Addendum to the Instructions for Use

Transcription

1 1Addendum Addendum to the Instructions for Use This addendum provides additional information for the IntelliVue Patient Monitor Instructions for Use: MP2: Part number X2: Part number MP5: Part number MP20-90: Part number MX : Part number If your Instructions for Use have a different part number, you may discard this addendum, otherwise please store it with your monitor documentation. Depending on the monitor model and the language of your Instructions for Use, some of this information may already be included in the version you have received. Managing Patients and Equipment Update to Section - Ending Monitoring for a Patient Take note of the following warning: WARNING Always end monitoring for the previous patient (with Dischrge Patient, Remove Monitor, End Case or New Patient) before starting monitoring for a new patient, even if your previous patient was not admitted. Failure to do so can lead to data being attributed to the wrong patient. Correction to Section - Quick Admitting a Patient The incorrect information currently included in the instructions for use is as follows: If the monitor is connected to an Information Center and only the ID field is entered, the patient name may be set to at the Information Center, depending on the configuration. With a PIIC ix, the Information Center can look-up patient information in a hospital information system (if available) and complete the patient demographics automatically. Otherwise, complete the rest of the demographic details as soon as possible to fully identify the patient on the network, on the monitor and on printed reports. To complete the details, open the Patient Demographics window and complete all required fields. The correct information is given here: If the monitor is connected to an Information Center and only the ID field is entered, the patient name may be set to at the Information Center, depending on the configuration. Complete the rest of the demographic details as soon as possible to fully identify the patient on the network, on the monitor and on printed reports. To complete the details, open the Patient Demographics window and complete all required fields. Published in Germany 12/ * *

2 Capturing 12-Lead ECG Updated Section - Downloading Analysis Results (PIIC ix only) Download analysis results from the IntelliVue Information Center by selecting Show Analysis. Return to the previous screen by selecting Hide Analysis. SpO 2 Updated Section - Setting Smart Alarm Delay Mode To set the mode for Smart Alarm Delays, in the Setup SpO₂ menu, 1 Check that SmartAlarmDelay is set to On. This setting is made in Configuration mode and will be shown in the menu in gray. If it is set to Off, a standard alarm delay is in use. 2 Select High Alarm Delay and choose Short, Medium, or Long mode. 3 Select Low Alarm Delay and choose Short, Medium, or Long mode. If you also use monitors with earlier software revisions, be aware that smart alarm delays will not be used after a transfer to one of these monitors. Monitors with earlier software revisions will always use the standard alarm delay. If you are not sure whether a monitor has the Smart Alarm Delay function, check whether there is a SmartAlarmDelay entry in the Setup SpO₂ menu. Care and Cleaning Updated Section - Cleaning, Sterilizing and Disinfecting Monitoring Accessories To clean, disinfect and sterilize reusable transducers, sensors, cables, leads, and so forth, refer to the instructions delivered with the accessory. If no instructions are delivered with the accessory, the instructions given in the Care and Cleaning chapter for cleaning, disinfecting and sterilizing the monitor are applicable. Additional Symbols The following symbols can appear on the monitor and its associated equipment. Start a measurement Stop a measurement Indicates location of the date of manufacture and/or name and address of manufacturer Indicates location of service number Indicates location of serial number Indicates location of catalog number Followed by two alphanumeric characters, indicates ingress protection grade.

