • Not a proper cable. • Replace with a proper cable. Refer to Section 8. *The SERVICE REQUIRED message is a numeric error code. Contact DanMedical for service. © 2013 DanMedical Ltd...
  • Page 64: Sensors, Cleaning & Reuse

    SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS, POTENTIALLY LEADING TO PATIENT HARM. ■ ALL SENSORS AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC MONITORS. VERIFY THE COMPATIBILIY OF THE MONITOR, CABLE AND SENSOR BEFORE USE, OTHERWISE PATIENT INJURY CAN RESULT. © 2013 DanMedical Ltd...
  • Page 65 ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 3% ± 1% DCIP 10 - 50 ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm ± 3% ± 1% © 2013 DanMedical Ltd...
  • Page 66 > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm DCIP 10 - 50 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm © 2013 DanMedical Ltd...
  • Page 67 < 3 kg ± 3% ± 3% ± 3 bpm ± 5 bpm ± 3% ± 3 bpm LNOPv Ad > 30 kg ± 2% ± 3% ± 3 bpm ± 5 bpm ± 2% ± 3 bpm © 2013 DanMedical Ltd...
  • Page 68 ± 3 bpm ± 3.5% ± 3 bpm LNCS TF-I > 30 kg ± 2% ± 3 bpm ± 2% ± 3 bpm NOTE: The LNCS TF-I and TC-I sensors were not validated under motion conditions. © 2013 DanMedical Ltd...
  • Page 69 68% of the population. SpO2 accuracy represents from 70% to 100%, pulse rate accuracy represents from 25 to 240 bpm, SpCO accuracy represents from 1% to 40% and SpMet accuracy represents from 1% to 15%. © 2013 DanMedical Ltd...
  • Page 70 MATERIALS, OR BRING THEM INTO CONTACT WITH ANYTHING THAT COULD SCRATCH THE PANEL. ■ DO NOT USE PETROLEUM-BASED OR ACETONE SOLUTIONS, OR OTHER HARSH SOLVENTS, TO CLEAN D-MAS. THESE SUBSTANCES ATTACK THE DEVICE’S MATERIALS AND DEVICE FAILURE CAN RESULT. © 2013 DanMedical Ltd...
  • Page 71: Resting Ecg

    Place 10 skin electrodes on the patient.  Connect the electrode clips to the patient skin electrodes  Connect the 12 lead ECG cable to the D-MAS ECG socket.  Launch D-MAS software to view ECG. Limb lead electrode placement. © 2013 DanMedical Ltd...
  • Page 72 Fifth intercostals space at midclavicular line Level with C4 at left anterior auxiliary line Level with C5 at left midaxillary line Note: When placing electrodes on female patients, always place leads C3-C6 under the breast rather than on the breast. © 2013 DanMedical Ltd...
  • Page 73 Note: ECG sensitivity settings are 5mm/mV, 10mm/mV and 20mm/mV. DanMedical recommends testing the sensitivity regularly with a calibrated ECG simulator. A filter is provided as the ECG may sometimes be affected by line interference. The ECG signals are sampled at 500 samples/s per channel during data acquisition. The skew between channels being used for determination of angles <100 μs.
  • Page 74: Blood Pressure

    1. To perform NIBP measurement, select and place the appropriately sized NIBP measurement cuff around the patient’s arm 2. Connect the NIBP hose to the cuff and then to the D-MAS NIBP hose connector D-MAS Remote NIBP hose connector © 2013 DanMedical Ltd...
  • Page 75 To start a Blood Pressure measurement, click “Start” To cancel a Blood Pressure measurement at any time click “Cancel”. Once measurement has started, the user may observe displayed cuff pressure, the pulse signal height and the measurement time. © 2013 DanMedical Ltd...
  • Page 76 “Error: deflation steps too small” possible blockage in cuff hose  “Error: deflation steps too large” possible leak in cuff  “Pressure released: determination time in access of 120s” NIBP measurement has taken to long  “Error: Inflation failure” Check cuff is connected, possible leak © 2013 DanMedical Ltd...
  • Page 77: Spirometry

