LifeSense LS1-9R Operators Manual

Consult Instructions for Use

LifeSense® is a registered trademark of MedAir AB. LifeSense bears the CE marking and complies with the provisions of the Medical Device Directive 93/42/EEC. MedAir AB 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 notes, warnings and cautions. Copyright MedAir 2007. All rights reserved. Unauthorized use, copying, or distribution of this manual is prohibited without the written consent from MedAir AB. This manual reflects LifeSense version 9R (LS1-9R)

MedAir AB Stationsgatan 12 820 60 Delsbo Sweden + 46-653-717979 Fax + 46-653-717980 info@MedAir .se www.MedAir .se

References to “NONIN” in this manual shall imply NONIN Medical, Inc. NONIN® is a registered trademark of NONIN Medical, Inc.

Content Chapter 1 – General Information Introduction Indications for Use ...7 About LifeSense...7 About Capnometry ...8 About Pulse Oximetry ...8 Operator Requirements...8 Equipment Symbols and Definitions...9

Safety Messages Contraindications ...10 Warnings ...10 Cautions...11

Chapter 2 – Product Description Description of Components Monitor Front View...15 Operating Screen……………………………………………….16 Trend Page Screen ...16 Screen Icons and Display Descriptions...17 Monitor Rear View...19 Monitor Right Side View...20 Replacing Moisture Trap / Filter ...21

Chapter 3 - Installation Installation Unpacking...23 Standard Kit ...23 Stationary Use ...23 Battery Operation...24 Mounting ...24

Chapter 4 – Set-Up Pulse Oximeter Sensor Indications for Use ...25 Applying the Sensor ...25

Sample Line Indications for Use ...26 Applying the Sample Line...26

Getting started Preparations...27

Patient hook up Connect the Patient...27 Turn on the Monitor...27 Check the Alarm Limits ...28 Up and Running ...28

End of procedure Disconnect the Patient ...28

3

Chapter 5 – Settings and Alarms Settings Touch Panel Display ...29 Factory Default Settings...29

Alarm Limits Pulse Limits ...30 SpO2 Limits...30 Respiration Limits ...30 ETCO2 Limits ...30

Changing Settings Procedure ...31

Alarms Alarm Function...32 Alarm Silence...32 High Priority Alarm ...32 Low Priority Alarm...33 Disable Alarm ...34

Chapter 6 – Maintenance and Inspection Battery Battery Operation...35 Charging the Battery ...35 Checking Battery Capacity ...35 Battery Message ...35 Battery Care...36

Maintenance Ensuring Optimal Performance ...36 Moisture Trap...36 Cleaning the Sensor...36 Cleaning the Monitor ...37 Cleaning the Moisture Trap ...37

Calibration Calibration Procedure...38

Recommended Inspections Functional Check ...39 Yearly Inspection...40

Troubleshooting Fault Messages...41

Accessories List of Accessories ...44 Capnography Accessories...44 Pulse Oximeter Accessories...45 Monitor Accessories ...46

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Chapter 7 – Technical Information Environmental Requirements Working Environment ...47 Storage Environment ...47 Power Requirements...47

Specifications Power Data ...48 Battery Data...48 Physical Data ...48 Pump ...48 Operation ...48 Storage ...48 Alarms ...48 Classification per IEC 60601-1 ...48 Pulse Oximeter Specifications...49 SpO2 Accuracy Testing ...49 Capnography Specifications...50

Manufacturer’s Declaration Manufacturer’s Declaration...51

Technical Information Pulse Oximeter Response Time...54

Manufacturer Manufacturer...55

Short Form Instructions Quick step with LifeSense LS1 To start ...56 Alarm ...56 Battery ...56 When finished ...56

5

LifeSense

Chapter 1

Indications for Use & General information

CHAPTER 1 Introduction Indications for Use The LifeSense is a lightweight portable battery operated monitor that measures and displays carbon dioxide in expired air (ETCO2), respiration, functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate of adult, pediatric, and neonatal patients. It is intended for continuous, non-invasive monitoring of these parameters in hospitals, medical facilities, post-operative care, patient transport, homecare environment Emergency Medical Service (EMS) environments, and in other emergency situations where the need for an early warning system is required.

