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Operators Manual Multi-parameter veterinary monitor " LifeWindow LW6000V-MR " 1

LifeWindow

LW- 6000V-MR

MULTI-PARAMETER VETERINARY MONITOR

Operator’s Manual

Quality and Technology... To Touch Life

Operators Manual Multi-parameter veterinary monitor " LifeWindow LW6000V-MR " 1

Table of Contents Section 1 - Introduction A. About this Manual ................................ 2 B. Manufacture's Responsibility ................ 2 C. Warranty .............................................. 2 D. Unpacking and Accessories .......... ........ 2 E. General Safety ...................................... 3 F. System Description.................................. 5 G. Installation ...................................... 5 Section 2 - Controls, Connectors and Indicators A. Front Panel .......................................... 6 B. Patient Panel ........................................... 7 C. Rear Panel .....................………………… 8 D. Monitoring Mode Screen.......................... 9 E. System Messages ........................……. 11 Section 3 - Operation Instructions A. Initial Operation ..................................... 11 B. Patient Management…………………….. 12 C. Date and Time.......................................... 13 D. Sound and Setting.................................... 13 E. Traces Setting....................………………. 13 F. Trends ..........................…………………. 13 G. Battery Operation .........................……… 14 H. Printer……………………………………….14 Q. Power-OFF..........................……………. 15 Section 4 - ECG Monitoring A. Introduction ......................................... 15 B. ECG Mode ................................... 15 C. Patient Connections............……………… 16 D. ECG Scale ............................................. 17 E. ECG Filter .................................... 18 F. Heart Rate Limits ............................... 18 G. ECG Sweep Speed.................................. 19 H. ST Segment ..................................... 19 I. Arrhythmia Detection................................. 20 J. ECG Pulse Test.................................... 20 K. ECG Patient Type.................................... 21 L. ECG Pace Maker.................................... 21 M. ECG Alarms.................................... 21 Section 5 - Oxygen Saturation Monitoring A. Theory of operation .............................. 23 B. Patient connections ................................ 24 C. SpO2 monitoring .................................. 25

D. SpO2 Waveform and Bar-graph................25 E. SpO2 alarm limits .. ............................... 25 F. SpO2 alarm messages ......................... 26 Section 6 - CO2 Sidestream Monitoring A. Principle of Operation …...............……..26 B. Patient Interface ........................…………27 C. Calibration………………………………….28 D. CO2 Monitoring……………………………29 Section 7- NIBP Monitoring A. Theory of Operation .........................……30 B. Patient Connections................................ 31 C. NIBP Monitoring .………………………… 31 C. NIBP Alarm Messages………………… 32 Section 8 - Technical Specification A. Mechanical Description ......................... 33 B. Power Requirements ........................... 33 C. ECG ................................................... 33 D. SpO2 Pulse Oximeter .......................... 34 E. Non-Invasive Blood Pressure.................. 34 F. CO2 – Capnography Sidestream............ 35 G. Display ……….............................………. 35 H. Environment Specifications .................. 35 I. Trends ................................................ 35 J. Auxiliary Output (Rear Panel) .................. 36 Section 9- Maintenance A. The Monitor ........................................... 36 B. Probes .................................................. 36 C. Patient Cables ......................................... 37 D. Battery .................................................. 37 Warranty Terms & Conditions ................ 38 Rev1 Aug 08

Digicare Biomedical Technology Inc.

Operators Manual Multi-parameter patient monitor " LifeWindow LW6000V-MR " 2

SECTION 1 – Introduction

A . About This Manual This operator’s manual has been prepared to provide information on the correct use of the DIGICARE BIOMEDICAL TECHNOLOGY INC. LifeWindow LW6000V-MR multi-parameter veterinary monitor. It contains performance specifications and installation, operation and maintenance information. It is intended for trained animal-care professionals. Follow each chapter in the manual sequentially, (specially) if the monitor is being used for the first time.

B . Manufacturer's Responsibility The manufacturer of this equipment is responsible for the effects on safety, reliability, and performance of the equipment only if: -The equipment is used in accordance with the instructions in this manual. -The electrical installation complies with all applicable regulations. -Assembly operations, extensions, re-adjustments, or repairs are carried out by person’s authorized by the manufacturer. It is up to the user to ensure that any applicable regulations respecting the installation and operation of the monitor be observed. The operator should read this manual careful ly and thoroughly before attempting to use the monitor.

Incorrect operation or failure of the user to maintain the monitor in accordance with proper maintenance procedures relieves the manufacturer or his agent from all consequent non-compliance, damage or injury.

C . Warranty All products manufactured by Digicare Biomedical Technology Inc. are warranted to be free from defects in material and workmanship and to operate within published specifications, under normal use, for a period of one year from date of original shipment. The warranty on accessories is ninety (90) days. If an examination by Digicare, discloses such products or component parts be been defective, then our obligation is limited to repair or replacement (at our option).

D . Unpacking and Accessories



Carefully remove the monitor and its accessories form the shipping carton. Save the packing materials in case the monitor must be shipped or stored. Ensure your LifeWindow LW6000V-MR has the items listed in the SHIPPING LIST inside the carton.

E . General Safety 1 - INDICATIONS The LifeWindow LW6000V-MR is a Multiparameter Physiologic Veterinary Monitor indicated for use in monitoring Electrocardiogram (ECG), functional oxygen saturation of arterial hemoglobin (SpO2), Non-Invasive Blood Pressure (NIBP) and Capnogram (CO2), in a Magnetic Resonance (MR) environment. The LifeWindow LW6000V-MR series is intended for use by person’s trained in professional animal care. The operator must be thoroughly familiar with the instructions in this manual before using the instrument. If the Operator have doubt about the integrity of the external protective conductor, equipment SHALL BE operated from its internal battery only. 2- CONTRAINDICATIONS • Explosion Hazard: Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gasses. • The LifeWindow LW6000V –MR Base cannot be used in the MRI room. • The Televue ECG device is designed to be used in the MRI room, only with it’s own battery. • The Televue ECG battery charger cannot be used in the MRI room. 3 - CAUTIONS

• This equipment complies with IEC 60601-1-2:2001 for electromagnetic compatibility for medical electrical equipment and/or systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device. Medical electrical equipment needs special precautio ns regarding EMC, and all equipment must be installed and put into service according to the EMC information specified in this manual. • Portable and mobile RF communications equipment can affect medical electrical equipment. • If this device fails to respond as described, discontinue use until the situation is corrected by qualified technical professionals. • Do not place liquids on top of this device.



• Do not immerse this device or sensors in any liquids. • Do not use caustic or abrasive cleaning agents on the unit or sensors. • Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries. Use only Digicare-approved battery packs. 4 - WARNINGS • This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. • Use only accessories provided by Digicare Animal Health in the LifeWindow LW6000V -MR. • Using other manufacturers’ sensors and cables can result in improper performance. • Do not use a damaged sensor. • Do not use this device in or around water or any other liquid, with or without AC power. • As with all medical equipment, carefully route patient cables and connections to reduce the possibility of entanglement or strangulation. • Use this device only with power adapters supplied by Digicare Animal Health. • The use of accessories, sensors, and cables other than those listed in this manual may result in increased electromagnetic emission and/or decreased immunity of this device. • When operating the Televue ECG in an MR environment, securely fasten this device to a non-movable pole mount or other large object, and keep it as far from the magnetic field as possible. For magnetic equipment with a magnetic strength of 1.5T or less, the device must be a minimum of 2 meters away from the magnet. • The SpO2 Fiber Cable for this device is extremely sensitive and must be handled with caution at all times. Do not use a damaged sensor. • The ECG cable and leadwires for this device is extremely sensitive and must be handled with caution at all times. Do not use a damaged cable and leadwires. • Use only MRI compatible electrodes with this equipment. Do not use other type or damaged electrodes. • To avoid injury or potential equipment damage, always keep the Televue ECG device, beyond the distance of magnetic attraction. To ensure safe operation of the Televue ECG in the MRI room, it must be located outside the 200 Gauss line of the MR room and must be firmly attached to a fixed object. • When audible alarms cannot be heard due to ambient noise, visible alarms must be used.



