Operator’s Manual RespSense LS1R-9R TM Capnography Monitor English
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Consult Instructions for Use ® RespSense™ is a registered trademark of Nonin Medical AB, a Nonin Medical, Inc. company. Nonin makes no claim for use of the product other than for those uses specified herein and disclaims any liability resulting from other uses. Observe all warnings, cautions, and notes.
Contents Indications for Use ..................................................................................................... 1 Contraindications .................................................................................................... 1 Warnings ................................................................................................................ 1 Cautions .................................................................................................................
Battery Care .................................................................................................... 21 Maintenance ......................................................................................................... 22 Ensuring Optimal Performance ....................................................................... 22 Cleaning the Monitor ....................................................................................... 22 Calibration...............................................
Indications for Use RespSense is a lightweight, portable, battery-operated monitor that measures and displays carbon dioxide in expired air (EtCO2), and respiration rate of adult, pediatric, and infant patients. It is intended for use in environments where patients require continuous, non-invasive monitoring of these parameters by a healthcare professional (e.g.
Cautions (continued) Do not mount RespSense directly above the patient. If the monitor is mounted, be sure to check that the adjustable mounting clamp is securely affixed. When mounting the monitor to a mobile pole, mounting the monitor higher than 1.5 meters (5 feet) or mounting more than 2 kilograms (4.5 pounds) of equipment onto the pole may result in tipping, damage to the equipment, or injury. Always turn off the monitor prior to cleaning the monitor or changing the moisture trap and/or filter.
Cautions (continued) In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this product as unsorted municipal waste. This device contains WEEE materials; please contact your distributor regarding take back or recycling of the device. If you are unsure how to reach your distributor, please call Nonin for your distributor’s contact information.
Guide to Symbols This table describes the symbols found on the RespSense monitor. Symbol Meaning CAUTION! Consult Instructions for Use Follow Instructions for Use CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices. Authorized representative in the European Community.
Introduction About RespSense RespSense allows healthcare professionals to non-invasively monitor capnometry on either intubated or spontaneously breathing patients. When measuring EtCO2, the patient is attached to the monitor by a sample line that can be an airway adapter for an endotracheal tube, a nasal cannula, or a nasal cannula with supplemental oxygen delivery.
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).
Table 1. Start-up Screen Icons and Display Descriptions No. Name Description 1. Audible Alarm Disable Pressing this icon turns the audible alarms off. It disables the audible alarms by setting all lower limits to 0. 2. Audible Alarm Enable Pressing this icon turns the audible alarms on. Default if no icon is chosen. 3. ≤30kg/66lbs Pressing this icon selects the default alarm limits for patients weighing 30 kg (66 lbs) or less.
2 3 14 16 17 18 4 5 1 6 8 7 9 10 11 13 12 15 Figure 2. Operating and Trend Screen Table 2. Device Icons and Display Descriptions No. 8 Name Description 1. 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. 2. Limit Settings The upper figures represent the highest value set by the operator. The lower figures represent the lowest value set.
No. Name Description 5. Audible Alarm Pause/Resume Audible alarms alert the operator when readings are outside the preset limits. The operator can temporarily disable the audible alarm by pushing the Audible Alarm Pause/Resume button. Alarms will be inactive for approximately 2 minutes or until the operator presses the Audible Alarm Pause/Resume button again. This button does not disable the visual alarms. The current alarm status displays on the LCD (see #11 below). 6.
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. 3 2 1 4 Figure 3. Rear View of Monitor Table 3.Rear View Features and Descriptions No. 10 Name Description 1. Single-Use, Disposable The filter is a single-use disposable component and should be replaced Moisture Trap with after each patient use or cleaning.
Monitor Right Side View Outputs and connections are located on the right hand side of the monitor as shown in figure 4. Names and descriptions of each component are listed in table 4. 1 2 Figure 4. Right Side of Monitor Table 4. Right Side Components and Descriptions No. 1. Name Description Serial Interface Serial interface works with either: lOlOl 2. DC Input • TrendSense, to transfer data to a PC. • NC1, Nurse Call Accessory, to add nurse call functionality.
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. Stationary Operation 1. Place the monitor in a position so the display can be clearly seen. 2. Connect the power supply to the monitor and a power outlet.
Mounting RespSense can be equipped with a mounting bracket and adjustable mounting clamp, intended to fit most hospital rails, poles, and table edges. The mounting bracket is screwed onto the back side of the RespSense monitor. After attaching the mounting bracket to the monitor, securely clamp the monitor to the hospital rail, pole or table edge. If the pole is mobile, do not attach the monitor to the pole higher than 1.5 meters (5 feet) and do not exceed a total of 2 kilograms (4.
Applying the Sample Line 1. Insert the cannula into each nostril. 2. Place the tubing behind each ear. 3. Connect the Luer lock fitting to the moisture trap, twist to tighten. Nafion Tubing 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.
Replacing the Moisture Trap/Filter CAUTION: The sample line, moisture trap, Nafion tubing, and filter are single-use disposable components. Do not disassemble the plastic parts of the single-use disposable moisture trap. Dispose all components in accordance with your local, state or national regulations regarding waste management. 1. Place the filter in the moisture trap as shown in figure 5 (1). 2. Slide the moisture trap into position (figure 5, 2) using the guide marks on the back of the monitor. 3.
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. See “Monitor Front Views” and “Changing Settings” for more information on disabling alarms and setting alarm limits.
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 startup screen, the operator can select from two different default settings (only if alarms are activated on the first start-up screen). Adjust settings according to each patient’s needs.
