Nonin RespSense LS1R-9R Operator's Manual
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Nonin RespSense LS1R-9R Operator's Manual

Capnography monitor
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Operator's Manual
RespSense
LS1R-9R
TM
Capnography Monitor
English

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Summary of Contents for Nonin RespSense LS1R-9R

  • Page 1 Operator’s Manual RespSense LS1R-9R Capnography Monitor English...
  • Page 2 Consult Instructions for Use. Nonin makes no claim for use of the product other than those uses specified herein and disclaims any liability resulting from other uses. Observe all warnings, cautions, and notes. Unauthorized use, copying, or distribution of this manual is prohibited without written consent from Nonin Medical, Inc.

  • Page 3: Table Of Contents

    Contents Indications for Use ..................1 Warnings ........................ 1 Cautions ......................... 2 Guide to Symbols ..................4 Introduction....................5 About RespSense....................5 About Capnometry....................5 Operator Requirements ..................5 Displays and Controls................... 6 Monitor Front Views....................6 Monitor Rear View ....................11 Monitor Right Side View ..................
  • Page 4 Contents (Continued) Disable Alarms....................22 Maintenance and Inspection ...............23 Battery Operation ....................23 Charging the Battery..................23 Checking Battery Capacity ................23 Low Battery Message ..................23 Battery Care.......................24 Maintenance......................24 Ensuring Optimal Performance................24 Cleaning the Monitor..................24 Calibration......................24 Recommended Inspections and Functional Check ...........25 Troubleshooting ...................27 Fault Messages.....................27 Troubleshooting ....................28 Accessories ....................29...
  • Page 5 Figures Figure 1. Start-up Screens ..................6 Figure 2. Operating and Trend Screen............... 8 Figure 3. Rear View of Monitor................11 Figure 4. Right Side of Monitor................12 Figure 5. Replacing the Moisture Trap/Filter ............16...
  • Page 6 Tables Table 1. Start-up Screen Icons and Display Descriptions.......... 7 Table 2. Device Icons and Display Descriptions............8 Table 3. Rear View Features and Descriptions ............11 Table 4. Right Side Components and Descriptions ..........12 Table 5. Factory Default Settings................19 Table 6.

  • Page 7: Indications For Use

    Accessories marked “single-use” must be used on one patient only and be disposed of after usage. Use only power supplies that either are supplied with RespSense or specified by Nonin (see “Accessories”). If RespSense fails to respond as described, discontinue use and contact Nonin Technical Service.

  • Page 8: Cautions

    If the EtCO value is out of normal range (4.4 – 5.7 Vol%/kPa or 33 – 43 mmHg) an internal air leak is possible. Replace the moisture trap and repeat the calibration procedure. If the problem persists, contact Nonin Technical Service.
  • Page 9 Do not attempt to replace the battery inside the monitor. The battery is not field replaceable and cannot be replaced by the operator. Use only Nonin-specified components. Contact Nonin Technical Service when the battery needs replacing. Battery replacement by inadequately trained personnel could result in a hazardous situation.

  • Page 10: Guide To Symbols

    Guide to Symbols This table describes the symbols found on the RespSense monitor. Symbol Meaning CAUTION! Consult Instructions for Use Follow Instructions for Use Type BF-Applied Part Indicates separate collection for electrical and electronic equipment (WEEE) Model/article number Serial number Protected against vertically falling water drops when enclosure is tilted up to IPX2 15 degrees per IEC 60529.

  • Page 11: Introduction

    Nafion tubing. Use only those accessories and replacement parts recommended by Nonin. Refer to the “Accessories” section for more information. RespSense has visual and audible alarms when limit readings are outside the predefined limits.

  • Page 12: Displays And Controls

    Displays and Controls A standard RespSense set-up consists of a monitor, moisture trap with filters, nasal cannula, and power supply. See “Accessories” for information on optional accessories. All operator settings are adjusted using the touch panel display on the monitor. Monitor Front Views When the monitor is turned on, it displays the start-up screens (figure 1 and table 1) and then the operating and trend screen (figure 2 and table 2).

  • Page 13: Table 1. Start-Up Screen Icons And Display Descriptions

    Table 1: Start-up Screen Icons and Display Descriptions Name Description Audible Alarm Disable Pressing this icon turns the audible alarms off. It disables the audible alarms by setting all lower limits to 0. Audible Alarm Enable Pressing this icon turns the audible alarms on. Default if no icon is chosen.

