Nonin RespSense II LS1R Manuel utilisateur

Operator’s Manual

RespSense™II

Model LS1R

Capnography Monitor

0123

English

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.

13700 1st Avenue North

Plymouth, MN 55441-5443 USA

+1 (763) 553-9968 (outside USA)

(800) 356-8874 (USA and Canada)

Fax: +1 (763) 553-7807

E-mail: [email protected]

Nonin Medical B.V.

Prins Hendriklaan 26

1075 BD Amsterdam, Netherlands

+31 (0)13 - 79 99 040 (Europe)

Fax: +31 (0)13 - 79 99 042

E-mail: [email protected]

nonin.com

MPS, Medical Product Service GmbH

Borngasse 20

D-35619 Braunfels, Germany

References to “Nonin” in this manual imply Nonin Medical, Inc. Nonin and RespSense are

registered trademarks or trademarks of Nonin Medical, Inc. Other trademarks and trade names

are those of their respective owners.

9819-001-02

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a

licensed practitioner.

Follow Instructions for Use.

01230123

REP

Contents

Indications for Use ........................................................................................ 1

Contraindications.................................................................................................... 1

Warnings ................................................................................................................ 1

Cautions ................................................................................................................. 2

Guide to Symbols .......................................................................................... 5

Introduction.................................................................................................... 7

About RespSense II................................................................................................ 7

About Capnometry.................................................................................................. 7

Operator Requirements .......................................................................................... 7

System Components ..................................................................................... 8

RespSense II Monitor ............................................................................................. 9

Battery .................................................................................................................. 11

Charging the Battery ......................................................................................... 11

Battery Replacement ........................................................................................ 12

Sample Line.......................................................................................................... 12

Intended Use..................................................................................................... 12

Applying the Sample Line ................................................................................. 12

Nafion Tubing ....................................................................................................... 13

Attaching the Nafion Tubing.............................................................................. 13

Single-Patient Use, Disposable Moisture Trap and Filter..................................... 13

Replacing the Moisture Trap/Filter.................................................................... 13

PSG DAC Cables ................................................................................................. 14

Capno RTC Cable ................................................................................................ 14

Display Screens ........................................................................................... 15

Select Alarm Group Screen.................................................................................. 15

Operating Screen ................................................................................................. 17

Using the RespSense II Monitor................................................................. 20

Start-up Sequence................................................................................................ 20

Shut Down Modes ................................................................................................ 21

Standby Mode................................................................................................... 21

Deep Sleep Mode ............................................................................................. 21

Using the Mounting Bracket ................................................................................. 21

System Setup ....................................................................................................... 21

Monitoring a Patient.............................................................................................. 22

Adjusting Display Brightness ................................................................................ 23

Adjusting Audible Alarm Volume .......................................................................... 23

Configuration Menu .............................................................................................. 24

Language/Units Screen ........................................................................................ 25

Responsible Organization Settings Screen .......................................................... 26

Minimum Alarm Volume.................................................................................... 27

Default Alarm Volume ....................................................................................... 27

Alarm Limits – EtCO2, RR................................................................................. 27

Reset Device to Factory Defaults ..................................................................... 28

Contents (Continued)

New PIN.............................................................................................................28

Factory Service..................................................................................................28

Date/Time Screen .................................................................................................29

Alarm Lock Mode Screen......................................................................................30

Calibration Screen.................................................................................................31

Calibration Procedure........................................................................................31

Alarm Limit Settings ...................................................................................33

Alarm Limits .........................................................................................................33

Alarms ...........................................................................................................35

High Priority Alarms ..............................................................................................35

Medium Priority Alarms .........................................................................................36

Inoperable Alarms .................................................................................................37

Low Priority Alarms ...............................................................................................37

Data Output and Software ...........................................................................38

Device Memory .....................................................................................................38

Download Patient Data .........................................................................................38

USB Drive Requirements...................................................................................38

Recommended SanDisk®USB Flash Drives .....................................................38

Download Data from the Monitor.......................................................................39

Clear Memory........................................................................................................39

Data Format ..........................................................................................................40

Monitor Software ...................................................................................................41

Connecting the Device into a Medical System......................................................42

Maintenance and Inspection .......................................................................43

Maintenance..........................................................................................................43

Ensuring Optimal Performance..........................................................................43

Cleaning the Monitor..........................................................................................43

Recommended Inspections and Functional Check ...............................................44

Troubleshooting ...........................................................................................45

Accessories .................................................................................................49

Service, Support, and Warranty..................................................................51

Warranty................................................................................................................51

Technical Information ..................................................................................52

Operating Environment .........................................................................................52