3 Addendum to the Instructions for Use 1 Addendum Additional CO 2 Default Settings Factory defaults H10/H20/H40 H30 (deviations from H10/H20/H40) CO 2 Settings Adult Pedi Neo Adult Pedi Neo IPI On On n/a Low Alarm (IPI) On On n/a Updated Monitor Performance Specifications Monitor Performance Specifications Alarm Signal System alarm delay. The system alarm delay is the processing time the system needs for any alarm to be indicated on the monitor, after the measurement has triggered the alarm. Delay for alarm availability on the network. This is the time needed after alarm indication on the monitor until the alarm signal is available on the network, to the IntelliVue Information Center or for transmission to other systems. Sound pressure range less than 4 seconds less than 5 seconds min. 0 db(a) max db(a) Updated Section - Synchronized Settings (from Chapter Managing Patients and Equipment) For some measurements, settings can be synchronized between the monitor and another measurement device. For example, if ECG is measured at the monitor, and then the patient is connected to a telemetry device for monitoring, the Information Center will use the monitor settings for the telemetry device. In general, the following settings will be synchronized: Heart Rate ECG Arrhythmia HR/Pulse Alarm On/Off, Heart Rate High/Low Limit, ECG On/Off 1, Primary Lead, Secondary Lead, Va Lead 2, Vb Lead 2, Lead Placement Analysis Mode, Arrhythmia On/Off, Asystole Threshold, Pause Threshold, VTach HR, VTach Run, PVCs/min, Vent. Rhythm, SVT HR, SVT Run, PVCs/min On/Off, Pacer not capture On/Off, Pacer not pace On/Off, Non-Sustain On/Off, Vent. Rhythm On/Off, Run PVCs On/Off, Pair PVCs On/Off, Missed Beat On/Off, Pause On/Off, R-on-T PVCs On/Off, Vent. Bigeminy On/Off, Vent. Trigeminy On/Off, Multiform PVCs On/Off, Irregular HR On/Off, SVT On/Off, Afib On/Off, Afib/IrrHR End Threshold, All ECG Alarm INOP mode 3

4 1 Addendum Addendum to the Instructions for Use ST QT ST Analysis On/Off, ST Alarm On/Off, ISO Point, J point, ST point, ST Alarm Limits, ST- Index On/Off, ISO/J-Point Detection, ST Lead On/Off, ST Baseline QT analysis On/Off, QT Lead, QTc High Alarm On/Off, QTc Alarm On/Off, QTc High Limit, QTc High Limit, QT Baseline 3 SpO 2 T SpO 2 Alarms on/off, SpO 2 Alarm limits, SpO 2 High Alarm Limit, Desat Alarm Limit NBP Alarm Suppression On/Off, Pulse(SpO 2 ) On/Off 1 ECG On/Off setting is forced to ON by the monitor, if the local setting is ON. 2 Va and Vb leads are reset to default (V2, V5) if the configured Va or Vb lead for the telemetry device is not one of V1 through V6. 3 With PIIC, QT baseline is synchronized, but not QT snippets. PIIC ix With the IntelliVue Information Center ix, the following additional measurement settings can be synchronized: ECG/Arrhythmia Some ECG Alarms INOP On/Off ST STE On/Off, STE Alarm On/Off NBP Sys/Dia/Mean Alarm Limits, Alarms On/ Off, Alarm Source Resp Apnea Time, Alarm Limits, Alarm On/Off, Resp On/Off SpO 2 SpO 2 Alarms on/off, SpO 2 Alarm limits, Desat Alarm Limit, NBP Alarm Suppression On/ Off, Pulse(SpO 2 ) On/Off, Measurement Mode 1, Repetition Time 1 1 Measurement Mode and Repetition Time can only be synchronized if SpO 2 comes from a Cableless SpO 2 Pod or a telemetry device. WARNING Not all settings are synchronized; after changing the measurement source, always check that the settings are appropriate. ECG: Va and Vb leads are reset to default (V2, V5) if the configured Va or Vb lead for the telemetry device is not one of V1 through V6. Additional NMT Information Modified Caution CAUTION Use only electrodes suitable for nerve stimulation deemed appropriate by the attending physician. Pay special attention to current densities exceeding 2 ma r.m.s/cm 2 for any electrodes. 4

5 Addendum to the Instructions for Use 1 Addendum Updated Section - Understanding Auto Mode Numerics The figure below shows the NMT measurement in Auto mode. 1 NMT: Auto mode, Repeat Time 30 sec. 2 Time until next measurement or the time the measurement was taken. 3 Bar graph showing relative strength of each twitch. If a calibration has been made, the strength of the calibration reference twitch is shown as a white line. 4 TOFrat expressed as %. If the repeat time is shorter than one minute, only one measurement per minute is stored in the aperiodic trend. Updated NMT Default Settings NMT Settings Factory Adult Factory Pedi Factory Neo 1 Stimulation TOF TOF TOF Mode Manual Manual Manual Repeat Time TOF 30sec 30sec 30sec Repeat Time Twitch 12 sec 12 sec 12 sec Current 50 ma 50 ma 50 ma Pulse Width 200 µsec 200 µsec 200 µsec Alarms Off Off Off Suppress Alarms On On On TOFcnt High Lim Stimul. Modes TOF/PTC TOF/PTC TOF/PTC Value Lifetime 5 min 5 min 5 min Color Light Green Light Green Light Green Updated NMT INOPs 1 The NMT measurement may not be used for neonatal patients and is therefore not supported in the neonatal mode. INOP Message, Indication NMT Alarm Suppress NMT Cable Disconn Explanation NMT alarms are suppressed until the TOF count reaches zero for the first time. No patient cable is connected to the NMT measurement module. Silencing this INOP switches the NMT measurement off. 5