  • Page 14: Figure 2. Operating And Trend Screen

    16 17 18 Figure 2: Operating and Trend Screen Table 2: Device Icons and Display Descriptions Name Description LCD Display The LCD monitor displays parameters, graphs, menus, and other information. It is also a touch panel from which all operator-defined settings are made.
  • Page 15 Table 2: Device Icons and Display Descriptions (Continued) Name Description Charge Indicator This indicator is green whenever the power supply is connected and the battery is charging. NOTE: When the external power supply is disconnected, the device automatically switches to battery power without loss of functionality.
  • Page 16 Table 2: Device Icons and Display Descriptions (Continued) Name Description Trend ETCO Displays a trend graph of the ETCO values. This scale is fixed and cannot be changed. Trend Cursor A trend cursor points out where the actual sample is in the time interval.

  • Page 17: Monitor Rear View

    Monitor Rear View The moisture trap, filter, and equipment label are located on the back of the RespSense (figure 3). Names and descriptions of each component are listed in table 3. Figure 3: Rear View of Monitor Table 3: Rear View Features and Descriptions Name Description Single-Use,...

  • Page 18: Monitor Right Side View

    Serial interface works with either: l O l O l • TrendSense, to transfer data to a PC. • NC1, Nurse Call Accessory, to add nurse call functionality. DC Input Used to connect the power supply to the monitor. Only use Nonin-specified power supplies.

  • Page 19: Using The Respsense Monitor

    Using the RespSense Monitor After unpacking the monitor and accessories, RespSense is ready for use. Ensure the RespSense battery is fully charged by viewing the status of the battery indicator on the display panel after the power supply is connected to the monitor and the power outlet. CAUTION: To prevent damage to the monitor, operate and store the monitor in an upright position.

  • Page 20: Mounting

    1.5 meters (5 feet) and do not exceed a total of 2 kilograms (4.5 pounds) of equipment on the pole. Contact Nonin Customer Support to order a mounting bracket and adjustable mounting clamp. CAUTION: Secure RespSense with mounting bracket if used in transport vehicles.

  • Page 21: Applying The Sample Line

    The Nafion tubing is a single-use disposable component designed to be placed between the moisture trap and the nasal cannula or sampling tubing to remove water vapor. It is intended for use only with Nonin’s LifeSense and RespSense monitors. CAUTION: Water or other liquid in the sampling tube may cause erroneous CO readings.

  • Page 22: Replacing The Moisture Trap/Filter

    Trap and Filters” for instructions on how to handle and maintain the moisture trap and filter. Connect the sample line to the adjacent connector on the monitor's side and secure it by turning the Luer lock connector clockwise. Only use sample lines recommended by Nonin (see “Accessories”).

  • Page 23: Connect The Patient

    Connect the Patient Attach the sample line to the patient, as described in “Applying the Sample Line,” or refer to the individual sample line Instructions for Use. Turn On the Monitor Turn on the monitor by pressing the ON/OFF button until you hear a beep. The monitor starts by running a self-test (this only takes a few seconds) before the graphs and settings are displayed.

  • Page 24: Connecting The Device Into A Medical System

    Connecting the Device into a Medical System Incorporating the device into a medical system requires the integrator to identify, analyze, and evaluate the risks to patient, operators, and third parties. Subsequent changes to the medical system after device integration could introduce new risks and will require additional analysis. Changes to the medical system that must be evaluated include: •...

  • Page 25: Settings And Alarms

    Settings and Alarms Touch Panel Display All adjustments and settings are made using the RespSense touch panel display. Each specific parameter is adjusted by using the up/down arrows on the display bar Factory Default Settings RespSense recalls and displays the factory default settings (table 5) upon start-up. At the start- up screen, the operator can select from two different default settings (only if alarms are activated on the first start-up screen).

  • Page 26: Alarm Limits

    Alarm Limits All parameters have built in limits that cannot be exceeded. Respiration Limits – Upper limit: 99 RPM – Lower limit: 0 RPM EtCO Limits – Upper limit: 9.9 kPa or 99 mmHg – Lower limit: 0 kPa or mmHg Changing Settings All settings follow the same procedure to increase or decrease an alarm limit.

  • Page 27: Alarms

    Alarms The intended operator’s position for correctly perceiving a visual alarm signal and its priority is 1 meter (3.3 feet). Alarm Function An alarm activates under certain conditions, such as if an alarm limit is outside the set limit, the patient is not connected, or if an equipment fault occurs.

  • Page 28: Low Priority Alarm

    Low Priority Alarm A low priority alarm indicates that an equipment fault has occurred and the device is unable to provide a measurement value. See table 7 for parameters, fault messages, and possible causes. Low priority alarms are both audible and visual: •...

