Interfacing Module N-DISPiCCO, ref. M Rev 01. Conformity according to the Council Directive 93/42/EEC concerning Medical Devices.

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1 GE Healthcare Interfacing Module N-DISPiCCO, ref. M Rev 01 Installation Guide 0537 Conformity according to the Council Directive 93/42/EEC concerning Medical Devices. CAUTION: U.S. Federal law restrict this device to sale by or on the order of a licensed medical practitioner. Outside the USA, check local laws for any restriction that may apply. All specifications are subject to change without notice. Document No. M January 2006 GE Healthcare Finland Oy Helsinki, Finland P.O. Box 900 FI GE Tel: , Fax: General Electric Company. All rights reserved.

2 Installation instructions for N-DISPiCCO Connects the PiCCO plus (trademark of PULSION Medical Systems AG) to the Datex-Ohmeda Critical Care, Compact Critical Care, Anesthesia and Compact Anesthesia Monitors Interfacing module (1) labeling specifying the external device (2) LED indicators (3) black bus cable from another interfacing module (if needed) (4) gray device specific cable to the communication port of the external device (5) black bus cable to the Datex-Ohmeda monitor's UPI4 or UPI4NET board (or to another interfacing module) WARNING: Make sure that you are connecting the interfacing module to the device specified in the labeling. CAUTION: When connecting the interfacing module to the external device, refer to the external device s instruction manual for complete instructions. Verify proper operation of the system before clinical use. NOTE: The Device Interfacing Solution requires B-UPI4(NET) and B-CPU4 or newer boards for the Critical Care or Anesthesia Monitors. To attach the interfacing module with the Small Device Mount (order code ): 1. Clean the surface you want to attach the module to with a mixture of isopropyl alcohol and water. 2. Attach the clip with its adhesive sticker to the cleaned surface and let dry for at least 24 h. 3. Attach the interfacing module on the clip. How to connect PiCCO plus with the Critical Care or Compact Critical Care, Anesthesia and Compact Anesthesia Monitors 1. Connect the device specific cable to the RS 232 connector in the PiCCO plus rear panel and the bus cable to the Datex-Ohmeda monitor s connector for Device Interfacing Solution, or to another interfacing module. 2. Turn on the external device. 3. Turn on the Datex-Ohmeda monitor. 2 (6)

3 Interfaced data 1. Events NOTE: The status message Connected appears on the Status Page (Monitor Setup - Interfacing - Status Page) after you have connected the external device to the interfacing module and turned it on. Note also that the monitor and the interfacing module must be operational. For instructions on how to view the interfaced data on the monitor screen, see the User s Guide of the monitor. Monitor Software 05 and newer applicable with CCM, CCCM, AM and CAM Parameter Description Unit CFI Mean Cardiac Function Index 1/min EVLW Mean Extravascular Lung Water ml GEDV Mean Global Enddiastolic Volume ml ITBV Mean Intrathoracic Blood Volume ml EVLWI Extravascular Lung Water Index ml/kg GEDI Global Enddiastolic Volume Index ml/m 2 GEF Global Ejection Fraction % SVV Stroke Volume Variation % SVRI Systemic Vascular Resistance Index dyne*s*cm 5 *m 2 How to configure Datex-Ohmeda Monitor Event Trend Page When the monitor is not connected to the icentral The transferred Events from the PiCCO plus can be seen on the Monitor Event Trend page (for example page1) by selecting Event 4 to the field 1-3. Configure the Event Trend Page by selecting: Monitor Setup Install/Service Trends&Snapshot Graphical Trend Page1 Field1 Event4. If user wants all the events coming from the PiCCO plus to be shown on the Monitor Event Trend Page, should 3 different Event4 fields be configured to the page1. The First Event4 enables CFI, EVLW, GEDV and ITBV, the second Event4 enables EVLWI, GEDI, GEF and SVV and the last Event4 enables SVRI. CFI, EVLW, GEDV, ITBV, EVLWI, GEDI and GEF are updated to the Monitor Event Trend 3 (6)

