DigiCare LifeWindow Lite LW8 Manual de usuario

Operators Manual Multi-parameter Patient Monitor " LifeWindow Lite LW8 " 1

Table of Contents

Section 1 -Introduction

A. About this Manual .......................................... ….2

B. Manufacture's Responsibility .........................….2

C. Warranty ........................................................….2

D. General Safety .............................................. ….2

E. Unpacking and Accessories .......................... ….3

Section 2 –Quick Start

A. Description .....................................................….4

B. Turning-On ..........................................................8

C. Alarm and Pulse Sound...................................….8

D. Patient Management.............................................8

E. Date and Time.......................................................9

F. Monitoring Screen.................................................9

G. Traces Setting.......................................................9

H. Patient Type..........................................................9

I. ECG Monitoring ...................................................10

J. SpO2 Monitoring...................................................10

K. CO2 Monitoring....................................................10

L. NIBP Monitoring....................................................11

M. Temperature Monitoring.......................................11

N. Invasive Pressure Monitoring...............................12

O. FIO2 Monitoring……............................................12

P. Trends……. ........................................................13

Q. Discharge Patient and Save Data………………..13

R. Battery Operation .........................…………..……13

B. Turning-OFF…......................…………………......14

Section 3 –Print, Reports and Networking

A.. Printing and Reports……………………………...14

B. Networking..........................………………………16

Section 4 -ECG Monitoring

A. Patient Connections............……………….………24

B. ECG Scale .........................................................26

C. Lead Selection.....................................................26

D. ECG Filter…… ...................................................26

E. Heart Rate Limits.................................................26

F. ECG Seep Speed.................................................27

G. ECG Pulse Test...................................................27

H. ECG Patient Type................................................27

I. ECG Alarms...........................................................27

Section 5 –Pulse Oximetry Monitoring

A. Patient connections .......................................….28

B. SpO2 monitoring ...........................................….29

C. SpO2 Waveform and Bar-graph...........................31

D. SpO2 Alarm Limits ..............................................31

E. SpO2 Alarm Messages .......................................31

Section 6 -CO2 Mainstream Monitoring

A. Overview……………..…...............…….................32

Section 6.1 -CO2 Mainstream Monitoring

A. Principle of Operation …...............…………….....32

B. Indications for Use....................……………….......32

C. Patient Connections…..………………………........33

D. Monitoring CO2 …………..…………………...........36

Section 6.2 -CO2 Sidestream Monitoring

A. Principle of Operation …...............………….........38

B. Indications for Use ............................……..…........38

C. Patient Connections ..………………………............39

D. Monitoring CO2………………………………...........43

Section 7-NIBP Monitoring

A. Cuff Selection and Placement...........……..……….45

B. NIBP Monitoring....................................................48

C. NIBP Alarm Messages.………………….………….49

Section 8-Temperature Monitoring

A. Patient Connections.........................................…..49

B. Temperature Monitoring..................................…..50

Section 9-Invasive Pressure Monitoring

A. Pressure Transducer......................................…..50

B. Transducer Connection...................................…..51

C. IP Scale and Label……...................................…..52

D. Trigger Source…….…….......................................53

E. Pulsatile / Static Mode….…….........................…..53

F. Transducer Zero…….……...............................…..53

G. IP Alarm Limits…….……......................................54

H. IP Alarm Messages…….……..........................…..54

Section 10 –Fraction of Inspired Oxygen

A. Principle of Operation ..........................................54

B. Patients Connections .................................... …..54

C. Calibration.......................................................…..56

D. FIO2 Monitoring.. ............................................…..56

Section 11 -Technical Specification

A. Mechanical Description ................................. …..58

B. Power Requirements ...........................................58

C. ECG ..............................................................…..58

D. SpO2 Pulse Oximeter .....................................…..59

E. Non-Invasive Blood Pressure................................59

F. Temperature………………...............................…..59

G. CO2………..……………….....................................60

H. Invasive Pressure..………………....................…..61

I. FIO2.………..………………...............................…..61

J. Display ………..............................………….………61

K. Environment Specifications ...........................…..61

L. Trends ...........................................................…..61

M. Auxiliary Output (Rear Panel) ........................…..62

Section 12-Maintenance

A. The Monitor ....................................................…..62

B. Probes ........................................................... …..62

C. Patient Cables ................................................…..63

D. Battery ...........................................................…..63

Warranty Terms & Conditions ........................ …..64

Rev5Jan 10

Digicare Biomedical Technology

Operators Manual Multi-parameter Patient Monitor " LifeWindow Lite LW8 " 2

SECTION 1 –INTRODUCTION

A. ABOUT THIS MANUAL

This operator’s manual has been prepared to provide information on the correct use of the

LifeWindowLite LW8 multi-parameter patient monitor. It contains performance specifications,

installation, operation and maintenance information. It is intended for trained health-care

professionals.