F . System Description

• The LifeWindow LW6000V -MR is composed by two equipments: • The LW6000V Base Monitor is a configurable multiparameter veterinary monitor. It is designed to be operated outside of the MRI environment. It has a 12.1” TFT color screen to display all vital signs waveform and readings from the patient. • The LW6000V -MR Pulse Oximetry uses a long Fiber Optic cable and sensor to reach the patient inside the MRI room. • The LW6000V -MR NIBP uses a long hose to reach the patient inside the MRI room. • The LW6000V -MR sidestream CO2 uses a long sample line to reach the patient inside the MRI room. • The LW6000V-MR ECG module is the Televue ECG Transmitter, that is designed to be operated inside the MRI room always from it’s own battery. It shall be firmly attached to a fixed object using the mounting bracket on the bottom of the device. • The Televue ECG wireless connect to the LifeWindow LW6000V Base, using a Bluetooth link.

G . Installation

• The LW6000V Base Monitor shall be installed in the Control Room, outs ide of the MRI room. • The LW6000V Base Monitor can be operated connected to the AC mains or from its internal battery. • The LW6000V Base Monitor shall be installed, if possible, close to the window in order to enable the screen to be seen from inside the MRI room. • The LW6000V Base Monitor accessories, NIBP hose, SPO2 Fiber Optical Cable and CO2 sample line, shall be routed through the waveguide to the interior of the MRI room. • The Televue ECG Transmitter shall be firmly attached to a fixed object using the mounting bracket on the bottom of the device. It shall be used outside the 2mT field.



SECTION 2 - Controls, Connectors and Indicators

A. Front Panel

FIG.1 1- TFT Active Matrix Color Flat Panel Display: Windows based Graphic Interface displays 6

user selectable physiologic waveforms, numeric values, indicators, alarm messages and physiologic parameters menu.

2- Pointer device. Ergonomic and ease to use menu selections. 3- SELECT pushbutton. 4- ALARM DISABLE dedicated pushbutton. 5- FREEZE dedicated pushbutton. 6- LEAD SELECTION dedicated pushbutton. 7- NIBP START dedicated pushbutton. 8- NIBP STOP dedicated pushbutton. 9- PRINT dedicated pushbutton. 10- BATTERY charge status LED indicator. 11- AC mains line LED indicator.



B. Patient Panel

FIG. 2 12- NIBP hose receptacle. Accept cuff to Non Invasive Blood Pressure and Pulse determination

and monitoring. 13- CO2 Sidestream receptacle. Accept Water Trap, cannula and sample line to sidestream

CO2 and Respiration Rate determination and monitoring. The CO2 water trap for the MRI application is located in the other side panel.

14- CO2 Mainstream connector. Not Applicable for MRI 15- Temperature Channel 1 connector. Not Applicable for MRI 16- Temperature Channel 2 connector. Not Applicable for MRI 17- FIO2 connector. Not Applicable for MRI



18- SpO2 connector. Accepts pulse oximetry Fiber Optic sensor cable to non-invasive determination and monitoring of the blood oxygen content.

19- Invasive Pressure Channel 1 connector. Accepts pressure transducer cable to invasive determination and monitoring of blood pressure.




23- ECG connector. Not Applicable for MRI

C. Rear Panel

FIG.3 24- Mains Line IEC connector. Accepts power cable from mains line and has 2 fuse holder

inside . 25- General Power switch. Opens power from internal battery and mains power supply. 26- On / Standby switch. Momentary contact switch to Turn-on and off the unit. 27- Printer Output. Connection to a parallel printer. 28- Ethernet Connector. Connection to ethernet network standard. 29- Phone Line Connector. Modem connection to Internet communication. 30- Keyboard Connector. Connection to a standard AT type keyboard used only to service

purposes.



31- Video Connector. Connection to a standard CRT video. 32- Auxiliary Connector. Supply analog out put signals, trigger signals and one RS232

communication port. ( see Section 2 Item O). 33- Expansion 1 Connector. Not Applicable for MRI. 34- Expansion 2 Connector. Not Applicable for MRI. 35- CO2 Sidestream Vent. Keep it always open to room air.

D. Monitoring Mode Screen

FIG.4 Note: In the monitoring screen, six waveform traces are user selectable with options for waveform source, trace speed, trace color, trace style and cascade . The Indicators to Pulse Detected, Numerical Resdaings and Alarm Messages have fixed screen positions . When the user changes the trace source, the Indicators and messages stay in the same position.



36 – First waveform user selected area, showing ECG waveform in Thin Line Style, with scale (-1 to +1mV), sweep speed of 25mm/s and the R wave detected INDICATOR (HEART). 37 – Second waveform user selected area, showing ECG waveform in Thin Line Style, (-1 to +1mV), sweep speed of 25mm/s. 38 – Third waveform user selected area, showing ECG waveform in Thin Line Style, (-1 to +1mV), sweep speed of 25mm/s. 39 – Fourth waveform user selected area, showing ECG waveform in Thin Line Style, (-1 to +1mV), sweep speed of 25mm/s. 40 – Fifth waveform user selected area, showing SpO2 waveform in Thin Line Style, with Pulse Level strength scale (1 to 8), sweep speed of 25mm/s. 41 – Sixth waveform user selected area, showing Capnogram (CO2) waveform in Fill In Style, with scale (10 to 50mmHg), sweep speed of 12.5mm/s. 42 – ECG menu selection. 44 – SpO2 menu selection. 45 – Not Applicable for MRI. 46 – CO2 menu selection. 47 – NIBP menu selection. 48 – Invasive Pressure menu selection. 49 – Not Applicable for MRI. 50 – Traces configuration menu selection. 51 – Trends menu selection. 52 – System configuration menu selection. 53 – Heart Rate value Indicator in Beats Per Minute (BPM). 54 – Large / Small Mode Selector and Indicator. 55 - System Indicators of Date and Time. 56 – SpO2 value Indicator in %. 57 – Battery Status Indicator. 58 – ECG Indicators: Lead I, II or III. Mains Filter ON/OFF Digital Filter ON/OFF 59 – FIO2 Indicators: 61 – Indicators: Systolic arterial pressure determined by NIBP in mmHg. Diastolic arterial pressure determined by NIBP in mmHg. Mean Arterial Pressure (MAP) determined by NIBP in mmHg. 62 – Indicators: NIBP mode selected indicator : Manual, Stat or Auto. NIBP cycle interval selected indicator. NIBP time to next cycle remaining indicator. 63 – Indicators: End tidal CO2 (EtCO2) value display in %. Inspired CO2 (InsCO2) value display in %. Respiration Rate determined by CO2 technique value displa y in RPM.



E. System Messages “AUDIBLE ALARMS OFF” – Flashing indicate AUDIBLE ALARMS disabled for 2 minutes. Permanently indicates AUDIBLE ALARMS OFF. “LOW BATTERY” – Indicates that the LifeWindow LW6000V -MR internal battery is close to be fully depleted. “No Communication with Televue Check Connection” – Indicates that the LifeWindow LW6000V -MR is not receiving and transmitting data to the Televue ECG Transceiver. “Lo Bat Televue” - Indicates that the Televue ECG Transceiver battery is almost fully depleted. SECTION 3 - Operation Instructions

A. Initial Operation

CAUTION: Read this manual completely before initiate the monitor’s installation and operation.

1 - LifeWindow LW6000V-MR Power-ON. • Plug the AC power cord in AC MAINS receptacle in rear panel and in the AC outlet. The LifeWindow accepts 110 or 220 VAC with automatic selection by the power supply. • The electrical installation of the room must have three pin outlets with earth connection for protection of patient, users and equipment. • The AC-ON LED indicator will light green and the BATTERY status indicator will light green if the battery is fully charged or yellow if charging. • Power-on the unit by double-clicking the ON switch on the rear panel.



