Dräger Globe-Trotter GT5400 Operator's Manual
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Dräger Globe-Trotter GT5400 Operator's Manual

Dräger Globe-Trotter GT5400 Operator's Manual

Portable bedside capnograph
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Operator's Manual
Portable Bedside Capnograph
PN: 010678-A

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  • Page 1 Operator’s Manual Portable Bedside Capnograph PN: 010678-A...
  • Page 2 Notice: Purchase of this instrument confers no express or implied license under any Oridion Medical patent to use the instrument with any accessory that is not manufactured or licensed by Oridion Medical 1987 Ltd. Capnography is covered by one or more of the following United States patents: 6,437,316;...

  • Page 3: Table Of Contents

    Table of Contents CHAPTER 1 SAFETY INFORMATION ....... 7 Warnings ............7 Symbols ............10 CHAPTER 2 INTRODUCTION........11 Monitor Features ..........11 CHAPTER 3 OVERVIEW .......... 13 Principles of Operation........13 CHAPTER 4 INITIAL SETUP........19 Power Requirements ........19 Unpacking and Inspection........
  • Page 4 Cleaning ............58 Calibration ............59 CO2 Calibration Check........59 Returning the Monitor........61 Technical assistance ........62 CHAPTER 10 SPECIFICATIONS......63 Physical ............63 Environmental ..........63 Safety Standards..........64 Compliance ............64 Manufacturer’s Declaration ......67 Performance............. 67 Power Specifications ........68 Electrical ............
  • Page 5 List of Figures Figure 1: Monitor Front and Side View......17 Figure 2: Monitor Rear View ..........18 Figure 3: Initialization Screen........... 24 Figure 4: Quick Guide ............26 Figure 5: Monitor Display Screen and LEDs ....30 Figure 6: Pump Off............45 Figure 7: Pump Off Additional Time .........
  • Page 6 List of Tables Table 1: Symbols on the Device ........10 Table 2: Display Screens..........32 Table 3: Factory Default Alarm Range Values....35 Table 4: Alarm Limits ............35 Table 5: Alarm Silence/Standby ........37 Table 6: Instrument Settings Parameters (Menu 1) ..38 Table 7: Instrument Settings Parameters (Menu 2) ..

  • Page 7: Chapter 1 Safety Information

    Do not touch this field - it is Chapter 1 invisible and does not appear in the final document Safety Information Warnings Symbols To use the portable capnograph correctly and safely, carefully read this operator’s manual and the Directions for Use for the Microstream EtCO consumables.
  • Page 8 Safety Information WARNING: The monitor is a prescription device and is to be operated by qualified healthcare personnel only. MRI Scanning WARNING: During MRI scanning, the monitor must be placed outside the MRI suite. When the monitor is used outside the MRI suite, EtCO monitoring can be implemented using the FilterLine XL.
  • Page 9 Warnings Electrical WARNING: To protect against electric shock hazard, the monitor’s cover is to be removed only by qualified service personnel. There are no user-serviceable parts inside. WARNING: To ensure patient electrical isolation, connect only to other equipment with circuits that are electrically isolated.

  • Page 10: Symbols

    Safety Information Symbols The following symbols appear on the monitor and monitor LCD (liquid crystal display): Table 1: Symbols on the Device Symbol Description See Directions for Use Gas Outlet Defibrillator-proof Type BF equipment (patient electrically isolated) Audio Alarms Off Plug Icon Battery Icon Respiratory Rate (breaths per...

  • Page 11: Chapter 2 Introduction

    Do not touch this field - it is Chapter 2 invisible and does not appear in the final document Introduction Monitor Features This manual provides directions for setup and operation of the portable capnograph monitor. The device is a portable capnograph that continuously monitors end tidal carbon dioxide (EtCO ), fractional inspired carbon dioxide (FiCO...
  • Page 12 Introduction • Displays EtCO and FiCO values in mmHg, kPa or Vol%. • Provides output for printer, PC, and Digital to Analog Converter • Provides interface to hospital nurse call systems. Portable Bedside Capnograph...