About LifeSense LifeSense offers the healthcare professional or qualified operator the ability to non-invasively monitor pulse oximetry and capnometry on either intubated or spontaneous breathing patients. This very useful combination serves as a reliable indication of the patient’s respiratory status. When measuring ETCO2 the patient is attached to the monitor by a sample line that can be an airway adapter for endotracheal tube, a nasal cannula or a nasal cannula with supplemental oxygen delivery. A variety of sample lines can be used and connected to a specially designed moisture trap which is easily snapped into the slot on the left side of the monitor. Pulse rate and SpO2 are measured by a NONIN-branded PureLight® finger clip sensor, provided with the system. It is essential to only use the accessories and replacement parts recommended by MedAir. Refer to the Accessories list in Chapter 6 for further information. LifeSense alarms both audibly and visually when predefined limits are exceeded. Limits can easily be adjusted using the touch panel display. The operator can pause or resume the alarm by activating the audible alarm pause button. LifeSense is equipped with a touch panel display where all settings and adjustments are made. The touch panel display also shows battery status and fault messages. The only actual buttons on the monitor are placed on the right hand side of the front panel and are the On/Off button and the audible alarm pause button. Next to these buttons there is a small charging indicator that will turn green as soon as the monitor is connected to the power outlet. LifeSense can 7

LifeSense

Chapter 1

Indications for Use & General information

be operated on battery for 8 hours minimum, without being plugged into a power outlet.

About Capnometry The monitor uses sidestream non-dispersive infrared (NDIR) spectroscopy to continuously measure the amount of carbon dioxide (CO2) during every breath, the amount of CO2 present at the end of exhalation (ETCO2), and respiratory rate (RR). Capnometry has been proven to be a reliable method for detecting esophageal intubation, hypoventilation and disengagement of the endotracheal tube during mechanical ventilation. CAUTION: When using sample lines that also deliver oxygen to the patient, it is important to be aware that the ETCO2 value will be diluted when used in combination with supplemental oxygen. To obtain a true ETCO2 reading it is recommended that the supplemental oxygen be disconnected for a few seconds.

About Pulse Oximetry Pulse oximetry is a non-invasive method that passes red and infrared light through perfused tissue and detects the fluctuating signals caused by arterial pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) from this color difference by measuring the ratio of absorbed red and infrared light as the volume fluctuates with each pulse.

Operator Requirements The concept of LifeSense is simplicity in combination with accurate measurements. Even though the LifeSense monitor is easy to operate it is necessary for each operator to read this manual before using the monitor. LifeSense should only be operated by healthcare professionals or qualified operators.

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LifeSense

Chapter 1

Symbols & Definitions

Equipment Symbols and Definitions This table describes the symbols that are found on the LifeSense monitor Symbol Meaning Consult Instructions for Use Type BF applied part. CE mark. Indicates that the product complies with the Medical Device Directive 93/42/EEC. Indicates separate collection for electrical and electronic equipment (WEEE). Model / article number. Serial number. Date of manufacture. IPX1

Protected against a uniform flow of water drops over the whole area of the enclosure. Per IEC 60529, clause 14.2.1.

Indicates the ON/OFF switch on the device. Audible alarm pause button. Charging indicator. When the monitor is connected to the power outlet the charge indicator will be green. This also means that the batteries are charging. DC input. Connection of battery charger.

l0l0l

Serial port for use with SleepSense Data Memory Module only

SpO2

Connection for NONIN-branded PureLight® SpO2 sensor.

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LifeSense

Chapter 1

Contraindications & Warnings

Contraindications Do not use LifeSense in an MRI environment. Do not use LifeSense during defibrillation. Do not use LifeSense in an explosive atmosphere or in the presence of flammable anaesthetics or gases.

Warnings LifeSense is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. 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 a MedAir authorized service technician before it can be used again. Accessories marked “Single-Use” must be used on one patient only and be disposed of after usage. Use only NONIN-branded PureLight® pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications of MedAir pulse oximeters. Using other manufacturers’ sensors can result in improper pulse oximeter performance. When selecting a sensor application site use an extremity without a catheter, blood pressure cuff or intravascular infusion line. Do not use a damaged Sensor. Misuse or improper handling of the pulse oximeter sensor could damage the sensor or the cable which may lead to inaccurate readings. Never alter or modify the sensor since this also may affect the performance or accuracy. If the LifeSense fails to respond as described, discontinue use and contact MedAir service technician. Use only MedAir recommended accessories and replacement parts. See the Accessories list in Chapter 6.

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LifeSense

Chapter 1

Warnings & Cautions

Warnings, continued 2

ETCO value will be diluted when used in combination with supplemental oxygen. To get a true ETCO2 reading it is recommended that the supplemental oxygen is disconnected for a few seconds Oximeter readings may be affected by the use of an electrosurgical unit (ESU). 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. To comply with relevant product safety standards, ensure that all alarm volumes are set appropriately and are audible in all situations. Do not cover or obstruct any speaker openings.

