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Tyco Healthcare Nellcor OxiMax N-85 Operator's Manual

Portable bedside capnograph/ pulse oximeter
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N-85
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Operator's Manual
Portable Bedside Capnograph/
Pulse Oximeter

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Summary of Contents for Tyco Healthcare Nellcor OxiMax N-85

  • Page 1 N-85 ™ Operator’s Manual Portable Bedside Capnograph/ Pulse Oximeter...
  • Page 2 Operator’s Manual Portable Bedside Capnograph/Pulse Oximeter...
  • Page 3 Smart CapnoLine™, CapnoLine™, Smart BiteBloc™ and NIV Line™ are trademarks of Oridion Medical 1987 Ltd. Nellcor Puritan Bennett Incorporated is an affiliate of Tyco Healthcare. The following are trademarks of Nellcor Puritan Bennett Incorporated: ® ®...
  • Page 4 Contents Safety Information ........7 Introduction..........13 Overview ..........15 Initial Setup..........23 Accessories..........33 Basic Operation ........39 Communication Interface ...... 59 Troubleshooting ........61 Maintenance........... 71 Specifications ........77 Portable Bedside Capnograph/Pulse Oximeter To Purchase, Visit Avobus.com or call 1-800-674-3655...

  • Page 5: Table Of Contents

    Table of Contents Safety Information............7 Warnings................7 General..............7 MRI Scanning............8 Alarms ...............8 Fire Hazard..............9 Electrical ..............9 Electro-magnetic Interference .........10 Symbols .................10 Introduction ..............13 Monitor Features ............13 Overview ..............15 Principles of Operation ..........15 Capnography............15 Microstream EtCO Consumables ......16 FilterLine ................17 Pulse Oximetry ..............18 Displays, Controls and Connectors ......21 Initial Setup..............
  • Page 6 Single Parameter Setup Options.........29 Measuring Mode............30 Battery Pack and AC Operation......31 Quick Guide..............32 Accessories ..............33 Microstream EtCO Consumables ......33 Basic Principles............34 Nellcor SpO Sensors...........34 Selecting Nellcor SpO Sensors ......35 Performance Considerations........37 Basic Operation ............39 Data Display Screens ...........39 Waveform ............40 Time Base ............40 Trends .............41 Meter Mode .............42...
  • Page 7 Changing Instrument Settings.........52 Institutional Settings ..........55 MRI Scanning ..............56 Standby ................57 Pump Off Mode..............57 Pump Off/On Label............58 Communication Interface ........... 59 Troubleshooting............61 Alarms and Messages ..........61 Alarm and Message Priorities .........61 Warnings ..............61 Cautions ..............63 Advisory Messages ..........64 Silent Advisories............65 Troubleshooting Guide ..........67 Maintenance ..............
  • Page 8 Transport and Storage ..........78 ® Sensor Power Dissipation......79 Safety Standards............79 Compliance..............80 ISO 9919:2005 Compliance ........80 Manufacturer’s Declaration .........82 Performance ..............83 Capnograph ............83 Display Update Interval ...........84 Pulse Oximeter............84 Power Specifications............87 External Power Source ...........87 Internal Power Source..........87 Electrical ................88 Instrument ...............88 ®...
  • Page 9 List of Figures Figure 1: Monitor Front View ..........21 Figure 2: Monitor Rear View...........22 Figure 3: Initialization Screen .........28 Figure 4: Self Test Screen..........29 Figure 5: Quick Guide ............32 Figure 6: Monitor Display Screen and LEDs ....40 Figure 7: Pump Off ............57 Figure 8: Pump Off Additional Time .......58 Figure 9: Pump Off/On Label .........58 List of Tables...

  • Page 10: Safety Information

    Safety Information Warnings Symbols To use the portable capnograph/pulse oximeter monitor correctly and safely, carefully read this operator’s manual and the Directions for Use for the SpO sensors and Microstream EtCO consumables. Use of the monitor requires full understanding and strict observance of these instructions, the precautionary information in boldface type, and the specifications.