  • Page 29: Maintenance And Inspection

    To check the battery’s capacity, time how long a fully charged battery is able to power the device. When a fully charged battery only provides approximately 4 hours of operation, it needs to be replaced. Contact Nonin Technical Service for battery replacement. Low Battery Message RespSense displays BATT LOW when the battery is almost depleted.

  • Page 30: Battery Care

    Battery Care The battery, made of Lithium Ion (LiIon) rechargeable cells, is integral to the device and cannot be replaced by anyone other Nonin Technical Service. The life expectancy of the battery is approximately 1 year. For optimal performance, the battery should be replaced once per year to limit the amount of Li build up if the battery is charged in a cold environment.

  • Page 31: Recommended Inspections And Functional Check

    “Capnography Specifications” section. NOTE: If the reading is out of range, an internal air leak is possible. Replace the moisture trap and repeat the calibration procedure. If the out of range reading continues, contact Nonin Technical Service.
  • Page 32 WARNING: Never allow liquids to enter into or to be spilled onto the monitor. If liquid has penetrated into the monitor it must be checked by Nonin Technical Service. CAUTION: Be careful not to drop RespSense on the floor or strike it against hard surfaces.

  • Page 33: Troubleshooting

    The fault conditions are either operator- or system-generated. The table below lists common messages, descriptions, and advice on actions to take. If the problem persists, contact Nonin Technical Service. Message Description...

  • Page 34: Troubleshooting

    Recharge the monitor with the occurred, possibly due to power supply. interference or loss of power. If the problem persists, contact Nonin Technical Service. Low EtCO alarm All alarms for low EtCO require the Check patient status.

  • Page 35: Accessories

    The following list of accessories can be ordered from Nonin or your distributor. Nonin may update the Accessories List at any time. It is the purchaser’s responsibility to always ask for the current list, by model number, when ordering accessories.

  • Page 36: Capnography Accessories

    Capnography Accessories Item Description Nasal CO Sample Single-use, disposable, universal sample line with male Luer lock Line connectors at both ends. 2.1 m. Adult Pediatric Infant Oxygen Delivery CO Single-use, disposable O delivery sample line with male Luer lock Sampling Nasal connector.

  • Page 37: Technical Information

    Rated supply voltages or voltage ranges for the power supply 100 – 240 VAC 50 – 60 Hz Input voltage to RespSense from the power supply 12 VDC, 720 mA WARNING: Only use power supplies that either are supplied with RespSense or specified by Nonin (see “Accessories”).

  • Page 38: System Specifications

    System Specifications Power Data Power Supply: 100 – 240 VAC 50 – 60 Hz Power Consumption: 3.6 W with battery operation 9 W with power supply Input: 12 VDC, 720 mA Battery Data Type: Lithium Ion (Li-Ion) internal battery, non-field replaceable, rechargeable Battery Capacity: Approximately 8 hours Charging Time: Approximately 24 hours...

  • Page 39: Capnography Specifications

    Capnography Specifications Respiration Range: 3 to 60 respirations/minute Update Frequency: Once every breath (No Breath alarm after 25 seconds) Respiration Accuracy: 3 to 50 respirations/min ± 2 51 to 60 respirations/min ± 3 EtCO Range: 0 to 9.9 kPa or 0 to 99 mmHg †...

  • Page 40: Manufacturer's Declaration

    Manufacturer’s Declaration See the following tables for specific information regarding this device’s compliance to IEC 60601-1-2. Table 8: Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment—Guidance This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is used in such an environment.

  • Page 41: Table 9. Electromagnetic Immunity

    Table 9: Electromagnetic Immunity IEC 60601 Test Electromagnetic Immunity Test Compliance Level Level Environment—Guidance This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is used in such an environment. Electrostatic ±6 kV contact ±6 kV contact...

  • Page 42: Table 10. Guidance And Manufacturer's Declaration-Electromagnetic Immunity

    Table 10: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment—Guidance This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 43: Equipment Response Time

    Table 11: Recommended Separation Distances This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Customers or users of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the device as recommended below, according to maximum output power of the communications equipment.

  • Page 44: Service, Support, And Warranty

    Nonin shall repair or replace any RespSense found to be defective in accordance with this warranty, free of charge, for which Nonin has been notified by the purchaser by serial number that there is a defect, provided said notification occurs within the applicable warranty period. This warranty shall be the sole and exclusive remedy by the purchaser hereunder for any RespSense delivered to the purchaser which is found to be defective in any manner, whether such remedies be in contract, tort, or by law.

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