• The monitor will then perform a “boot” sequence (approx. 1. 5 min.) to load functions. Use Touchscreen operation or mouse and clicker to make desired selections. 2 - TeleVue ECG Transmitter Power-ON and Connection. • The Televue ECG Transceiver must be operated always from it’s own battery. It is not designed to be connected to any type of recharger or DC external power supply or AC to DC converter. • The Televue ECG Transceiver battery when fully charged, can supply power for up to 7 hours of continuous operation. • The Televue ECG Transceiver is supplied with one extra battery and one battery charger. The battery charger is not designed to be used inside the MRI room. • Turn-ON the Televue after the LifeWindow LW6000V -MR is already On. • Turn-ON the Televue ECG by sliding the switch in the side of the unit. • The ECG link LED in the Televue ECG Transceiver indicates the status of the Bluettoth link connection to the LifeWindow LW6000V -MR receiver. • The ECG link LED flashing, indicates that the Televue ECG Transceiver is not connected to the LifeWindow receiver. The LifeWindow LW6000V-MR display also a message indicating that the Televue ECG Transceiver is not connected. • The ECG link LED steady, indicates that the Televue ECG Transceiver is connected to the LifeWindow LW6000V -MR and the ECG function is operational. • All the ECG functions are controlled in the LifeWindow LW6000V -MR ECG menu. 3 - TeleVue ECG Transceiver Low Battery Indicator. • The Televue ECG Transceiver has one Low Bat LED indicator in the front panel of the transmitter. When it is ON, indicates that the battery can supply power for the Transceiver for approximately 30 minutes. • The Low Bat condition is also transmitted to the LifeWindow LW6000V -MR, so the Televue ECG Transceiver Lo Bat condition is displayed in the LifeWindow LW6000V-MR screen.

B. Patient Management Every time the monitor is turned on the Patient Management screen is displayed. 1- To admit a new patient, click on the ADMIT NEW PATIENT button. One screen asking to

confirm if you want to discharge current patient is displayed. Click yes.



2- The Patient Admission menu is displayed. Enter the name and the ID code to the patient and press the ADMIT PATIENT button.

3- To keep the same patient press the KEEP SAME PATIENT button. 4- The Name and ID code of the patient is display ed on the Monitoring screen. 5- When the monitor is turned off, a screen asking if you want to save patient data is displayed.

Press YES if you want the monitor to save the data from the actual patient or NO if you want to discard the patient data.

C. Date and Time 1 – The current Date and Time are displayed in the Indicators ( 48 ) and ( 49 ). 1 – Move the Pointer to the SYSTEM menu icone and press select button. 2 – Set current location Date and Time.

D. Sound Setting 1 – Move the Pointer to the SYSTEM menu icone and press Select button. 2 – Set Pulse Volume level. The Pulse Volume level can be so low that disable the Pulse sound. 3 – Set Alarm Volume Level. The Alarm Volume level can NOT be disabled by this procedure. 4 – When the unit turns-on, the Alarm sound is disabled by 2 minutes. To disable the Alarm sound by 2 minutes press quick the Alarm Sound Disable dedicate pushbutton ( 4 ) in the front panel. The ALARM OFF message flashes in screen.. To permanently disable the ALARM SOUND press and hold by 4 seconds the Alarm Sound disable dedicated pushbutton ( 4 ). The ALARM OFF message is continuously displayed on screen.

E. Traces Setting You can select any physiological waveform from one to six of the available traces. You can also cascade the traces up to 3 individual loops. 1 – Move the Pointer to TRACES icon and press the Select pushbutton. 2 – Select TRACE waveform source (ECG, SpO2 Plethysmogram, Capnogram, or No Selection). 3 – Select TRACE sweep speed (6.25mm/s, 12.5mm/s, 25mm/s or 50mm/s). 4 – Select TRACE color. 5 – Select TRACE style (Thin line or Fill In). 6 – Press the Cascade Traces button if you want to cascade two or more traces. You can create until 3 cascade loops: Loop 1, Loop 2 and Loop 3. Select the Loop waveform Source. Each trace in the same Loop can have different Sweep Speed, Color and Style. 7 – Press the Done button to finish.

F. Trends 1 – Move the Pointer to the TRENDS icon and press the Select button. 2 – Select the desired TREND period: 15min, 1H, 4H,12H, 24H, 48H and 72H. 1- All physiological variables trends are displayed at same time.



G. Battery Operation -The LifeWIndow LW6000V -MR internal battery has autonomy to approximately one hour of operation when fully charged. -The CHARGE STATUS LED indicator ( 10 ) stays yellow when battery is recharging, green when the battery is fully charged and Off when the battery is disconnected or during battery operation. - With the monitor operating ( ON ) the battery status indicator ( 95 ) displays the charge status of the battery with the unit operating in AC or in battery operation. - In battery operation, the LOW BATTERY alarm message is triggered when there is charge to 5 minutes of operation. After 5 minutes with the LOW BATTERY message the unit will start a shut-down. Televue ECG Transceiver - The Televue ECG Transceiver battery has autonomy to 7 hours of continuously operation. -The CHARGE STATUS LED indicator in the front panel of the Televue ECG Transceiver lights RED indicating that there is battery charge for about 30 minutes.

H. Printer - The LifeWindow LW6000V -MR can be connected to any external windows based printer directly to the rear panel of the unit using it’s own USB connector, or to a network printer. - The Epson C88 Plus is installed as default printer. - It also print to a PDF virtual printer creating PDF print reports. - To Print and change Print settings, go to the Print Menu and Select Printer and PDF. - Set the Print DPI. Default is set to 360 DPI (Epson). Other manufacturer uses 300 DPI. Check your printer documentation to verify correct DPI. - Set Charting Speed. Options are: 6.25, 12.5, 25 (default), 50, 100 and 200 mm/s. - Set Scale. Changing scale will change the amplitude of the ECG in the print out. Options are: 2.5, 5 (default), 10, 20, 40, 80 and 160 mm/mV. As you increase the Scale it will increase the size of the ECG in the printout. - Set Grid On (default) or Off. - Click on the “Print ECG to Printer” to start printing to the connected printer. The printout will have the last 10 seconds of ECG followed by current time ECG. - Click on the “Print ECG to PDF” button to create a PDF printout of the ECG. - Set Interval Between Measurements (minutes), default is 1 minute, For Tabular Reports printout. - Set Numbers of Pages to Print. The default is 1 page. Each page has 45 measurements. - Click in the “Print Report to Printer” to print the Tabular Report in the connected printer. _ Click in the “Print Report to PDF” to create a PDF Tabular Report. Strip Chart Recorder (Optional) - Pressing the Print dedicated button in the Front Panel Overlay, starts a printing on the Strip Chart Recorder.



- Change the settings for the Strip Chart Recorder in the Print Menu, selecting the Strip Chart. - Select the charting speed to the ECG trace: 6.25mm/s, 12.5mm/s, 25mm/s or 50mm/s. - Select the Grid ON or OFF to be printed with the ECG waveform. - Select the ECG scale: 2.5mm/mV, 5mm/mV, 10mm /mV, 20mm/mV, 40mm/mV, 80mm/mV or 160mm/mV. - Activate or not the Triggering events to autom atically start printing the ECG in case of an ECG alarm. TABULAR REPORTS - Select the Interval time between the data acquisition in minutes. - Select the numbers of page to print (8 measurements by page). - Press the Print Report button to start printing the report. - Press the Stop Recorder to stop printing any time.

I. Power-Off 1 – To Shut down the unit just press and release the ON / Standby (26) pushbutton on the rear panel or press the Shutdown option in the system menu. One screen asking to confirm if you want to shutdown the unit is displayed. 2 – If any problem occur with the shutdown function, the user can shut -off the unit by pressing and hold the ON / Standby (26) pushbutton for 15 seconds. In this option the patient data will be lost.

SECTION 4 - ECG Monitoring

A. Introduction • The LIFEWINDOW LW6000V-MR continuously monitors the Electrocardiogram (ECG) waveform, Heart Rate (HR), ST Segment and Arrhythmia Analysis. The screen displays up to 6 simultaneously ECG lead waveforms, Heart Rate, High and Low Heart Rate alarm limits, selected lead (I,II or III, avr, avl and avF), QRS detected ( ♠ ) indicator, alarm messages. Filter selection, and arrhythmia event counters.