  • Page 13: Chapter 3 Overview

    Do not touch this field - it is Chapter 3 invisible and does not appear in the final document Overview Principles of Operation FilterLine Displays, Controls, and Connectors The monitor incorporates Oridion’s Microstream capnography technology. Principles of Operation The monitor uses Microstream non-dispersive infrared (NDIR) spectroscopy to continuously measure the amount of CO during every breath, the amount of CO...
  • Page 14 Overview quickly flushed, allowing for fast rise time and accurate CO readings, even at high respiration rates. The Microbeam IR source illuminates the microsample cell and the reference channel. This proprietary IR light source generates only the specific wavelengths characteristic of the CO absorption spectrum.
  • Page 15 FilterLine Special Procedure FilterLines • FilterLine XL – Provides extended length so that the monitor can be used safely during MRI (see MRI Scanning on page 44). Note: The generic term FilterLine, used in this manual, is interchangeable with any of the Microstream EtCO consumables.
  • Page 16 Overview FilterLine Recognition Safeguard When the FilterLine is attached to the monitor, the FilterLine Recognition Safeguard (FRS) identifies the FilterLine and activates the monitor, thus enabling measuring. Airway Adapter The airway adapter design provides multiple channels for the sampled air from the airway, minimizing the possibility of water infiltration or line blockage.

  • Page 17: Figure 1: Monitor Front And Side View

    Displays, Controls, and Connectors Displays, Controls, and Connectors Figure 1: Monitor Front and Side View The numbered labels in Figure 1: Monitor Front and Side View are described below. On/Off Switch Port for AC Adapter or communication adapters Alarm Bar 10.

  • Page 18: Figure 2: Monitor Rear View

    Overview Figure 2: Monitor Rear View The numbered labels in Figure 2: Monitor Rear View are described below. Clamp Connector Serial Number Label Space for Quick Guide Battery Pack Release Adhesive Label Button Battery Pack Portable Bedside Capnograph...

  • Page 19: Chapter 4 Initial Setup

    Do not touch this field - it is Chapter 4 invisible and does not appear in the final document Initial Setup Power Requirements Unpacking and Inspection Start-up and Self test Measuring Mode Quick Guide Power Requirements The monitor operates on batteries or on AC power. It is equipped with a rechargeable Nickel Metal Hydride battery pack.
  • Page 20 Initial Setup Battery and Power Usage If power is lost when the monitor is operating from AC power, it automatically switches to its internal battery pack for power. A plug-shaped icon at the bottom right side of the graphic display is displayed when the monitor operates from an external power source and the battery pack is fully charged.
  • Page 21 Power Requirements CAUTION: Important! The following information relates to the safe handling, storage, and disposal of the monitor battery pack. Battery Testing The battery pack charge level should be tested before each use by observing the level on the battery icon after Self Test. For a correct reading, wait for the battery charge level to stabilize.

  • Page 22: Unpacking And Inspection

    Initial Setup Unpacking and Inspection Components Remove the monitor and the accessories from the box carefully. Check that the items listed on the back cover of this manual are included. Inspect each component. If the package is damaged or any component is missing, contact your local representative.

  • Page 23: Start-Up And Self Test

    Start-up and Self test Note: For information on operating the monitor with any accessory, refer to the specific accessory’s Directions for Use. CAUTION: To protect the unit, the manufacturer recommends using the carrying case, the clamp, or the protective boot, depending on the type of application.

  • Page 24: Figure 3: Initialization Screen

    Initial Setup Note: When the monitor is used in stationary applications, secure it with the clamp (available as an optional accessory). Initialization CAUTION: If any monitor response does not seem appropriate, do not use the monitor. Instead, contact your local representative.

  • Page 25: Measuring Mode

    Measuring Mode Measuring Mode In Measuring mode, the monitor measures, displays, and stores event data, or prints data that has been stored in its memory. During measuring, the monitor shows EtCO and respiration rate readings on the digital displays. Waveform, respiration rate, and other information, according to the selected screen (see Basic Operation on page 29), are shown on the graphic display.

