- I
037.007.0001 Rev.2
Doc ID:
IFU-OMNI-7002
OMNI Express Patient Monitor
USER’S MANUAL
Page 1: ...I 037 007 0001 Rev 2 Doc ID IFU OMNI 7002 OMNI Express Patient Monitor USER S MANUAL 037 007 0001 Rev 2...
Page 2: ...8434 International 1 727 531 8434 Fax 1 727 531 8436 To obtain information about a warranty if any for this product contact Infinium Medical Inc Technical Services or your local Infinium Medical Inc r...
Page 3: ...PLAY MODE 10 THREE WAVEFORMS DISPLAY MODE 10 WAVEFORM AREA 11 PARAMETER AREA 11 MESSAGE AREA 11 SYSTEM SETUP 12 FACTORY SEVICING SETUP 12 OPTIONAL MODULE 13 WAVEFORM SELECT 13 PRINTER 13 CONFIG MANAGE...
Page 4: ...IMITATIONS 33 SPO2 ERROR MESSAGES 34 MASIMO INFORMATION 34 NELLCOR INFORMATION 36 NIBP MONITORING 37 NIBP MONITORING PRINCIPLE 37 NIBP CUFF FITTING 37 NIBP MONITORING INITIALIZATION 38 NIBP SETUP 38 N...
Page 5: ...AINSTREAM PROBE 60 INTRODUCTION 60 SAFETY 61 SYSTEM ASSEMBLY INSTRUCTION 61 ZEROING PROCEDURE 63 ALARMS 64 CLEANING 65 MAINTENANCE 65 PHASEIN ISA SIDESTREAM ANALYZER 66 INTRODUCTION 66 SAFETY 67 ANALY...
Page 6: ...OVERVIEW 87 CABLE CONNECTION 87 EXPORTING TREND DATA 87 PRINTER OPTIONAL 88 PRINTER SETUP 88 PRINT REAL TIME WAVEFORM 88 PRINT TABULAR TREND 88 GRID OUTPUT 89 PRINT ALARM EVENT 89 PRINT EVENT LIST 89...
Page 7: ...User s Manual of OMNI Express Patient Monitor VII 037 007 0001 Rev 2 ELECTROMAGNETIC IMMUNITY 105...
Page 8: ...18 Sketch Map for Replacing The Bladder 42 Figure 19 Tree Diagram for Temp Setup Menu 43 Figure 20 Temperature Site and Patient Age 45 Figure 21 Tree Diagram for QTemp Setup Menu 50 Figure 22 Tree Di...
Page 9: ...ring defibrillation or while an electrosurgical unit is in use but the readings may be inaccurate during use and shortly thereafter WARNING The OMNI Express Patient Monitor is a prescription device an...
Page 10: ...e same time as these monitors WARNING DO NOT use the OMNI Express to monitor patients who are linked to heart lung machines WARNING DO NOT autoclave ethylene oxide sterilize or immerse these monitors...
Page 11: ...Certain steps can be taken to mitigate against this problem such as not using small ECG electrodes selecting ECG electrode sites remote from the expected RF paths using large electrosurgical return e...
Page 12: ...es SpO2 respiration temperature EtCO2 and anesthetic gas AG for adult neonate and pediatric patients in all hospital areas and hospital type facilities It may be used during hospital transport and in...
Page 13: ...TOR In normal mode no indicator lights In alarm mode the alarm indicator lights up or flashes 2 2POWER SWITCH This toggle switch turns the secondary power from on to off The monitor will continue to c...
Page 14: ...FT SIDE PANEL Figure 2 Left Side Panel No FUNCTION 1 Oxygen Saturation Sensor Socket 2 NIBP Socket 3 Temperature Probe Socket 4 AAMI ECG Cable Connector 5 EtCO2 Gas QTemp Sensor Socket Optional RIGHT...
Page 15: ...wer connection is where the power cord is connected to the monitor the AC power fuse must be replaced with the same type of fuse 100 240V 50 60Hz 150VA 3 Ethernet Interface RJ45 interface used to conn...
Page 16: ...handled with care This Way Up Indicates correct up right position of the transport package Keep Away From Rain Transport package should be kept away from rain Stacking Limit By Number Maximum number o...