B. ECG Mode • The LifeWindow LW6000V -MR has option to operate in 3 leads (default mode for MRI) or 5 leads mode.



• To change from 5 Lead to 3 Lead mode go to the ECG Menu and change the ECG Mode. 5 Lead Mode • The 5 Leads Mode has two modes of monitoring, 6 channels (default) and 2 channels. • In the 6 channels mode, Lead I, II, III, aVr, aVf and aVl waveforms can be simultaneously displayed. In this mode the Vx waveform can not be displayed. • In the 2 channels mode, any of the 7 Leads can be displayed, including VX, but with the limitation of only two simultaneously waveforms. • To select or change the ECG waveforms that are being displayed, go to the Traces Menu and select the desired ECG waveform. • To change from 6 channels to 2 channels mode, go to the ECG Menu, select the 5 Lead System and select the 2 channels mode. 3 Lead Mode • In the 3 Lead Mode only one ECG Lead waveform can be displayed, Lead I, II or III. • The default is Lead II. • To change Lead selected, press the dedicated membrane key in the front overlay , or change in the ECG Menu. • To cascade the ECG waveform or change other waveform settings, go to t he Trace Menu. • During MR imaging, the use of the 3 Lead System is recommended to reduce the numbers of electrodes and leads, reducing interference and risk. • The 5 Lead cable is not supplied with the unit. If the user wants to use the 5 Lead System, contact Digicare Animal Health about the MRI 5 Leads cable system . • The Leadwire selection can be changed to improve QRS detection, noise elimination and Heart Rate count by the LifeWindow LW6000V -MR.

C. Patient Connections • The Televue ECG is supplied for MRI application with a three leads fiber carbon leadwire cable. These leadwire is assembled in a special wrap to avoid loop formation. • The three fiber carbon leadwires are connected to a special shielded, non Ferro-magnetic cable. • The three electrodes must be MRI compatible type and shall be installed close to each other in the chest of the animal.



• Prepare the site of electrode installation, by following standard procedures for improving the electrodes contact with the animal skin. • Connect the three leadwires to the three electrodes and route the leadwire cable in a way to avoid loops and minimum contact with the animal’s skin. • Connect the ECG cable to the Televue ECG Transceiver. • Turn-on the LifeWindow LW6000V -MR. After booting the LifeWindow monitoring screen, the message: “NO COMMUNICATION WITH TELEVUE” will be displayed until the Bluetooth connection is made. The ECG traces in the LifeWindow LW6000V -MR will not start the sweep in the screen until connection with the Televue ECG device is made. • Turn-on the Televue ECG Transceiver. The ECG link status LED will flash indicating NO CONNECTION with the LifeWindow LW6000. After a few seconds the ECG link LED will turn to steady solid light, indicating the CONNECTION with the LifeWindow LW6000V -MR was made. • The LifeWindow LW6000V -MR default screen will display four cascaded traces for ECG with Lead II selected as default.

D. ECG Scale • The Size of the ECG waveform displayed in the screen is set by the ECG Scale. • The Auto Scale is a mode where the selection of the ECG Scale is done automatically for the best possible size of the ECG in the screen. • The ECG Scale can be changed in the ECG Menu to the following options: AUTO Scale -0.1 mV to +0.1 mV -0.25 mV to +0.25 mV -0.5 mV to +0.5 mV -0.75 mV to +0.75 mV -1 mV to +1 mV -2 mV to +2 mV -3 mV to +3 mV -4 mV to +4 mV -5 mV to +5 mV -6 mV to +6 mV



E. ECG Filter • Two Filters are used to eliminate artifact and noise from the ECG signal, The Main Filter and the Notch Filter. • The Main filter has 5 different modes to select. The settings change the frequency response of the filter, reducing noise and artifact in the ECG but at the same time they reduce the ECG frequency components. Diagnostic Mode: Monitoring 1 Mode: Surgery Mode: Strong Filter: Monitoring 2:

- Diagnostic is the Mode where the ECG is less filtered, but at the same time more susceptible to noise and artifact.

- Monitoring 1 is the Mode of use for most of applications where moderate filtering is necessary. - Monitoring 2 has more filtering than Monitoring 1 and less than Surgery Mode. necessary.

- Surgery Mode is recommended when High Levels of Noise and artifact are present, as happen in the MRI environment during images process.

- Strong Filter is the highest level of filtering and is recommended to situations where

high levels of noise and artifact are present, as happen in the MRI environment during images process.

• The Notch is a narrow band pass filter tuned to eliminate the 60Hz (50Hz) interference due to the mains line frequency. This filter is normally in the ON state and can be turned off together with Diagnostic Mode in order to have the maximum ECG signal frequency response. • Change the ECG Filter Mode in the ECG Menu. .

F. Heart Rate Limits • Heart Rate Limits are set by default to: High Heart Rate Limit: 140 BPM. Low Heart Rate Limit: 60 BPM. • Change the Heart Rate Limits in the ECG menu. High Heart Rate Limit Range: 5 to 300 BPM – or OFF - non overlaping. Low Heart Rate Limit Range: 0 to 295 BPM – or OFF - non overlaping.



The values selected are stored by the unit after power-off. To return to the factory default values, go to the SYSTEM menu and select the DEFAULT VALUES button.

G. ECG Sweep Speed . • There are 4 sweep speeds for the ECG: 6.25, 12.5, 25 and 50mm/sec. The sweep speed is selected in the TRACE menu together with other trace selections like channel, style, scale, color and cascade options. All TRACE settings are stored after power-off. To return to the DEFAULT values go to the SYSTEM menu and select the DEFAULT VALUES button.

H. ST Segment • The ST Segment Analysis is being measured for all ECG Lead vectors selected. This Function is ON by default. • To turn-off or change settings in the ST Segment Analysis, go to the ECG Menu and click on the “ST & Arrhyt” button, and the ST Analysis and Arrhythmia Detection Setup screen will open. • When a ST segment is higher than the St High Limit (ST elevation) or Lower than the ST Low Limit (ST depression), an audible and visual alarm are triggered. If the unit has a Strip Chart Recorder, it will also be triggered if set to automatic printing for ST event alar m. • The ST Segment is measured in mV and displayed in the ECG readings screen. • The ST Segment default alarm limits are: High ST limit: -1.99 mV to +2.00 mV, non-overlaping, with default to +0.20 mV. Low ST limit: -2.00 mV to +1.99 mV, non-overlaping, with default to -0.20 mV. • A waveform with the ECG ST Segment Event is displayed in the “ST Segment Analysis and Arrhythmia Detection Setup”. • Two vertical lines are show in the ECG ST Segment Event Display:

- The Red line determines the Isometric Point of the ECG waveform, and is the reference baseline for the ST measurement. - The Blue line determines the point where the T elevation is measured in reference to the Isometric point. - Both lines have a default positioning. The position of both lines can be changed by the

user. - The ISO line (red) default position is -53.340 ms. - The ST line (blue) default position is 72.009 ms. - To change the ISO line or the ST line, click on the line and drag it to the desired position. - To save the new ISO and or ST line positions, click on “Set” in the ECG ST Segment

Event Display. - To return the ISO and or ST line positions to default click on “Def’t” button in the ECG ST

Segment Event Display.