  • Page 11: Mri Scanning

    Safety Information WARNING: readings, respiratory rate, pulse oximetry readings, and pulse signal can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. WARNING: The monitor is a prescription device and is to be operated by qualified healthcare personnel only. MRI Scanning WARNING: Do not use Nellcor oximetry sensors during magnetic...

  • Page 12: Fire Hazard

    Warnings Fire Hazard WARNING: When using the monitor with anesthetics, such as high concentrations of oxygen or nitrous oxide, connect the gas outlets to a scavenger system. WARNING: The monitor is not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide.

  • Page 13: Electro-Magnetic Interference

    Safety Information Electro-magnetic Interference This device has been tested and found to comply with the requirements for medical devices according to the standard EN60601-1-2/2001. These standards are 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 the healthcare environments (for example: cellular phones, mobile two–way radios,...
  • Page 14 Symbols Plug Icon Battery Icon EtCO End tidal carbon dioxide value Oxygen saturation value DC Input Refer to manual for connector interface and other information Pump Off Pump Off/On Portable Bedside Capnograph/Pulse Oximeter...

  • Page 16: Introduction

    Introduction Monitor Features This manual provides directions for setup and operation of the monitor. The monitor is a portable bedside capnograph/pulse oximeter that continuously monitors end tidal carbon dioxide (EtCO ), respiratory rate (RR), fractional inspired carbon dioxide (FiCO ), oxygen saturation (SpO ), and pulse rate.
  • Page 17 Introduction • Provides interface to hospital nurse call systems. Portable Bedside Capnograph/Pulse Oximeter...

  • Page 18: Overview

    Overview Principles of Operation FilterLine Pulse Oximetry Displays, Controls and Connectors The monitor combines Oridion’s Microstream capnography technology with Nellcor pulse oximetry technology. Principles of Operation Capnography The monitor uses Microstream non–dispersive infrared (NDIR) spectroscopy to continuously measure the amount of CO during every breath, the amount of CO present at the end of exhalation (EtCO...

  • Page 19: Microstream Etco 2 Consumables

    Overview specific wavelengths characteristic of the CO absorption spectrum. Therefore, no compensations are required when different concentrations of N O, O , anesthetic agents and water vapor are present in the inhaled and exhaled breath. The IR that passes through the micro-sample cell and the IR that passes through the reference cell are measured by the IR detectors.

  • Page 20: Filterline

    FilterLine Special Procedure FilterLines • FilterLine XL – Provides extended length so that the monitor can be used safely during MRI (see page 56). Note: The generic term FilterLine, used in this manual, is interchangeable with any of the Microstream EtCO consumables.

  • Page 21: Pulse Oximetry

    Overview infiltration or line blockage. These multiple channels allow uninterrupted monitoring for all adapter orientations and in all applications. The airway adapter provides optimal performance in all directions and is seldom disabled by secretions or liquids. Pulse Oximetry Operating Principles Pulse oximetry is based on two principles: 1) oxyhemoglobin and deoxyhemoglobin, which differ in their absorption of red and infrared light (spectrophotometry), and 2) changes in the volume of arterial...
  • Page 22 Pulse Oximetry Automatic Calibration Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies, an oximeter must know the mean wavelength of the sensor's red LED to accurately measure During monitoring, the instrument's software selects coefficients that are appropriate for the wavelength of that individual sensor's red LED.
  • Page 23 Overview Use of Functional Testers and Patient Simulators Some models of commercially available bench top functional testers and patient simulators can be used to verify the proper functionality of Nellcor pulse oximeter sensors, cables and monitors. See the individual testing device's Operator's Manual for the procedures specific to the model of tester being used.

  • Page 24: Displays, Controls And Connectors

    Displays, Controls and Connectors Displays, Controls and Connectors Figure 1: Monitor Front View The numbered labels in Figure 1 are described below. Label Description Label Description Connector Battery Pack Off/On Switch FilterLine Input Connector Alarm Bar Gas Outlet Digital Display of SpO Digital Display of EtCO Graphic Display Photo Resistor...