Alarm Limits All parameters have built in limits that cannot be exceeded. Respiration Limits – Upper limit: 99 RPM – Lower limit: 0 RPM EtCO2 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. on the right side of a displayed parameter bar is used to increase an alarm • The up arrow limit. • The down arrow alarm limit.
Alarms 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. The alarm is both visual (a blinking parameter, limit, or a message) and audible (beeping tones at different intervals). Alarm Silence The operator can silence the audible alarm by pressing the Audible Alarm Pause/Resume button .
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: • Audible alarms beep slower in a low priority situation than in a high priority situation. • The fault message displays on the monitor. Table 7.
Maintenance and Inspection Battery Operation RespSense is designed to operate continuously when connected to a power outlet or on battery power for approximately 8 hours. When RespSense is disconnected from the outlet and is ON, it automatically runs on battery. Charging the Battery The battery is rechargeable and charges itself whenever the monitor is connected to a power outlet, even when the monitor is turned off. The green indicator on the front panel of the monitor indicates the battery is charging.
Maintenance Ensuring Optimal Performance In order to ensure safety and optimal performance of RespSense, it is necessary to perform recommended maintenance and inspections (see the “Recommended Inspections” section). CAUTION: Always turn off the monitor prior to cleaning the monitor or changing the moisture trap and/or filter. Cleaning the Monitor Clean the monitor with a soft cloth moistened with isopropyl alcohol. Allow the monitor to dry completely after cleaning.
9. Verify calibration: a. Connect the gas valve, which is already equipped with a T-connector, to a gas bottle containing 5 Vol% of CO2 (verifying gas) and RespSense. NOTE: Older versions of the gas valve do not have a pre-attached T-connector. For this configuration, connect a Tconnector and gas sampling tube before connecting the gas valve to the gas bottle and RespSense. The T-connector allows excess flow to exit into the room. b.
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. If such an incident happens, do not use RespSense until a functional test has been carried out. Yearly Inspection A comprehensive inspection should be carried out annually by Nonin Technical Service to ensure optimal performance of RespSense.
Troubleshooting Fault Messages RespSense has built-in self-diagnostics for detection of fault conditions. Detected fault conditions are presented as messages on the touch panel display. 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 Action OCCLUSION Sample line or cannula occlusion. Remove obstruction.
Troubleshooting 26 Problem Possible Cause Possible Solution Continuous beeping sound The alarm beeps continuously. The monitor is not functioning. This indicates that a problem has occurred, possibly due to interference or loss of power. Turn off the monitor and then turn on again. Recharge the monitor with the power supply. If the problem persists, contact Nonin Technical Service. Low EtCO2 alarm even though the patient’s EtCO2 is suspected to be normal.
Accessories RespSense is designed to be used with Nonin-recommended accessories only. Use of other brands will compromise the function and performance. 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. Monitor Accessories Item Description Power Supply Approximately 100 – 240 VAC, 50 – 60 Hz (USA / Canada).
Capnography Accessories 28 Item Description Nasal CO2 Sample Line Single-use, disposable, universal sample line with male luer lock connectors at both ends. 2.1 m. Adult Pediatric Infant Oxygen Delivery CO2 Sampling Nasal Cannula Single-use, disposable O2 delivery sample line with male Luer lock connector. Infant Pediatric (22 mm ID x 6 mm OD adapter included) Adult (22 mm ID x 6 mm OD adapter included) CO2 Sample Line Single-use, disposable 2.1 m.
Technical Information Operating Environment The equipment must only be used in situations that meet the system’s specified environmental conditions. Refer to “System Specifications” in this section. Storage Environment Refer to “System Specifications” in this section for the system’s specified storage conditions. CAUTION: If RespSense is intended to be stored for longer periods of time, always charge the battery to full capacity before storing it in order to prevent damage to the equipment.
System Specifications Power Data Power Supply: Power Consumption: 100 – 240 VAC 50 – 60 Hz for USA / Canada 3.6 W with battery operation 9 W with power supply Input: 12 VDC, 720 mA Type: Lithium Ion (LiIon) internal battery, non-field replaceable, rechargeable Battery Data Battery Capacity: Charging Time: Approximately 8 hours Approximately 17 hours, or 2 hours for each hour of use Physical Data Dimensions: Weight: 200 x 135 x 50 mm (7.9 x 5.3 x 2 in.) 800 grams (1.
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 EtCO2/CO2 Range: 0 to 9.9 kPa or 0 to 99 mmHg EtCO2/CO2 Accuracy: ±0.
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. Group 1 This device uses RF energy only for its internal function.
Table 9. 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. Electrostatic Discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete, or ceramic tile.
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.
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.
Service, Support, and Warranty A return authorization number is required before returning any product to Nonin. To obtain this return authorization number, contact Nonin Technical Service: Nonin Medical, Inc. 13700 1st Avenue North Plymouth, Minnesota 55441-5443 USA (800) 356-8874 (USA and Canada) +1 (763) 553-9968 (outside USA and Canada) Fax: +1 (763) 553-7807 E-mail: technicalservice@nonin.
QUICK STEP with RespSense LS1R-9R To Start: 1. Visually inspect the monitor and sample line to make sure it has no visible signs of damage. 2. Use a new sample line, Nafion tubing, moisture trap, and filter for each patient. 3. For AC power, plug the RespSense power supply into a power outlet. 4. Replace the moisture trap and filter after each patient use. Connect the sample line or Nafion tubing to the Luer lock connector on the moisture trap. 5.