• The ST Segment Analysis and ST Segment alarms can be turned on and off in the ECG menu, “ST Segment Analysis and Arrhythmia Detection Setup” ,

I. Arrhythmia Detection • The LifeWindow LW6000 can detect the following arrhythmias:

- Asystole - Ventricular Fibrillation. - Ventricular Tachycardia. - Pair of PVC (couplet) - Bigeminy. - Trigeminy. - R on T - Run of 3 or 4 PVC - Missed Beat - Single Ventricular Premature (VPB)

• To see the individual counters and settings for the arrhythmias, go to the ECG menu and click on the “ST & Arrhyt” button. • Each of the above arrhythmias has a counter that keeps adding the number of events occurred for each different arrhythmia type. • The VPB counter counts and display the total VPB events. • When an arrhythmia is detected, an audible and visual alarm is triggered. If the unit has a Strip Chart recorder, it will also be triggered if set to automatic printing for arrhythmia event alarm. • The Arrhythmia detection can be turned on and off in the ECG menu, “ST Segment Analysis and Arrhythmia Detection Setup”

J. ECG Pulse Test • A square test waveform is generated to test the functioning of the Televue ECG Transceiver. • With the Televue ECG Transceiver turned on, the LifeWindow LW6000V -MR on and the ECG link status LED in the Televue steady, indicating connection, go to the ECG menu in the LifeWindow LW6000V -Mr and press the Test button. • A screen “ECG Calibration Test Waveforms” will open with the message “This command will generate calibration test waveforms for: ECG Channel input > 1mV”. • Press “Yes” and the Test Waveform will be generated in the screen. The Test waveform is a square wave with 1 mV amplitude and it lasts for 30 seconds in the screen. No Heart Rate count is generated by this test waveform.



K. ECG Patient Type • Patient Type has two modes: Large and Small. Selection of Patient Type changes the ECG sensitivity detection for Heart Rate count and monitoring. • Change the Patient Type in the ECG menu or direct in the main screen.

L. ECG Pace Maker • Pace Maker can generate extra-pulses causing double-count of the Heart Rate. • Selecting Pace Maker “Installed” in the ECG menu removes double count in the Heart Rate. • Pace Maker is not applicable in MRI use.

M. ECG Alarms “ECG LA LEADS OFF” – Yellow message - indicates that the LA leadwire is disconnected from the patient. “ECG RA LEADS OFF” – Yellow message - indicates that the RA leadwire is disconnected from the patient. “ECG LL LEADS OFF” – Yellow message - indicates that the LL leadwire is disconnected from the patient. “ECG RL LEADS OFF” – Yellow message - indicates that the RL leadwire is disconnected from the patient. “ECG Vx LEADS OFF” – Yellow message - indicates that the Vx leadwire is disconnected from the patient. “ECG ASYSTOLE” – Red message - indicates NO detection of R waves from ECG waveform. “ECG LOW HR” – Red Message - indicates that HR value is lower than the selected LOW HR LIMIT. “ECG HIGH HR” – Red Message - indicates that HR value is higher than the selected HIGH HR LIMIT. ECG ST Segment and Arrhythmia Alarms and Messages. “Normal” – Green message indicating the ECG waveform being analyzed has a normal profile.



“No Signal” – Yellow message indicating that no ECG signal is being detected. “Learning” – Yellow Message indicating that the ECG waveform is being analyzed. “(BGM) Ventricular Bigeminy” – Red message indicating that one Ventricular Bigeminy arrhythmia event was detected. “(TGM) Ventricular Trigeminy” – Red message indicating that one Ventricular Trigeminy arrhythmia event was detected. “(CPT) Run Two of Premature Ventricular” – Red message indicating that one Pair of PVC arrhythmia event was detected. “Run 3/4 of Premature Ventricular” – Red message indicating that a sequence of 3 or 4 of PVC arrhythmia event was detected. “(VF/VTA) Ventric. Tachyc. Ventric. Fibril. ” – Red message indicating that a Ventricular Tachycardia or Ventricular Fibrilation arrhythmia event was detected. “Asystole” - Red message indicating that a Asystole arrhythmia event was detected. “R on T Premature Ventricular” – Red message indicating that a R on T Premature Ventricular arrhythmia event was detected. “(VPB) Single Premature Ventricular” - Red message indicating that a Single Premature Ventricular arrhythmia event was detected. “(MIS) Miss Beat” - Red message indicating that a Missed Beat arrhythmia event was detected. “ECG High ST Channel 1” – Red message indicating the ST segment measured is higher than the high ST limit set for ECG vector in channel 1. “ECG High ST Channel 2” – Red message indicating the ST segment measured is higher than the high ST limit set for ECG vector in channel 2. “ECG Low ST Channel 1” – Red message indicating the ST segment measured is lower than the low ST limit set for ECG vector in channel 1. “ECG Low ST Channel 2” – Red message indicating the ST segment measured is lower than the low ST limit set for ECG vector in channel 2.



SECTION 5 - Oxygen Saturation Monitoring

A. Theory of Operation The functioning of the LIFEWINDOW LW6000V-M R pulse oximetry is based on the assumption that hemoglobin exists in two principle forms in the blood: - Oxygenated ( With O2 molecules loosely bound) or HbO2. - Reduced ( With No O2 molecules bound ) or Hb. Arterial oxygen saturation ( SpO2 ) is defined as the ratio of oxygenated hemoglobin ( HbO2 ) to total hemoglobin ( HbO2 + Hb + other types of hemoglobins ). An Oximeter measures the absorption of selected wavelengths of light passing through a living, tissue sample. Since oxygenated hemoglobin and reduced hemoglobin absorb light as know functions in wavelengths, the relative percentage of these two constituents, a nd SpO2 are calculated. The problem is translating oximetry theory into a medical device is differentiating between the absorption due to oxygenated and reduced hemoglobin and the absorption due to all other tissue constituents. The problem is solved with a two wavelength pulsatile system. The pulsation of arterial blood flow present, at a particular test site modulates the light the oximeter’s probe detects. Since other fluids and tissues present at the test site generally don’t pulsate, they do not mo dulate the light passing, through the test site area. Therefore the attenuation of light energy due to arterial blood flow can be detected, and isolated. Thus providing the basis for the necessary calculations, by using the pulsatile portion of the incoming signal.

FIG.8

600 700 900 800 1000

10x

1

0

-1

-2

HbO2

Hb

660 nm 940nm

SpO2 = HbO2 + Hb + (others Hemoglobins)

HbO2



Two wavelengths of light, red and infrared, are utilized to gauge the presence of oxygenated and reduced hemoglobin. Oxygenated hemoglobin (HbO2) and reduced hemoglobin (Hb) exhibit markedly different absorption (extinction) characteristics to red and infrared lights. (FIG.8). The probe’s photodetector converts the light, which is partially absorbed and modulated as it passes through the tissue sample, into an electronic signal. FIG.9. Fig FIG.9 FIG 9

B. Patient Connections Operating Instructions Operating in the MR Environment Use only NONIN-branded 8000FC or 8000FI Fiber Optic Sensors. Do not use cables or sensors that contain conductive wires. Parts and Accessories The following NONIN accessories function with the LifeWindow LW6000V -MR. Pulse Oximeter Reusable Sensors 8000FC Adult Fiber Optic Pulse Oximeter Sensor 8000FI Infant/Pediatric Fiber Optic Pulse Oximeter Sensor Sensor Accessories 8000FW Adult Sensor Wrap 8000TW Infant/Pediatric Sensor Wrap

TIME

ABSORTION



C. SpO2 Monitoring Until the patient cable is connected and the probe is placed in patient, the message SpO2 SENSOR is displayed on screen. In normal operation, the monitor displays SpO2 and Pulse Rate values, the plethysmogram waveform, a bar graph indicating pulse height and alarm limits. - The sensor is to tight. - There is excessive illumination (e.g., a surgical or bilirubin lamp or direct sunlight). - The sensor is placed on an extremity with a blood pressure cuff, arterial catheter or intravascular line. - The patient experiences shock, hypertension, severe vasoconstriction, severe anemia, hypothermia, arterial occlusion to the sensor, or cardiac arrest. Inaccurate measurements may be caused by: - Incorrect application of dysfunctional hemoglobin’s, such as c arboxyhemoglobin or methemoglobin. - Significant, levels of indocyanine green, ethylene blue or other intravascular dyes. - Exposure to excessive illumination, such as surgical lamps, especially ones with a xenon light source; bilirubin lamps, fluorescent lights; infrared heating lamps; or direct sunlight. - Excessive patient movement. - Venous pulsation’s. - Electrosurgical interference. - Placement of the sensor on an extremity that has a blood pressure cuff, arterial catheter or intravascular

line. Do not attach a probe to the same limb with a blood pressure cuff. The data received will not be valid when the cuff is inflated. Attach the probe to the limb opposite the site used for the blood pressure cuff.

