VITALOGIK Configured Patient Monitor Service Manual 641-OPT-112 July 2006

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices Manufacturer’s Name: Mennen Medical Ltd. 4 Hayarden Street, Yavne, 81228 P.O. Box 102, Rehovot, 76100, Israel Tel.: +972-8-9323333 Fax: +972-8-9328510 European Representative: Charter-Kontron Limited Unit 18 Avant Business Centre 21 Denbigh Road Milton Keynes MK1 1DT England Tel.: 01908 646070 Fax: 01908 646030 US Representative: Mennen Medical Corp 101 Witmer Road Suite 100 Horsham, PA 19044-2200 Phone: 215-259-1020x1026 Fax: 215-675-6212

Toll Free: 800-223-2201-1026

Publication No. 641-OPT-11 Revision: JULY 2006 Copyright © Mennen Medical Mennen Medical Ltd. 2006. All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders.

TABLE OF CONTENTS Chapter 1: System Description Overview... 1-1 System Features and Capabilities... 1-2 Monitor and Main Processing Unit... 1-3 Inputs... 1-3 System Configuration Setup (Basic)... 1-4 System Specifications... 1-6 Chapter 2: Hardware System Description Vitalogik Overview... 2-1 CPU Card... 2-2 BIOS Setup Flash Memory... 2-3 Sound Card... 2-3 Main Storage... 2-3 Main Power Supply... 2-3 Front Panel... 2-4 Front End Board Inputs... 2-5 ECG / RSP... 2-6 2BP / CO... 2-7 Temp... 2-8 NIBP... 2-9 SPO2 (Nellcor)... 2-12 SPO2 (Masimo)... 2-12 Micrestream... 2-13 Display Monitor... 2-14 Remote Keypad and QuicKnob Functional Description... 2-15 Patient Preparation Checklist... 2-16 Electrode Types... 2-16 Chapter 3: System Installation Overview... 3-1 Safety Precautions... 3-2 Grounding the System... 3-3 Equipotential Grounding... 3-3 Electrosurgery, Diathermy and Defibrillation Protection... 3-4 Mounting of Monitors... 3-4 Accidental Wetting of the Equipment... 3-4 Patient Connections... 3-5

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Envoy / Enguard / Ensemble Operating Manual

General Hazards... 3-5 Site Survey... 3-5 Unpacking and Inspection... 3-8 Setting Up the Basic System... 3-8 Connecting and Wiring the LAN Cables... 3-9 Mounting the LAN outlets... 3-10 Mounting and Connecting the LAN Hub and the Patch Panel... 3-11 Mounting the Vitalogik Monitor on the Wall... 3-11 Mounting Options... 3-21 Mounting the Nurse Station Devices... 3-28 Mounting the Flat Screen... 3-28 Chapter 4: Upgrading Software Replacing the Hard Disk:... 4-1 Upgrading Using Microsoft Windows Utilities... 4-4 General... 4-4 Required Hardware... 4-4 Required Software... 4-4 Downloading the New Version... 4-5 Upgrading Vitalogik... 4-5 Changing the IP Address of your Laptop... 4-5 Copying the Tar file from a Laptop to a Vitalogik... 4-6 Upgrading Vitalogik Software... 4-7 Chapter 5: Maintenance and Cleaning Cleaning the VitaLogik Bedside Monitor... 5-1 Calibration and Preventive Maintenance... 5-2 VitaLogik5500 And VitaLogik5000 Patient Monitors BOM... 5-3

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CHAPTER 1 SYSTEM DESCRIPTION 1.1 Overview The VitaLogik bedside monitor is a standalone bedside unit consisting of a main processing unit and a mountable color monitor. The VitaLogik monitors the patient's vital signs. The vital sign data derived by the VitaLogik is presented on the monitor as waveform and numeric displays. The VitaLogik’s user interface is especially designed for user-friendly operation. The fixed buttons and unique QuicKnob control on the front panel of the main processing unit enables quick and direct access to system parameters and functions. An optional Touch Screen is available for control of the VitaLogik setting and menus without the hardware keys and Quicknob.