  • Page 26: Quick Guide

    Initial Setup check that the battery icon on the right side of the graphic display is full). AC operation: Connect the AC adapter to the monitor, and plug the cord into the mains power supply. Switch the monitor on. Check that the battery icon displays a filling pattern or the plug icon appears.

  • Page 27: Chapter 5 Consumables

    Do not touch this field - it is Chapter 5 invisible and does not appear in the final document Consumables MICROSTREAM EtCO2 Consumables MICROSTREAM EtCO Consumables • FilterLine Set • FilterLine H Set • Smart CapnoLine and Smart CapnoLine Plus (available with O delivery) •...
  • Page 28 Consumables WARNING: The FilterLine may ignite in the presence of O when directly exposed to laser, ESU devices, or high heat. When performing head and neck procedures involving laser, electrosurgical devices or high heat, use with caution to prevent flammability of the FilterLine or surrounding surgical drapes.

  • Page 29: Chapter 6 Basic Operation

    Do not touch this field - it is Chapter 6 invisible and does not appear in the final document Basic Operation Data Display Screens Displayed Data Options Alarm Functions Alarm Limits Menu Alarm Silence/Standby Menu Instrument Settings Menus MRI Scanning Standby Pump Off Mode Pump Off/On Label...

  • Page 30: Figure 5: Monitor Display Screen And Leds

    Basic Operation event is stored in the monitor’s memory and will appear on the data printout marked by an asterisk (*) on the tabular trend printout and as a mark on the graphic trend printout (perpendicular to the trend graph). Figure 5: Monitor Display Screen and LEDs There are four data display screens (Table 2: Display Screens on page 32):...
  • Page 31 Data Display Screens 3 seconds <25 bpm for 10 seconds 6 seconds Initialization, "No Breath" or 6 seconds blockage During periods of high respiration rates, the display will automatically depict the shorter time base to avoid compression of the waveform. The time base appears at the top right side of the graphic screen as a Temporary Silent Advisory and is shown for 5 seconds each time the instrument enters the CO...

  • Page 32: Displayed Data Options

    Basic Operation The real-time EtCO and respiration rate values are shown on the real- time digital display. Meter Mode The Meter Mode screen displays the EtCO value on the left side of the screen and the respiration rate on the right side of the screen. This mode is recommended in the following cases: •...

  • Page 33: Alarm Functions

    Alarm Functions To View Press Result Trend – 30 1st short press Trend - 8 hr. 2nd short press Meter Mode 3rd short press waveform 4th short press Note: To return to CO waveform (Home) from any screen or menu, long press the button.
  • Page 34 Basic Operation Alarms Warnings are the highest level of alarms, used to alert the user that the patient’s condition is beyond predefined limits. Alarms can be set from the Alarm Limits menu (see Alarm Limits Menu on page 35). The monitor has the following alarms with adjustable level settings: •...

  • Page 35: Alarm Limits Menu

    Alarm Limits Menu Table 3: Factory Default Alarm Range Values Parameter Adult Neonate Maximum Minimum Default Default EtCO high 60 [8.0] 60 [8.0] 100 [13.0] 5 [0.5] EtCO 99 [12.9] 0 [0.0] FiCO2 high 8 [1.1] 8 [1.1] 99 [12.9] 2 [0.1] RR high RR low...
  • Page 36 Basic Operation To access any displayed parameter short press To change the short parameter's value press/long press*** To exit and return to Measuring mode (at any point in the Alarm long press Limits menu)**** If after 15 seconds no action is taken, the display returns to Measuring mode.

  • Page 37: Alarm Silence/Standby Menu

    Alarm Silence/Standby Menu • ALL: All the audible alarms are turned off. • CO2: audible alarms (including No Breath message) are turned off. Note: When any alarm is disabled, a single caution burst can sound once every three minutes if this option is selected through Institutional Settings (refer to Institutional Settings on page 43).

  • Page 38: Instrument Settings Menus

    Basic Operation Objective Action Result To change the setting of the selected short press parameter To exit and return to measuring display (at any point in the Alarm long press Silence/Standby If after 15 seconds no action is taken, the display returns to Measuring mode.
  • Page 39 Instrument Settings Menus Parameter User options Print Screen – the current display is printed Graphic Trend – real time trend is printed in a graphic form Trend History – stored trend is printed in graphic and tabular form Tab. Trend (5s) Real time trend data is printed in tabular form (every 5 seconds) Tab.

