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Primedic DefiMonitor EVO Operating Instructions Manual

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DefiMonitor EVO
Operating Instructions
MGA 22955 / GB / B01

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Summary of Contents for Primedic DefiMonitor EVO

  • Page 1 DefiMonitor EVO Operating Instructions MGA 22955 / GB / B01...
  • Page 2 D-78628 Rottweil Germany Telephone: + 49 (0) 741 / 257-0 Fax: + 49 (0)741 / 257-235 e-mail: info@primedic.com Web: www.primedic.com Date of issue: 03/2018 Proprietary note METRAX GmbH reserves all rights to these operating instructions. Without approval from METRAX GmbH, these operating instructions may not be duplicated or made accessible to third parties.
  • Page 3 Mobile phones should not be used in the vicinity of the PRIMEDIC DefiMonitor Note EVO. Any device not complying to the EMC standard that is used with the PRIMEDIC Note DefiMonitor EVO renders the PRIMEDIC DefiMonitor EVO as non-compliable to the EMC standard.
  • Page 4 Product brand names shown in this manual are likely to be the trademark or registered trademark of the company concerned. The PRIMEDIC DefiMonitor EVO is equipped with epoch-making ECG monitoring function incorporating the cutting edge software for analysis of electrocardiograms developed by the University of Glasgow in UK, which includes signal processing, diagnostic interpretation of electrocardiograms from individuals of all ages and analysis of cardiac rhythm.
  • Page 5 1 Safety Information General Safety Information Warnings Cautions 2 Introduction Intended Use for the PRIMEDIC DefiMonitor EVO About this Manual 2.2.1 Symbols used in this oeration manual Identifying the PRIMEDIC DefiMonitor EVO Configurations 3 Description of the PRIMEDIC DefiMonitor EVO...
  • Page 6 9.1.2 Heart Rhythm 9.1.3 Detecting Fibrillation 9.1.4 Rhythm Recognition Performance Preparing for Defibrillation Operating the AED Mode of the PRIMEDIC DefiMonitor EVO AHA/ERC guidelines (Rescue protocol) Summary of CRP Guidelines 9.5.1 Using AED Mode Performing CPR 6 / 325 DefiMonitor EVO / GB / B01...
  • Page 7 Description of AED Mode Menu Functions 10 Manual Mode 10.1 General 10.2 Preparing for Defibrillation 10.3 Operating the Manual Mode of PRIMEDIC DefiMonitor EVO 10.4 Defibrillating (async mode) 10.5 Synchronized Cardioversion (sync mode) 10.6 Description of Manual Mode Menu Functions 10.6.1 6/12-Lead...
  • Page 8 18.5.2 Scale 18.5.3 Label 18.5.4 Limit Alarm Pause 19 Self-test Function 19.1 General 19.1.1 Manual Self-test 19.1.2 Auto Self-test 19.1.3 Button test 19.2 Functions to be tested in Self-test 8 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 9 23.3 Mission printout recording 23.3.1 Header recording 23.3.2 Event messages recording 23.3.3 Waveform recording 23.3.4 Shock information recording 23.3.5 Trend recording auto print. 23.3.6 Print Setting 24 External Interface 24.1 General Operating Instructions DefiMonitor EVO / GB / B01 9 / 325...
  • Page 10 24.1.1 SD Memory Card 24.1.2 Wireless Connection 24.1.3 Central System Communication 25 Maintenance 25.1 Recycling and Disposal 25.2 Returning the PRIMEDIC DefiMonitor EVO and System Components (except rechargeable battery) 25.3 Returning the PRIMEDIC AkuPak EVO 25.4 Service 25.5 Periodic Safety Checks 25.6 Cleaning...
  • Page 11 Table of contents 29.2 Tables 30 Contact details Operating Instructions DefiMonitor EVO / GB / B01 11 / 325...
  • Page 12 This section contains important safety information related to general use of the PRIMEDIC DefiMonitor EVO. Other important safety information appears throughout the manual. The PRIMEDIC DefiMonitor EVO will be referred to as the PRIMEDIC DefiMonitor EVO throughout this manual. Important! Before use, read this manual carefully, the directions for use of all accessories, all precautionary information and specifications.
  • Page 13 Safety Information WARNING When using the PRIMEDIC DefiMonitor EVO with a commercial electric power source, use the PRIMEDIC DefiMonitor EVO with an electric power wall socket with a grounding wire for medical use. Not doing so could cause electric shock.
  • Page 14 This instruction manual does not carry the caution selections for such equipment. WARNING Do not open cover or disassemble the PRIMEDIC DefiMonitor EVO. Doing so could cause electric shock or fire. The device contains no operator serviceable components and dangerous high voltages may be present.
  • Page 15 WARNING The PRIMEDIC DefiMonitor EVO is protected against the discharge of a defibrillator. However, do not touch the PRIMEDIC DefiMonitor EVO when a defibrillator is being discharged (electrified), as doing so may cause electric shock.
  • Page 16 PRIMEDIC DefiMonitor EVO. WARNING Do not place anything on top of the PRIMEDIC DefiMonitor EVO. If something is spilled over the PRIMEDIC DefiMonitor EVO or gets into it, such spillage may cause fire or electric shock. If fluid gets into the...
  • Page 17  Place an “Out of Order” sign on the device and do not use it. WARNING Do not connect more than one patient to the PRIMEDIC DefiMonitor EVO. Do not connect more than one PRIMEDIC DefiMonitor EVO to a patient.
  • Page 18 The defibrillator delivers up to 360 Joules of electrical energy. Unless properly used as described in this manual, this electrical energy may cause serious injury or death. Do not attempt to operate the PRIMEDIC DefiMonitor EVO unless thoroughly familiar with this manual and the functions of all controls, indicators, connectors and accessories.
  • Page 19 PRIMEDIC DefiMonitor EVO WARNING Do not discharge the PRIMEDIC DefiMonitor EVO into the open air. To remove an unwanted charge, change the energy selection, or change the mode, or turn off the PRIMEDIC DefiMonitor EVO.
  • Page 20 Safety Information WARNING The PRIMEDIC DefiMonitor EVO should be out of contact with water puddles. It may cause electrical shocks and device failure. Electrical safety of the PRIMEDIC DefiMonitor EVO may not work properly when wet. WARNING Defibrillation may cause implanted devices to malfunction. Place standard paddles or pads away from implanted devices if possible.
  • Page 21 The module has been tested and certified to be equipped safely. WARNING Do not immerse any portion of the PRIMEDIC DefiMonitor EVO in water or other fluids. Avoid spilling any fluids on PRIMEDIC DefiMonitor EVO or accessories. Spilled liquids entering the interior of the device may cause the PRIMEDIC DefiMonitor EVO and accessories to perform inaccurately or fail.
  • Page 22 Medical electrical equipment which does not incorporate defibrillator protection should be disconnected during defibrillation. WARNING Operating the PRIMEDIC DefiMonitor EVO or its accessories in conditions outside the environmental specifications can result in device or accessory malfunction. The PRIMEDIC DefiMonitor EVO should be allowed to stabilize within the operating temperature range prior to operation.
  • Page 23 Federal law restricts this device to sale by or on the order of a physician. CAUTION The PRIMEDIC DefiMonitor EVO may not operate properly if it is operated or stored at conditions outside the ranges stated in this manual, or subjected to excessive shock or dropping.
  • Page 24 Safety Information CAUTION Accessory equipment connected to the PRIMEDIC DefiMonitor EVO’s data interface must be certified according to IEC60950 for data-processing equipment or IEC60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC60601-1-1 system requirements. Anyone who connects additional equipment to the signal input or signal...
  • Page 25 Intended Use for the PRIMEDIC DefiMonitor EVO The PRIMEDIC DefiMonitor EVO is intended for use by trained medical technician, doctor, nurse or medical specialist in outdoor and indoor emergency care settings including ground and air ambulances within the environmental conditions specified. Manual and Automated external defibrillation, External pacing, Diagnostic electrocardiography (12-lead ECG) are intended for use on adult and pediatric patients.
  • Page 26 About this Manual This manual explains how to set up and use the PRIMEDIC DefiMonitor EVO. Read the entire manual including the Safety Information section, before you operate the PRIMEDIC DefiMonitor EVO. 26 / 325...
  • Page 27  Second step of an action you should take.  etc. Follow the instructionsin the order of the Operating Instructions. This line marks lists • Numbers in brackets refer to items in diagrams. Operating Instructions DefiMonitor EVO / GB / B01 27 / 325...
  • Page 28 Identifying the PRIMEDIC DefiMonitor EVO Configurations The following table identifies PRIMEDIC DefiMonitor EVO configurations and how they are indicated. The reference number and serial number are located on the back of the product. All information in this manual, including the illustrations, is based on a device configured with...
  • Page 29 Description of the PRIMEDIC DefiMonitor EVO Description of the PRIMEDIC DefiMonitor EVO Front Panel Components Figure 1 Front panel components Paddles (Sternum + Apex) SHOCK button Status LEDs Multi function knob LCD Display Pacing Mode buttons Soft key NIBP button...
  • Page 30 Description of the PRIMEDIC DefiMonitor EVO Table 1: PRIMEDIC DefiMonitor EVO Front Panel Controls Symbols Description Mode Select Switch Selects five modes of operation: AED: Automated External Defibrillation • MAN: Manual Defibrillation • MONITOR: Patient monitoring mode • • PACER: External Pacing Mode •...
  • Page 31 Description of the PRIMEDIC DefiMonitor EVO Symbols Description Rate button Adjusts the rate of pacing waveform mA button Adjusts the current of pacing waveform NIBP button Toggles between starting and stopping NIBP measurements. PRINT button Prints measured data. ALARM button Pauses the audible alarm temporarily.
  • Page 32 Description of the PRIMEDIC DefiMonitor EVO Table 2: PRIMEDIC DefiMonitor EVO paddle controls Symbols Description APEX Paddle SHOCK button To deliver shock REC button Prints the measured data CHARGE button charges to the desired energy level automatically. LED indicates completion of charging process.
  • Page 33 Description of the PRIMEDIC DefiMonitor EVO Rear Panel Components Figure 3: Rear Panel Components 1 AC connector 4 Lock plates 2 GND terminal 5 Charger contacts 3 Power supply 6 Rechargeable battery Operating Instructions DefiMonitor EVO / GB / B01...
  • Page 34 Description of the PRIMEDIC DefiMonitor EVO Left Panel Components Figure 4: Left Panel Components 1 Temperature 1 connector 4 Temperature 2 connector 2 EtCO₂ connector 5 IBP 1 connector 3 NIBP connector 6 IBP 2 connector 34 / 325 DefiMonitor EVO / GB / B01...
  • Page 35 Description of the PRIMEDIC DefiMonitor EVO Right Panel Components Figure 5: Right Panel Components 1 Paddle/Pads connector 3 SpO2 connector 2 ECG connector 4 USB/SD Card Slot Operating Instructions DefiMonitor EVO / GB / B01 35 / 325...