  • Page 25: Figure 2: Monitor Rear View

    Overview Figure 2: Monitor Rear View The numbered labels in Figure 2 are described below. Label Description Label Description FilterLine Input Battery Pack Release Connector Button Clamp Connector Battery Pack Space for Quick Guide Connector Latch Adhesive Label Serial Number Label Portable Bedside Capnograph/Pulse Oximeter To Purchase, Visit Avobus.com...

  • Page 26: Initial Setup

    Power Requirements Initial Setup Power Requirements Unpacking and Inspection Start-Up and Self Test Single Parameter Setup Options 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. When a power outlet is available, use the medical grade AC adapter provided with the monitor.

  • Page 27: Battery And Power Usage

    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. A plugshaped 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 28 Power Requirements 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. Replace or recharge the battery pack when the advisory message Battery ! appears on the graphic display screen (refer to Troubleshooting on page 61).

  • Page 29: Unpacking And Inspection

    Initial Setup Unpacking and Inspection Components 1. Remove the monitor and the accessories from the box carefully. 2. Check that the items listed in the table on the back cover of this manual are included. 3. Inspect each component. If the package is damaged or any component is missing, contact your local representative.

  • Page 30: Start-Up And Self Test

    Start-Up and Self Test CAUTION: To protect the unit, the manufacturer recommends using the carrying case, the clamp, or the protective boot, depending on the type of application. Start-Up and Self Test WARNING: Do not lift the monitor by the SpO sensor cable or the FilterLine as they could disconnect from the monitor, causing it to drop on the patient.

  • Page 31: Preparation

    Initial Setup Preparation Prior to start-up: 1. Slide open the FilterLine input connector shutter and connect the appropriate FilterLine. Connect the appropriate Nellcor SpO sensor firmly into the sensor port. 2. Connect the FilterLine and Nellcor SpO sensor to the patient as described in the Directions for Use.

  • Page 32: Single Parameter Setup Options

    Single Parameter Setup Options 6. As the monitor continues to test its internal subsystems, the Self Test screen appears (refer to Figure 4). During this test, there is an option to choose a single parameter operation. This option is Figure 4: Self Test also available from the Setup Screen menu (see the Basic...

  • Page 33: Measuring Mode

    Initial Setup Table 1: Single Parameter Setup Options Parameter Action Display Startup measuring both CO No action required and SpO : (factory set option) Startup measuring only CO long press (during Self Test) Startup measuring only SpO long press (during Self Test) Measuring Mode In measuring mode, the monitor measures, displays, and stores event data, or prints data that has been stored in its memory.

  • Page 34: Battery Pack And Ac Operation

    Measuring Mode The monitor begins measuring after recognizing one breath (after monitor power up or after exiting Standby). The monitor recognizes two breath measurement ranges: Valid breath: values > 7.5 mmHg (for adult mode) or > 5.0 mmHg (for neonatal mode) Low readings breath: values <...

  • Page 35: Quick Guide

    Initial Setup Quick Guide The Quick Guide adhesive label is included in the monitor packaging. Apply the label to the monitor as shown in Figure 2: Monitor Rear View on page 22. Figure 5: Quick Guide Portable Bedside Capnograph/Pulse Oximeter...

  • Page 36: Accessories

    Accessories Microstream EtCO Consumables Nellcor SpO Sensors Microstream EtCO Consumables • FilterLine Set • FilterLine H Set • Smart CapnoLine and Smart CapnoLine Plus (available with O delivery) • Smart CapnoLine H Plus (available with O delivery) • CapnoLine H (available with O delivery) •...

  • Page 37: Basic Principles

    Accessories 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 38: Selecting Nellcor Spo Sensors

    Nellcor SpO2 Sensors This information of sensor wavelength range can be especially useful to clinicians, e.g., those performing photodynamic therapy. Sensor LED light output falls within Class 1 Level per IEC 60825-1:2001 Safety of Laser Products; no special safety precautions are needed. Selecting Nellcor SpO Sensors When selecting a sensor, consider the patient's weight and activity, the...