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.

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.

• It is up to the user to ensure that any applicable regulations respecting the installation and

operation of the monitor be observed.

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 to be defective, then

our obligation is limited to repair or replacement (at our option).

D. GENERAL SAFETY

1 -INDICATIONS

The LifeWindowLW8 Lite series is a Class 1 device designed for continuous operation in

accordance with the Safety Standard EN60601-1.The Class 1 device MUST BE connected to

the external protective conductor to be operated with the external MAINS LINE. It is intended for

use by person’s trained in professional health care, in the hospital / clinic environment. The

operator must be thoroughly familiar with the instructions in this manual before using the

instrument.

The unit is configured to measure and monitor the following available parameters:

• ECG Waveform (3 and 5 leads);

• Heart Rate (HR) from ECG ;

• ECG arrhythmia and ST segment analysis (5 Leads ECG);

• Blood oxygen saturation (SpO2or pulse oximetry);

• SpO2 waveform (Plethysmogram);

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Operators Manual Multi-parameter Patient Monitor " LifeWindow Lite LW8 " 3

• Two Temperature channels;

• Two Invasive Pressure channels;

• Pulse (from SpO2 ,NIBP, IP1 or IP2) rate;

• NIBP Systolic, Diastolic and mean arterial pressure;

• End-tidal CO2 concentration (EtCO2) –Mainstream or Sidestream;

• Inspired CO2 concentration (inCO2) –Mainstream or Sidestream;

• Respiration rate (from EtCO2 waveform);

• Inspired Fraction of O2 ( FIO2 );

CONFIGURATIONCODE

Electrocardiogram –3 Lead ECG........................................................................................E

Electrocardiogram –5Lead ECG.......................................................................................5E

Pulse Oximetry and Plethysmogram ................................................................................. S

FIO2 –Inspired Fraction of Oxygen ................................................................................. F

CO2 -Sidestream Capnography ................................................................................. C

CO2 -Mainstream Capnography ............................................................................. M

CO2 DualCap –Mainstream and Sidestream Capnography ..............................................D

Non-invasive Blood Pressure -NIBP .......................................................................... N

Invasive Pressure (up to two channels) ......................................................................... #P

Temperature (up to two channels) ......................................................................................#T

The applied parts are classified accordingly to the degree of electrical isolation from the patient

and defibrillation protection.

•The ECG patient connection is DEFIBRILLATION PROOF type CF applied part.

•The Invasive Pressure connection is type CF applied part and is not DEFIBRILLATION

PROOF.

•The Temperature connection is type BF applied part and is not DEFIBRILLATION PROOF.

•The SpO2 is type BF applied part and is not DEFIBRILLATION PROOF.

•All other patient connections are NOT DEFIBRILATION PROOF type B applied part.

2 -CAUTIONS

The LifeWindow™ Lite LW8 was designed and tested accordingly to the ELECTRO-MAGNETIC

COMPATIBILITY Standard IEC601-1-2. However, the operator is responsible to verify if the

monitor is been affected or affecting others electrical equipment. Equipments like electrocautery

and image scanners can generate interference and cause degradation of the

LifeWindow™ Lite LW8 performance. To avoid this situation, it should be installed as far as

possible of those equipment.

3-CONTRAINDICATIONS

The LifeWindow™ Lite LW8 series is NOT intended to be used during MRI (magnetic

resonance imaging).

The LifeWindow™ Lite LW8 is NOT suitable for use in the presence of a flammable anaesthetic

mixture with air or with oxygen or nitrous oxide.

E. 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Lite LW8

has the items listed in the SHIPPING LIST inside the carton.

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Operators Manual Multi-parameter Patient Monitor " LifeWindow Lite LW8 " 4

SECTION 2–QUICK START

A. DESCRIPTION

1 –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-ALARM DISABLE dedicated pushbutton.

3-FREEZE TRACES dedicated pushbutton.

4-ECG LEAD SELECTION dedicated pushbutton.

5-NIBP START dedicated pushbutton.

6-NIBP STOP dedicated pushbutton.