  • Page 36 Description of the PRIMEDIC DefiMonitor EVO Table 3: Panel and Label Symbols Symbol Symbol Description Description IP55 AC indicator Dust and water resistance Direct current CE mark Battery charging status indicator Consult Instructions for use Service indicator Separate Collection Type CF- Defibrillator Proof...
  • Page 37 Description of the PRIMEDIC DefiMonitor EVO Display 4 5 6 Figure 6: Display Shock count number/Icon SpO2 waveform Defibrillator message IBP waveform area Battery status icons EtCO2 waveform WiFi/3G icon Alarm/informative message area Elapsed time (power on) Waveform area Bed number...
  • Page 38 Description of the PRIMEDIC DefiMonitor EVO Table 4: Display Symbols Symbols Symbols Description Description ECG source: Paddle Temperature unit: Celsius ECG source: Lead l Temperatureunit: Fahrenheit ECG source: Lead ll SpO2 unit or EtCO2 unit: % ECG source: Lead lll...
  • Page 39 Description of the PRIMEDIC DefiMonitor EVO Symbols Symbols Description Description IBP1 waveform icon Alarm active IBP2 waveform icon Audio pause Audio off or Limit alarm IBP2 waveform icon pause IBP2 waveform icon Pacer pulse detection icon IBP 2 waveform icon...
  • Page 40 Description of the PRIMEDIC DefiMonitor EVO Table 5: Display Colors Factory Defaults Function Color ECG Waveform Green SpO2 Waveform Cyan Respiration Waveform Light Blue EtCO2 Waveform Light Purple Green NIBP White SpO2 Cyan Respiration Rate Light Blue EtCO2 Light Purple...
  • Page 41 Setting up the PRIMEDIC DefiMonitor EVO WARNING Do not immerse any portion of the PRIMEDIC DefiMonitor EVO in water or other fluids. Avoid spilling any fluids on PRIMEDIC DefiMonitor EVO or accessories. Spilled liquids entering the interior of the device may cause the PRIMEDIC DefiMonitor EVO and accessories to perform inaccurately or fail.
  • Page 42 Note information. Set the PRIMEDIC DefiMonitor EVO to the user’s intended position where the user can easily recognize the visual and audible monitoring conditions. Normally it is recommended to set at a distance of 1m from the user. Also the viewpoint is at any point within the base of a cone by an angle of 30°...
  • Page 43 Setting up the PRIMEDIC DefiMonitor EVO Part number Name 96892 Nellcor SpO2 Finger Sensor 97223 Extension Hose for Blood Pressure Cuff 97312 Blood Pressure Cuff Small (13-22 cm ) 97313 Blood Pressure Cuff Medium (22-32cm ) 97222 Blood Pressure Cuff Large (32-42cm )
  • Page 44 Do not connect to an electrical outlet controlled by a wall switch or dimmer because the device may be accidentally turned off. CAUTION If the integrity of the AC power source is in doubt, the DefiMonitor EVO must be operated from its internal battery. 4.3.1...
  • Page 45  Verify that the DC power input icon appears on the screen, Battery charging status LED and AC/DC in LED on the PRIMEDIC DefiMonitor EVO’s front panel is lit. Battery A charging status LED indicates battery A is installed and being charged...
  • Page 46 Setting up the PRIMEDIC DefiMonitor EVO If the Battery charging status LED is not lit, check: Note the power cord • the connection of the PRIMEDIC Charger EVO to its DC power • source the AC input connector • the electrical contact between the PRIMEDIC DefiMonitor EVO’s DC •...
  • Page 47 4.4.1 ECG Cables and Leads Connect an ECG cable to the “ECG” connector on the right connector panel of the PRIMEDIC DefiMonitor EVO making sure that the mechanical codings of connector and plug are matching.
  • Page 48 Figure 10: Connecting the Paddle/Pads connector to the defibrillator’s plug  Connect the paddle or the adapter cable for connection to adhesive pads to paddle / pads connector on the on the right connector panel of the PRIMEDIC DefiMonitor EVO.
  • Page 49  Connect the interface cable(s) for the transducer(s) to the “IBP” connector on the left connector panel of the PRIMEDIC DefiMonitor EVO (see Figure 4: Left Panel Components). An interface cable for the transducer has to be selected correctly as it depends on the transducer type (refer to chapter 18).
  • Page 50 Recharging the battery is strongly recommended when it has not been fully recharged for 6 or more months. CAUTION Do not install the battery into the PRIMEDIC DefiMonitor EVO when storage may exceed 90 days. Battery damage may occur. 50 / 325...
  • Page 51 Check for the battery-in-use indication when the PRIMEDIC DefiMonitor EVO is operating on mains and apply corrective action. CAUTION Do not operate the PRIMEDIC DefiMonitor EVO without a battery. Keep a fully charged spare battery pack with the device at all times. CAUTION Partial charge of battery results in a shortened service life.
  • Page 52 It is recommended to keep AC power source connected to the PRIMEDIC Note DefiMonitor EVO when not in use. This will ensure a fully charged battery whenever it is needed. As the battery is used and recharged over a period of time, the amount of time...
  • Page 53 Battery Operation Operating the DefiMonitor EVO on Battery Power The PRIMEDIC DefiMonitor EVO has a rechargeable battery that can be used to power the device when AC power sourceor a DC power supply by the PRIMEDIC Charger EVO is not available.
  • Page 54 No recording • Ambient temperature at 25°C±5°C • If there is the combination of battery A and B in the PRIMEDIC DefiMonitor EVO, Note two new, fully charged batteries will provide 10 hours monitoring operation. 54 / 325 DefiMonitor EVO / GB / B01...
  • Page 55 This alarm cannot be paused while running on battery power. Connecting the PRIMEDIC DefiMonitor EVO to AC power will stop the alarm. A high priority alarm occurs for about 5 minutes before the PRIMEDIC DefiMonitor EVO shuts off. The “SYSTEM: Critically low battery condition” message is displayed on the screen.
  • Page 56 Using the PRIMEDIC DefiMonitor EVO Using the PRIMEDIC DefiMonitor EVO WARNING Each time the PRIMEDIC DefiMonitor EVO is used, check alarm limits to make sure that they are appropriate for the patient being monitored. WARNING If different alarm presets are used for the same or similar equipment in any single area, e.g.
  • Page 57 WARNING Ventricular fibrillation may be induced with improper synchronization. Do not use the ECG from another monitor (slaving) to synchronize the PRIMEDIC DefiMonitor EVO’s discharge. Always monitor the patient’s ECG directly through the PRIMEDIC DefiMonitor EVO’s ECG cable or pad cable.
  • Page 58 PRIMEDIC DefiMonitor EVO to disarm itself. CAUTION Do not discharge the PRIMEDIC DefiMonitor EVO except as indicated in the instructions. 58 / 325 DefiMonitor EVO / GB / B01...
  • Page 59 CAUTION Be sure to safely discharge external paddles. Turning on the DefiMonitor EVO Before using the PRIMEDIC DefiMonitor EVO, confirm that it is working properly and is safe to use as described below. CAUTION Look for display motion before accepting any displayed data as a current measurement.
  • Page 60 Using the PRIMEDIC DefiMonitor EVO If unusual sound like buzzer can be heard, do not use the DefiMonitor EVO. Note Instead, please contact qualified service personnel or your local supplier. Figure 12: Mode Select Knob Rotate Mode Select Knob to desired mode.
  • Page 61 Menu will appear. Table 8: Date/Time Menu Level 1 Menu Level 2 Menu or Response Date format YY/MM/DD MM/DD/YY DD/MM/YY Return Set Date Year Month Return Set Time Hour Minute Operating Instructions DefiMonitor EVO / GB / B01 61 / 325...
  • Page 62 The PRIMEDIC DefiMonitor EVO retains the previous settings when it is turned off for less than 10 seconds. And if the PRIMEDIC DefiMonitor EVO was not turned off and less than 10 minutes have elapsed since the operation mode was last used, the PRIMEDIC DefiMonitor EVO retains the previous settings of last operation mode.
  • Page 63 4-ch Wave Screen: ECG + SpO2 + ABP + EtCO2 Figure 15: Normal Screen (4 waveform, Defibrillation mode, Full option) Large Numeric Screen Figure 16: Large Numeric Screen (2 waveform, Defibrillation mode, Full option) Operating Instructions DefiMonitor EVO / GB / B01 63 / 325...
  • Page 64 Using the PRIMEDIC DefiMonitor EVO Black-white Invert Screen (Mono-color screen) Figure 17: Black-white Screen (4 waveform, Defibrillation mode, Full option) 64 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 65 Alarms and Limits Alarms and Limits WARNING Each time the PRIMEDIC DefiMonitor EVO is used, check alarm limits to make sure that they are appropriate for the patient being monitored. WARNING If different alarm presets are used for the same or similar equipment in any single area, e.g.
  • Page 66 Alarms and Limits Each key-control should result in some audible tone to prevent invalid key-controls Note of being ignored. Have the PRIMEDIC DefiMonitor EVO serviced if the key- controls fail. 7.1.1 Changing Alarm Volume User can select an alarm volume level of 1 to 8.
  • Page 67 2 seconds when the PRIMEDIC DefiMonitor EVO is in multiple alarm conditions.Refer to chapter 26 for recommended actions. 7.2.1 High Priority Alarms A high priority alarm indicates that immediate operator response is required.
  • Page 68 (ex {label}: P1, P2, ABP, CVP, PAP, LAP) {label}: Low systolic blood pressure limit IBP Under the systolic lower limit violated (ex {label}: P1, P2, ABP, CVP, PAP, LAP) 68 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 69 Temp High Temperature limits violated TEMP1: High Temperature limits violated TEMP2: High Temperature limits violated Low Temperature limits violated TEMP1: Low Temperature limits violated TEMP2: Low Temperature limits violated Operating Instructions DefiMonitor EVO / GB / B01 69 / 325...
  • Page 70 LAP) Out of range {label}: Out of range. (ex {label}: P1, P2, ABP, CVP, PAP, LAP) Cable/Sensor disconnected {label}: Cable/Sensor disconnected. (ex {label}: P1, P2, ABP, CVP, PAP, LAP) 70 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 71 EtCO2: Sensor Disconnected Adapter Calibration Failed EtCO2: Adapter Calibration failed Check Adapter EtCO2: Check Adapter Printer out of paper SYSTEM: Printer out of paper System Low Battery SYSTEM: Low Battery Operating Instructions DefiMonitor EVO / GB / B01 71 / 325...
  • Page 72 6/12 lead data tranmitted SYSTEM : 6/12lead data transmitted Telemetry module not available SYSTEM : Telemetry module not available There may be other informative messages that are not listed above. Note 72 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 73 Alarms and Limits 7.2.5 Defibrillator messages PRIMEDIC DefiMonitor EVO messages indicate a condition related to Manual Mode, AED Mode and Pacing Mode. Table 13: Defibrillator Messages Condition Messages Voice prompt Unit OK Unit OK. Unit Fail Unit Fail. Low Battery Low Battery, insert fresh battery.