Cautions LifeSense should only be operated by healthcare professionals or qualified operators. Secure LifeSense with mounting hardware if used in an Ambulance. Do not hang LifeSense directly above the patient. If the monitor is mounted be sure to check it is secured. Dispose or recycle all waste material in accordance with your local, state, or national regulations for waste management. Always turn off the monitor prior to changing the pulse oximeter sensor or emptying /replacing the moisture trap. Portable and mobile RF communications equipment may interfere with medical electrical equipment. This equipment complies with IEC 60601-1-2:2001 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

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LifeSense

Chapter 1

specified in this manual.

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Warnings & Cautions

LifeSense

Chapter 1

Cautions

Cautions, continued Cardiogreen and other intravascular dyes may affect the accuracy of the SpO2 measurement. Fluctuating or very bright light, moisture, blood pressure cuffs, infusion lines, venous pulsations, insufficient pulse signals, anemia, arterial catheters, nail polish, and/or artificial nails may degrade the Spo2 device’s performance. Do not cover or block speaker opening; this may significantly reduce the sound volume. Adjust or set alarm parameters one at a time, not simultaneously. Significant levels of dysfunctional hemoglobin may affect SpO2 measurement accuracy. Ear Clip and Reflectance sensors are not recommended for pediatric or neonatal use. The accuracy of these sensors has not been established for pediatric or neonatal use. Always store and ship the device in its case to avoid accidental damage. Inspect the pulse oximeter sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors and/or double-backed adhesive strips may vary due to medical status or skin condition. Before each use, it is the operator’s responsibility to verify that the alarm limits are appropriate for the patient being monitored. Always clean the NONIN PureLight® reusable finger clip sensor after each patient use. Before cleaning the sensor, unplug it from the monitor. Always clean the reusable moisture trap after each patient use. Before cleaning the moisture trap, unplug it from the monitor. The patient’s nasal passage may dry out if continuous monitoring is required. Check patient hourly for nasal comfort. If the ETCO2 value is out of the normal range (4.7-6.0 Vol%/KPa or 35-45 mmHG) an internal air leak is possible. Replace the moisture trap and repeat the calibration procedure. If the problem persists contact MedAir service technician. If LifeSense is intended to be stored for longer periods of time always charge the battery to full capacity before storing it in order to prevent

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LifeSense

Chapter 1

Cautions

damage to the equipment.

Cautions, continued Avoid rapid temperature change or extreme temperatures. This can cause malfunction. Never store or transport LifeSense where condensation can occur. However if this has occurred, wait until all condensation has evaporated before using LifeSense. Prior to connecting LifeSense to the battery charger and the power outlet, be sure to verify the voltage and frequency rating on the battery charger are compatible with the outlet. If this is not the case, do not connect the monitor and battery charger to the outlet. Do not attempt to replace the battery inside the monitor. The battery is hard wired to the circuit board and cannot be replaced by the operator. Contact MedAir service technician when the battery needs replacing. Expected lifetime for the battery is 1 year. Do not operate LifeSense while charging a depleted battery. This may cause permanent damage to the monitor. Charge the battery prior to operating the monitor. The moisture trap filters are “Single-Use disposable components”. Do not sterilize or autoclave the monitor or sensors. Do not immerse in liquids. Do not disassemble the plastic parts of the moisture trap. Never open the monitor housing/case. By opening the case you render your warranty invalid. The oximeter sensor might not work on cold extremities due to reduced circulation. Warm or rub the finger to increase circulation, or reposition the sensor. Do not reuse the moisture trap if it is obstructed. 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 MedAir for your distributor’s contact information.

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LifeSense

Chapter 1

15

Cautions

LifeSense

Chapter 2

Description of Components

Chapter 2 Description of Components A standard LifeSense set-up consists of a monitor, moisture trap with filters, NONIN-branded PureLight® finger clip sensor (8000AA), nasal cannula (Ref 4000), and battery charger (A41208G 230v). It is shipped in a specially designed case. See the Accessories list in Chapter 6 for information on optional accessories.

Monitor Front View All operator settings are made using the touch panel display on the monitor. The components and functions used and displayed on the front panel of the monitor are shown in the figures below. Names and descriptions of each component are listed in the table below.