Page 17: ...osed IPX1 N1 X which means it was not required N2 1 Protection against vertically falling water drop Caution Federal law USA restricts this device to sale by or on the order of a licensed healthcare p...
Page 18: ...OMNI Express Patient Monitor 10 037 007 0001 Rev 2 DISPLAY SCREEN PARTITION TWO WAVEFORMS DISPLAY MODE Figure 5 Display Screen for Two Waveforms THREE WAVEFORMS DISPLAY MODE Figure 6 Display Screen fo...
Page 19: ...This area consists of HR Resp SpO2 Temp NIBP SYS DIA MAP EtCO2 Gas and so on MESSAGE AREA Time Patient Information Power State and some prompt information are listed here Assuming the main screen is...
Page 20: ...Output Waveform 2 Auto Print Waveform 1 Waveform 3 Hospital Name Load User Config Save Current Config Parameters Only Delete User Config Export User Config Heart Sound About QTemp Module Gas Module Fi...
Page 21: ...int a 8 second slip of waveform the preceding 4 seconds before the recording till the current 4 seconds when an alarm is triggered AUTO PRINT Available intervals are every 5 minutes 10 minutes 20 minu...
Page 22: ...o input the user s name in order to distinguish different settings The Patient Monitor can save multiple user configurations The screen will display a menu to let you confirm the setup After returning...
Page 23: ...l for screen display There are ten levels for choice I II III IV and The larger the value is the brighter the screen is SOUND LEVEL I II III IV and OFF for choice IV is the loudest sound HEART SOUND Q...
Page 24: ...e main screen after 25 seconds 4 Connect the detector with the patient 5 Set monitoring parameters see chapters below 6 Enter the monitoring state CAUTION If the OMNI Express is to be stored for a per...
Page 25: ...Resp NIBP Temp IBP and EtCO2 Indicates that prompt response from the operator is required Low Level Sensor or lead s off such as ECG Leads Off SpO2 Cable Sensor Disconnect Temperature Probe Disconnect...
Page 26: ...The background color of the Alarm Information Column will change to a solid blue green ALARM SUSPEND If you want to prevent alarms temporarily from sounding you can suspend alarms by pressing the soft...
Page 27: ...ulses repeat once for total of 10 pulses HEART BEAT PULSE TONE The heartbeat or pulse tone is a sound of RUB A DUB In the Setup menu you may choose QRS PULSE and OFF and when the choice is QRS the sys...
Page 28: ...If the skin is found to be inflamed or damaged evidently put a new electrode in another position 5 Make sure no conductive part of electrodes is in contact with the ground or other conductive materia...
Page 29: ...ne horizontal with the V4 electrode V3R V7R is on the right side of the chest in positions corresponding to those on the left VE is over the xyphoid As for the V lead position on the back it should be...
Page 30: ...Alarm Switch HR Alarm High HR Alarm Low Pacemaker Detection ECG Test Lead Type ST Analysis ARR Analysis ST Alarm High ST Alarm ST Analysis ST Alarm Low ST Adjust PVC Monitor ARR Analysis ARR Source PV...
Page 31: ...er setting defines how ECG waveforms are smoothed The three modes to select from are Surgery Monitor or Diagnose The factory setting is Monitor Monitor Use under normal measurement conditions Diagnose...
Page 32: ...es ST segment depression This feature is not intended for neonatal patients As shown in the figure below the ST measured for each beat complex is the vertical difference between two measurement points...
Page 33: ...e opened by selecting TREND to see the tendency displaying on the graph or table ST ADJUST ISO Base Point Set the baseline point The adjustable range is 508 ms 4 ms and the default value is 80ms indic...
Page 34: ...cular contraction times exceed the PVC ALARM COUNT the system will alarm PVC ALARM COUNT The set range is from 1 to 10 The factory setting is 10 ARR RELEARN Self relearn to adjust to new conditions Fo...
Page 35: ...Signal Weak Monitor system cannot calculate HR value when the ECG Signal is too weak MAINTENANCE AND CLEANING PATIENT CABLE AND LEAD After every use the cable must be cleaned following the methods be...