  • Page 74 Select mA Pacing Paused Pacing paused Pacing stopped. ECG lead Pacing stopped. ECG lead off. off. Pacing stopped. Pads off. Pacing stopped. Pads off. Pacer output Pacer output ○○○mA 74 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 75 Do not turn off the audible alarm or decrease its volume if patient safety could be compromised. WARNING Make sure that the DefiMonitor EVO speaker is not obstructed. Failure to do so could result in an inaudible alarm tone. Operating Instructions...
  • Page 76 Verifying Audible Alarm Indication If the PRIMEDIC DefiMonitor EVO fails to perform as specified in this test, contact qualified service personnel or your local supplier for assistance. You can verify the alarm operation for all parameters like ECG, SpO2, NIBP, Temp, EtCO2, IBP and Respiration by following the below procedures.
  • Page 77 Changing Alarm Limits WARNING Each time the DefiMonitor EVO is used, check alarm limits to make sure that they are appropriate for the patient being monitored. WARNING If different alarm presets are used for the same or similar equipment in any single area, e.g.
  • Page 78 Alarms and Limits Figure 19: Alarm Limit Menu 7.6.2 Alarm Limits Ranges Table 16 describes the possible alarm limits. The PRIMEDIC DefiMonitor EVO is shipped with factory default settings. Authorized personnel can define the way to save the power-up default settings. Note The detailed information is described in the service manual.
  • Page 79 -45 ~ 300 mmHg, 90 mmHg -50 ~ 295 mmHg, 50 mmHg 5 mmHg (0.6 or 0.7 kPa) (-6.0 ~ 40.0 kPa, 12.0 kPa) (-6.7 ~ 39.3 kPa, 6.7 kPa) P1 Diastolic (mmHg, kPa) Operating Instructions DefiMonitor EVO / GB / B01 79 / 325...
  • Page 80 -45 ~ 300 mmHg, 70 mmHg -50 ~ 295 mmHg, 40 mmHg 5 mmHg (0.6 or 0.7 kPa) (-6.0 ~ 40.0 kPa, 9.3 kPa) (-6.7 ~ 39.3 kPa, 5.3 kPa 80 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 81 WARNING If an alarm condition occurs while in the Audio Off state, the only alarm indication on the PRIMEDIC DefiMonitor EVO will be visual displays related to the alarm condition. WARNING Default startup setup is with Audio off on Power ON. If Audio Alarms are required, make sure to activate audio alarm ON for the patient being monitored.
  • Page 82 The periods can only be changed by authorized personnel via the Service menu. Note Alarm Off may disable the visual alarm manifestation if sensors, probes, or Note modules are intentionally disconnected by operator. 82 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 83 Metrax GmbH. WARNING Line isolation PRIMEDIC DefiMonitor EVO transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. Such transients may be minimized by proper electrode and cable placement, as specified in this manual and electrode directions for use.
  • Page 84 This will minimize interference and the risk of burns to the patient.. WARNING For pacemaker patients, the PRIMEDIC DefiMonitor EVO may continue to count pacemaker rate during occurrences of cardiac arrest or some arrhythmias. To reduce the likelihood of this, ensure that the Pacer Detect setting is On in the ECG waveform Menu when monitoring such patients.
  • Page 85 EVO processes and amplifies these signals and presents the ECG waveform on the screen. Also, the PRIMEDIC DefiMonitor EVO computes the minute heart rate at least every second by moving average. In addition to the acquisition of the QRS complex, the circuitry performs a number of other functions.
  • Page 86 One of 5-1 to 5-6 Lead electrode placement sites for the fifth lead. Note  Connect the ECG lead.  Connect the ECG lead to the ECG connector on the PRIMEDIC DefiMonitor EVO’s right connector panel.  Attach the leads to the electrodes, and then apply the electrodes to the patient, using the color-code guide inTable 18.
  • Page 87 PR and QT intervals, hypertrophy, early repolarization, myocardial infarction and culprit artery detection. Operating Instructions DefiMonitor EVO / GB / B01 87 / 325...
  • Page 88 Six V/C electrodes are placed on the chest as shown in Figure 26: 12 lead Placement. The right leg electrode is the neutral electrode. This PRIMEDIC DefiMonitor EVO is equipped with epoch-making monitoring function incorporating the cutting edge software for...
  • Page 89 Basically the approach conforms to the recommendations of the CSE working party (of which one of the Glasgow team was a member), which were published in 1985. Figure 22: Varying choice of baselines Operating Instructions DefiMonitor EVO / GB / B01 89 / 325...
  • Page 90 (Q or R) of the QRS complex as recommended by the CSE group. Similar considerations apply at the end of the QRS complex (Figure 24). A sorting algorithm is then 90 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 91 This was found to be more reliable than fitting a straight line between P onset and P termination even in cases where the P wave was superimposed on the T wave in the case of a tachycardia. Operating Instructions DefiMonitor EVO / GB / B01 91 / 325...
  • Page 92  Attach the 12 lead cable lead wires to the electrodes on the patient.  Attach the 12 lead cable to the PRIMEDIC DefiMonitor EVO right connector panel.  Turn on the Monitor Mode of DefiMonitor EVO by rotating the Mode select knob to Monitor Mode.
  • Page 93 RESTRICTED ANALYSIS • MISCELLANEOUS PRELIMINARY STATEMENTS • 8.5.2 Measurement Parameter Measurement parameters are fundamentally obtained after ECG analysis. HEART RATE • INTERVALS • ATRIAL ABNORMALITIES • QRS AXIS DEVIATION • Operating Instructions DefiMonitor EVO / GB / B01 93 / 325...
  • Page 94 8.5.6 Measurement Matrix The electrocardiographs can be programmed so that the Measurement Matrix is written out after the analysis report. The Measurement Matrix consists of 12 columns which contain 94 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 95 Amplitude in microvolts at a point which is 2/8 of the ST-T interval. 3/8STT Amplitude in microvolts at a point which is 3/8 of the ST-T interval. T+AMP T+ wave amplitude in microvolts. Operating Instructions DefiMonitor EVO / GB / B01 95 / 325...
  • Page 96 EtCO2 are not visible on the Preview Screen, related alarms, measurements and alarm messages remain active and are reported in Parameter Blocks 1 and 2 and the general status area. 96 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 97 Bell icon HR/PR unit Figure 30: ECG Waveform Display ECG waveform icon ECG lead pair ECG waveform HR/PR source Pacer Detect Filter Select Alarm Limit Return Figure 31: HR/PR Menu Operating Instructions DefiMonitor EVO / GB / B01 97 / 325...
  • Page 98 You may select Auto, HR or PR to decide the source of the heart rate or pulse rate. If you select Auto, the PRIMEDIC DefiMonitor EVO automatically derives the heart rate or pulse rate from one of the monitoring parameters in this order of priority: ECG, IBP, SpO or NIBP.
  • Page 99 ECG Monitoring 8.7.3 Filter Select The PRIMEDIC DefiMonitor EVO can filter ECG waveform noise with different ranges of frequency response: 0.5 Hz to 21 Hz: Expands the range to display very low frequencies down to 0.5 Hz. 0.05 Hz to 40 Hz: Choose this mode to see just the ECG waveform monitoring.
  • Page 100 AED (Automated External Defibrillator) Mode AED (Automated External Defibrillator) Mode WARNING The PRIMEDIC DefiMonitor EVO will only administer a shock if it is needed. A voice prompt will tell you when to press the SHOCK button to administer defibrillation therapy.
  • Page 101 PRIMEDIC DefiMonitor EVO is charging for defibrillation and delivering a shock. The AED Mode of the PRIMEDIC DefiMonitor EVO is designed for the treatment of sudden cardiac arrest (SCA). It should only be used to treat someone who may be a victim of a SCA...
  • Page 102 Survival for an SCA victim depends on immediate cardio-pulmonary resuscitation (CPR). The use of an external PRIMEDIC DefiMonitor EVO within the first few minutes of collapse can greatly improve the patients' chances of survival. Heart attack and SCA are not the same, though sometimes a heart attack can lead to a SCA.
  • Page 103 Note physiological state and the circumstances surrounding the patient incident. Failure to have a successful patient outcome is not a reliable indicator of PRIMEDIC DefiMonitor EVO’s performance. The presence or absence of a muscular response to the transfer of energy during electrical therapy is not a reliable indicator of energy delivery or device performance.
  • Page 104 Aggressive handling of multifunction pads in storage or prior to use can damage the pads. Discard the pads if they become damaged. Impedance is the resistance between the PRIMEDIC DefiMonitor EVO’s pads or Note paddles that the PRIMEDIC DefiMonitor EVO must overcome to deliver an effective discharge of energy.
  • Page 105 AED if there is an AED nearby.. Start chest compressions. 30 Compressions 2 Breaths After 30 compressions open the airway again and deliver UNTIL EMC ARRIVE. two rescue breaths. Operating Instructions DefiMonitor EVO / GB / B01 105 / 325...
  • Page 106 (approximately 2minutes) 9.5.1 Using AED Mode  Turn on the AED Mode of PRIMEDIC DefiMonitor EVO by rotating the Mode select knob.  Verify the AED Mode of PRIMEDICDefiMonitor EVO is activated normally and follow audio guidance and STEP icon.
  • Page 107 < Give 30 chest compressions > [Beep] <Give two rescue breaths.> <Stop chest compression.>If pads are connected to PRIMEDIC DefiMonitor EVO during STEP3, DefiMonitor EVO will go on to STEP4 directly. STEP 4 < Remove clothes from the patient's chest.
  • Page 108 DefiMonitor to AC power or place it on the PRIMEDIC Charger EVO (DC-DC adaptor).  <Resume analyzing.>: Pressing the Resume analyzing button at the bottom of the the PRIMEDIC DefiMonitor, CPR will be stopped.  Move to Step 5. 108 / 325...
  • Page 109 At least more than 100 beats per minutes is the recommended rate to perform compressions under AHA/ERC 2010 guidelines. The PRIMEDIC DefiMonitor EVO will remain in CPR mode for 2 minutes or 5 cycles. After 2 minutes of CPR you will hear the following voice prompt: <...
  • Page 110 Event records Data review Print Return Name Gender Return NIBP history Print Return 6/12 lead records Print Transmission Name Gender Return Return Mission printout Return Pediatric ON / OFF 110 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 111 The following menu entries in AED Mode may be activated in the service menu: Note 12 Lead • Setup • Alarm limit • Please refer to chapter 21 for layout of these menus. Operating Instructions DefiMonitor EVO / GB / B01 111 / 325...
  • Page 112 Disconnect non-defibrillation-proof electronic devices or equipment from patient before defibrillation. WARNING The PRIMEDIC DefiMonitor EVO has a mechanism to inhibit its output when the impedance of human body which can be measured by paddle is out of range between 15 and 250 Ohm.
  • Page 113 The defibrillator may be damaged internally and unusable to resuscitate a patient.  Do not discharge DefiMonitor EVO with the paddle surfaces shorted together  Use self-test functionality for testing.  Use paddles only as described in the operating instructions.