  • Page 40: Table 7: Instrument Settings Parameters (Menu 2)

    Basic Operation Whenever autoscale is selected, the trend scale (and printed graphic scale) will be the high-level scale limit. The Factory Default CO is 0-50 mmHg. The CO scale option will not return to the Factory Default after being changed by the user. See User-defined Parameters on page 40.

  • Page 41: Table 8: Changing Instrument Settings (Menu 1)

    Instrument Settings Menus Changing Instrument Settings Table 8: Changing Instrument Settings (Menu 1) and Table 9: Changing Instrument Settings (Menu 2), both below, describe how to change the instrument settings. Note: If after 15 seconds no action is taken, the display returns to Measuring mode.

  • Page 42: Table 9: Changing Instrument Settings (Menu 2)

    Basic Operation To exit and return to the Measuring mode at any point in the Instrument long press Settings menu To exit and return to the Alarm Limits menu long press Table 9: Changing Instrument Settings (Menu 2) Objective Action Result To access the Instrument Settings menu 2.

  • Page 43: Table 10: Institutional Settings

    Instrument Settings Menus Objective Action Result short press To switch languages (until desired language appears) Institutional Settings The factory default parameter settings in Table 10: Institutional Settings, below, can be changed by your local service representative. Table 10: Institutional Settings Parameter Factory Default Setting Alarm Default Settings*...
  • Page 44 Basic Operation Where FCO = % CO2/100 Pb = the ambient pressure = the partial pressure of CO at BTPS MRI Scanning WARNING: Do not use the FilterLine H Set Infant/Neonatal consumable during magnetic resonance imaging (MRI) scanning. Using the FilterLine H Set Infant/Neonatal during MRI scanning could harm the patient.

  • Page 45: Figure 6: Pump Off

    Pump Off Mode Silence/Standby on page 37). The Standby screen appears. A long press of any key restores the Measuring mode. (The Alarm Limits menu appears briefly before the Measuring mode but the alarms cannot be changed at this time). The monitor will automatically enter Standby mode if, after Power ON, no signal is registered for 10 minutes.

  • Page 46: Figure 7: Pump Off Additional Time

    Basic Operation During the last two minutes an alarm sounds indicating there are two minutes left before the device exits Pump Off mode automatically. This alarm cannot Figure 7: Pump Off Additional be disabled. One long press Time resets Pump Off mode to the default time.

  • Page 47: Chapter 7 Communication Interface

    Do not touch this field - it is Chapter 7 invisible and does not appear in the final document Communication Interface Communication Interface Communication Interface The monitor can integrate data to the following devices: • Communication Adapter • Printer (Seiko DPU-414) •...
  • Page 48 Communication Interface WARNING: When using the printer/PC with mains line power, it is recommended to use a medical grade power supply complying with the following standards: EN60601-1, UL 60601-1, CSA C22.2 No. 601.1-M90. If the power supply is not medical grade, the printer/PC must be placed at least 1.5 meters from the patient environment to comply with standard EN60601-1-1.

  • Page 49: Chapter 8 Troubleshooting

    Do not touch this field - it is Chapter 8 invisible and does not appear in the final document Troubleshooting Alarms and Messages Troubleshooting Guide This section lists the alarms and messages and the corresponding actions the operator should take. The Troubleshooting section discusses potential problems and suggestions for resolving them.

  • Page 50: Table 11: Warning Messages

    Troubleshooting Warnings WARNING: Always respond immediately to a system alarm since the patient may not be monitored during certain alarm conditions. Warnings refer to either patient or alarm limit settings problems. They are serious and require immediate operator attention. The message appears on the screen followed by !!!, the numerical parameter associated with the alarm blinks, the alarm bar flashes red, and a special, repetitive warning tone is heard.