Page 36: ...CG leads sometimes affects HR but it will eventually stabilize The change of gain and filter may influence the HR calculating stability too Another factor that affects the HR calculation is the QRS wa...
Page 37: ...is better to place the two RESP electrodes laterally in the right axillary and left lateral chest areas at the maximum point of breathing movement to optimize the respiratory waveform The sensor of RE...
Page 38: ...ALARM LOW The Resp alarm lower limit the range is 6 100 rpm The default alarm limit is changed with different patient type When the patient type is adult or pediatric the factory setting is 8 rpm whe...
Page 39: ...asuring the light absorption during a pulsation it is possible to derive the oxygen saturation of the arterial blood Detecting the pulsation gives a PLETH waveform and pulse rate signal About SpO2 SaO...
Page 40: ...e factory setting is 130 bpm and the single step adjustable step length is 1 bpm PR ALARM LOW Set the PR alarm upper limit The range is 20 150 bpm and the factory setting is 50 bpm and the single step...
Page 41: ...applied Anemia 2 The measurement is also determined by how well the oxyhemoglobin and reduced hemoglobin absorb the light of the specific wave length They can cause the measurement to be inaccurate or...
Page 42: ...r more of the patents relating to this device MEASUREMENTS If the accuracy of any measurement does not seem reasonable first check the patient s vital signs by alternate means and the check the MS boa...
Page 43: ...immerse the sensor or patient cable in water or solvents or cleaning solutions The sensors and connectors are not waterproof Placement of a sensor on an extremity with a blood pressure cuff arterial...
Page 44: ...OR INFORMATION TRADEMARK AND LICENSING LABELS NELLCOR PATENS This device is covered under one or more the following U S Patents 4 802 486 4 869 254 4 928 692 4 934 372 5 078 136 5 351 685 5 485 847 5...
Page 45: ...t the cuff is not wrapped too tightly around the limb Excessive tightness may cause discoloration and eventual isocheimal of the extremities 3 Make sure that the cuff has not been twisted 4 Insert the...
Page 46: ...he NIBP alarm limit and the settings are set to ON then the alarm will be activated When the settings are set to OFF the alarm indicator will not light up the corresponding alarm parameter will not fl...
Page 47: ...g end and the measurement process will have finished If the NIBP value cannot be measured the NIBP parameter area will display any error messages and automatically attempt to take the measurement agai...
Page 48: ...information area will read STOP STAT TEST and the monitor will stop the NIBP measurement and exit from this mode TIME INTERVAL This setting is used by the automatic inflation mode You can input the ti...
Page 49: ...pulses in arterial pressure and increase the time needed to take the measurement CARDIAC ARRHYTHMIA S Measurements will be unreliable or impossible to take if the patient s cardiac arrhythmia has caus...
Page 50: ...method remember to remove the rubber bag The cuff should not be dry cleaned The cuff can be machine washed or hand washed hand washing may prolong the service life of the cuff Before washing remove th...
Page 51: ...EMP SETUP Touch the Temp parameter area to open the TEMP Setup menu which is laid out as below Temp Setup Alarm Switch Temp Alarm high Temp Alarm Low Temp Unit Temp Adjust Figure 19 Tree Diagram for T...
Page 52: ...1 0 2 TEMP ADJUST Servicing engineers use only TEMP ERROR MESSAGES TEMP SENSSOR OFF the TEMP probe has fallen off of the monitor MAINTAINENCE AND CLEANING REUSABLE TEMP PROBES 1 The TEMP probe should...
Page 53: ...ent s recent level of activity metabolism rate or medications Normal body temperatures also tend to decrease with age Please see the chart below for normal temperature ranges by patient age and site R...
Page 54: ...od of time 13 Dispose of batteries in a manner consistent with local environmental and institutional policy for Lithium or Alkaline battery disposal 14 Dispose of old battery powered electronic equipm...
Page 55: ...place 7 The probe is connected to the thermometer automatically 8 To change probes remove the isolation chamber as described previously 9 Grasp the sides of the L shaped connector piece with one hand...
Page 56: ...Thermometer turns on automatically 3 An icon identifying rectal mode is always displayed provided the Red isolation chamber probe assembly is attached Pressing the Site button on the front panel to c...