  • Page 39: Table 2: Nellcor Spo 2 Sensors

    Accessories Table 2: Nellcor SpO Sensors Oxygen Sensor Model Patient Weight ® oxygen transducer MAX-N <3 kg or >40 kg (single patient use) MAX-I 3 to 20 kg MAX-P 10 to 50 kg MAX-A >30 kg MAX-AL >30 kg MAX-R >50 kg MAX-FAST >40 kg...

  • Page 40: Performance Considerations

    Nellcor SpO2 Sensors Performance Considerations WARNING: Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions, sensor application errors, and patient conditions. WARNING: Tissue damage can be caused by incorrect application or inappropriate duration of use of an SpO sensor.
  • Page 41 Accessories High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of an SpO sensor. To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material.

  • Page 42: Basic Operation

    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 Data Display Screens In Measuring mode, the monitor constantly measures and displays the waveform, EtCO numerical value, respiratory rate (RR), FiCO (user selected), SpO...

  • Page 43: Co 2 Waveform

    Basic Operation Figure 6: Monitor Display Screen and LEDs There are seven graphic display screens (refer to Table 3 on page 44): • • Waveform Plethysmograph • • Trend, 30 Trend, 30 minutes minutes • • Trend, 8 Trend, 8 hours hours •...

  • Page 44: Co 2 Trends

    Data Display Screens 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 waveform screen or after every change of the time base.

  • Page 45: Meter Mode

    Basic Operation Meter Mode The Meter mode screen includes the four numerical parameters for CO , respiration rate, and pulse rate. This mode is recommended in the following cases: • When the power management is Low (see Table 7, page 50). •...

  • Page 46: Pulse Bar Amplitude Indicator

    Data Display Screens seconds for Pulse Rate, a low priority alarm state results: the pulse search indicator begins flashing, the SpO and pulse rate displays flash zeros indicating a loss of pulse condition and the audible alarm state is activated. Pulse Bar Amplitude Indicator The Pulse Bar Amplitude Indicator indicates pulse beat and shows the relative (non-normalized) pulse amplitude.

  • Page 47: Displayed Data Options

    Basic Operation Displayed Data Options Table 3: Display Screens To View Press Result waveform Appears automatically Trend – 30 min 1 st short press Trend - 8 hr 2 nd short press Meter Mode 3 rd short press Plethysmograph 4 th short press Trend –...

  • Page 48: Alarm Functions

    Alarm Functions Alarm Functions WARNING: Do not turn off the audible alarm or decrease the audible alarm volume if patient safety could be compromised. Pressing the alarm silence button turns the audible alarms OFF and turns the alarm silence icon LED indicator ON.

  • Page 49: Factory Default Alarm Range Values

    Basic Operation Factory Default Alarm Range Values Table 4 lists the default values of the various alarm ranges. These can be changed from the Alarm Limits menu. CAUTION: Make sure that the monitor default alarm settings are appropriate for the specific patient being monitored. CAUTION: The monitor will revert to its default alarm limit settings at power on, power interruption, and when...

  • Page 50: Alarm Limits Menu

    Alarm Limits Menu Alarm Limits Menu Table 5 explains how to access the Alarm Limits menu and to change the parameters and values. CAUTION: “No Resp” will appear as “No Breath” on the monitor display. Table 5: Alarm Limits Objective Action Result To access the Alarm Limits...

  • Page 51: Alarm Silence

    Basic Operation **** Display does not necessarily return to the wave form shown in the Results column; it returns to the screen active prior to entering the Alarm Limits menu. Alarm Silence Alarms can be temporarily silenced. A short press of the alarm silence button will temporarily disable the audible alarm for a pre-set period of time and the alarm silence indicator will be lit.

  • Page 52: Alarm Silence/Standby Menu

    Alarm Silence/Standby Menu Alarm Silence/Standby Menu Table 6: Alarm Silence/Standby Objective Action Result To access the Alarm Silence/Standby menu from any measuring display.* long press To change the silence period.** short press To access any displayed parameters. short press To change the setting of the selected parameter.