D. SpO2 Waveform and Bar Graph The plethysmogram sweep speed can be selected from: 6.25, 12.5, 25 and 50 mm/sec in TRACE menu. The amplitude of the pulse waveform is automatically adjusted in screen. The Bar graph indicates the pulse signal height and varies from 1 to 8. Increasing the signal amplitude increases the Bar graph value. Bellow number 2 in bar graph, the message WEAK PULSE is displayed.

E. SpO2 Alarm Limits At Power-on the SpO2 ALARM LIMITS goes to the factory default values. To modify the limit s, go to the SpO2 menu. After power-off the new selected limit values are stored by the unit. To return to the DEFAULT values go to the SYSTEM menu and press the DEFAULT button.



F. SpO2 Alarm Messages SENSOR SpO2- This message indicate that the SpO2 probe is disconnected from the patient or

the patient cable is disconnected from the monitor or a malfunction in sensor or in patient cable.

SpO2 LOW AND HIGH ALARM LIMITS - This messages indicates that the SpO2 value overlap the LOW or HIGH ALARM LIMIT selected. WEAK PULSE - This message is displayed if the amplitude of the pulse signal is low causing

instability in SpO2 monitoring. Check the probe installation, site perfusion and body temperature.

CHECK SITE - This message is displayed there are instability in the SpO2 readings after the monitor try

to adjust the detection and can not find a good signal. Verify the probe installation and try to change the probe site.

SECTION 6 - Co2 Sidestream Monitoring

A. Principe of Operation CO2 measurement is based on the Infra-Red (IR) absorption characteristics of CO2 molecules. The CO2 sensor uses non-dispersive IR spectroscopy to measure the number of CO2 molecules present in the sample gas. CO2 gas has a unique absorption band which is related to a CO2 molecule’s composition and mass. CO2 gas concentration is measured by detecting absorption in this band. Due to the nature of the measurement technique employed, user calibration is necessary with this sys tem. The basic components of the CO2 sensor include: - IR source - Dual element IR detector - Optical filter - Non-volatile memory The IR source emits energy that is directed toward a dual element thermopile IR detector. The dual element design uses two opposing thermopiles connected in series. As the ambient temperature changes, the two elements change in similar fashion resulting in an output near zero. Only one element is exposed to energy from the IR source, resulting in a voltage change due to only that energy. The detector generates a voltage based on the amount of energy it receives. In the IR path between the IR source and the detector is an optical filter which allows only a specific IR wavelength to pass and the gas sample within the sensor chamber. A temperature sensor is attached to the detector housing for temperature compensation beyond the thermopile’s designed compensation, including temperature changes in the system sensitivity.



Measurement Calculation Measurements provided by the CO2 sidestream module include ETCO2, Inspiratory CO2 (InsCO2) and respiratory rate (RR). These three measurements are collectively referred to as breath data. The breath algorithm incorporates an initial learning period which, based on certain assumptions of CO2 waveform morphology, establishes CO2 reference points for threshold determinations. A sliding window is used to detect a stable maximum, or ETCO2 value, and a baseline, or InsCO2 value. Thresholds are updated in real time with each breath. A signal averaging technique is used to calculate the RR based on this set of measurements. By incorporating these adaptive and signal averaging techniques, the breath algorithm effectively reports accurate CO2 measurements while maintaining a high level of noise immunity. Measurement Compensation IR absorption in the CO2 wavelength band may be affected by a number of factors that alter the CO2 measurement. The CO2 module automatically compensates for these factors. These factors include: - water vapor - pressure broadening - gas mixing - oxygen, nitrous oxide and desflurane (O2 / N2O / desflurane) - Body temperature, ambient Pressure and Saturated with water vapor (BTPS)

B. Patient Interface

Warning! Do not use a damaged airway adapter. Refer to the directions for use included with each airway specific instructions. Airway adapters marked as single -patient use only should not be sterilized or cleaned for reuse on another patient.

Intubated Sidestream Monitoring 1– Insert the large end of the airway adapter onto the elbow with the saddles upright. 2- Connect the small end of the airway adapter onto the ventilator circuit. Note: Place the sidestream CO2 airway adapter as close as possible to the patient. 3- Connect one side of the sample line to the air way adapter and the other side to the Water Trap in the unit’s patient panel.

Non-Intubated Sidestream Monitoring 1– Connect the nasal cannula to the Water Trap and to the patient. Note: A variety of cannulas are available to accommodate patient requirements. Nasal, oral / nasal and divided cannulas which deliver oxygen and sample CO2 simultaneously may be used.



C. CO2 Calibration 1– In TRACE menu, select the trace channel to display the CO2 waveform. 2- In the CO2 menu, turn-on the CO2 function. 3- In the CO2 menu, select the CO2 scale to see the capnogram 4- In the CO2 menu, select the flow rate. Default selection is 175ml / min. 5- Proceed the ZERO calibration: ZERO CALIBRATION REQUIREMENT The Zero calibration adjusts the offset voltage used by the CO2 sensor to generate the CO2 values and the IR source current. The required frequency of Zero Calibration depends on the amount and type of usage, and may be typically required every two weeks. The procedure requires the use of clean, dry air (0% CO2) at room / ambient temperature. In order to provide the 0% CO2, an external device, called a “CO2 scrubber” (or CO2 absorber), is used to absorb CO2 from room air. The scrubber contains a chemical which reacts wit h and eliminates CO2 as it is drawn through the scrubber. The CO2 scrubber is available from Digicare and is designed to be attached directly to the Watertrap by the user before a Zero Calibration. The scrubber is removed after successful calibration. The scrubber has a shelf life of approximately one year. Although the scrubber is considered re-usable, it’s life depends on application and exposure to CO2. To get an accurate calibration, the LifeWindow needs to be operating for at least 5 minutes in measurement mode with the scrubber installed. The LifeWindow monitors the run time and will not allow a Zero Calibration if the run time requirement has not been met.

ZERO CALIBRATION PROCEDURE

1- Select a well ventilated room to perform the calibration. 2- Make sure the LifeWindow has been operating for at least 5 minutes prior to the Zero

Calibration. 3- Attach the CO2 scrubber to the watertrap inlet. Let the unit operate for one minute. 4- After approximately 1 minute, in the CO2 menu, press the Zero Calibration button. 5- Disconnect the CO2 scrubber from the watertrap after the zero calibration. TWO-POINT USER CALIBRATION The Two-Point User Calibration, updates two of the gas calculations constants used to generate the CO2 values. The required frequency of this calibration depends on the amount and type of usage. Typically it may be required every six months. The LifeWindow does not monitor time between calibrations, nor does it alert when calibration is needed. It is up to the user to determine when calibration is required. To get an accurate Two-Point Calibration, the LifeWindow needs to be operating for at least 5 minutes in measurement mode. The LifeWindow internally monitors the run time and will not allow a Two-Point Calibration if the run time requirement has not been met.



EQUIPMENT NEEDED: - Calibration gas canister (8 – 12% CO2 medical-grade gas) - Gas valve and tubing - Sample elbow or tee - flow meter - sample line - watertrap - CO2 scrubber TWO-POINT USER CALIBRATION PROCEDURE 1– Select a well-ventilated room to perform the calibration. 2- Let the LifeWindow run for at least 5 minutes prior to calibration. 3- Attach the CO2 scrubber to the watertrap inlet. 4- In the CO2 menu, press the Two_Point Calibration button.0 5-Set the Reference gas concentration in % (9 – 12%). 6- After 1 minute running with the scrubber, press Enter. 7- Remove the scrubber and connect the watertrap inlet to the sample line with the reference

gas connected. 8- Open the reference gas and verify the Instantaneous CO2 reading in mmHg. If the readin g

is equal to the reference gas (10% = 76mmHg at sea level), press CANCEL to abort calibration, but if the reading is out of range, press ENTER to calibrate.

D. CO2 Monitoring 1– In the TRACE menu, select the channel to display the capnogram, the sweep speed, the trace style, trace color and cascade options.