6 1 Addendum Addendum to the Instructions for Use INOP Message, Indication NMT Cable Unknown NMT Cal Failed NMT Cal Running NMT Cannot Measure NMT Equip Malfunct NMT Impedance High NMT Incompatible NMT Lead Off NMT Neo Patient? NMT Noisy Signal NMT Overcurrent NMT Overrange NMT Sensor Malfunc NMT Upgrade Explanation The patient cable connected to the NMT module is not supported or cannot be identified. Replace it with a supported cable. The NMT calibration cycle failed. Check that the sensor and the electrodes are placed properly, then start another calibration. If calibration fails again, replace the patient cable. If INOP persists, contact your service personnel. An NMT calibration is running. Wait until the calibration is complete. NMT is unable to reliably derive measurement values. Check that the sensor and the electrodes are placed properly and start another measurement. If this INOP persists, try another patient cable. There is a problem with the NMT hardware. Unplug the NMT measurement module then plug it in again. If the INOP persists contact your service personnel. The impedance of the NMT stimulation electrodes has exceeded the allowed limit. Check that the electrodes are placed properly, have firm skin contact and have not dried out. This version of the NMT measurement module is not supported, or the module firmware is incomplete and needs to be upgraded. Contact your service personnel. One or both NMT stimulation electrodes have become detached from the patient. Check that both electrodes have firm skin contact, that the electrodes are placed properly and that the lead wires are connected. The NMT measurement does not support neonatal patients. Check the patient category. The NMT signal is too noisy to derive measurement values reliably. If electrosurgery is currently being used, repeat the NMT measurement after it has stopped. The current through the NMT stimulation electrodes is too high. Check that electrode leads are not shorted and that the electrodes are placed properly. The signal from the acceleration sensor is out of the measurement range. Check that the acceleration sensor is positioned properly. If this INOP persists, try another patient cable. There is a problem with the acceleration sensor of the NMT patient cable. Disconnect and reconnect the patient cable. If this INOP persists, replace the cable. An NMT module firmware upgrade is in progress. NMT monitoring is currently not possible. Wait until the upgrade has completed and this INOP is no longer displayed. Do not unplug the module or switch off power. 6

7 Addendum to the Instructions for Use 1 Addendum Updated NMT Specifications NMT Performance Specifications Stimulator Output Current Pulse 100, 200, or 300 µsecs; monophasic rectangle pulse Current Range 5 to 60 ma in increments of 5 ma Current Accuracy ± 5% or ± 2 ma, whichever is greater Maximum Skin Resistance 3 kohm Maximum Output Voltage 300 V ±10% Train-Of-Four Stimulation Mode TOF Count (TOFcnt) 0 to 4 (resolution: 1) TOF Ratio (TOFrat) 5 to 150% (resolution: 1) Repeat Time Manual, or 12 sec, 30 sec, 1 min, 5 min, 10 min, 15 min, 30 min, 60 min Minimum Recovery Time 10 sec Profiles WARNING If your monitor is configured to show the profile name in the info line at the top of the screen, be aware that individual settings may have been changed by other users or by settings synchronization since the profile was loaded. Hence settings may be different than implied by the profile name. Protocol Watch - SSC Sepsis Protocol Updated Section - SSC Sepsis Protocol The SSC Sepsis Protocol is for use in screening for severe sepsis and monitoring of its treatment. It is a computerized implementation of the January 2008 Surviving Sepsis Campaign Guidelines for Management of Severe Sepsis and Septic Shock [Dellinger RP, Levy MM, Carlet JM et al: Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2008 (published correction appears in Crit Care Med; 36: ). Crit Care Med : ], including the Amendment from October