  • Page 114  Attach the adapter cable for PRIMEDIC SavePads to the PRIMEDIC DefiMonitor EVO.  Unpack the PRIMEDIC SavePads and plug in their connector to the adapter cable.  Remove the protective film from the adhesive pads and place them on the patient’s bare chest according to the positions indicated on the back side of the...
  • Page 115 Manual Mode 10.3 Operating the Manual Mode of PRIMEDIC DefiMonitor EVO  Select Manual Mode of PRIMEDIC DefiMonitor EVO by rotating the Mode select knob.  When the Manual Mode of PRIMEDIC DefiMonitor EVO is activated normally, the energy select display will be displayed on the top of the screen and other parameter information will be displayed.
  • Page 116 When using paddles, you should monitor the ECG through monitoring electrodes connected to a 3-, 5- or 12- lead ECG cable and a PRIMEDIC DefiMonitor EVO. You may choose to monitor through an alternate source when using pads, as well. Cardioversion is still delivered through either pads or paddles.
  • Page 117 It is important to continue to hold the SHOCK button (or the paddle SHOCK Note buttons) until the shock is delivered. The PRIMEDIC DefiMonitor EVO shocks with the next detected R-wave. Defibrillation current can cause operator or bystander injury. Do not touch the Note patient, or other equipment connected to the patient, during defibrillation.
  • Page 118 Wave Sector 1. Repeat Steps 2-5 above. To turn off the Sync function of the DefiMonitor EVO, press the Sync off soft key. The maximum time delay between synchronization pulse and delivery of energy Note does not exceed 60ms.
  • Page 119 Patient info Name Gender None Male Female Return Event records Data review Name Gender Return Return NIBP history 6/12 lead records Print Transmission ID # Name Gender Return Return Operating Instructions DefiMonitor EVO / GB / B01 119 / 325...
  • Page 120 Printer Setting Print on alarm Print on shock 6/12 lead auto printing Analyze auto printing Return Erase data Erase 6/12 lead records Erase event records Erase internal memory Return 120 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 121 I, II, III, aVL, aVF, 4th Waveform aVR, Pads, V1, V2, V3, V4, V5, V6 SpO2 RESP IBP1 IBP2 EtCO2 Return Display Mode Brightness Large numeric display Black-white Invert Mode Return Operating Instructions DefiMonitor EVO / GB / B01 121 / 325...
  • Page 122 Manual self-test Button test Service menu (Display 3 digit code) Return Alarm Limit ▲: Upper Alarm Limit ▼: Lower Alarm Limit Limit Alarm On, Off Pause Patient Info Name 122 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 123 Event records Data review Print Name Gender None Male Female Return Return Return NIBP history Print Return 6/12 lead records Print Transmission Name Gender None Male Female Return Return Return Operating Instructions DefiMonitor EVO / GB / B01 123 / 325...
  • Page 124 0.05hz~40Hz and 0.05Hz~150Hz. 12 lead ECG is transmitted to external devices via wireless communication from the PRIMEDIC DefiMonitor EVO. To start streamin 12 Lead ECG. Press Start stream soft key, to stop streaming of 12 Lead ECG press Stop stream soft key.
  • Page 125 To Erase 12lead records, Erase event records or Erase internal memory in the PRIMEDIC DefiMonitor EVO, select the desired item with the Multi function knob, press itand select Yes or No with the Multi function knob. Pressing the Multi function knob will then perform the selected action.
  • Page 126 10.6.3 Alarm Limit Figure 38: Alarm Limit Menu Press the Multi function knob to select Alarm limits. The PRIMEDIC DefiMonitor EVO will display all alarm limits thatare currently in effect for all monitored parameters. Select the alarm limits to set.
  • Page 127  Press the Sync On / Off soft key to operate the Sync mode. When pressing Sync On soft key, Sync On soft key will be changed to Sync off soft key. Operating Instructions DefiMonitor EVO / GB / B01 127 / 325...
  • Page 128 If you are using the pacing function with battery power and the low battery appears, plug the device into AC power. When the device powers back up, pacing is no longer activated. Press Pacer to re-activate the pacing function. 128 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 129 Pacing therapy is used to deliver pace pulses to the heart. Pace pulses are delivered through multifunction electrode pads that are applied to the patient’s bare chest. Use only approved lead sets when pacing with the PRIMEDIC DefiMonitor EVO Note...
  • Page 130 ECG noise makes R-wave detection unreliable or when monitoring electrodes are not available. The DefiMonitor EVO requires a 3-, 5-, 12-lead ECG cable and monitoring electrodes as the source of the ECG during standard pacing. Pace pulses are delivered through the multifunction electrode pads.
  • Page 131  When the RATE button is pressed, each color of pulse rate value is changed and it can be modified.  The ‘Select BPM’ PRIMEDIC DefiMonitor EVO message is displayed.  Press and rotate the Multi function knob to select the desired value of pace pulses per minute.
  • Page 132  When the RATE button is pressed, each color of Pulse rate value is changed and it can be modified.  The ‘Select BPM’ PRIMEDIC DefiMonitor EVO message is displayed.  Rotate the Multi function knob to the desired value of pace pulse per minute and then press the Multi function knob to select the desired value of pace pulse per minute.
  • Page 133 Pacing Mode  The ‘Select mA’ PRIMEDIC DefiMonitor EVO message is displayed.  Rotate the Multi function knob to the desired output value and then press the Multi function knob to select the desired output value. The value is changed by 2 mA.
  • Page 134 Erase data Erase 6/12 lead records Erase event records Erase internal memory Return Waveform setting 2 Waveform I, II, III, aVL, aVF, aVR, Pads, V1, V2, V3, V4, V5, V6 134 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 135 V3, V4, V5, V6 RESP IBP1 IBP2 EtCO Return Display Mode Brightness Large numeric display Black-white Invert Mode Return Clinical action list Items 1-10 on Clinical Action List Return Operating Instructions DefiMonitor EVO / GB / B01 135 / 325...
  • Page 136 Button test Service menu (Display 3 digit code) Return Alarm Limit ▲: Upper Alarm Limit ▼: Lower Alarm Limit Limit Alarm On, Off Pause Patient Info Name Gender None 136 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 137 Print Name Gender None Male Female Return Return Return NIBP history Print Return 6/12 lead records Print Transmission Name Gender None Male Female Return Return Return Mission printout Return Operating Instructions DefiMonitor EVO / GB / B01 137 / 325...
  • Page 138 Rotate the Multi function knob to select a volume level. Press the Multi function knob to enter a desired volume into the PRIMEDIC DefiMonitor EVO. Printer setting This menu allows you to set Print on alarm, Print on shock, 12 lead auto printingor Analyze auto printing.
  • Page 139 To Erase 12lead records, Erase event records or Erase internal memory in the PRIMEDIC DefiMonitor EVO, select the desired item with the Multi function knob, press it and select Yes or No with the Multifunction knob. Pressing the Multifunction knob will then perform the selected action.
  • Page 140 11.6.3 Alarm Limit Figure 43: Alarm Limit Menu Press the Multi function knob to select Alarm limits. The PRIMEDIC DefiMonitor EVO will display all alarm limits that are currently in effect for all monitored parameters. Select the alarm limits to set.
  • Page 141 12.2 Operating the Monitor Mode of PRIMEDIC DefiMonitor EVO  Turn on the Monitor Mode of PRIMEDIC DefiMonitor EVO by rotating the Mode select knob.  When the Monitor Mode of PRIMEDIC DefiMonitor EVO is activated normally, the display will look like shown in Figure 45, according to pre-defined settings.
  • Page 142 6/12 lead Acquire Setup Filter 0.05Hz ~ 40Hz 0.05Hz ~ 150Hz Return Start stream / Stop stream (Toggle button) Return 12 lead ON / (Toggle button) Patient info Name 142 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 143 Data review Print Return Name Gender Return Return NIBP history Print Return 6/12 lead records Print Transmission ID # Name Gender Return Return Mission printout Return Return Setup Volume Alarm Operating Instructions DefiMonitor EVO / GB / B01 143 / 325...
  • Page 144 Erase 6/12 lead records Erase event records Erase internal memory Return Waveform setting 2nd Waveform I, II, III, aVL, aVF, aVR, Pads, V1, V2, V3, V4, V5, V6 SpO2 RESP 144 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 145 RESP IBP1 IBP2 EtCO2 Return Display Mode Brightness Large numeric display Black-white Invert Mode Return Clinical action list Items 1-10 on Clinical Action List Return Network setting On, Off Operating Instructions DefiMonitor EVO / GB / B01 145 / 325...
  • Page 146 (Display 3 digit Service menu code) Return Alarm Limit ▲: Upper Alarm Limit ▼: Lower Alarm Limit Limit Alarm On, Off Pause Patient Info Name Gender None Male Female 146 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 147 Gender None Male Female Return Return Return NIBP history Print Return 6/12 lead records Print Transmission Name Gender None Male Female Return Return Return Mission printout Return Emergency Mode Operating Instructions DefiMonitor EVO / GB / B01 147 / 325...
  • Page 148 Press the Multi function knob. Levels of Alarm volume, Beep volumeor Button volume will appear. Rotate the Multi function knob to select a volume level. Press the Multi function knob to enter a desired volume into the PRIMEDIC DefiMonitor EVO. 148 / 325 DefiMonitor EVO / GB / B01...
  • Page 149 To Erase 12lead records, Erase event records or Erase internal memory in the PRIMEDIC DefiMonitor EVO, select the desired item with the Multi function knob, press it and select Yes or No with the Multi function knob. Pressing the Multi function knob will then perform the selected action.
  • Page 150 12.3.3 Alarm Limit Figure 48: Alarm Limit Menu Press the Multi function knob to select Alarm limits. The PRIMEDIC DefiMonitor EVO will display all alarm limits that are currently in effect for all monitored parameters. Select the alarm limits to set.
  • Page 151 Do not place the cuff, the catheter or SpO2 sensor on an extremity being used for intravenous infusion or any area where circulation is compromised or has the potential to be compromised. Never fit NIBP system with Luer Lock adapters. Operating Instructions DefiMonitor EVO / GB / B01 151 / 325...
  • Page 152 WARNING Do not pull the hose because this could cause the disconnection of the hose from the PRIMEDIC DefiMonitor EVO and can cause a measurement error. WARNING Do not place the cuff over a wound as this could cause further injury when pressurized.
  • Page 153 In Automatic Mode, the PRIMEDIC DefiMonitor EVO displays results of the last blood pressure measurement until another measurement starts. If a patient’s condition changes during the time interval between measurements, the PRIMEDIC DefiMonitor EVO will not detect the change or indicate an alarm condition. CAUTION Any excessive patient motion may cause inaccurate measurements of non- invasive blood pressure.
  • Page 154 The PRIMEDIC DefiMonitor EVO lowers cuff pressure at a controlled rate. As the cuff pressure goes down, blood starts to flow through the artery. The increasing blood flow causes the amplitude of the pressure pulses in the cuff to increase.