Page 57: ...eard no temperature will be stored for the recall function Quick Mode Oral Only 1 Quick Mode is an oral predictive measurement mode intended for situations where fast temperature measurements are desi...
Page 58: ...ode Option Configuration Menu 1 To enter Bio Tech Mode the thermometer must be in sleep mode probe securely in place with blank screen 2 Press and hold the Site and buttons at the same time for 4 seco...
Page 59: ...toring MAINTAINENCE AND CLEANING 1 The entire device may be easily wiped clean Water temperature should not exceed 130 F 55 C Do not submerge or soak under water 2 A mild detergent may be added to wat...
Page 60: ...an airway adapter directly inserted into the patient s breathing system 2 Sidestream Microstream measurement samples expired patient gas at a constant sample flow from the patient s airway and analyz...
Page 61: ...st that a zero be performed These requests stem from changes in the airway adapter that may indicate that the sensor is not in optimal measuring condition When this occurs the airway adapter should be...
Page 62: ...pted by the host system 4 Place the nasal cannula kits onto the patient as shown in following figure 5 Some patients are prone to mouth breathing The Oral Nasal sampling cannula should be used on thes...
Page 63: ...Zero Gas Type Balance Gas Anesthetic Fill In Waveform Wave Scale Sweep Speed Sweep Color Figure 22 Tree Diagram for EtCO2 Setup Menu ALARM SWITCH Can be ON or OFF and the factory setting is ON When t...
Page 64: ...mHg FILL IN WAVEFORM Use this setting to fill in the bottom portion of the waveform on any channel of the display the fill in can be canceled by choosing NO SWEEP SPEED Options are 12 5mm s and 25mm s...
Page 65: ...nt s airway In the CO2 module the temperature of the gas in the airway also effects the CO2 measurement It is necessary to adjust the instrument setting for the gas temperature to achieve the maximum...
Page 66: ...ing Sensor Zeroing A zero is currently in progress Zero Required To clear check airway adapter and clean if necessary If this does not correct the error perform an adapter zero If you must perform an...
Page 67: ...hypochlorite bleach a 2 gluteraldehyde solution ammonia mild soap or disinfectant spray cleaner such as Steris Coverage Spray HB 2 Wipe down with a clean water dampened cloth to rinse and dry before u...
Page 68: ...egulator a CPU and a RS 232 digital interface The unit weighs less than 25 g The probe is available in various configurations for different clinical applications Concentrations of carbon dioxide nitro...
Page 69: ...probe is intended for use by authorized and trained medical personnel only The IRMA probe must not be used with flammable anesthetic agents Disposable IRMA airway adapters shall not be reused Reuse o...
Page 70: ...5 Connect the 15mm female connector of IRMA airway adapter to the patient s endotracheal tube Alternatively connect an HME Heat Moisture Exchanger between the patient s endotracheal tube and the IRMA...
Page 71: ...patient circuit Perform the tightness check of the patient circuit with the IRMA probe snapped on the IRMA airway adapter ZEROING PROCEDURE In order to secure high precision of the IRMA probe measurem...
Page 72: ...warm up of the IRMA AX probes after power on and after changing the IRMA airway adapter before proceeding with the Zeroing Procedure The green LED on the probe will be blinking for approximately 5 sec...
Page 73: ...um 70 ethanol or maximum 70 isopropyl alcohol Remove the disposable IRMA Airway Adapter prior to cleaning the IRMA probe MAINTENANCE Gas readings should be verified at regular intervals with a referen...
Page 74: ...spired expired gases during anesthesia recovery and respiratory care The intended environment is the operating suite intensive care unit and patient room ISA CO2 is also intended to be used in road am...
Page 75: ...nfigurations with adults as this may cause excessive flow resistance DO NOT use the ISA sidestream gas analyzer with metered dose inhalers or nebulized medications as this may clog the bacteria filter...
Page 76: ...icensed healthcare practitioner ANALYZER SYSTEM SET UP 1 Securely mount the ISA analyzer 2 Connect the ISA analyzer interface cable to the OMNI Express Patient Monitor 3 Connect a Nomoline Family samp...