1) Start-up Screens

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LifeSense

Chapter 2

No

1

2

Name Audible Alarm 1 silence Icon

2

5 3

3

Description of Components

4 4

5 5

17

Description Icon for selecting alarms off (disables audible alarms by setting all lower limits to 0) Icon for selecting alarms Alarms on on. Default if no icon is Icon chosen. Icon for selecting default alarm limits for patients weighing ≤ 30kg. Only ≤ 30kg Icon available if alarms on icon is chosen on previous screen. Icon for selecting default alarm limits for patients > 30kg weighing >30kg. Only Icon available if alarms on icon is chosen on previous screen. Shows LifeSense version. If error occurs LifeSense during start-up, an error version number will be shown here and the monitor will alarm.

LifeSense

Chapter 2

Description of Components

2) Operating Screen 4 1

2

5

6

3

7

9

8

10

11

12

13

14

15

17

16 18

3) Trend Page Screen

19 25 20 21 22

23

24

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LifeSense

Chapter 2

Description of Components

Screen Icons and Display Descriptions No 1.

2.

3.

4.

5.

6.

Name

Description

LCD Display

The LCD monitor displays parameters, graphs, menus and other information. It also functions as a touch panel from which all the operator defined settings are made.

Limit Settings

The upper figures represent the highest value set by the operator. The lower figures represent the lowest value set. When the parameter is within the range of low and high setting they are treated as normal values. Values exceeding these limits activate alarm function, which is both audible and visual. The exceeded limit is also displayed as inverted blue and white figures if the alarm is silenced.

Up/Down Bar

Control buttons for increasing or decreasing an alarm limit.

The charge indicator is green whenever the battery charger is connected between the power outlet and LifeSense. This also indicates that the battery is Charge Indicator charging. When there is no outlet power connected the indicator will remain off.

Audible Alarm Pause Button

Audible alarm function alerts the operator when preset limits are exceeded. The operator can temporarily disable the audible alarm by pushing the audible alarm pause button. Alarms are still indicated visually on the display when limits are exceeded, and on the status texts. If the alarm is paused it will remain inactive for approximately 2 minutes before it will reactivate again. The current alarm status is indicated visually on the LCD (See No 13; Alarm symbols in this table). This button turns the monitor ON or OFF. This button will also enable or disable the audible pulse beep function by depressing the ON/OFF button briefly.

Note: depressing this button > 1 second will turn the monitor off. When enabled the audible pulse beep ON/OFF Button (tone) increases as the SpO2 rate increases or decreases as the SpO2 rate decreases. The default setting is OFF

7.

HR

Displays the pulse rate as beats per minute. The pulse rate is updated on the display each second.

8.

SpO2

Displays oxygen saturation (% SpO2) The SpO2 value is updated on the display every 1.5 seconds.

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LifeSense

Chapter 2

20

Description of Components

LifeSense

Chapter 2

Description of Components

No

Name

Description

9.

ETCO2

Displays the volume of end tidal CO2 in expired air. ETCO2 is shown as mmHg or kPa. The value is updated after each breath without averaging.

10.

RR

Displays the respiratory rate in breaths per minute. The value is the mean of four breaths.

11.

Status Text

Shows alarm messages for the pulse oximeter and battery. See alarms under Chapter 5 for more information.

12.

Status Text

Shows alarm messages for the capnometer. See alarms under Chapter 5 for more information.

13.

Space for alarm symbols. No symbol means audible alarms are active. A bell with a cross of broken lines indicates that audible alarm is paused. A bell with a cross of solid lines indicates that audible alarm is disabled.

14.

Push the icon for displaying a trend page. The trend page will remain visible until the operator touches the screen.

Alarm Symbols

Trend Icon

15.

Displays a graph giving information on the oximetry Pulse Oximetry signal (plethysmograph). The signal displays 25 Plethysmograph samples per second.

16.

Plethysmograph Displays a scale factor for the plethysmogram. Scale Scale Factor factor can be either /1, /2, /4 or /8

17.

Respiration Graph

18.

Battery Indicator

19.

Trend HR

Displays a trend graph of the pulse rate.

20.

Trend SpO2

Displays a trend graph of the SpO2 values.

21.

Trend RR

Displays a trend graph of the respiration rate.

22.

Trend ETCO2

Displays a trend graph of the ETCO2 values.

23.

Trend Cursor

A trend cursor points out where the actual sample is in the time interval.

24.

Trend Time Scale

Timescale is presented in half hour segments.

Trend Time

The total trend time is approximately 4 hours of volatile internal memory. Real time data can be collected using the SleepSense memory module for download to a PC.

25.

Displays a graph of the CO2 in expired air (capnograph). Displays the battery status. See Chapter 6 for more information.

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