  • Page 155 The main test conditions are as follow: A. Data comparing the Intra-arterial or the auscultatory by the clinical experts with the automated sphygmomanometer. B. For data collection and the data analysis, Bland-Altman Plot is used. Operating Instructions DefiMonitor EVO / GB / B01 155 / 325...
  • Page 156 The measurement technology used in the PRIMEDIC DefiMonitor EVO utilizes a unique deflation technique, Dynamic Linear Deflation. This cuff deflation technique allows the PRIMEDIC DefiMonitor EVO to measure each small change in the cuff pressure oscillations that directly correspond to the measurement’s systolic, mean and diastolic blood pressure values.
  • Page 157 Measure the patient’s limb and select a proper size cuff. As a general rule, cuff width should span approximately two-thirds of the distance between the patient’s elbow and shoulder. Connect the cuff hose to the connector on the PRIMEDIC DefiMonitor EVO’s left connector panel and turn to right to lock.
  • Page 158 Table 26: Cuff models and sizes Model Number Arm circumference (cm) Pediatric HEM-CS23 13 to 22 Adult HEM-CR23 22 to 32 HEM-CL23 32 to 42 HEM-CX23 42 to 50 158 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 159 In order to access the NIBP Menu, select the NIBP parameter window on the right side of the monitoring display using the Multi function knob. The selected parameter window is highlighted. Operating Instructions DefiMonitor EVO / GB / B01 159 / 325...
  • Page 160 The inflating pressure can be set from 120 to 280 mmHg for adult and pediatric, or from 80 to 140 mmHg for neonatal. If measurement was stopped because measurement time exceeded blood Note pressure measurement might be repeated up to 2 times. 160 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 161 The total measurement time will be integral multiple of the selected interval starting from 0 minute. 13.4.3 Limit Alarm Pause When the Limit Alarm Pause is set to On, the audible alarm for NIBP systolic, MAP and diastolic limit violation is paused. Operating Instructions DefiMonitor EVO / GB / B01 161 / 325...
  • Page 162 Do not sterilize SpO2 sensors by irradiation, steam or ethylene oxide. Refer to the cleaning instructions in the directions for use for reusable SpO2 sensors. 162 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 163 WARNING Do not pull the cable because pulling this could cause the disconnection of the cable from the PRIMEDIC DefiMonitor EVO and can cause a measurement error. WARNING Do not use a damaged sensor or cable. Do not alter the sensor or cable in any way.
  • Page 164 (such as nail polish) may interfere with oximeter performance. The operator should be thoroughly familiar with the operation of the oximeter prior to use. 164 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 165 CAUTION Reusable sensors may be used on the same site for a maximum of 4 hours, provided the site is inspected routinely to ensure skin integrity and correct positioning. Operating Instructions DefiMonitor EVO / GB / B01 165 / 325...
  • Page 166 The PRIMEDIC DefiMonitor EVO uses the pulsatile nature of arterial flow to identify the oxygen saturation of arterial hemoglobin. During systole, a new pulse of arterial blood enters the vascular bed, and blood volume and light absorption increase.
  • Page 167 When calculating saturation from a blood gas partial pressure of oxygen (PO ), the calculated value may differ from the SpO measurement of the PRIMEDIC DefiMonitor EVO. This usually occurs when saturation calculations exclude corrections for the effects of variables such as pH, temperature, the partial pressure of carbon dioxide (PCO...
  • Page 168 3 to 20 kg >30 kg OXIMAX Dura-Y® multisite oxygen transducer D-YS >1 kg (Reusable, non-sterile) For use with the Dura-Y sensor: Ear clip (Reusable, non-sterile) D-YSE >30 kg 168 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 169 In order to access the SpO Menu, select the SpO parameter window on the right side of the monitoring display using the Multi function knob. The selected parameter window is highlighted. Operating Instructions DefiMonitor EVO / GB / B01 169 / 325...
  • Page 170 Lower Alarm Limit Limit Alarm Pause: On, Off Return Return Limit Alarm Pause When the Limit Alarm Pause is set On, the audible alarm for SpO limit violation is paused. 170 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 171 PRIMEDIC DefiMonitor EVO can cause inaccurate respiration readings. Do not rely entirely on the PRIMEDIC DefiMonitor EVO respiration readings for patient assessment. If measured waveforms are not appropriate readings, check external conditions to ensure there is no equipment causing...
  • Page 172 Impedance respiration source (IM). The airway respiration measurement uses gases coming into the airway adapter in case of the CO2 equipped. The DefiMonitor EVO detects respiration rate by computing each breath cycle form the continuous EtCO2 waveform; Airway respiration source (AW).
  • Page 173 Impedance respiration monitoring is active only if the paddles are not connected to Note the PRIMEDIC DefiMonitor EVO or if pads are not connected to pads cable. In case pads or paddles are connected, the respiration rate is displayed as “---” and waveform of respiration is not displayed on the screen.
  • Page 174 User can select either Airway or Impedance for source of the respiration rate. If the Auto option is selected, the PRIMEDIC DefiMonitor EVO will automatically derive the respiration rate from one of the monitoring parameters in this order of priority: First Airway and then Impedance.
  • Page 175 When the patient’s breath is not detected from the airway measurement for the selected time setting, the PRIMEDIC DefiMonitor EVO will activate an apnea alarm. When 60 seconds is selected, the PRIMEDIC DefiMonitor EVO will generate two tones after 20 seconds without any breath detected.
  • Page 176 PRIMEDIC DefiMonitor EVO is functioning correctly. WARNING The PRIMEDIC DefiMonitor EVO should not be used as an apnea monitor. WARNING To ensure patient safety, do not place the PRIMEDIC DefiMonitor EVO in any position that might cause it to fall on the patient.
  • Page 177 The mainstream/sidestream capnography module should not be used in the presence of flammable anesthetics or other flammable gases. Use of this device in such an environment may present an explosion hazard. Operating Instructions DefiMonitor EVO / GB / B01 177 / 325...
  • Page 178 In high-altitude environments, EtCO2 values may be lower than values observed at sea level, as described by Dalton's law of partial pressures. When using the PRIMEDIC DefiMonitor EVO in high-altitude environments, it is advisable to consider adjusting EtCO2 alarm settings accordingly.
  • Page 179 This help keep patient secretions from pooling into the tubing. CAUTION To prevent moisture from during into the mainstream airway or into the sidestream airway adapter tubing, do not place the adapter in a gravity dependent position. Operating Instructions DefiMonitor EVO / GB / B01 179 / 325...
  • Page 180 16.3 Setup Connections The DefiMonitor EVO has one capnography sensor receptacle which may be used for a mainstream capnography sensor or a sidestream capnography sensor. Capnography is not analysed during unit warm-up. However, the capnograph does Note display values to indicate that the monitor is working properly.
  • Page 181 16.3.3 Sidestream Operation Sidestream monitoring uses an external, sidestream sensor that plugs into the capnography port on the PRIMEDIC DefiMonitor EVO. Adult, pediatric, or infant sampling lines are then plugged into the sensor receptacle. Respiration can be monitored for intubated or non- intubated patients via an airway adapter, nasal cannula, or nasal/oral cannula using the sidestream function of the module.
  • Page 182 Sampling cell Sidestream CO sensor 16.4 Description of EtCO Menu Functions Figure 67: EtCO2 Display EtCO icon EtCO unit EtCO value Bell icon InCO icon InCO unit InCO value 182 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 183 To access the EtCO Menu, select the EtCO parameter window on the right side of the monitoring display using the Multi function knob. The selected parameter window is highlighted. Operating Instructions DefiMonitor EVO / GB / B01 183 / 325...
  • Page 184 If capnography is activated using the EtCO soft key, display of EtCO (end-tidal partial pressure of carbondioxide in respiratory gases) value and InCO (inspired carbon dioxide) value and display of capnogram are activated. 184 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 185  When switching the mainstream sensor from one airway adapter type to another, such as when switching from a disposable to a reusable airway adapter.  When requested by the PRIMEDIC DefiMonitor EVO. Zeroing is not required when switching from the same type of airway adapter, such Note as a disposable to a disposable airway adapter.
  • Page 186 16.4.3 Limit Alarm Pause When Limit Alarm Pause is set to On, the audible alarm forEtCO or InCO or limit violation is paused. 186 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 187 The PRIMEDIC DefiMonitor EVO is designed to accept the signals from a range of electrically isolated temperature probes from YSI-400 and YSI-700 series. The probes may be used for skin or rectal temperature measurement.
  • Page 188 In order to access the Temperature Menu, select the Temperature parameter window on the right side of the monitoring display using the Multi function knob. The selected parameter window is highlighted. 188 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 189 The temperature unit can only be changed by authorized personnel via the Service Note Menu. 17.4.1 Limit Alarm Pause When the Limit Alarm Pause is set to On, the audible alarm for Temperature limit violation is paused. Operating Instructions DefiMonitor EVO / GB / B01 189 / 325...
  • Page 190 5 VDC, and a measurement range of -50 to 300mmHg. WARNING Do not reuse disposable (single use) transducers. WARNING Check the time limit on the package not to use transducers with expired dates. 190 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 191 To ensure patient safety, do not contact any conductive parts to the applied part. WARNING Never install or remove the IBP module while the PRIMEDIC DefiMonitor EVO is powered on. It is likely to break when installing or removing it while powered on.
  • Page 192 To reduce this respiration artifact the module uses a variable weight filter technique in the processing of the pressure values. 192 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 193 Connect the interface cable for the transducer to the IBP connector (6pin, red round connector) on the PRIMEDIC DefiMonitor EVO’s left connector panel. An interface cable for the transducer has to be selected correctly as it depends on the transducer type used.
  • Page 194 SYS Lower Limit Adjust ▲ MEAN Upper Limit Adjust ▼ MEAN Lower Limit Adjust ▲ DIA Upper Limit Adjust ▼ DIA Lower Limit Adjust (Limit Alarm Pause) On, Off Return 194 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 195 The scale can be selected as 0 to 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~ 300mmHg or Auto. If Auto is selected, the PRIMEDIC DefiMonitor EVO automatically sets the scale upon the IBP measurement value.
  • Page 196 The user-selectable pressure waveform scale allows you to adjust the scale of a pressure waveform. The scale can be selected as 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~ 300mmHg or Auto. If Auto is selected, the PRIMEDIC DefiMonitor EVO automatically sets the scale upon the IBP measurement value.
  • Page 197 Pressure) or LAP (Left Atrial Pressure). 18.5.4 Limit Alarm Pause When the Limit Alarm Pause is set to On, the audible alarm for IBP 2 limit violation is paused. Operating Instructions DefiMonitor EVO / GB / B01 197 / 325...
  • Page 198 AC or DC power supply, the Self-test will not be performed. If the PRIMEDIC DefiMonitor EVO is in use at the time of a scheduled Auto Self-test, the Auto Self-test will be cancelled. If the PRIMEDIC DefiMonitor EVO is turned on when the Auto Self- test is in process, the Auto Self-test will be cancelled, and the device will be operating normally.