    Click ‘Print’ to produce a paper copy or create a Pdf if set up. If a Spirometry manoeuvre has been performed and the results are saved, the results and flow loop graphics are available for review from the Welcome Screen by double clicking on the file name. © 2013 DanMedical Ltd...
  • Page 78: Monitor Mode

    Connect sensors to patient and to D-MAS:  Pulse CO-Oximeter sensor  ECG Electrodes and ECG Patient Cable  Blood Pressure Cuff and hose To view the Monitor Mode screen from the Welcome Screen, click the “Monitor” button: Monitoring Screen © 2013 DanMedical Ltd...
  • Page 79 Cuff pressure reading Blood Pressure BPM display with alarm limits Pulse waveform display Blood pressure trend results Battery indicator At the end of the patient monitoring session, close the Monitor Mode screen by selecting the close button (12). © 2013 DanMedical Ltd...
  • Page 80: Alarms And Limits

    Factory default setting can be selected by clicking 'Load Default' The settings are saved by clicking 'Save Exit' To cancel with making no change to the alarm limits, click 'Cancel'. Parameters that are disabled are not available. © 2013 DanMedical Ltd...
  • Page 81: Retrieving Patient Data

    To print a Spirometry report: 1. View the Welcome Screen 2. Click “File” and then “Open”, then select the required file. 3. Previously stored Spirometry measurments are viewed by double clicking the required file name. 4. Select “Print” © 2013 DanMedical Ltd...
  • Page 82 Maintenance: General D-MAS is required to be serviced annually. Service and maintenance should only be performed by DanMedical or a DanMedical approved service provider and includes calibration and safety checks to ensure the correct operation of the device. Maintenance: Storage When not in use, it is recommended that D-MAS and all accessories are stored carefully for safe keeping.
  • Page 83: Battery

    WARNING: FIRE HAZARD: TO PROTECT AGAINST FIRE HAZARD, REPLACE ONLY WITH CORRECT BATTERY OF THE SAME TYPE, CURRENT RATING, AND VOLTAGE RATING. DO NOT OPEN BATTERY BLADE. NO USER SERVICEABLE PARTS INSIDE. REFER TO QUALIFIED PERSONEL. © 2013 DanMedical Ltd...
  • Page 84: Device Function Check

    15. Remove the Black 'N' electrode and observe that all waveforms are dashed lines and lead off label is displayed for all waveforms (Apart from aVR, aVL & aVF) 16. If any unexpected lead off labels are presented then suspect a broken ECG Patient cable and requires replacing. © 2013 DanMedical Ltd...
  • Page 85 If the readings do not agree closely (within 3 mmHg) please call for technical assistance or refer the D-MAS to qualified technical personnel. *EN 60601-2-30 © 2013 DanMedical Ltd...
  • Page 86 Spirometer. 6. Observe graphic loop and measurement display. 7. Repeat test 3 times for repeatabilty. 8. If any degradations in performance are observed, contact technical assistance or refer the D-MAS to qualified technical personnel. © 2013 DanMedical Ltd...
  • Page 87: Troubleshooting

    DM DOC 040 Rev 1.0 Troubleshooting general When responding to a D-MAS alarm condition, you must check the patient first and then check the D-MAS performance. If D-MAS problems persist, notify DanMedical service personnel. Description Corrective action General power failure...
  • Page 88 Inappropriate sensor or sensor size. Verify proper sensor and sensor size for the patient. Excessive ambient or strobing light. Shield the sensor from excessive or strobing light. As with all CO-Oximeters, elevated methemoglobin levels may cause falsely elevated carboxyhemoglobin values. © 2013 DanMedical Ltd...
  • Page 89 Troubleshooting Resting ECG Description Corrective action ECG cable not detected Use only ECG cables supplied by DanMedical. ECG cable detected but Check patient condition & ensure correct patient preparation. no waveform or Check that electrodes are correctly placed and attached to the patient.
  • Page 90 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 Identification (I.D.) and Password dialogue box to remote support personnel. Remote assistance software © 2013 DanMedical Ltd...
  • Page 91: Replacement Parts And Accessories