Figure 1-1: The VitaLogik Bedside Monitor Mennen Medical

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1.2 System Features and Capabilities The VitaLogik displays a wide range of vital sign clinical parameters. It includes: •

ECG/Respiration multi-lead for monitoring ECG and respiration.

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Dual BP inputs for monitoring two invasive blood pressures.

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CO/2TMP connector to measure either thermodilution Cardiac Output or two temperatures.

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Temp connector.

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NIBP input for monitoring non-invasive blood pressure using the oscillometric method.

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Pulse Oximetry.

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Microstream End Tidal CO2 (EtCO2) for monitoring CO2 during exhalation (EtCO2) and inhalation (inCO2) and Respiration Rate.

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Serial Input for communication and interface with an external, auxiliary device.

Vitalogik is supplied in four customized configurations which are combinations of: •

Invasive / non-invasive BP/CO

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Nellcor / Masimo SPO2

In addition an optional EtCO2 Microstream option can be added. The VitaLogik’s main monitoring features include: •

Continuously updated vital sign parameter data displayed as numeric values and continuous waveforms.

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Clinical and technical alarm detection as well as alarm notification in audio and visual formats.

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Easy access to collected data in the form of tabular charts and graphical trends as well as various types of clinical reports.

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Patient data output to a recorder or a printer, if connected.

You can interact with the VitaLogik: •

Using interactive panels These panels include menus and dialog panels that enable you to configure system and monitoring parameters.

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Responding to Events Fixed keys on the front panel of the main processing unit enable you to respond quickly to events such as alarms.

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Reviewing Clinical Data Charts, Trends, Full Disclosure and Overview enable you to view and compare data in different formats and over selected time periods.

1.2.1 Monitor and Main Processing Unit The VitaLogik can display up to eight traces, depending on how the vital sign display is configured. For monitor control procedures, refer to the User’s Manual. All clinical data collected from the inputs is stored in the main processing unit. This data includes waveforms, vital signs, trends, charts and beat-to-beat data. The main processing unit can store at least 36 hours of patient data for review purposes. The front panel of the main processing unit contains 5 fixed keys and the Quicknob. These features enable you to interact with the system. The back panel contains connectors to connect the main processing unit to other components in the system (the display monitor and the network) and to the power supply. A remote keypad provides direct access, via the orange keys, to the menus of Vital signs, Patient data, and Setup, via the green keys, to Event, Print, Record, and Freeze and by the yellow key to Timer. This allows the user to reach these functions without opening the Main menu.

Display Features The main screen display is divided into four areas: •

Global Header Area

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Patient Area

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Patient Display Area

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QuicKeys

1.2.2 Inputs The Vital Signs inputs are housed on the front panel. They include: •

12 Lead ECG/RSP

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Dual BP

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CO/2TMP

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Temp

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NIBP

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SpO2

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EtCO2 MicroStream

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Figure 1-2: The VitaLogik Front Panel Inputs Connectors

Figure 1-3: The VitaLogik Remote Keypad

1.3 System Configuration Setup (Basic) The system configuration setup consists of a Central Nurse Station (“Ensemble”) connected through an Ethernet-LAN hub to the VitaLogik bedside monitors, local recorder and central recorder. The VitaLogik bedside monitors and recorders are hard-wired and remain stationary.

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Figure 1-4: System Basic Setup (with recorder)

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1.4 System Specifications General

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Configured monitor CPU with user controls Class II Equipment (Enclosure Grounded) Ordinary equipment continuous operation Applied Part Type BF for: NIBP, SpO2, EtCO2 - Defibrillation-proof Applied Part Type CF for: ECG, BP, CO/2 Temp - Defibrillation-proof

CPU Details

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Intel X86 family main CPU Sound Blaster, 4W audio power 128 MB RAM (subject to change/upgrade) Mass storage: 40GB fixed disk, optional expansion available Operating system: QNX Window manager: Photon

User Controls

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Fixed Keys QuicKnob™ Remote keypad

Unit Dimensions (not including display)

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Height: 9.0 cm/3.625 in Width: 33.0 cm/13.0 in Depth: 37.0 cm/14.5 in Weight: 8 kg/17.6 lb