7-PRINT dedicated pushbutton.

8-BATTERY charge status LED indicator.

9-AC mains line LED indicator.

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2 –PATIENT CONNECTIONS PANEL

FIG. 2

10-Internal CO2 Sidestream module receptacle. Accept sample line to Sidestream CO2 and

Respiration Rate determination and monitoring.

11-NIBP hose receptacle. Accept cuff to Non Invasive Blood Pressure and Pulse determination

and monitoring.

12-SpO2 connector. Accepts pulse oximetry patient sensor cable to non-invasive determination

and monitoring of the blood oxygen content.

13-ECG connector. Accepts ECG cable for electrocardiogram and Heart Rate monitoring.

14-Invasive Pressure Channel 1 connector. Accepts pressure transducer cable to invasive

determination and monitoring of blood pressure.

15-FIO2 connector. Accept cable and sensor to Inspired Fraction of Oxygen determination and

monitoring, using an air way adaptor.

16-Temperature Channel 1 and Channel 2 connectors. Accepts temperature cable and sensor

for non-invasive Temperature determination and monitoring.

17-CO2 External Sidestream or Mainstream module connector. Accepts CO2 mainstream cable

connector. Also accepts External Sidestream module cable connector, for determination and

monitoring of CO2 and Respiration Rate.

18-Invasive Pressure Channel 2 connector. Accepts pressure transducer cable to invasive

determination and monitoring of blood pressure.

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Operators Manual Multi-parameter Patient Monitor " LifeWindow Lite LW8 " 6

3 –REAR PANEL

FIG.3

19-On / Standby switch. Momentary contact switch to turn-on and off the unit. To turn-on the

unit, double click this switch.

20-Video Connector. Connection to a standard CRT video.

21-Keyboard Connector. PS2 connection to a standard AT type keyboard used only to service

purposes.

22-Auxiliary Connector. Supply analog output signals, trigger signals and one RS232

communication port.

23-Ethernet Connector. Connection to Ethernet network standard.

24-Mains Line IEC connector. Accepts power cable from mains line. Have 1 main fuse and 1

spare fuse inside.

25-General Power switch. Interrupt power from internal battery and mains power supply.

26-Antenna for wireless networking.

27-USB 1 and USB 2 connectors.

28-Internal CO2 Sidestream Vent port. Keep it always open to room air.

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4 –MONITORING SCREEN

FIG.4

29 –First waveform user selected area, showing ECG waveform in Thin Line Style, scale

(-1 to +1mV), sweep speed of 25mm/s and QRS detected INDICATOR (HEART).

30 –Second waveform user selected area, showing Invasive Pressure 1 waveform in Thin Line

Style, scale (0 to 180mmHg), sweep speed of 25mm/s.

31 –Third waveform user selected area, showing Invasive Pressure 2 waveform in Thin Line

Style, scale (0 to 180mmHg), sweep speed of 25mm/s.

32 –Fourth waveform user selected area, showing SpO2 waveform in Thin Line Style, with

Pulse Level strength scale (1 to 8), sweep speed of 25mm/s.

33 –Fifth waveformuser selected area, showing Capnogram (CO2) waveform in Fill In Style,

with scale (10 to 50mmHg), sweep speed of 12.5mm/s.

34 –Sixth waveform user selected area, showing Capnogram (CO2) waveform in Fill In Style,

with scale (10 to 50mmHg), sweep speed of 12.5mm/s.

35 –ECG menu selection.

36 –SpO2 menu selection.

37 –FIO2 menu selection.

38 –CO2 menu selection.

39 –NIBP menu selection.

40 –Invasive Pressure menu selection.

41 –Temperature menu selection.

42 –Traces configuration menu selection.

43 –Trends menu selection.

44 –Print menu selection.

45 –System configuration menu selection.

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46 –Patient Name and ID indicator

47-Date and Time indicators.

48 –Battery Status Indicator.

49 –Adult / NeonatalMode selector and indicator.

50 –ECG Heart Rate (BPM) and ECG settings.

50 –Invasive Pressure 1 Indicator and IP1 settings.

51 –Invasive Pressure 2 Indicator and IP2 settings.

53 –SpO2 Indicator in % and SpO2 settings.

54 –Indicators and settings: End tidal CO2 (EtCO2) value display in %.

Inspired CO2 (InsCO2) value display in %.

Respiration Rate in RPM.

55 –FIO2 Indicator in % and settings:

56 –Indicators: NIBP mode selected indicator: Manual, Stat or Auto.