    DM DOC 040 Rev 1.0 Replacement parts and accessories D-MAS battery replacement is recommended annually. Contact DanMedical Ltd. for spare parts or accessories. Replacement parts Part number 10 lead ECG Cable DMPN-2013-V2-1001 BP Cuff- small adult DMPN-2013-V2-1002 BP Cuff- adult...
  • Page 92: Specifications & Factory Defaults

    10 Ah Environmental Operational temperature All models 0 to 50°C Operational humidity All models 0 to 95%NC Storage temperature All models -5 to 60°C Storage humidity All models 0 to 95%NC Pressure D-MAS HyperSat 450msw (45 bar) © 2013 DanMedical Ltd...
  • Page 93 30 bpm QRS amplitude 2 mV 0.5 mV Spirometer Type Bi-Directional transducer Resolution volume 10ml Resolution flow 0.03l/s Spirometer limits of +/-3% To ATS recommendations accuracy Operation of D-MAS below the minimum specification may cause inaccurate results. © 2013 DanMedical Ltd...
  • Page 94 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population. © 2013 DanMedical Ltd...
  • Page 95 Display/Indicators Data display: %SpO2, %SpCO, %SpMet, pulse rate, pleth waveform, alarm status, trends, status messages, Signal IQ, perfusion index, pleth variability index, APOD and FastSat Display update rate: 1 second Response Time: < 20 second delay © 2013 DanMedical Ltd...
  • Page 96 Parameter Setting Cuff target pressure: 150 mmHg Alarm parameter High limit Low limit Systolic 200 mmHg 70 mmHg 175 mmHg 60 mmHg Diastolic 155 mmHg 50 mmHg Pulse rate 140 beats per minute (bpm) 45 bpm © 2013 DanMedical Ltd...
  • Page 97 Set to High: 140/Low: 50 ALARM LIMIT SpMet HIGH/LOW ALARM LIMIT Set to High: 3.0/Low: --- SpCO HIGH/LOW ALARM LIMIT Set to High: 10/Low: --- ALARM SILENCE Set to 120 seconds ALARM DELAY Set to 5 seconds © 2013 DanMedical Ltd...
  • Page 98 DM DOC 040 Rev 1.0 Guidance and Manufacturer’s Declarations The DanMedical D-MAS needs special precautions regarding EMC and needs to be installed and put into service according to the following EMC information provided. Portable and mobile RF communications equipment can affect the DanMedical D-MAS.
  • Page 99 D-MAS should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the D-MAS. b) Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m. © 2013 DanMedical Ltd...
  • Page 100 3 A/m 3 A/m be at levels characteristic of a IEC 61000-4-8 typical location in a typical commercial or hospital environment. Note: UT is the A.C. mains voltage prior to application of the test level. © 2013 DanMedical Ltd...
  • Page 101 The customers or the users of D-MAS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DanMedical D-MAS as recommended below, according to the maximum output power of the communications equipment.
  • Page 102: Warranty & Returns

    DM DOC 040 Rev 1.0 Warranty DanMedical warrants to the initial purchaser that each new D-MAS will be free from defects in workmanship or materials for a period of one (1) year from the date of purchase. DanMedical's sole obligation under this warranty is to repair or replace any product that DanMedical deems to be covered under warranty with a repaired or a replacement D-MAS.
  • Page 103 Transfer Restrictions: The software/firmware is licensed to the Purchaser, and may not be transferred to anyone, except other end-users, without the prior written consent of DanMedical. In no event may you transfer, assign, rent, lease, sell, or otherwise dispose of the software/firmware or the products on a temporary basis.

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