Power Requirements

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90-230 VAC, 50/60 Hz

Network

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Physical: IEEE 802.3 Ethernet interface with Category 5, 10BaseT and 100BaseT twisted pair media. Other media available. Protocol: TCP/IP

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Color Display

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Size: 15", 17" LCD display. Traces: 1 to 8, depending on parameter-specific setup choices Resolution: 1024 x 768

12 lead ECG/RSP

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LED for function indication

ECG

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Sampling Rate and Resolution - 640Hz sampling rate - 22 bit resolution Frequency Response - 0.05 to 150 Hz - 0.5 to 40 Hz - 1.0 to 25 Hz QRS Detection Range - 0.25 to 5.0 millivolt height - 70 to 120 milliseconds width Heart Rate Counting - 20 to 350 BPM - Accuracy: ± 2 BPM Note: Values below 20 are forced to zero. Heart Rate Alarm Settings - High and low rate: 20 - 350 BPM non-overlapping

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Leads analyzed for: - Heart Rate and Arrhythmia Configuration Top two displayed Fixed: I, II, III, aVR, aVL, aVF, V (5 Lead cable) I, II, III, aVR, aVL, aVF, Va, Vb (6 Lead cable); V1-V6 (12 Lead cable) - Common Mode Rejection - 120 dB, minimum - Lead Fault Detection: based on impedence - Pacemaker Detection and Rejection Amplitude: 2 mV to 700 mV Width: 0.1 ms to 2.0 ms Pacemaker flag inserted into displayed waveform ST Measurements • All leads • ST Range: -0.9 to +0.9 mVolt • ST Alarm Limits : -0.6 to +0.6 mVolt Data Storage: - Beat notification - RR Interval - Heart Rate - ST values - Arrhythmia - Alarms

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Respiration

System Description

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Blood Pressure

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Lead Selection - RA-LA or RA-LL Respiration Sensitivity Range - 0.2 oHm to 5.0 oHm Impedance Range - 100 to 3,000 oHm @ 65kHz Respiration Rate Counting Range - 8 to 150 BPM Respiration Frequency Response - 0.13 to 2.5 Hz (-3 dB) - Sampling rate: 640 Hz Respiration Alarm Settings - Low rate: 0 - 150 BPM - High rate: 8 - 150 BPM - Apnea: User configurable 10-90 seconds duration and reset - Cardiac coincidence alarm Data Storage: - Respiration rate - Respiration rate Alarms - Apnea alarms

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LED for function indication. Site Labels: - BPX, ART, PAP, CVP, RAP, LAP, ICP

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Input Sensitivity 5 microVolt/Volt/mmHg

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Dynamic Range - Pressure range: -50 to +350 mmHg - Zero range: ±150 mmHg - Total dynamic range: -200 to +450 mmHg

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Transducer Excitation Voltage - +7.5 VDC - Separate excitation driver for each channel

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Zero Accuracy - ±0.2 mmHg

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Zero Drift - Less than ±0.2 mmHg in 24 hours (at constant temperature)

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Blood Pressure Accuracy - ±2 mmHg or ±2%, whichever is greater, exclusive of transducer

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Blood Pressure Linearity - within 1% across entire range

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Waveform Frequency Response - 0 - 15 Hz

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Sampling Rate - 320 Hz

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Fault Detection - Shorted transducer - Transducer in/out - Cable out

• Data Storage: - Systolic, Diastolic and Mean - Alarms Temperature

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YSI 400 - Blood temperature: 0 degrees C to 45 C - Injectate temperature: 0 degrees C to 45 C - Body temperature: 0 degrees C to 45 C Temperature Alarm range : 25 degrees C to 45 C

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Cardiac Output and Temperature

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Adapter and Compatability Cables - COSet™ Interface cable - Ice Bath Cardiac Output interface cable - Dual temperature interface cable (ysi-400)

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Temperature Ranges - Blood temperature: 0 degrees C to 45 C - Injectate temperature: 0 degrees C to 45 C - Body temperature: 0 degrees C to 45 C

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Accuracy - Blood temperature: ±0.1°C - Injectate temperature: ±0.1°C