Page 77: ...utions the Nomoline Family sampling lines have been developed for the ISA sidestream gas analyzers Unlike traditional solutions that remove water vapor and collect water in a container the Nomoline Fa...
Page 78: ...ty cannulas for oral and nasal sampling Combining the Nomoline Adapter with the Nomo Extension and T adapter results in a similar product as the Nomoline Airway Adapter Set see below Combining Nomolin...
Page 79: ...ension are single patient use products They should be replaced according to good clinical practice or when an occlusion message appears Occlusion occurs when the sample flow is too low This is indicat...
Page 80: ...age check as below and verify gas readings with a reference instrument or with calibration gas Calibration gas can be ordered from PHASEIN AB www phasein com LEAKAGE CHECK 1 Connect a new Nomoline sam...
Page 81: ...N Et AA X AA Et AA X AA Et X AA HAL 0 75 ENF 1 7 ISO 1 15 SEV 2 05 DES 6 0 SYMBOLS Symbol Title Explanation Instructions for use Consult instructions for use Catalog number Serial number Batch code Ye...
Page 82: ...ction Splash proof Rx only US Only Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner CO2 ISA equipped to measure CO2 only Multigas AX or OR ISA...
Page 83: ...ng gas flows through the sampling line the gas temperature will adapt to ambient before reaching the gas analyzer As the NOMO section removes all condensed water no water will reach the ISA gas analyz...
Page 84: ...N the alarm is activated when the choice is OFF the alarm indicator will not light the relative alarm parameter will not flash and relative parameter area will display the icon APNEA DELAY This settin...
Page 85: ...natal 30 rpm Neonatal FI N2O 0 100 factory setting 100 0 100 factory setting 0 ET N2O 0 100 factory setting 100 0 100 factory setting 0 FI O2 18 100 factory setting 100 18 100 factory setting 18 ET O2...
Page 86: ...r Patient name only supports English characters The user can input 9 characters at most SEX Set the patient gender The default setting is MALE BLOOD Set the blood type of patient It can be N A unknown...
Page 87: ...re are two ways to do this 1 Touch the Patient ID area directly 2 Open the Pause menu and then choose Start new case DELETE PATIENT The monitor can save eight groups of patient information for recall...
Page 88: ...ion button to open the graph below TIME SETUP In order to review data easily and intuitively you should set the monitor s time Touch the time area at the top right corner to open Time Setup menu The a...
Page 89: ...u is as shown below Figure 27 Window for Mark Event Setup MARK EVENT Choose the related event item you want from A B C and D There is a V mark signal for the ones selected Select YES to exit and the e...
Page 90: ...data is on the right side of the graph time is displayed on the bottom of the graph on a 24 hour scale and the upper and lower limits of the parameter are displayed on the left side of graph CURSOR BA...
Page 91: ...he entire trend memory can be transferred to an external computer via the RS 232 interface Refer to the RS 232 INTERFACE section for details ALARM EVENT In this window you can recall alarm information...
Page 92: ...or Last Waveform Review When there are waveforms to display for demonstration or real time measurement the system only save data for the last 16 seconds and displays two selectable waveforms The time...
Page 93: ...of data the oldest recall data will be overwritten by new data RECALL DATA DISPLAY The Recall data are displayed in graphical or tabular format The recall information in graphical format for a selecte...
Page 94: ...Select one ID for a patient and then enter the Trend Management window with Patient ID which appears as below Figure 35 Window for Trend Management with ID NOTE This trend management default window is...
Page 95: ...interface to a suitably configured personal computer Its pin layout is as follows RS 232 Serial Interface Connections Pin Signal Definition 1 not used 2 TXD Transmit Data 3 RXD Received Data 4 not use...
Page 96: ...key again The printer will stop immediately and the statement Printing Stopped will appear on the bottom of screen The monitor can print a burst of two or three waveforms and the waveforms data from t...
Page 97: ...ng is turned ON it will print the waveform over a period of 8 seconds the 4 seconds before and after the alarm when the alarm is triggered PRINT EVENT LIST Print out the event list for review Figure 3...
Page 98: ...ter Door Open Printer door has been opened Printer Door Close Printer door has been closed Printer Paper Ok Indicated that printer paper has been installed properly Printer No Paper Printer paper has...