  • Page 53: Instrument Settings Menus

    Basic Operation Instrument Settings Menus Instrument Settings Menu Parameters Table 7 below and Table 8 on page 51 explain the user-defined parameters that can be set from the Instrument Settings menus. Table 7: Instrument Settings Parameters (Menu 1) Parameter User options units mmHg, kPa, Vol% Power Mgmt...

  • Page 54: Co 2 Scale: Autoscale

    Instrument Settings Menus WARNING: Make sure the patient type and CO scale are appropriate for each patient. An error in the patient type can cause incorrect alarm limits or incorrect CO readings. If the CO scale is not appropriate, the waveform will be either incomplete or small.

  • Page 55: User-Defined Parameters Stored As Defaults

    Basic Operation User-defined Parameters Stored as Defaults The following parameters will not return to their defaults after being changed by the user. These parameters are stored in the memory of the monitor until the next time they are changed by the user. •...

  • Page 56: Table 9: Changing Instrument Settings (Menu 1)

    Instrument Settings Menus Table 9: Changing Instrument Settings (Menu 1) Objective Action Result To access the Instrument Settings menu 1 (From any long press (x2) measuring display, the 1 long press accesses the Alarm Limits menu. The 2 long press accesses the Instrument Settings menu 1.) To change a parameter setting.

  • Page 57: Table 10: Changing Instrument Settings (Menu 2)

    Basic Operation Table 10: Changing Instrument Settings (Menu 2) Objective Action Result To access the Instrument Settings menu 2. (From long press (x3) any measuring display, the long press accesses the Alarm Limits menu. The long press accesses the Instrument Settings (menu 1).

  • Page 58: Institutional Settings

    Instrument Settings Menus Institutional Settings The factory default parameter settings in Table 11 below can be changed by your local service representative. Table 11: Institutional Settings Parameter Factory Default Setting Alarm Default Settings* See Table 4: Factory Default Alarm Range Values on page 3 Min Alert (to remind user that alarms are set to off)

  • Page 59: Mri Scanning

    Basic Operation MRI Scanning WARNING: Do not use Nellcor oximetry sensors during magnetic resonance imaging (MRI) scanning. Conducted current could cause burns. The sensors may affect the MRI image and the MRI unit may affect the accuracy of oximetry measurements. WARNING: Do not use the FilterLine H Set Infant/Neonatal consumable during magnetic resonance imaging (MRI)

  • Page 60: Standby

    Standby Standby The Standby mode is an automatic or selectable function designed to reduce power consumption and to avoid unnecessary alarms. To set the monitor manually in the Standby mode, choose the Standby ON option from the Alarm Silence/Standby menu (Table 6 on page 49). The Standby screen appears.

  • Page 61: Pump Off/On Label

    Basic Operation Note: During Pump Off mode the CO parameter is dashed and the SpO function operates normally. Note: Note: The time range for Pump Off is 5–30 minutes. The factory default time for Pump Off mode is 15 minutes. To change the factory default, contact a qualified service technician.

  • Page 62: Communication Interface

    Communication Interface The monitor can integrate data to the following devices: • Communication Adapter Kit • Printer (Seiko DPU-414) • • Digital to Analog Converter • Nurse Call Interface Kit • MSM Interface Kit – (provides remote paging and central station networking to Oxinet III and MSM Bernoulli systems.) Note: The monitor interfaces to the PC or Printer with the...

  • Page 64: Troubleshooting

    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. If the problem persists and the message remains, contact a qualified service person or your local representative.

  • Page 65: Table 12: Warning Messages

    Troubleshooting associated with the alarm blinks, the alarm bar flashes red, and a special, repetitive warning tone is heard. If one of the following warning messages appears, first check the patient, then check the ventilation equipment (if used), and then check the alarm limits settings (Table 12).

  • Page 66: Cautions

    Alarms and Messages Cautions Caution messages appear during Measuring mode and indicate that a problem has occurred requiring the operator’s attention. The message appears on the screen followed by !!, the alarm bar will flash yellow and a special repetitive caution tone is heard (Table 13). Table 13: Caution Messages Message Possible Causes...