  • Page 199 To check the status of the battery. Real time clock test To check the accuracy of the time. Installed module alive test To check if installed measurement parameter modules are operational and working correctly. Operating Instructions DefiMonitor EVO / GB / B01 199 / 325...
  • Page 200 If there has been no fail, the service LED will be blinking. But if any fail was detected, service LED and buzzer sound will be generated (if the PRIMEDIC DefiMonitor EVO is using AC or DC power, the result of auto self-test will be displayed). If the residual of battery power has dropped below 60%, the LED and buzzer will be turned off for saving power.
  • Page 201 Self-test Function 19.6 Button test The PRIMEDIC DefiMonitor EVO has a button test function. By this, the user can check whether buttons of the device are working correctly. It can be performed by ‘Button Test’ function in Setup Menu. Button test is to check button is working correctly by pressing the denoted buttons. Button test can be divided into two types: Front panel and paddles.
  • Page 202 Rotate the Multi function knob to ‘Event records’ on the screen and press the Multi function knob to display. The event data is stored in memory. When the PRIMEDIC DefiMonitor EVO turns on and starts to measure vital signs, it saves data of elapsed time before and after 10 seconds from the point of event generation.
  • Page 203 20.3 Event Review Display Event information in graphical format for ECG data is displayed in a graph. The PRIMEDIC DefiMonitor EVO displays the event information for a 10seconds time frame before and after the event occurred. When printing the event information, all the parameters like ECG, SpO NIBP, Temp, EtCO , IBP and Respiration are printed.
  • Page 204 ID, name, NIBP value time are displayed. The newest data appears at the top of tabular trends. To scroll the NIBP history, rotate the Multi function knob when NIBP history is displayed. 204 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 205 Event Figure 84: NIBP History Operating Instructions DefiMonitor EVO / GB / B01 205 / 325...
  • Page 206 0.05 Hz ~ 150Hz Return Start stream/ Stop stream (Toggle button) Return 12 lead ON /OFF (Toggle button) Patient info Confirm Return Name Confirm Return Confirm Return Gender None Male Female Return 206 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 207 Print Transmission ID # Return Mission printout Return - Setup Patient type Adult Pediatric Neonatal Return Volume Alarm Beep Button Charging alarm Voice prompt CPR Metronome Pacing alarm Return Operating Instructions DefiMonitor EVO / GB / B01 207 / 325...
  • Page 208 Print on alarm Print on shock 6/12 lead auto printing Analyze auto printing Return Erase data Erase 6/12 lead redords Erase event records Erase internal memory Return Waveform setting 2nd Waveform 208 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 209 Menu Structure Pads SpO2 RESP IBP1 IBP2 EtCO2 3rd Waveform ECG Waveform Pads Operating Instructions DefiMonitor EVO / GB / B01 209 / 325...
  • Page 210 Menu Structure SpO2 RESP IBP1 IBP2 EtCO2 4th Waveform ECG Waveform Pads SpO2 RESP IBP1 IBP2 EtCO2 Return Display Mode Brightness 210 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 211 Network setting Wi-Fi Live streaming CPR guide display Chest compressions 30 compressions /2 breaths 15 compressions /2 breaths Continuous CPR rate 90 bpm 100 bpm 110 bpm 120 bpm Operating Instructions DefiMonitor EVO / GB / B01 211 / 325...
  • Page 212 Menu Structure Self-test Manual self-test Button test Service Menu Display 3 digit code Return 212 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 213 “ HR/PR SpO2 RESP EtCO2 InCo2 TEMP1 TEMP2 39.0 39.0 36.0 36.0 NIBP MEAN MEAN Return - Patient Info Confirm Return Name Confirm Return Confirm Return Gender Male Operating Instructions DefiMonitor EVO / GB / B01 213 / 325...
  • Page 214 Event records Data review Print Return ID # Name Gender Return Return Return NIBP history Print Return 6/12 lead records Print Transmission Name Gender Return Return Mission printout Return 214 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 215 Pediatric On/Off (Toggle button) Return 21.2 AED Mode Menu Patient info Confirm Return Name Confirm Return Confirm Return Gender Male Female Return Event records Data review Print Return Operating Instructions DefiMonitor EVO / GB / B01 215 / 325...
  • Page 216 Menu Structure ID # Name Gender Return Return NIBP history Print Return 6/12 lead records Print Transmission Name Gender Return Return Mission printout Return Pediatric On/Off (Toggle button) 216 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 217 Return Volume Alarm Beep Button Charging alarm Voice prompt CPR Metronome Pacing alarm Return Printer setting Print on alarm Print on shock 6/12 lead auto printing Analyze auto printing Operating Instructions DefiMonitor EVO / GB / B01 217 / 325...
  • Page 218 Menu Structure Return Erase data Erase 6/12 lead redords Erase event records Erase internal memory Return Waveform setting 2nd Waveform Pads SpO2 218 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 219 Menu Structure RESP IBP1 IBP2 EtCO2 3rd Waveform ECG Waveform Pads SpO2 RESP IBP1 IBP2 EtCO2 4th Waveform ECG Waveform Operating Instructions DefiMonitor EVO / GB / B01 219 / 325...
  • Page 220 Menu Structure Pads SpO2 RESP IBP1 IBP2 EtCO2 Return Display Mode Brightness Large Numeric display Black-white Invert Mode Return Clinical action list Network setting 220 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 221 /2 breaths compressions /2 breaths Continuous CPR rate 90 bpm 100 bpm 110 bpm 120 bpm Mute beep Self-test Manual self-test Button test Service Menu Display 3 digit code Return Operating Instructions DefiMonitor EVO / GB / B01 221 / 325...
  • Page 222 “ HR/PR SpO2 RESP EtCO2 InCo2 TEMP1 TEMP2 39.0 39.0 36.0 36.0 NIBP MEAN MEAN Return - Patient Info Confirm Return Name Confirm Return Confirm Return Gender 222 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 223 Female Event records Data review Print Return ID # Name Gender Return Return NIBP history Print Return 6/12 lead records Print Transmission Name Gender Return Return Mission printout Return Operating Instructions DefiMonitor EVO / GB / B01 223 / 325...
  • Page 224 0.05 Hz ~ 150Hz Return Start stream / Stop stream (Toggle button) Return 12 lead ON /OFF (Toggle button) Patient info Confirm Return Name Confirm Return Confirm Return Gender None Male Female 224 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 225 Return NIBP history Print Return 6/12 lead records Print Transmission ID # Return Mission printout Return Return - Setup Volume Alarm Beep Button Charging alarm Voice prompt CPR Metronome Operating Instructions DefiMonitor EVO / GB / B01 225 / 325...
  • Page 226 Print on alarm Print on shock 6/12 lead auto printing Analyze auto printing Return Erase data Erase 6/12 lead redords Erase event records Erase internal memory Return Waveform setting 2nd Waveform 226 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 227 Menu Structure Pads SpO2 RESP IBP1 IBP2 EtCO2 3rd Waveform ECG Waveform Pads Operating Instructions DefiMonitor EVO / GB / B01 227 / 325...
  • Page 228 Menu Structure SpO2 RESP IBP1 IBP2 EtCO2 4th Waveform ECG Waveform Pads SpO2 RESP IBP1 IBP2 EtCO2 Return Display Mode 228 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 229 Clinical action list Network setting Wi-Fi Live streaming CPR guide display Chest compressions 30 compressions /2 breaths 15 compressions /2 breaths Continuous CPR rate 90 bpm 100 bpm 110 bpm Operating Instructions DefiMonitor EVO / GB / B01 229 / 325...
  • Page 230 Display 3 digit code Return Alarm „Alarm limits adjustment/Limit Alarm Pause for each Limit parameter “ HR/PR SpO2 RESP EtCO2 InCo2 TEMP1 TEMP2 39.0 39.0 36.0 36.0 NIBP MEAN MEAN 230 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 231 - Patient Info Confirm Return Name Confirm Return Confirm Return Gender Male Female Event records Data review Print Return ID # Name Gender Return Return NIBP history Print Return Operating Instructions DefiMonitor EVO / GB / B01 231 / 325...
  • Page 232 Menu Structure 6/12 lead records Print Transmission Name Gender Return Return Mission printout Return 232 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 233 Return Pacer Detect Enabled Disabled Return Filter Select 0.5 Hz ~ 21 Hz 0.05 Hz ~ 40 Hz 1 Hz ~ 21 Hz Return Alarm limit HR/PR Return Return Operating Instructions DefiMonitor EVO / GB / B01 233 / 325...
  • Page 234 „Adult/Pedi“ 120 mmHg 140 mmHg 160 mmHg 180 mmHg 200 mmHg 220 mmHg 240 mmHg 260 mmHg 280 mmHg Return “Neonatal” 80 mmHg 100 mmHg 120 mmHg 140 mmHg 234 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 235 3 min 5 min 10 min 15 min 20 min 30 min 60 min 90 min Return Alarm limit NIBP Return Return 21.8 IBP1 Menu Zero Setting Enter Return Operating Instructions DefiMonitor EVO / GB / B01 235 / 325...
  • Page 236 Menu Structure Scale 0~50mmHg 0~100mmHg 0~200mmHg 0~300mmHg Auto Return Label Return Alarm limit Return Return 236 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 237 Menu Structure 21.9 IBP2 Menu Zero Setting Enter Return Scale 0~50mmHg 0~100mmHg 0~200mmHg 0~300mmHg Auto Return Label Return Alarm limit Return Return Operating Instructions DefiMonitor EVO / GB / B01 237 / 325...
  • Page 238 Menu Structure 21.10 EtCO Menu EtCO2 Return Average 1 breaths 10 seconds 20 seconds 30 seconds Return Alarm limit EtCo2 InCO2 Return Return 238 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 239 Auto Impedance Airway Return Size X 0.5 X1.5 Return Return Apnea Time Setting 10 seconds 20 seconds 30 seconds 40 seconds 50 seconds 60 seconds Return Alarm limit Resp Operating Instructions DefiMonitor EVO / GB / B01 239 / 325...
  • Page 240 Menu Structure Return Return 21.12 Temperature Menu Alarm limit TEMP1 TEMP2 39.0 39.0 36.0 36.0 Return Return 240 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 241 Menu Structure 21.13 Date Time Menu Date Format YY/MM/DD MM/DD/YY DD/MM/YY Return Set Date Year Month Return Set Time Hour Minute Second Return Return Operating Instructions DefiMonitor EVO / GB / B01 241 / 325...
  • Page 242 Set Print on alarm, Print on shock, 12 lead auto printing and Analyze auto printing. 22.2.1 Print on alarm If Print on alarm is set to On, the PRIMEDIC DefiMonitor EVO will automatically print out when a physiological alarm condition is activated.
  • Page 243 Figure 87: Print-out on shock 22.3.3 Print-out on 12 lead ECG data If 12 lead auto printing is set to On, the PRIMEDIC DefiMonitor EVO prints the 12 lead ECG data automatically after 12 lead ECG analysis. When the PRIMEDIC DefiMonitor EVO displays 12 lead records, desired 12 lead ECG analysis can be printed by pressing PRINT button.