4 Page in the beginning of the Case and after that everytime when user makes a thermodilution measurement in PiCCO monitor. SVV and SVRI are updated to the Monitor Event Trend Page every four-minute. When the monitor is connected to the icentral If the Datex-Ohmeda Monitor is connected to the icentral and user wants the events from PiCCO plus to be shown on the Monitor Event Trend Page, three files (fixed1.txt, anercfg.082 and acf) had to be updated to the icentral. To update these files take contact to your local distributor. The transferred Events from the PiCCO plus can be seen on the Monitor Event Trend page (for example page1) by selecting Event4 to the field 1-3. Configure the Event Trend Page by selecting: Monitor Setup Install/Service Trends&Snapshot Graphical Trend Page1 Field1 Event4. If user wants all the events from PiCCO plus to be shown on the Monitor Event Trend Page, should 3 different Event4 fields be configured to the page1. At the First Event4 is enabled CFI, EVLW, GEDV and ITBV, at the second Event4 is enabled EVLWI, GEDI, GEF and SVV and at the last Event4 is enabled SVRI. CFI, EVLW, GEDV, ITBV, EVLWI, GEDI and GEF are updated to the Monitor Event Trend Page in the beginning of the Case and after that everytime when user makes a thermodilution measurement in PiCCO monitor. SVV and SVRI are updated to the Monitor Event Trend Page in every four-minute. NOTE: If user wants only Continuous Cardiac Output (CCO) to be shown on the monitor digit field or version of the icentral is 4.4 or higher, there is no need to update icentral. 2. Numeric values Monitor Software 05 and newer applicable with CCM, CCCM, AM and CAM Parameter CCO NOTE: Datex-Ohmeda Monitor is capable of calculating Continuous Cardiac Index (CCI) from transmitted Conitinuous Cardiac Output (CCO) if patient height and weight are determined. Because Datex-Ohmeda Monitor calculates Body Surface Area (BSA) slightly differently than PiCCO plus, there might be minor difference in CCI between Datex-Ohmeda Monitor and PiCCO plus Monitor. For more instructions on how to view the interfaced data on the monitor screen, see the User s Guide of the monitor. Communication protocol RS-232, baud rate 19200, parity even, data bits 8, stop bits 1 4 (6)

5 Functional check There are two ways to perform a functional check of the Device Interfacing Solution: 1. Press the Monitor Setup key on the Datex-Ohmeda monitor and select Interfacing - Status Page. The Status Page shows you the current communication status of the interfacing modules connected to the bus. Up to 10 Device Interface Solutions can be connected simultaneously with Anesthesia Monitor, Critical Care Monitor, Compact Anesthesia Monitor, and Compact Critical Care Monitor. 2. Check the LED indicators on the interfacing module (the green LED indicates physical connections, the yellow LED software selections): GREEN YELLOW INDICATION lit dark Physical connections between the monitor, interfacing module and external device are in order and the device has been selected in the menu. dark lit There is something wrong with the physical connections between the monitor, interfacing module and external device; the external device has not been selected in the menu (see the User s Reference Manual of the monitor). lit lit Physical connections between the monitor, interfacing module and external device are in order but the external device has not been selected in the menu (see the User s Reference Manual of the monitor). dark dark The interfacing module is not connected to the monitor. Selecting the external device 1. Press the Monitor Setup key on the monitor and select Interfacing. 2. Select the desired measurement parameter group (for example, C.O.). 3. Select the connected external device by its name (PiCCO). For instructions on how to view the interfaced data on the monitor screen, see the User s Guide of the monitor. NOTE: You must reselect the external device if the monitor or external device is turned off or restarted. In this case, follow the steps above but in step 3, select Module and then the external device by its name. NOTE: The device appears on the list only if it is correctly connected 5 (6)

6 Compatibility: The Device Interfacing Solution (DIS) is compatible with the Datex-Ohmeda Critical Care or Anesthesia Monitor when the monitor has B-UPI4(NET) and B-CPU4 or newer boards installed. Also, software L-ICU05(A) or L-ANE05(A) or newer has to be installed to the Datex-Ohmeda Monitor. The Device Interfacing Solution (DIS) is compatible with the Datex-Ohmeda Compact Critical Care or Compact Anesthesia monitor (e.g. F-CM(REC)1 frame). Also, software L- CICU05(A) or L-CANE05(A) or newer has to be installed to the Datex-Ohmeda Compact Monitor. The Device Interfacing Solution for PiCCO plus (N-DISPiCCO) is compatible with icentral if only Continuous Cardiac Output (CCO) is interfaced. If also Events from PiCCO plus are interfaced user had to update three files (fixed1.txt, anercfg.082 and acf) to the icentral. To update these files take contact to your local distributor. N-DISPiCCO is compatible with the Central versions S-CNET99, S-CNET01, S-CNET02, L-NET03 and L-NET05 when these three files have been updated. These three files are already updated in the Unity icentral v.4.4. The Device Interfacing Solution for PiCCO plus (N-DISPiCCO) is tested with PiCCO Plus SP7.0. This is the only version which compatibility can be guaranteed. WARNING WARNING WARNING CAUTION The manufacturer guarantees a reliable functioning of the devices with tested software versions only. Always verify the compatibility before use (see above). The monitor, interfacing modules and interfaced devices must be situated in the same patient environment (as defined in IEC ). Connecting electrical equipment together or using the same extension cord for more than one device may cause their leakage currents to exceed the limits specified in relevant safety standards. Always make sure that the combination complies with the international safety standard IEC for medical electrical systems and with the requirements of local authorities. Make sure that the interfacing module is always used in vertical position to prevent water from entering the module. 6 (6)

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