NIBP cycle interval selected indicator.

NIBP time to next cycle remaining indicator.

57 –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.

58 –Temperature Indicators and settings

B. TURNING-ON

• Plug the AC power cord in AC MAINS receptacle at rear panel connector (24) and in the AC

outlet. The LifeWindow™ Lite LW8 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 ( 19 ) on the rear panel.

• The monitor will then perform a “boot” sequence (approx. 1.5 min.).

C. ALARM AND PULSE SOUND

• When the unit turns-on, the Alarm Sound is disabled by 2 minutes.

• To disable the Alarm Sound for more 2 minutes press and release the “Alarm Sound”

dedicated pushbutton ( 2 ) in the front panel. The AUDIBLE ALARMSOFF message flashes in

screen.

• To permanently disable the Alarm Sound press and hold 4 seconds the “Alarm Sound”

dedicated pushbutton ( 2 ). The AUDIBLE ALARMS OFF message is displayed steady on

screen.

• The Pulse and Alarm sound volume levelsare set to default levels. To change the Pulse and

Alarm Sound volume level, touch in System menu and Sound Volume. Select the Beep

Volume, Alarm Volume and Beep Source, if it is from the ECG, SpO2 or OFF (no Beep).

D. PATIENT MANAGEMENT

• the LifeWindow™ Lite LW8 starts the monitoring screen and start storing all Vital Signs.

• The “Patient Management” screen can be opened at any time by touching the “System” menu.

• The “Patient Management”screen is automatically displayed when the monitor is turned-on

with two options: “Admit New Patient” and “Cancel Pat Mangmt”.

• Touching “Cancel Pat Mangmt”, closes the “Patient Management” screen.

• Although the Patient can be admitted at a later time, we recommend to admit the Patient

before Patient data starts to be stored to prevent losing Patient Data.

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• To admit a patient, touch on the “Admit New Patient” button.

•Enter the Patient’s Name and Patient Control ID.

• Touch the “Admit Patient & Start Monitoring” button.

• If less then 5 minutes of monitoring occurred, the Patient is admitted and the screen is closed.

• If more then 5 minutes of data is available, you need to choose what to do with the with the

patient’s data in the buffer, with three options:

• “Keep for the new patient”. Touch to include data to new patient.

• “Save as different patient”. Touch to save data to different patient.

• “Discard Data”. Touch to discard.

E. DATE AND TIME

• Check if the current “Date and Time” displayed in the Indicator (47) are correct.

•To change the Date and Time, touch the “SYSTEM” menu and touch “Date/Time Settings”.

•Set current location “Date and Time”. Touch OK to finish.

F. MONITORING SCREEN

• The LifeWindow™ Lite LW8 monitoring screen is pre-configured accordingly to the Vital Signs

parameters that are installed and turned-on. The traces are pre-configured to keep “In-line

Logic” with the Indicators area in the right of the traces area.

•To turn-off any Vital Sign that is not going to be used in patient’s monitoring, touch the Vital

Sign menu and touch ECG OFF or SPO2 OFF, etc. The monitoring screen may change some

Traces settings and Indicators.

• Factory Default Settings are configured to standard applications. As the user changes Alarm

Limits and other settings, the LifeWindow™ Lite LW8 will save the changes when turned-off.

Next time the unit is turned-on, the last saved settings will remain.

• To return the unit to the Factory Defaults, touch in the “System” menu and touch in “Load

Factory Default Settings”.

G. TRACES SETTING

• The LifeWindow™ Lite LW8 six traces are configured and cascaded accordingly to the Vital

Signs parameters installed and turned-on.

• 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.

•Move the Pointer to TRACES icon and press the Select pushbutton.

•Select TRACE waveform source (ECG, SpO2 Plethysmogram, Capnogram, or No Selection).

•Select TRACE sweep speed (6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s or 100mm/s).

•Select TRACE color.

• Select TRACE style (Thin line or Fill In).

• 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. Select the Sweep Speed, Color and Style for each trace.

•Press the Done button to finish.

• Note: When the LifeWindow™ Lite LW8 is turned-off and turned back on, the traces will return

to the original pre-configuration accordingly to the physiological parameters that are installed

and turned-on, to keep “In-line Logic” with the Indicators area in the right of the traces area.

H. PATIENT TYPE

• Patient Type has two modes: Adults and Neonatal. It affectsthe ECG and NIBP functions only.

All other Vital Signs functions are not affected by the Patient Type selected.

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