In the CO2 menu, turn-on CO2 sidestream, select flow rate, scale to display capnogram and ETCO2, InsCO2 and Resp. Rate alarm limits.

2. CO2 Waveform Sweep Speed Selection: The sweep speed is selected in the TRACE menu together with other TRACE settings like

waveform style, color and cascade option. 3. Sidestream CO2 Alarms: “CO2 NO WATERTRAP” – Indicates that Sidestream CO2 watertrap is not connected to the unit. “CO2 OCCLUSION” – Indicates that there is a occlusion in the CO2 sidestram line. This occlusion could be outside or inside the unit. “CO2 LOW ETCO2” – Indicates that ETCO2 value is lower than the selected ETCO2 LOWER LIMIT. “CO2 HIGH ETCO2” – Indicates that ETCO2 value is higher than the selected ETCO2 UPPER LIMIT. “CO2 LOW InsCO2” – Indicates that InsCO2 value is lower than the selected InsCO2 LOWER LIMIT.



“CO2 HIGH InsCO2” – Indicates that InsCO2 value is higher than the selected InsCO2 UPPER LIMIT. “CO2 LOW RR” – Indicates that Respiration Rate value is lower than the selected RR LOWER LIMIT. “CO2 HIGH RR” – Indicates that Respiration Rate value is higher than the selected RR UPPER LIMIT. SECTION 7 - NIBP Monitoring

A. Theory of Operation The monitor’s automatic electronic sphygmomanometer measures and displays a patient’s arterial blood pressure, mean arterial pressure and pulse rate using the oscillometric technique. When the pressure in the cuff decreases, a sensor located in the monitor detects pressure fluctuations in the cuff. The pressure fluctuations are due to arterial volume changes that result from the blood flow as cuff pressure falls. 1) Systolic Threshold 2) Mean Threshold 3) Diastolic Threshold 130 120 110 100 90 80 70 FIG.12

CUFF PRESSURE DECREASE

PRESSURE OSCILATIONS

1

2

3



B. Patient Connections It is important to select the proper size blood pressure cuff. Use th e following chart to match the proper cuff to the circumference of the patient’s limb. These are available from DIGICARE using the following part number: CUFF SIZE RANGE Standard Adult 28 - 41 cm (11 - 16.2 in) Large Adult 33 - 47 cm (13 - 18,5 in) Thigh 40 - 58 cm (15.8 - 22.9 in) Child 20 - 28 cm (7.9 - 11 in) Pediatric/Infant 13 - 19 cm (5.1 - 7.5 in) Neonatal 6 - 12 cm (2,4 - 4.7 in)

Disposable Blood Pressure cuffs available by special order Arm Locate the cuff as you would to do an auscultatory blood pressure. Place the cuff around the patient’s upper arm with the bottom edge of the cuff at least one inch above the inner aspect of the arm. As the cuff is wrapped around the arm, be sure it fits snugly and evenly, and the bladder of the cuff is over the brachial artery. Thigh Place the cuff around the patient’s thigh with the bottom edge of the cuff at least one inch above the inner aspect of the knee. Be sure the cuff fits snugly and evenly, and the bladder of the cuff is over the popliteal artery. Calf of Leg Place the cuff around the calf of the leg with the top edge of the cuff at least one inch below the inner aspect of the knee. Be sure the cuff fits snugly and evenly, and the bladder of the cuff is over the popliteal artery.

C. Non-Invasive Blood Pressure Monitoring The NIBP monitor have three modes of operation: MANUAL, AUTOMATIC and STAT mode. At power-on the MANUAL mode is selected. To start a manual cycle press the dedicated NIBP START ( 7 ) pushbutton in the front panel. To stop the cycle and deflate the cuff, press the dedicated NIBP STOP ( 8 ) pushbutton in the front panel. In the manual cycle or in the first cycle of the automatic and stat modes, the cuff is inflated to 180mmHg (Adult/Pediatric) or 120mmHg (Neonatal). The monitor automatically detects the patient type (ADULT, PEDIATRIC or NEONATAL). If the systolic value is above 170mmHg (ADULT/PEDIATRIC) or 110mmHg (Neonatal) the cuff is deflated and re-inflated to a pressure 20 to 30mmHg higher than the initial pressure. In next cycles the cuff is inflated to a pressure 30mmHg higher than the last SYSTOLIC value.



C.1 - MANUAL MODE The MANUAL mode is a ONE CYCLE function. User can START a MANUAL cycle or STOP any ty pe of cycle using the dedicated pushbuutons ( 7 ) and ( 8 ) in the front panel or in the NIBP menu. C.2 - AUTOMATIC MODE - In the Automatic mode a cycle is repeated upon a selected period of time continuously. - In the NIBP menu select the AUTO mode and the cycle interval from 1 to 99 minutes. - Press the START button to start the NIBP determinations. C.3 - STAT MODE -In the STAT mode a cycle is repeated many times as possible during a selected period of time (1 to 4min). -In the NIBP menu select the STAT mode and the cycle (1 to 4 min). Press the NIBP START buttonto start the STAT cycle. At the end of each cycle the SYSTOLIC, DIASTOLIC, MEAN and Pulse values are displayed and the time to STAT total cycle finish is decremented in display.

D. NIBP ALARM MESSAGES “NIBP LOW SYS” – Indicates that Systolic value is lower than the selected SYSTOLIC LOWER LIMIT. “NIBP HIGH SYS” – Indicates that Systolic value is higher than the selected SYSTOLIC UPPER LIMIT. “NIBP LOW DIA” – Indicates that Diastolic value is lower than the selected DIASTOLIC LOWER LIMIT. “NIBP HIGH DIA” – Indicates that Diastolic value is higher than the selected DIASTOLIC UPPER LIMIT. “NIBP LOW MAP” – Indicates that MAP value is lower than the selected MAP LOWER LIMIT. “NIBP HIGH MAP” – Indicates that MAP value is higher than the selected MAP UPPER LIMIT.



SECTION 8 - Technical Specification

A . Mechanical Description Size : 13.6 x 9.0 x 8 inches (280 x 140 x 203 mm) Weight : 18lb (8Kg) Color : White

B . Power Requirements AC voltage Input : 100-240 VAC / 50-60 Hz Universal Power Input

C. ECG Lead Mode 5 Leads ( R, L, F, N, C or RA, LA, LL, RL, V) Lead selection I, II, III, avR, avL, avF , V, Waveform 2 ch Lead mode 3 Leads ( R, L, F or RA, LA, LL) Lead selection I, II, III, Waveform 1 ch Gain ×2.5mm/mV, ×5.0mm/mV, ×10mm/mV, ×20mm/mV HR and alarm Range Adult 15 ~ 300 bpm Neo/Ped 15 ~ 350 bpm Accuracy ±1% or ±1bpm Resolution 1 bpm Sensitivity > 200 uV(V

P-P)

Differential Input Impedance > 5 MO CMRR Monitor > 110 dB( with 50/60Hz notch filter open) Diagnosis > 95 dB Electrode offset potential >±400mV Leakage Current <10 uA Baseline Recovery < 3 s After Defi.(monitor or surgery) ECG Signal Range ±8 mV(Vp-p) Bandwidth Surgery 1 ~ 20 Hz Monitor 0.5 ~ 40 Hz Diagnostic 0.05 ~ 120 Hz Calibration Signal 1 mV p-p, ±5% Accuracy Pace detect +/-4mV~+/-700mV, 0.1mS~2mS Pace rejection +/-2mV~+/-700mV, 0.1mS~2mS(No overshoot) ST Segment Monitoring Range



Measure and Alarm -2.0 ~ +2.0 mV ARR Detecting Type: ASYSTOLE, VFIB/VTAC, COUPLET, BIGEMINY, TRIGEMINY, R ON T, VT>2, PVC, TACHY, BRADY, MISSED BEATS, PNP, PNC

D. SpO2 - Pulse Oximeter Nonin Fiber Optic SpO2 technology Oxygen Saturation Range: 0 to 100% SpO2 Pulse Rate Range 18 to 321 pulses per minute (BPM) SpO2 Accuracy: FO Sensor 70-100% ± 2 digits Pulse Rate Accuracy: No Motion ±3 digits, 18-300 BPM Low Perfusion ±3 digits, 40-240 BPM Measurement Wavelengths and Output Power: Red: 660 nm @ 0.8 mW maximum average Infrared: 910 nm @ 1.2 mW maximum average.