8 1 Addendum Addendum to the Instructions for Use Updated Screen for Severe Sepsis Screening Legend; Hyperglycemia (Glucose >7.7mmol/l or >140mg/dl) in absence of diabetes Updated Section - Hypotension Evaluation If the Lactate value was not above 4 mmol/l, a further window asks whether the patient has persistent hypotension. The protocol defines Hypotension as: SBP < 90mmHg (12.0kPa), or MAP < 70mmHg (9.3kPa), or SBP decrease > 40mmHg (5.0kPa) below baseline. You can see this definition in the window by selecting Show Details. If the patient has persistent hypotension as defined, select Yes. This acknowledges that the patient meets the criteria for severe sepsis and a final window appears recommending authorized clinician review before entering the Sepsis Resuscitation Bundle. If the patient does not have persistent hypotension, select No. After an hour a screen appears asking Is the previously acknowledged infection still present?. If you select Yes, the window for the Lactate measurement will reappear. If you select No, screening continues - comparing heart rate, temperature and respiration rate values against the screening criteria. 8

9 Addendum to the Instructions for Use 1 Addendum Updated Screen for the Sepsis Resuscitation Bundle Legend: Achieve ScvO 2 >=70% (SvO 2 >=65%) Updated Screen for the Sepsis Management Bundle Legend: Maintain Insp. Plateau Pressure <=30cmH 2 O The boxes for Maintain Glucose <8.3mmol/l (150 mg/dl) and Maintain Insp. Plateau Pressure <=30cmH 2 O can only be checked when the timer has reached 20 hours to ensure that the stabilization of these values is achieved long-term. Check these boxes if the recommendation has been fulfilled. 9

10 1 Addendum Addendum to the Instructions for Use Accessories - Additional NBP Cuffs The following cuffs may not be included in your Instructions for Use but do belong to the Philipsapproved accessories for your patient monitors. Adult/Pediatric Single Patient Cuffs Patient Category Limb Circumference Part No. Tubing Adult (Thigh) 42 to 54 cm M1879A M1598B (1.5 m) Large Adult 34 to 43 cm M1878A or M1599B (3 m) Adult 27 to 35 cm M1877A Small Adult 20.5 to 28 cm M1876A Pediatric 14 to 21.5 cm M1875A Infant 10 to 15 cm M1874A Neonatal/Infant Single Patient, Soft Cuffs Cuffs Limb Circumference Part No. Tubing Size to 5.7 cm M1866S M1596C (1.5 m) Size to 8.0 cm M1868S or M1597C (3 m) Size to 10.9 cm M1870S Size to 13.1 cm M1872S Size 5 (Infant) 10 to 15 cm M1873S Neonatal/Infant Cuff Kits Cuff Kits Standard, Single Patient, Luer connector: 10 x M1866A, 10 x M1868A, 10 x M1872A, and 20 x M1870A Standard, Single Patient, ISO compliant connector: 5 x M1866B, 10 x M1868B, 20 x M1870B, 10 x M1872B, and 5 x M1873B Soft, Single Patient, ISO compliant connector: 5 x M1866S, 10 x M1868S, 20 x M1870S, 10 x M1872S, 5 x M1873S Part No. M MP2 and X2 Only Updated Section - Using the Battery Extension To provide enough power for the use of an MMS Extension during transport, you can use the Battery Extension (865297). The Battery Extension provides additional battery power for situations when no mains power is available and can typically power the monitor with MMS Extension for at least 6 hours. When running from the Battery Extension with no mains supply available, the monitor will not charge its internal battery. 10

11 Addendum to the Instructions for Use 1 Addendum MX Only Updated Section - Monitoring After a Power Failure A monitor that was switched on prior to a temporary power loss switches on again when power is restored. A monitor that was switched off prior to a temporary power loss remains off when power is restored. If the monitor is without power for less than one minute, monitoring will resume with all active settings unchanged. If the monitor is without power for more than one minute, the behavior depends on your configuration. If Automat. Default is set to Yes, the default profile will be loaded when power is restored. If Automat. Default is set to No, all active settings are retained, if power is restored within 8hours. The Automat. Default setting is made in Configuration Mode. Updated Section - CE Marking Philips The monitors, together with the Multi-Measurement Modules (M3001A/M3002A), the Flexible Module Racks FMS-8 (M8048A) and FMS-4 (865243), and all modules and MMS extensions, comply with the Medical Device Directive 93/42/EEC. Covidien Covidien BISx, Covidien BIS Engine and Covidien DSC comply with the Medical Device Directive 93/42/EEC. 11

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