  • Page 67: Advisory Messages

    Troubleshooting Message Possible Causes Action Blockage !! FilterLine is twisted or Disconnect and clogged. The message reconnect the appears after 30 seconds of FilterLine. unsuccessful clearing of the Disconnect and replace FilterLine. with a new FilterLine. FilterLine airway connection Check the airway is clogged.

  • Page 68: Silent Advisories

    Alarms and Messages Silent Advisories Silent Advisories are instrument status messages indicating the operational state of the monitor or accessories. Silent advisories are low priority signals and only a message appears (with no exclamation marks and no other visual or audible indicator). See Table 15: Silent Advisory Messages.
  • Page 69 Troubleshooting Message Possible Causes Action BTPS On BTPS setting is on. No action required. Ready and CO modules are operational but neither pulse nor breath are detected. Note: If BTPS is set to OFF, only Ready appears. FiCO = xx The FiCO value (xx No action required.

  • Page 70: Troubleshooting Guide

    Troubleshooting Guide Troubleshooting Guide Table 16: Troubleshooting Guide below lists potential problems you may experience while using the monitor and suggestions for resolving them. If you are unable to correct the problem, contact qualified service personnel or your local representative. Table 16: Troubleshooting Guide Problem Cause...
  • Page 71 Troubleshooting Problem Cause Action EtCO values are Physiological cause. Check patient. consistently higher Ventilator malfunction. Check ventilator and or lower than patient. expected. Improper calibration. Check calibration. See CO Calibration Check on page EtCO values are BTPS setting ON or Check BTPS setting on the consistently higher graphic display after Power...
  • Page 72 Troubleshooting Guide Problem Cause Action Inaccurate SpO Excessive illumination. Check sensor placement or measurements cover sensor with a dark or opaque material. Sensor placement on an Check sensor placement. extremity that has a blood pressure cuff, arterial catheter or intravascular line, or nail polish.
  • Page 73 To Purchase, Visit Avobus.com or call 1-800-674-3655...

  • Page 74: Maintenance

    Maintenance Periodic Maintenance Service Cleaning Calibration Calibration Check Returning the Monitor Technical Assistance Periodic Maintenance Periodic maintenance is recommended according to operating hours: • Pump and Flow System should be replaced every 7,000 operating hours. • Monitor should be returned to the manufacturer for periodic maintenance every 14,000 operating hours.

  • Page 75: Service

    Maintenance Table 17: Accessing the Service Mode Objective Action Result To access the During Self Test, Service mode press and hold simultaneously Note: Contact your local representative 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 76: Cleaning

    Cleaning Cleaning To clean the monitor’s surfaces, dampen a cloth with a commercial, nonabrasive cleaner and wipe the top, bottom, and front surfaces lightly. CAUTION: Do not spray or pour any liquid directly on the monitor, accessories or consumables. CAUTION: Do not use caustic or abrasive cleaners.

  • Page 77: Co Calibration Check

    Maintenance Calibration Check The process should be performed only after the device has been operating for at least 20 minutes in a normal operating mode and connected to a FilterLine. The calibration check must be performed with a manufacturer authorized Calibration Kit containing 5% CO gas and the connecting means.

  • Page 78: Table 18: Co 2 Calibration Check

    CO2 Calibration Check Start the process from the Setup menu as described in Table 18. Table 18: CO Calibration Check Objective Action Result Access Instrument Settings menu. long press x3 (long press x2 for software versions prior to 2.7) Change option to start.

  • Page 79: Returning The Monitor

    Maintenance Objective Action Result To return to Measuring mode if long press calibration is not required. If calibration is required, contact your local service representative. Returning the Monitor If it is necessary to return the monitor for repairs, call the local representative for shipping instructions.

  • Page 80: Specifications

    Specifications Physical Environmental Safety Standards Compliance Manufacturer’s Declaration Performance Pulse Oximeter 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 850 grams (1.87 lb.) (including battery pack) Noise Emission maximum 45 dB(A) Environmental...