E. Non-Invasive Blood Pressure Method : Automatic Oscillometric Measured Parameters : Systolic, Diastolic, Mean Arterial Pressure, Pulse. Scale : mmHg (Kpascal optional) Operating Modes : Manual, Automatic, Stat Auto Repeat Cycles : 1 - 99 minutes Stat Cycle : 1 - 4 minutes Systolic Range : Adult/Pediatric 60 - 250 mmHg : Neonatal 40 - 130 mmHg Diastolic Range : Adult/Pediatric 40 - 220 mmHg : Neonatal 20 - 90 mmHg Mean Range : Adult / Pediatric 45 - 235 mmHg : Neonatal 35 - 105 mmHg Cuff Pressure Range : Adult/Pediatric 0 - 330 mmHg : Neonatal 0 - 160 mmHg Absolute Maximum Inflation Pressure : Adult / Pediatric 300 mmHg : Neonatal 160 mmHg Measurement Time : Adult / Pediatric 30 seconds typical 100 seconds maximum : Neonatal 30 seconds typical 80 seconds maximum Pressure Display Accuracy : ± 3 mmHg Pressure Resolution : 1mmHg BP Pulse Rate Accuracy : ± 3 BPM 40 - 200 BPM : ± 5 BPM to 255 BPM Cuffs : Neonate, Infant, Pediatric, Standard Adult, Large Adult, : Air Hose with Lure Lock Fitting



F. CO2 – Capnography Sidestream Operation Principle :NDIR, single beam, ratiometric method Sensor Type : Built-in Sidestream sensor. Calibration : Zero Calibration: Typically required every two weeks depending on the amount and type of use. Two-Point User Calibration: Typically required every six months depending on amount and type of use. CO2 Range : 0 to 99 mmHg Accuracy : 0 to 40 mmHg : ± 3 mmHg 41 to 76 mmhg : ± 8% of reading 77 to 99 mmHg : ± 10% of reading Respiration Rate Range : 1 to 99 breaths per minute. Start -Up Time : Less than 10 seconds to acquire CO2 waveform data. Less than 3 minutes to full operating specification. Flow Rate Range : User selectable 90, 150 and 175ml/min.

G. Display Type : 12.1” TFT – Active Matrix Color Flat Panel Display Effective Display Area : 246.0(H) x 184.5(V) mm.

H. Environment Specifications Temperature : Operating 5°C to 45°C : Transport and Storage 5°C to 55°C Relative Humidity : Operating 30 - 75% (Non-Condensing) : Transport and Storage 30 - 75% (Non-Condensing) Atmospheric Pressure : Operating 700 – 1060hpa : Transport and Storage 700 – 1060hpa

I. Trends GRAPHICAL TRENDS: Present all physiologic variables trend waveforms for a passed period of time selected by the operator: 15 min, 1, 4, 12, 24, 48 and 72 hours. TABULAR TRENDS: Present all physiologic variables trend in tabular data format since the patient was admitted until the present time.



J. Auxiliary Output -Auxiliary Output Pin 1 - NA Pin 2 - ECGx1000 analog waveform. Pin 3 - ECG Trigger Pulses: +12V positive pulses to defibrillator synchronism. Pin 4 - NA Pin 5 - Invasive Pressure 1 analog waveform. Pin 6 - Invasive Pressure 2 analog waveform. Pin 7 - Invasive Pressure 3 analog waveform. Pin 8 - Invasive Pressure 4 analog waveform. Pin 9, Pin10, Pin11, Pin12 - GND Pin13 - RS232 – RXD optional depends on the model. Pin14 - RS232 – TXD optional depends on the model. Pin15 - RS232 – GND optional depends on the model.

DB15

SECTION 9 - Maintenance

A. The Monitor When necessary, clean the exterior surfaces of the monitor with a cloth or swab dampened with warm and a mild detergent solution. Do not allow fluids to enter the interior of the instrument. WARNING: Electrical shock and flammability hazard - always turn the monitor off and disconnect it from AC mains power before cleaning. CAUTION: Do not autoclave or pressure sterilize this monitor. Do not stack or immerse this monitor in any liquid. Do not gas sterilize this monitor. Do not touch, or rub the display panel with abrasive cleaning compounds, instruments, brushes, rough surfaced materials or make contact with anything that can sc ratch the panel.

B. Probes - The probes are the only surfaces of this monitor that come in contact with the patient. Clean the probes after each patient use.

8 7 6 5 3 2 1

15

4

14 13 12 11 10 9



- Clean the monitor’s probes with a commercial cleaning solution before attaching a new patient. Probes should be cleaned until signs of wear or splitting occur. At this time a new probe is required. - If disinfection is required, wipe the surfaces with Isopropyl alcohol or cider and use a water rinse. When sterilization is required, use ethylene oxide and be sure to follow hospital procedures. - Inspect the probe for wear or splitting after every disinfecting/sterilization process is complete. - If wearing or splitting of the probe is found upon visual inspection, a new probe should be

used.

C. Patient cables - Do not autoclave the patient cables. - Wipe the cables using soap and water or alcohol. Never submerge the cables in any liquid or allow liquids to enter the electrical connections.

D. BATTERY - The LifeWindow LW6000V-MR series monitor has two batteries 12V / 2.9AH SEALED ACID. To ensure long life and proper operation follow the instructions: - Use the LW6000V-MR powered by its internal batteries at least once time a month until the “LO BATTERY” message appears on display. - If the LW6000V-MR is stored for long period without use, connect the LW6000V-MR to the AC line to recharge the batteries for at least 18 hours once for each month period. - In case you need to replace the batteries refer to the service manual. - The Televue ECG transceiver has one 12V / 2.0AH Sealed Acid battery. This battery is non -

ferromagnetic. - The Televue ECG transceiver battery charger shall be used outside the MRI room only. - The Televue ECG Transceiver battery takes 8 hours to be charged. - It is supplied one extra battery to be used as spare for the Televue ECG. - Keep the spare battery always charged. Charging the battery overnight is recommended. - The charger maintain a maintenance charge current after the battery is fully charged, so it is

safe to keep the battery connected to the charger for long time.



WARRANTY TERMS & CONDITIONS DIGICARE BIOMEDICAL TECHNOLOGY, INC. covers all of their monitors with a 1 year warranty: Monitors 1 year parts and labor Accessories: 90 days on accessories only DIGICARE BIOMEDICAL TECHNOLOGY, INC. will provide the necessary parts and labor to maintain the monitor (s) listed on the Warranty Certificate in a usable condition during the covered period. DIGICARE BIOMEDICAL TECHNOLOGY, INC. will, at its option, repair or replace any product which proves to be defective during the warranty period, if returned to the factory with prior authorization, transportation prepaid. Not covered by this agreement are repairs necessitated by any of the following conditions: 1 - Inadequate power or power failure. 2 - Neglect, abuse or misuse of equipment. 3 - Servicing of equipment by person’s other than DIGICARE INC. 4 - Any unit opened or tampered with, without prior aut horization. When returning a monitor for extended warranty repair, you must first contact DIGICARE BIOMEDICAL TECHNOLOGY, INC. to receive a Returned Goods Authorization Number (RGA #) that is to be clearly marked on top of the shipping carton. Please mak e sure that your company name, shipping address, area code and telephone number and person to contact is located in and/or on the box. ANY UNIT THAT IS RETURNED TO THE FACTORY WITHOUT AN RGA# WILL BE REFUSED.

Model # __________________________ Serial # _____________________ Dealer Name: ________________________________________________ Date Equip. Purch.: ________________________ Expiration Date: ___________________

DIGICARE BIOMEDICAL TECHNOLOGY INC. 6879 Vista Parkway North

West Palm Beach, FL 33411

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