Page 99: ...d shut off automatically when the battery s capacity is low When the battery s capacity is lower than 25 of its total capacity the alarm will sound and a message of Battery Power Low will be displayed...
Page 100: ...from the Patient Monitor and recycle it properly Follow local laws when disposing the batterty DISPOSAL OF DEVICE COMPONENTS Follow local governing ordinances and recycling instructions when disposin...
Page 101: ...commend replacing the monitor every 5 years CLEANING To clean the OMNI Express dampen a cloth with a commercial nonabrasive cleaner and wipe the exterior surfaces lightly Do not allow any liquid to co...
Page 102: ...0 Trace 2 or 3 waveforms Waveforms ECG I II III aVR aVL aVF V PLETH RESP EtCO2 Indicator Alarm indicator Power indicator QRS beep and alarm sound Trend time 60 hours ECG Input 3 or 5 ECG cable and sta...
Page 103: ...When the test is performed based on part 4 1 2 1 c of ANSI AAMI EC13 2002 the heart rate meter will reject all 100ms QRS complexes with less than 1 0mV of amplitude and T waves with T wave interval o...
Page 104: ...Lower Limit 50 100 PR Alarm Limit Upper Limit 70 239 bpm Lower Limit 20 150 bpm BCI SpO2 SpO2 Measurement Range 0 100 SpO2 Resolution 1 SpO2 Accuracy 70 100 2 non motion 70 100 3 motion 0 69 Undefine...
Page 105: ...non repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 100 SpO2 against a laboratory co oximeter and ECG monitor 1 has been added to the res...
Page 106: ...PS Body Temperature Pressure Saturated CO2 Resolution 0 69 mmHg 0 1 mmHg 70 150 mmHg 0 25 mmHg CO2 Accuracy 0 40 mmHg 2 mmHg 41 70 mmHg 5 of reading 71 100 mmHg 8 of reading 101 150 mmHg 10 of reading...
Page 107: ...inimum reported differential value between the baseline and CO2 value shall be 5 mmHg Inspired CO2 Measurement Range 3 50 mmHg Method Lowest reading of the CO2 waveform in the previous 20 s Selection...
Page 108: ...of reading 0 3 vol 2 of reading Unspecified N2O 0 100 0 100 0 2 vol 2 of reading HAL ISO ENF 0 5 5 12 0 8 8 25 0 15 vol 5 of reading Unspecified SEV 0 8 8 15 0 10 10 25 0 15 vol 5 of reading Unspecifi...
Page 109: ...d broadening effects on CO2 Calibration No span calibration is required for the IR bench An automatic zero reference calibration is performed at startup and then every 24 hours1 Warm up Time ISA CO2 1...
Page 110: ...g Industry Standard IEEE 802 3 wired network Connected Bedside Number Up to 32 bedside monitors RJ45 Interface or RS232 Serial Port Wireless Networking Industry Standard 802 11b g wireless network Tra...
Page 111: ...91301 ECG CABLE 3LEADS 5LEADS 12LEADS Type Model Application PN Size mm Shield Remark Grab M0202233 Adult 0109031501 3600 No 3Leads Removable M0202232 Adult 0109031301 3600 No 5Leads Removable Snap M0...
Page 112: ...10 400 01090104 Adult 140 500 01090101 Adult Big 170 550 01090109 TEMP TEMP PROBE Type Model Application Position Length mm Shield PN Cycle Use M0511025 Adult Rectal 3000 No 020903 M0511021 Adult Surf...
Page 113: ...environment specified below The customer of the user of the device should assure that it is used in such an environment Emission Tests Compliance Electromagnetic Environment guidance Radio frequency...
Page 114: ...ariations on power supply input lines IEC 61000 4 11 5 UT1 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT2 95 dip in UT fo...
Page 115: ...ient Monitor including cables than the recommended separation distance which can be calculated using the formula applicable to the frequency of the transmitter Recommended separation distance P d 2 1...
Page 116: ...liance level verify that the OMNI Express Patient Monitor works normally If you observer abnormal performance you may need to reorient or relocating the OMNI Express Patient Monitor b Over the frequen...
Page 117: ...23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated usi...