  • Page 81: Pressure And Altitude (For Operating And Storage)

    Specifications Pressure and Altitude (for operating and storage) Parameter Value 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 in shipping container For Microstream Accessories:...

  • Page 82: Oxi Max Sensor Power Dissipation

    Safety Standards ® Sensor Power Dissipation Sensor Dissipation ® MAX-N 52.5 mW ® MAX-I 52.5 mW ® MAX-P 52.5 mW ® MAX-A 52.5 mW ® MAX-AL 52.5 mW ® MAX-R 52.5 mW ® Oxiband OXI-A/N 52.5 mW ® Oxiband OXI-P/I 52.5 mW ®...

  • Page 83: Compliance

    Specifications Compliance ISO 9919:2005 Compliance When used with Nellcor OxiMax sensors and the appropriate Nellcor pulse oximetry cable, the Portable Bedside Handheld Capnograph and Pulse Oximeter is compliant with ISO 9919:2005 with the following exceptions: Clause 50.101 See SpO Data Update Period information in this document. Clause 201.5.4.1 See Alarm Functions information in this document.
  • Page 84 Compliance Item Compliant With Rigid case IEC 60601-1, sub-clause 21(a) Case mechanically strong IEC 60601-1, sub-clause 21(b) Resistant to rough IEC 60601-1, sub-clause 21.6 handling Tip/tilt test IEC 60601-1, sub-clause 24.1 Resistant to liquid ingress IEC 60601-1, sub-clause 44.3 as modified by ISO due to spills 9919 clause 44.6 Environmental...

  • Page 85: Manufacturer's Declaration

    Specifications Item Compliant With emissions Electrostatic discharge EN 61000-4-2, level 3 table top equipment immunity Radiated radio-frequency IEC 61000-4-3 at 3 V/m electromagnetic field immunity Electrical fast IEC 610004-4-4 transient/burst immunity Surge immunity IEC 61000-4-5 Conducted EMI IEC 61000-4-6 at 3 V/m susceptibility Power frequency magnetic IEC 61000-4-8 at 3A/m...

  • Page 86: Performance

    Performance Performance Capnograph Parameter Value Sampling Rate 50 ml/min. Range 0-99 mmHg (0-13.2 kPa and 0-13.0 Vol%) at sea level Accuracy From power up until steady state is reached, the EtCO readings reading accuracy is: 0 - 38 mmHg: (+ 4 mmHg) 39 - 99 mmHg: (+ 12% of reading) The CO...

  • Page 87: Display Update Interval

    Specifications Display Update Interval 2 seconds Pulse Oximeter Parameter Value 0-100% SpO Saturation Range (% SpO , +1 SD) Saturation Accuracy ® oxygen transducer (single patient use) MAX-A, 70—100% +/- 2 digits MAX-AL 0—69% Unspecified MAX-N 70—100% +/- 2 digits (Adult) 0—69% Unspecified...
  • Page 88 Performance Parameter Value OxiCliq N 70—100% +/- 2.5 digits (Adult) 0—69% Unspecified OxiCliq N 70—100% +/- 3.5 digits (Neonate) 0—69% Unspecified OxiCliq I 70—100% +/- 2.5 digits 0—69% Unspecified Reusable Sensor Models D-YS (Infant to 70—100% +/- 3 digits Adult) 0—69% Unspecified D-YS...
  • Page 89 Specifications Parameter Value Accuracy Specifications: Accuracy specifications are based on controlled hypoxia studies with healthy, non-smoking adult volunteers over the specified saturation SpO range. Pulse oximeter SpO readings were compared to SaO values of drawn blood samples measured by hemoximetry. All accuracies are expressed as + “X”...

  • Page 90: Power Specifications

    Power Specifications Parameter Value Reading accuracy in the presence of low perfusion (detected IR pulse modulation amplitude < 1.5%) was validated using signals supplied by a patient simulator. and pulse rate values were varied across the monitoring range over a range of weak signal conditions and compared to known true saturation and pulse rate of the input signals.