  • Page 51: Table 12: Caution Messages

    Alarms and Messages xxx= the number of seconds elapsed since the last valid breath has been detected. The FiCO value is displayed if selected in the Instrument Settings menu 1 (Refer to Instrument Settings Menus on page 38). Cautions Caution messages appear during Measuring mode and indicate that a problem has occurred requiring the operator’s attention.

  • Page 52: Table 13: Advisory Messages

    Troubleshooting Advisory Messages Advisories are informative messages appearing at start-up before any patient input has been detected by the monitor, or during operation. The message appears on the screen followed by !. The alarm bar will light yellow and a special one-time advisory tone is heard (see Table 13: Advisory Messages, below).

  • Page 53: Table 14: Silent Advisory Messages

    Alarms and Messages Silent Advisories Silent Advisories are instrument status messages indicating the operational state of the monitor or consumables. Silent advisories are low priority signals and only a message appears (with no exclamation marks, nor any other visual or audible indicator) (see Table 14: Silent Advisory Messages, below).

  • Page 54: Troubleshooting Guide

    Troubleshooting Demo User mistakenly activated Reset the monitor Demo mode by sliding the on/off switch to off position and then to on position BTPS On BTPS setting is on. No action required. Ready module is operational but breath is not detected. Note: If BTPS is set to OFF, only Ready appears.

  • Page 55: Table 15: Troubleshooting Guide

    Troubleshooting Guide resolving them. If you are unable to correct the problem, contact qualified service personnel or your local representative. Table 15: Troubleshooting Guide Problem Cause Action Monitor does not Power cable Check power cable turn on. improperly attached connection and check or disconnected, or that on/off switch is on.
  • Page 56 Troubleshooting EtCO values read Mechanically No action needed. erratically. ventilated patient who breathes spontaneously. A leak in the airway. Check for connection and line leaks to patient and correct if necessary. EtCO values are Physiological cause. Check patient. consistently higher Ventilator malfunction.

  • Page 57: Chapter 9 Maintenance

    Do not touch this field - it is Chapter 9 invisible and does not appear in the final document Maintenance Periodic Maintenance Service Cleaning Calibration CO2 Calibration Check Returning the Monitor Technical assistance Periodic Maintenance Periodic Maintenance is recommended according to operating hours: The Pump and Flow System should be replaced every 7,000 operating hours.

  • Page 58: Service

    Maintenance Table 16: Accessing the Service Mode Objective Action Result To access the During Self Test, Service mode press and hold simultaneously Note: Contact your local distributor to order spare parts, calibration kits, or to answer any questions regarding periodic maintenance. Service The monitor requires no routine service other than any performance testing mandated by the operator’s institution.

  • Page 59: Calibration

    Calibration CAUTION: Microstream EtCO consumables are designed for single patient use and are not to be reprocessed. Do not attempt to disinfect or flush the FilterLine as the monitor can be damaged. Calibration Calibrate after 1,400 hours of initial use. After that, calibration should be performed any time the monitor displays the advisory message Calibration Required.

  • Page 60: Table 17: Co2 Calibration Check

    Maintenance CAUTION: The instrument should not be in Standby Mode before beginning the calibration check process. To prevent the device from entering Standby Mode, measure at least two breaths. The device will then remain in normal operating mode with an active Apnea (for software versions prior to 2.7) or No Breath (from software version 2.7) alarm.

  • Page 61: Returning The Monitor

    Returning the Monitor Connect the Start Cal. Check calibration gas via process. the connecting means. Check the Press the gas valve measured values for 15 seconds until (shown in Vol% in the readings the EtCO digital stabilize. display).* *Calibration is not required if the measured value is the same as the concentration of the calibration gas (±...

  • Page 62: Technical Assistance

    Maintenance Technical assistance For technical information, contact Technical Services or your local representative. The Service Manual includes information that is required by qualified personnel to service the monitor. Portable Bedside Capnograph...

  • Page 63: Chapter 10 Specifications

    Do not touch this field - it is Chapter 10 invisible and does not appear in the final document Specifications Physical Environmental Safety Standards Compliance Manufacturer’s Declaration Performance Power Specifications Electrical Components and User Interface Physical Size 206 mm H x 88 mm W x 52.5 mm D (8.11”H x 3.46” W x 2.06”D) Weight 750 grams (1.66 lb.) (including battery pack) Noise Emission...