Storage Environment ............................................................................................52

Power Requirements.............................................................................................52

Manufacturer’s Declaration ...................................................................................53

Equipment Response Time...................................................................................56

System Specifications ...........................................................................................57

Capnography Specifications .................................................................................58

iii

Figures

Figure 1. Monitor Features......................................................................................... 9

Figure 2. Replacing the Moisture Trap/Filter ............................................................ 14

Figure 3. Select Alarm Group Screen ...................................................................... 15

Figure 4. Operating Screen...................................................................................... 17

Figure 5. Start-up Screen......................................................................................... 20

Figure 6. Access Configuration Menu (Nonin Logo) ................................................ 24

Figure 7. Configuration Menu................................................................................... 24

Figure 8. Language/Units Screen............................................................................. 25

Figure 9. Responsible Organization Settings Screen............................................... 26

Figure 10. Date/Time Screen ................................................................................... 29

Figure 11. Alarm Lock Mode Screen........................................................................ 30

Figure 12. Calibration Screen................................................................................... 31

Figure 13. Operating Screen with Alarms ................................................................ 35

Figure 14. Sample Patient Data (_gd.csv File)......................................................... 40

Figure 15. Sample Capnography Waveform Data (_cw.csv File) ............................ 40

Tables

Table 1. Symbols ....................................................................................................... 5

Table 2. Monitor Features........................................................................................ 10

Table 3. Select Alarm Group Screen – Display Descriptions................................... 16

Table 4. Operating Screen – Display Descriptions .................................................. 17

Table 5. Alarm Limit Settings ................................................................................... 33

Table 6. High Priority Alarms ................................................................................... 36

Table 7. Medium Priority Alarms.............................................................................. 36

Table 8. Inoperable Alarms...................................................................................... 37

Table 9. Low Priority Alarm...................................................................................... 37

Table 10. Electromagnetic Emissions...................................................................... 53

Table 11. Electromagnetic Immunity........................................................................ 54

Table 12. Guidance and Manufacturer’s Declaration—Electromagnetic Immunity.. 55

Table 13. Recommended Separation Distances ..................................................... 56

Indications for Use

The RespSense II, Model LS1R, capnography monitor is indicated for use in simultaneously

measuring, displaying, monitoring, and recording end tidal carbon dioxide (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,

including hospitals, long-term care, medical facilities, sleep laboratories, home healthcare,

subacute environments, and Emergency Medical Services (EMS), including patient transport.

Contraindications

Do not use the monitor in an MR environment or in the presence of flammable anesthetics or gases.

This system is not intended to be used simultaneously on multiple patients.

Warnings

This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with other

methods of assessing clinical signs and symptoms.

The monitor is not classified as an apnea monitor.

This monitor is not intended for use with inhalation halogenated agents.

Verify all alarm settings and limits during system start-up to ensure that they are set as intended.

Before each use, it is the operator’s responsibility to verify that the alarm limits are appropriate for the patient

being monitored.

Ensure that all alarm volumes are audible in all situations. Do not cover or obstruct any speaker openings.

When turning on the monitor, verify that a beep is heard. If a beep is not heard, do not use the device. The

speaker may not be functioning properly.

Atmospheric pressure compensation occurs during system startup.

- An increase in the surrounding environment’s atmospheric pressure may cause the system to display incorrect

readings until the system stabilizes.

- A decrease in the surrounding environment’s atmospheric pressure may cause the system to not detect an

occlusion when the condition exists.

A hazard can exist if different presets are used on multiple RespSense II monitors in one care area.

To prevent improper performance and/or patient injury, verify compatibility of the monitor and accessories before

use.

No modifications to this device are allowed as it may affect device performance.

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.

To avoid patient injury, only use Nonin-specified power supplies, cables, and accessories (see Accessories).

The monitor displays a flashing yellow battery indicator (low battery) when it has approximately 60 minutes of use

remaining before it shuts itself off.

This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is

necessary, the device should be observed carefully to verify normal operation.

Indications for Use

Prior to connecting the monitor to the power supply and a power outlet, be sure to verify the voltage and

frequency rating on the power supply are the same as the outlet. If this is not the case, do not connect the monitor

and power supply to the outlet.

The use of accessories other than those specified in this manual may result in increased electromagnetic

emission and/or decreased immunity of this device.

As with all medical equipment, carefully route cables and cannula to reduce the possibility of entanglement,

strangulation, or tripping.

Cautions

RespSense II should only be operated by trained licensed practitioners.

To prevent damage to the monitor, operate and store the monitor in an upright position.

Visually inspect the monitor for damage before each use. Do not use a damaged monitor or system.