  • Page 91: Electrical

    Specifications Electrical Instrument Rated 100-250VAC, 50/60HZ, 0,5A ® Sensors Parameter Value Wavelength and Power The wavelength range of the light emitted are near 660 nm and 890 nm with the energy not exceeding 15 mW. Electromagnetic Emissions The monitor is suitable for use in the specified electromagnetic environment.

  • Page 92: Electromagnetic Immunity

    Electrical Electromagnetic Immunity The monitor is suitable for use in the specified electromagnetic environment. The user of the monitor should assure that it is used in an electromagnetic environment as described below. Immunity IEC 60601-1-2 Compliance Electromagnetic Test Test Level Level Environment Guidance...
  • Page 93 Specifications Immunity IEC 60601-1-2 Compliance Electromagnetic Test Test Level Level Environment Guidance Voltage dips, <5% U <5% U Mains power short quality should be interruptions and that of a typical voltage commercial and/or (>95% dip in U (>95% dip in variations on hospital for 0.5 cycle...

  • Page 94: Electromagnetic Immunity

    Electrical Electromagnetic Immunity The monitor is suitable for use in the specified electromagnetic environment. The user of the monitor should assure that it is used in an electromagnetic environment as described below: Immunity Compliance Electromagnetic 60601-1-2 Test Test Level Level Environment Guidance Conducted 3 Vrms...
  • Page 95 Specifications Immunity Compliance Electromagnetic 60601-1-2 Test Test Level Level Environment Guidance Radiated 3 V/m 3 V/m d = 1.2√P 80 MHz to 800 MHz RF IEC 80 MHz to 2.5 d = 2.3 √P 800 MHz to 2.5 61000-4-3 where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d...

  • Page 96: Recommended Separation Distances

    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 frequency maximum of transmitter output power 150 kHz to 80 80 MHz to 800 800 MHz to 2.5 of transmitter d=1.2√P d=1.2√P...

  • Page 97: Electric And Communication Cables

    Specifications Electric and Communication Cables Cables and Maximum Complies ® Sensors Length with: • RF emissions, 791001, Power cord 10 ft. (3 m) CISPR 11, Class North America B/ Group 1 RJ11 communication 10 ft. (3 m) • Harmonic cable (contained in emissions.

  • Page 98: Sensors

    Electrical Sensors Cable/Sensor Patient Type Maximum Complies Length with: • DEC 4 Extension 4 ft. (1.2m) RF emissions, cable CISPR 11, Class B/ Group 1 DEC 8 Extension 8 ft. (2.4 m) • cable Harmonic emissions. IEC OxiMax® Sensors 61000-3-2 MAX-A Adult 1.5 ft.
  • Page 99 Specifications Cable/Sensor Patient Maximum Complies Type Length With : • OxiMax® OxiCliq Sensors RF emissions, CISPR 11, Class OC-3 OxiCliq 3 ft. (0.9m) B/ Group 1 Sensor Cable • Harmonic Pediatric (10 - 3 ft. (0.9m) emissions. IEC 50 kg) 61000-3-2 Neonatal/Adult 3 ft.

  • Page 100: Components And User Interface

    Components and User Interface Components and User Interface Displays Parameter Value Graphic LCD display (128 x 64 dots) with LED backlight dimension 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...
  • Page 101 Package Components Portable Bedside Capnograph/Pulse Oximeter Package Components • Capnography/Pulse Oximetry monitor • EtCO Sample Kit • SpO Sensor Assortment Pack or Reusable Sensor • Sensor Extension Cable • Power Cord • Power Supply • Operation Manual (English only) • Operation Manual CD (operation manual in 17 languages) •...
  • Page 102 Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton, CA 94588 USA Authorized Representative Tyco Heathcare UK LTD 154 Fareham Road Gosport PO13 0AS, U.K. © 2006 Nellcor Puritan Bennett Inc. All rights reserved To Purchase, Visit Avobus.com...

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