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Excitation - 10µA, maximum

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Cardiac Output Determination Range - 0 to 20 liters per minute

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Injectate Volumes - 1, 3, 5, and 10cc

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Computation Constants - Table built as new values are used

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Displayed Data - Cardiac Output, Cardiac Index, Stroke Volume, Stroke Volume Index, Blood Temperature, Injectate Temperature, Trial Number

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• Data Storage: • In Cardiac Output mode: - Cardiac Output - Hemodynamic Calculation results - Measuring time • -In Two Temp mode: - Temperatures and Delta-Temp - Temperature Alarms Non-Invasive Blood Pressure

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LED for function indication

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Oscillometric Method

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Displayed Parameters - Systolic, Diastolic, Mean pressure values - Time of last measurement, Next measurement time

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Cuff Size - Adult, Pediatric, Infant, Neonatal

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Inflation Time - Depends on cuff type and inflation pressure - Adult - typical within 20 sec. - Neonatal - typical within 5 sec. - initial inflation target: 150 mmHg, Adult/Pediatric - initial inflation target: 120 mmHg, Neonatal

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Cuff Pressure Limits - Adult/Pediatric Software Over Pressure Limits - Adult: 290 mmHg - Neonate: 145 mmHg Redundant Hardware Over Pressure Limits - Adult: 300 to 330 mmHg - Neonate: 150 to 165 mmHg

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Measurement Time (Excluding cuff pressurization time) - 25 seconds typical; 120/80 @75 BPM Adult - 20 seconds typical; 120/80 @75 BPM Adult STAT mode - 20 seconds typical; 60/30 @160 BPM Neonate

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BP time-out: 60 - 180 sec.

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Measurement Ranges (in mmHg) Adult/Pediatric - Systolic: 30-255 - Diastolic: 15-220 - Mean: 20-235 Measurement Ranges (in mmHg) Neonatal - Systolic: 30-135 - Diastolic: 15-110 - Mean: 20-125

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Modes: Adult, Auto, Manual, STAT, Neonatal

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Pressure (Transducer) Accuracy - ±3 mmHg or ±2%, whichever is greater

• Data Storage: - Systolic, Diastolic, Mean pressures - Measuring time - Alarms Pulse Oximetry (Sp02)

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Masimo Technology

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Saturation Range (Functional) - 50% to 100% Sp02

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Sp02 Accuracy - % SpO2 ± 1 standard deviation

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Pulse Rate Range - 20 to 250 BPM ±3 BPM

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Saturation alarm limits: 50% to 100%

• Data Storage: - Heart rate and O2 saturation End Tidal CO2 Microstream (EtCO2) (Option)

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LED for function indication Air outlet for sidestream monitoring

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Displayed Data - Waveform labels and annotations - EtCO2, in CO2 and respiration rate values

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CO2 Display Range: 0-100 mmHg

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Measurement Resolution; Typical Accuracy: - ±2 mmHg for CO2 range of 0-38 mmHg -

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Alarms

±5% for CO2 range of 39-99 mmHg + 0.08%for every 1 mmHg above 38 mmHg

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Respiration Rate - 0 - 70 bpm +/- 1 bpm - 71 - 120 bpm +/- 2 bpm - 121 - 150 bpm +/- 3 bpm

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Rise Time 190 msec (10% - 90%)

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Delay Time 2.7 Sec (10% - 90%) typical.

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CO2 Alarm Limits: 0 to 100 mmHg/0 - 10%/0-15 kPA

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Accuracy: - for % measurement: 0.1% - for mmHg measurement: 1mm

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Respiration Rate Alarm Limits: - Neonatal: 0 to 150 BMP - Adult: 0-50 BPM

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Sidestream Flow Rate: 130 ml/min nominal

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Start-up Time: - 30 sec. typical

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Automatic Compensation: At least once per hour

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Ambient Temperature: - 0-65° C Sidestream - 10-40° C Mainstream

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Humidity: 10-95% RH, non-condensing

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Barometric Pressure: 430-795 Hg (-1250 to 15,000 ft.)

• Data Storage: - EtCO2, in CO2 and Respiration Rate values -

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Alarms Apnea Alarm

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