  • Page 64: Safety Standards

    Specifications Pressure and Altitude (for operating and storage) Pressure 430 mmHg to 795 mmHg Altitude -380m to 4,570m (-1,250 ft. to 15,000 ft.) Transport and Storage Parameter Value Temperature For Monitor: -35 C to 70 C (-31 F to 158 F) not °...
  • Page 65 Compliance Item Compliant With Resistant to liquid IEC 60601-1, sub-clause 44.6 for class ingress IPX1 Drip-Proof equipment Degree of safety in UL 60601-1, sub-clause 5.5, Not suitable presence of a flammable anesthetic Applied sensor label IEC 60601-1 Symbol 2 of Table DII of to indicate Type BF Appendix D applied part...
  • Page 66 Specifications Item Compliant With Front panel and case IEC 60878, EN 980, ISO 7000, EN 60417- labeling 1, EN 60417-2 Button spacing ISO 7250 Year of manufacture EN 980 symbol Conductive coating UL 60601-1, clause 55 and polymeric materials Operation during IEC 60068-2-27 at 100 g physical shock Operation during...

  • Page 67: Manufacturer's Declaration

    Manufacturer’s Declaration Item Compliant With Conducted EMI IEC 61000-4-6 at 3 V/m susceptibility Power frequency IEC 61000-4-8 at 3A/m magnetic fields Laser Safety The sensor LED light output falls within Class I level, according to 60825-1:2001. No special safety precautions are required. Operation with line IEC 61000-4-11 voltage variations...

  • Page 68: Power Specifications

    Specifications Respiration Rate 0-150 breaths/min. Warm-up Time 30 seconds (typical) Frequency EtCO accuracy is maintained up to 80 Response breaths/min. (For maintaining accuracy for respiration rate over 60 bpm, use the neonatal mode.) From 81 to 150 bpm accuracy is ±12%, if the EtCO is higher than 18.8 mmHg in neonatal mode.

  • Page 69: Electrical

    Electrical will decrease capacity. Note: If the battery pack is stored for 6 months or longer, you must charge and discharge it (leave unit on, not connected to AC power, until battery is empty) three times before use in order to ensure full capacity. Recharging Period Approximately 4.5 hours internal recharging Charger Type...
  • Page 70 Specifications Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Class B The monitor is suitable for use in all establishments, CISPR 11 including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
  • Page 71 Electrical Immunity Test IEC 60601- Compliance Electromagnetic 1-2 Test Level Environment Level Guidance (ESD) ±8 kV air ±8 kV air ceramic tile. If IEC 61000-4-2 floors are covered with synthetic material, the relative humidity should be at least 30%. Electric fast ±2 kV for ±2 kV for Mains power...
  • Page 72 Specifications Immunity Test IEC 60601- Compliance Electromagnetic 1-2 Test Level Environment Level Guidance power supply 40% UT 40% UT environment. If input lines. (60% dip in (60% dip in the user of the IEC 61000-4- UT) for 5 UT) for 5 monitor requires cycles cycles...
  • Page 73 Electrical Recommended Separation Distances Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the monitor (IEC60601-1-2) Rated Separation distance according to maximum frequency of transmitter output power 150 kHz to 80 80 MHz to 800 MHz to 2.5 of transmitter 800 MHz d=1.2√...
  • Page 74 Specifications Electric and Communication Cables Cables Maximum Complies Length with: 791001, Power cord 10 ft. (3 m) RF emissions, CISPR North America 11, Class B/ Group 1 Harmonic emissions. RJ11 10 ft. (3 m) IEC 61000-3-2 communication Voltage cable (contained in fluctuations/flicker 048127 emission.

  • Page 75: Components And User Interface

    Components and User Interface Components and User Interface Displays Graphic LCD (128 x 64 dots) with LED backlight dimension display 75 mm x 53 mm. Two numeric fields 3 digits each, using 7-segment LED dimension 22 mm x 14 mm. Alarm bar yellow, red Controls and Indicators...

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