  • Page 244 Figure 88: Print-out on 12 lead ECG data 22.3.4 Print-out on setting information When the PRIMEDIC DefiMonitor EVO is in Service Menu, the PRIMEDIC DefiMonitor EVO will print out all internal settings by pressing the PRINT button. Refer to the service manual for the detailed instructions.
  • Page 245 In order to write by user, the comments, weight, height, device type and operator are left blank. 23.3.1 Header recording PRIMEDIC DefiMonitor EVO prints case, patient info and defibrillator/monitor info in header as shown in Figure 90. Operating Instructions...
  • Page 246 Figure 92. The time, number of shock and energy is displayed from left to right. Table contains maximum 20 data. When exceeding 20 data, data is displayed next table. 246 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 247 If the print is not available, ‘Printer is not available’ message is displayed. When a printer runs out of paper, ‘Out of paper’ message is displayed. Operating Instructions DefiMonitor EVO / GB / B01 247 / 325...
  • Page 248 24.1 General The PRIMEDIC DefiMonitor EVO provides external connectors on the right panel to support communication with external equipment and functions such as software upgrade or data download. The PRIMEDIC DefiMonitor EVO with its optional wireless network (3G or Wi-Fi) module, functionality performs the same as a defibrillator/monitor connected to the central system.
  • Page 249 The self-test result and the log file are transmitted to the biomedical engineer in • the hospital. The PRIMEDIC DefiMonitor EVO condition, service action according to the self-test and the history of the key pressing are transmitted by the 3G/Wi-Fi module network. All vital sign can be transmitted in real-time.
  • Page 250 Do not use the PRIMEDIC DefiMonitor EVO when the case appears damaged. WARNING Do not spray, pour, or spill any liquid on the PRIMEDIC DefiMonitor EVO, its accessories, connectors, switches or openings in the chassis. WARNING Unplug the power cord from the PRIMEDIC DefiMonitor EVO before cleaning the PRIMEDIC DefiMonitor EVO.
  • Page 251 CAUTION Do not clean any part of this PRIMEDIC DefiMonitor EVO or accessories with bleach dilution or phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not attempt to sterilize this PRIMEDIC DefiMonitor EVO or any accessories unless otherwise specified in accessory operation instructions.
  • Page 252 Returning the PRIMEDIC DefiMonitor EVO and System Components (except rechargeable battery) Pack the PRIMEDIC DefiMonitor EVO with sensors, cables or other accessory items in its original shipping carton. If the original carton is not available, use a suitable carton with appropriate packing material to protect the PRIMEDIC DefiMonitor EVO during shipping.
  • Page 253 Manual of Test and Criteria, Part III, Subsection 38.3 (UN Transport Test). Because of the fact that the PRIMEDIC AkuPak EVO has an energy content less than 100 Wh, and has passed the UN Transport Test, it is released from the necessity for transporting as hazardous goods.
  • Page 254 PRIMEDIC AkuPak EVO during transport. If you send the PRIMEDIC AkuPak EVO together with a PRIMEDIC DefiMonitor EVO or other items, you should wrap it completely in a non- conducting material so that they cannot come into contact with it.
  • Page 255 Avoid spilling liquid on the PRIMEDIC DefiMonitor EVO, especially in connector areas. If liquid is accidentally spilled on the PRIMEDIC DefiMonitor EVO, clean and dry thoroughly before reuse. If in doubt about PRIMEDIC DefiMonitor EVO safety, refer the unit to qualified service personnel for checking.
  • Page 256 Li-ion batteries together, as they might leak electrolyte heat or explode. CAUTION Do not mistreat the battery, or use the battery in applications not recommended by Metrax GmbH. 256 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 257 CAUTION If the PRIMEDIC DefiMonitor EVO has not been used for 6 months, the Li-ion battery will need charging. To charge the battery, connect the PRIMEDIC DefiMonitor EVO to an AC or DC power source as described in the Battery Operation section.
  • Page 258 Maintenance Make sure that the paper is aligned in the slot and has not been pinched in the Note door. Figure 94: Printer Paper Replacement 258 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 259 26.1 General If the PRIMEDIC DefiMonitor EVO detects an error or potential problem during use, it displays a system or momentary message. If service is necessary, contact qualified service personnel. Before calling to qualified service personnel or your local supplier, make sure that environmental conditions provided in the manual are met as temperature, humidity, altitude and so on.
  • Page 260 Keep patients under close surveillance when monitoring. It is possible, although unlikely, that radiated electromagnetic signals from sources external to the patient and the PRIMEDIC DefiMonitor EVO can cause inaccurate measurement readings. Do not rely entirely on the PRIMEDIC DefiMonitor EVO readings for patient assessment.
  • Page 261 WARNING Do not use the PRIMEDIC DefiMonitor EVO with nuclear spin tomography (MRT, NMR, NMT) as the function of the PRIMEDIC DefiMonitor EVO may be disturbed. This device has been tested and found to comply with the limits for medical devices to the IEC60601-1-2, and the Medical Device Directive 93/42/EEC.
  • Page 262 • DefiMonitor EVO. The PRIMEDIC DefiMonitor EVO generates, uses, and can radiate radio frequency energy. If the PRIMEDIC DefiMonitor EVO is not installed and used in accordance with these instructions, the PRIMEDIC DefiMonitor EVO may cause harmful interference with other devices in the vicinity.
  • Page 263 Factory Defaults Factory Defaults 27.1 General The PRIMEDIC DefiMonitor EVO is shipped with factory default settings. Authorized personnel can use the procedures described in the service manual to change default settings. 27.2 Parameter Ranges and Default Settings Table 39: Parameter Ranges and Factory Defaults.
  • Page 264 (5 mmHg, 0.6 or 0.7kPa steps) neonatal 90 mmHg (12 kPa) NIBP SYS Low adult/pediatric adult Alarm Limits 30 to 265 mmHg 90 mmHg (4.0 to 35.3 kPa) (12.0 kPa) neonatal pediatric 264 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 265 Alarm Limits 20 to 255 mmHg 60 mmHg (2.6 to 34.0 kPa) (8.0 kPa) neonatal pediatric 30 to 105 mmHg 50 mmHg (4.0 to 14.0 kPa) (6.6 kPa) Operating Instructions DefiMonitor EVO / GB / B01 265 / 325...
  • Page 266 -50 to 295 mmHg adult 50 mmHg Alarm Limits (-6.7 to 39.3 kPa) (6.6 kPa) (5 mmHg , 0.6 or 0.7kPa steps) pediatric 40 mmHg (5.3 kPa) neonatal 20 mmHg 266 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 267 -50 to 295mmHg adult 90 mmHg Alarm Limits (-6.7 to 39.3 kPa) (12 kPa) (5 mmHg, 0.6 or 0.7kPa steps) pediatric 70 mmHg (12.0 kPa) neonatal 40 mmHg (5.3 kPa) Operating Instructions DefiMonitor EVO / GB / B01 267 / 325...
  • Page 268 (5 mmHg, 0.6 or 0.7kPa steps) pediatric 50 mmHg (6.7 kPa) neonatal 30 mmHg (4 kPa) IBP unit* mmHg, kPa mmHg EtCO2 EtCO2 On, Off N2O Gas On, Off O2 Gas On, Off 268 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 269 (32.0 to 121.8 °F) (96.8 °F) (0.1°C, 0.1 or 0.2°F steps) TEMP Unit* °C, °F °C Respiration Menu Respiration On, Off RR Source Auto Auto Impedance Airway Size x0.5, x1, x1.5, x2 Operating Instructions DefiMonitor EVO / GB / B01 269 / 325...
  • Page 270 ECG V, Pads, SpO2, RESP, IBP1, IBP2, EtCO2 Print on alarm On, Off Print on shock On, Off 6/12 lead auto On, Off printing Analyze auto On, Off printing Elapsed time Enabled, Disabled Enabled display* 270 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 271 Remain in sync On, Off mode after shock* Charging hold 15 sec, 60 sec 15 sec time* ECG display On, Off under paddle open* Setup Menu* Enabled, Disabled Disabled Operating Instructions DefiMonitor EVO / GB / B01 271 / 325...
  • Page 272 (If Above 200J setting is ‘Enabled’, more than 200J of (Pediatric) 100J manual mode shock energy can be selected.) 3rd energy* 1 ~ 100J (Pediatric) Fix pacing* On, Off 272 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 273 6464FA(Light blue), FA96FA(Pink), FA0000(Red), FAFA00(Yellow), 9696C8(Light purple), FA9600, 0096FA, FA00FA, 96FA32, C8C8C8, 0096C8, C89600, C8C832 Parameters Color 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 9696C8(Light - EtCO2* 6464FA(Light blue), FA96FA(Pink), FA0000(Red), purple) FAFA00(Yellow), 9696C8(Light purple), FA9600, Operating Instructions DefiMonitor EVO / GB / B01 273 / 325...
  • Page 274 Print on alarm On, Off Print on charge On, Off Print on mark On, Off Print on BP On, Off Print on self-test On, Off Wi-Fi* On, Off 274 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 275 3rd waveform: SpO2 4th waveform: Respiration EVO III Basic + SpO + NIBP + TEMP+ EtCO 1st waveform: ECG I 2nd waveform: ECG II 3rd waveform: SpO2 4th waveform: EtCO2 Operating Instructions DefiMonitor EVO / GB / B01 275 / 325...
  • Page 276 4th waveform: EtCO2 EVO IV Basic + SpO + NIBP + TEMP + EtCO 1st waveform: ECG I + IBP 2nd waveform: ECG II 3rd waveform: SpO2 4th waveform: EtCO2 276 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 277 Notification Audible and Visual Setting Default and Individual Alarm Volume Level 45 to 85 dB 28.4 Physical Characteristics and Printer Instrument Dimensions 350 × 430 × 220 (mm) (W×H×D) Operating Instructions DefiMonitor EVO / GB / B01 277 / 325...
  • Page 278 Instrument Power Requirements AC Mains 100 to 240 V, 50/60 Hz, 160 VA DC Mains Use PRIMEDIC Charger EVO with DC/DC adapter (Input: 12- 16Vdc, 160VA, Output: 18Vdc, 7.0A) 278 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 279 80% capacity after about 24 months. - The battery is designed not to be charged for safety reason when it reaches 40°C.) After 2 months storage the DefiMonitor EVO would run for 50% of stated battery life. 28.6 Environmental Conditions...
  • Page 280 Pitch (± 34.85Hz) 697 Hz Pulse width (± 10 210 msec msec) Number of pulses 3 pulses per 1 sec, 15 sec inter burst Repetitions Continually Low Priority Alarm Tone 280 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 281 Key Beep Volume level Adjustable (Off, level 1~7) Pitch 440 (± 22)Hz (valid) 168 (± 8.4)Hz (invalid) Pulse width (± 5msec) 100 msec Number of pulses Repetitions No repeat Operating Instructions DefiMonitor EVO / GB / B01 281 / 325...