Verify display functionality before each use.

Setting alarm limits to extremes can render the alarm system useless.

Each time the system is turned on, audible alarms are silenced for 2 minutes unless the operator presses the

Audio Pause button.

When an alarm is acknowledged and audible alarms are paused, new alarms will have visual indicators, but not

an audible indicator.

To ensure the longevity and safety of the monitor, the carrying case must be used when operating the monitor in

an emergency medical services (EMS) environment.

Do not mount the monitor 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.

Do not place the device in liquid or clean it with agents containing ammonium chloride or bleach.

Do not sterilize or autoclave the monitor or accessories. Do not immerse in liquids.

Always turn off the monitor prior to cleaning the monitor.

Do not simultaneously touch the accessible connector pins and the patient.

After exposing the monitor to an environment outside of normal room temperature/humidity conditions, always

replace the moisture trap and filter before each use.

The sample line, moisture trap, filter, and Nafion tubing are single-patient use, disposable components. Do not

reuse disposable accessories. Accessories marked “single-use” must be used on one patient only and be

disposed of after usage. Dispose of all components in accordance with your local, state or national regulations

regarding waste management.

Set or adjust alarm parameters one at a time.

The patient’s nasal passage may dry out if continuous monitoring is required. Check patient hourly for nasal

comfort.

Warnings

Indications for Use

When using sample lines that also deliver oxygen to the patient, it is important to be aware that the EtCO2value

may be diluted when used in combination with supplemental oxygen. To obtain a true EtCO2reading, it is

recommended that the supplemental oxygen be disconnected for a few seconds to establish a baseline.

If the EtCO2value is out of normal range (4.4 – 5.7 Vol%/kPa or 33 – 43 mmHg) an internal air leak is possible

(see Troubleshooting). Replace the single-use, disposable moisture trap and perform the calibration procedure. If

the problem persists, contact Nonin Technical Service.

In order to prevent damage to the equipment, always charge the battery to full capacity before storing the

monitor.

Avoid rapid temperature change or extreme temperatures. This can cause malfunction.

Never store or transport the monitor where condensation can occur. If condensation does occur, wait until all

condensation has evaporated before using the monitor.

The temperature of the monitor may exceed 41 °C, but will not exceed 48 °C when operating at high ambient

temperatures (40 °C). Limit skin contact to less than 10 minutes and inspect the contact area often. Patient

sensitivity may vary due to medical status or skin condition.

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. Use of another battery may present a risk of fire

or explosion. Contact Nonin Technical Service when the battery needs replacing. Battery replacement by

inadequately trained personnel could result in a hazardous situation.

Do not charge Li-Ion batteries at a temperature of 0 °C (32 °F) or less as this may result in significantly reduced

battery life.

Do not use the power supply if the integrity of the AC cord conductors or the outlet is in doubt.

This device is a precision electronic instrument and must be repaired by qualified technical professionals. Field

repair of the device is not possible. Do not attempt to open the case or repair the electronics. Opening the case

may damage the device and void the warranty.

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.

When using the monitor in the home, avoid exposing the monitor to lint and dust.

When using the monitor around small children and pets, avoid leaving the monitor unattended. Cables and

cannulas pose a risk of injury, including strangulation.

Be careful not to drop the monitor on the floor or strike it against hard surfaces. If such an incident happens, do

not use the monitor until a functional test has been carried out.

The monitor is equipped with automatic barometric pressure compensation. End tidal pCO2values displayed are

calculated based on an atmospheric pressure of 760 mmHg and pH2O of 47 mmHg (example: 760 – 47 = 713,

713 x 5% = 36 mmHg).

Water or other liquid in the sample line may cause erroneous EtCO2readings or an occlusion.

Ensure that all connections are tight, leak-free, and properly attached.

If the Nafion tubing becomes contaminated or damaged during use, discard it and replace it with a new one.

Portable and mobile RF communications equipment can affect medical electrical equipment.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM radio broadcast towers and TV broadcast towers may affect accuracy.

Cautions (Continued)

Indications for Use

This equipment complies with IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment

and/or systems. This standard is 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 healthcare and other environments, it is possible that high levels of such

interference due to close proximity or strength of a source might disrupt the performance of this device. Medical

electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into

service according to the EMC information specified in this manual.

All parts and accessories connected to the USB port of this device must be certified according to at least

IEC Standard EN 60950, IEC 62368-1, or UL 1950 for data-processing equipment.

Failure of a network data coupling (USB cable/connectors) will result in loss of data transfer.

If the entire memory is filled, portions of the oldest record will be overwritten when new data is written.

Cautions (Continued)

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