  • Page 282 Charging Time to Within 6 seconds with rated main voltage/DC main voltage 200J* Within 7 seconds with fully charged battery *Charging time for other cases, refer to defibrillator (technical specification) 282 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 283 2msec and rise times 10% of width not to exceed 100msec Input Input Impedance 5 MOhm or more Input Dynamic Range ±5 mV AC, ±300 mV DC Voltage Range ±0.5 mV ~ ±5 mV Operating Instructions DefiMonitor EVO / GB / B01 283 / 325...
  • Page 284 HR change from 80 to 120 bpm: 3.16 sec rate meter to change in HR change from 80 to 40 bpm: 3.05 sec heart rate Time to alarm for Vent Tachycardia 1 mVpp, 206 bpm: tachycardia 284 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 285 500 to 2000 ohm Delta impedance 0.5 to 3 ohm Lead Off Condition Detected and displayed Defibrillator Protection Protected Display Sweep Speeds 25 mm/s Wave Size x0.5, x1, x1.5, x2 Operating Instructions DefiMonitor EVO / GB / B01 285 / 325...
  • Page 286 Initial Cuff Inflate Pressure Adult/Pediatric 120, 140, 160, 180, 200, 220, 240, 260, 280 mmHg (16.0, 18.7, 21.3, 24.0, 26.7, 29.3, 32.0, 34.7, 37.3 kPa) Neonatal 80, 100, 120, 140 mmHg 286 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 287 1 mmHg Accuracy ± 3 mmHg Input sensitivity 5µV/V/mmHg Transducer Volume 0.1mm /100mmHg Displacement Zero calibration range ± 100mmHg Frequency response DC - 10 Hz ± 1 Hz, -3db Operating Instructions DefiMonitor EVO / GB / B01 287 / 325...
  • Page 288 Operating Range and Dissipation Red Light Wavelength Approximately 660 nm Infrared Light Approximately 900 nm Wavelength Optical Output Power Less than 15 mW Power Dissipation 52.5 mW 288 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 289 25.0 mm/s Sound Noise Level Less than 41dB when ambient sound pressure level is 22dB 28.8.10 Temperature Thermistor Temp Probe Type Thermistor probe YSI compatible type Measurement Method Thermistor Operating Instructions DefiMonitor EVO / GB / B01 289 / 325...
  • Page 290 1 channel ECG waveform • saves Event date and time • saves HR/PR, NIBP, SpO2, Respiration, • Temperature, IBP 1, IBP 2, EtCO2 numeric data saves alarm condition • 290 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 291 26.7 power on to ready for discharge at maximum energy A used battery normally takes more time than the charging time specified in Note above. Operating Instructions DefiMonitor EVO / GB / B01 291 / 325...
  • Page 292 Specification The PRIMEDIC DefiMonitor EVO delivers shocks to load Waveform parameters impedances from 25 to 175 ohms. The duration of each pulse of the waveform is dynamically adjusted based on delivered charge, in order to compensate for patient impedance variations, as shown below: (When 200J is selected) Load resistance (Ω)
  • Page 293 The number of maximum energy discharges which are available from a new and fully charged battery at 20°C ambient temperature is above 200 times for 360J and 250 times for 200J Operating Instructions DefiMonitor EVO / GB / B01 293 / 325...
  • Page 294 • 28.11 Biphasic Waveform Characteristics The efficiency of the biphasic waveform used in the PRIMEDIC DefiMonitor EVO has been clinically verified during a ventricular fibrillation (VF) and ventricular tachycardia (VT) defibrillation study. This study and the findings are described below.
  • Page 295 The following figures show the biphasic waveforms that are produced when the PRIMEDIC DefiMonitor EVO is discharged into loads of 25, 50, 75, 100, 125, 150 and 175 Ohms at each energy setting (360, 300, 200, 175, 150, 125, 100, 75, 50, 40, 30, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 and 1 Joule[s]).
  • Page 296 Specification Figure 95: Biphasic Waveforms at 300 Joules and 360 Joules Figure 96: Biphasic Waveforms at 200 Joules 296 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 297 Specification Figure 97: Biphasic Waveforms at 175 Joules Figure 98: Biphasic Waveforms at 150 Joules Operating Instructions DefiMonitor EVO / GB / B01 297 / 325...
  • Page 298 Specification Figure 99: Biphasic Waveforms at 125 Joules Figure 100: Biphasic Waveforms at 100 Joules 298 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 299 Specification Figure 101: Biphasic Waveforms at 75 Joules Figure 102: Biphasic Waveforms at 50 Joules Operating Instructions DefiMonitor EVO / GB / B01 299 / 325...
  • Page 300 Specification Figure 103: Biphasic Waveforms at 40 Joules Figure 104: Biphasic Waveforms at 30 Joules 300 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 301 Specification Figure 105: Biphasic Waveforms at 20 Joules Figure 106: Biphasic Waveforms at 10 Joules Operating Instructions DefiMonitor EVO / GB / B01 301 / 325...
  • Page 302 Specification Figure 107: Biphasic Waveforms at 9 Joules Figure 108: Biphasic Waveforms at 8 Joules 302 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 303 Specification Figure 109: Biphasic Waveforms at 7 Joules Figure 110: Biphasic Waveforms at 6 Joules Operating Instructions DefiMonitor EVO / GB / B01 303 / 325...
  • Page 304 Specification Figure 111: Biphasic Waveforms at 5 Joules Figure 112: Biphasic Waveforms at 4 Joules 304 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 305 Specification Figure 113: Biphasic Waveforms at 3 Joules Figure 114: Biphasic Waveforms at 2 Joules Operating Instructions DefiMonitor EVO / GB / B01 305 / 325...
  • Page 306 Specification Figure 115: Biphasic Waveforms at 1 Joules 306 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 307 Requirements for regulating purposes EN ISO13485:2012/ AC:2012 Risk analysis managements – medical ISO14971:2007, devices EN ISO14971:2012 IEC60601-1:1988 General requirements for safety of medical +A1:1991+A2:1995, electrical equipment EN 60601-1:1990 +A1:1993+A2:1995 Operating Instructions DefiMonitor EVO / GB / B01 307 / 325...
  • Page 308 Requirements for environmentally conscious +A1:2013 design EN1789:2007+A1:2010 Medical vehicles and their equipment – Road Ambulance ambulances IEC60601-1-8:2006 Medical electrical equipment - Part 1-8: Alarms +A1:2012, General requirements for basic safety and 308 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 309 EN ISO 9919:2009 Temperature EN12470-3:2000 Performance of compact electrical +A1:2009 thermometers (non-predictive and predictive) monitoring with maximum device EN12470-4:2000 Performance of electrical thermometers for +A1:2009 continuous Measurement Operating Instructions DefiMonitor EVO / GB / B01 309 / 325...
  • Page 310 IEC61000-4-11:2004, Voltage dips, short interruption and voltage variation on power supply input lines Ed 2.0 EN61000-4-11:2004 CISPR11:2009 Limits and methods of measurement of radio +A1:2010, disturbance characteristics of industrial 310 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 311 -- Part 1: General requirements ISO15223-2:2010 Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation Operating Instructions DefiMonitor EVO / GB / B01 311 / 325...
  • Page 312 PRIMEDIC DefiMonitor EVO. The PRIMEDIC DefiMonitor EVO is suitable for use in the specified electromagnetic environment. The customer and/or user of the PRIMEDIC DefiMonitor EVO should assure that it is used in an electromagnetic environment as described below.
  • Page 313 Note: UT is the AC mains voltage prior to application of the test level. Operating Instructions DefiMonitor EVO / GB / B01 313 / 325...
  • Page 314 Interference may occur in the vicinity of equipment marked with the following symbol: 314 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 315 Complies with Test in cut mode Output power 300W, 5 times IEC60601-2-2 Test in coagulation mode Output power of 100W, Working frequency of 400 kHz ±10% , 5 times Operating Instructions DefiMonitor EVO / GB / B01 315 / 325...
  • Page 316 Recommended separation distance between portable and mobile RF communications equipment and the PRIMEDIC DefiMonitor EVO The PRIMEDIC DefiMonitor EVO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the...
  • Page 317 Defibrillator/AED Cable 3.0 m Surge, IEC 61000-4-5 Conducted RF IEC 61000-4-6 Temperature Cable 3.0 m Radiated RF, IEC 61000-4-3 EtCO2 Cable 2.0 m SpO2 Cable 4.0 m SpO2 Sensor 1.0 m Operating Instructions DefiMonitor EVO / GB / B01 317 / 325...
  • Page 318 Figure 26: 12 lead Placement ..................92 Figure 27: Measurement Reference ................93 Figure 28: 12-Lead ECG Preview Screen ..............97 Figure 29: HR/PR Display ..................... 97 Figure 30: ECG Waveform Display ................97 318 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 319 Figure 59: SpO Display ....................169 Figure 60: SpO Waveform ..................169 Figure 61: SpO2Menu Display ..................169 Figure 62:Respiration Display ..................173 Figure 63: Respiration Waveform Display ..............173 Operating Instructions DefiMonitor EVO / GB / B01 319 / 325...
  • Page 320 Figure 95: Biphasic Waveforms at 300 Joules and 360 Joules ........296 Figure 96: Biphasic Waveforms at 200 Joules ............296 Figure 97: Biphasic Waveforms at 175 Joules ............297 320 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 321 Figure 112: Biphasic Waveforms at 4 Joules .............. 304 Figure 113: Biphasic Waveforms at 3 Joules .............. 305 Figure 114: Biphasic Waveforms at 2 Joules .............. 305 Figure 115: Biphasic Waveforms at 1 Joules .............. 306 Operating Instructions DefiMonitor EVO / GB / B01 321 / 325...
  • Page 322 Table 5: Display Colors Factory Defaults ..............40 Table 6: Front Panel Indications for Power Source ............54 Table 7: The PRIMEDIC DefiMonitor EVO Battery Status Icon ........55 Table 8: Date/Time Menu ....................61 Table 9: High Priority Alarms ..................67 Table 10: Medium Priority Alarms .................
  • Page 323 Table 45: Electromagnetic Immunity (IEC60601-2-4) ..........314 Table 46: Electro-surgical Unit Interference (IEC60601-2-27, IEC60601-2-30) ..315 Table 47: Recommended Separation Distances ............316 Table 48: Cables (IEC60601-1-2) ................317 Operating Instructions DefiMonitor EVO / GB / B01 323 / 325...
  • Page 324 Contact details Contact details METRAX GmbH Rheinwaldstr. 22 D-78628 Rottweil Germany Tel.: +49 741 257-0 Fax: +49 741 257-235 www.primedic.com info@primedic.com 324 / 325 DefiMonitor EVO / GB / B01 Operating Instructions...
  • Page 325 Germany quality. Well-engineered and safe Tel.: +49 741 257-0 technology, simple operation, high Fax: +49 741 257-235 quality and absolute reliability under www.primedic.com extreme conditions. These are the info@primedic.com unmistakeable characteristics of PRIMEDIC defibrillators. Your dealer...