LifeSense LS1-9R Operators Manual 2007

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

Consult Instructions for Use

LifeSense® is a registered trademark of MedAir 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. Unauthorized use, copying, or distribution of this manual is prohibited without written consent from NONIN Medical, Inc.

NONIN Medical, Inc 13700 1st Avenue North Plymouth, MN 55441-5443 USA +1 (763) 553-9968 (800) 356-8874 (USA and Canada) Fax +1 (763) 553-7807 [email protected] www.NONIN.com

References to “NONIN” in this manual shall imply NONIN Medical, Inc. NONIN, Flexi-Form, FlexiWrap and PureLight are registered trademarks of NONIN Medical, Inc. TrendSense is a Nonin trademark.

© 2007 NONIN Medical, Inc. 5843-001-01

i

Content Chapter 1 – General Information Introduction Indications for Use, Contraindications, Warnings...1 Warnings ...2 Cautions ...3 Equipment Symbols ...6

General information About LifeSense...7

Chapter 2 – Description of Components Description of Components Monitor Front View ...9 Starty-Up Screen...9 Operating Screen ...10 Trend Page Screen ...10 Screen Icon and Display Descriptions ...11 Monitor Rear View...13 Monitor Right Side View...14 Replacing Single-Use Disposable Moisture Trap / Filter ...15

Chapter 3 – Installation Installation Unpacking ...16 Standard Kit ...16 Stationary Use...16 Battery Operation ...17 Mounting ...17

Chapter 4 – Set-Up Pulse Oximeter Sensor Intended Use...18 Applying the Sensor ...18

Sample Line Intended Use...19 Applying the Sample Line ...19

Getting started Preparations...20

Patient hook up Connect the Patient...20 Turn on the Monitor...20 Check the Alarm Limits ...20 Up and Running ...21

End of procedure Disconnect the Patient ...21

ii

Chapter 5 – Settings and Alarms Settings Touch Panel Display ...22 Factory Default Settings...22

Alarm Limits Pulse Limits...23 SpO2 Limits ...23 Respiration Limits...23 ETCO2 Limits...23

Changing Settings Procedure...24

Alarms Alarm Function ...25 Alarm Silence ...25 High Priority Alarm ...25 Low Priority Alarm ...26 Disable Alarm...26

Chapter 6 – Maintenance and Inspection Battery Battery Operation ...27 Charging the Battery ...27 Checking Battery Capacity...27 Battery Message ...27 Battery Care ...27

Maintenance Ensuring Optimal Performance...28 Single-Use, Disposable Moisture Trap ...28 Cleaning the Sensor ...28 Cleaning the Monitor ...28

Calibration Calibration Procedure ...29

Recommended Inspections Functional Check ...30 Yearly Inspection...31

Troubleshooting Fault Messages...32

Accessories List of Accessories ...34 Capnography Accessories ...34 Pulse Oximeter Accessories ...35 Monitor Accessories...36

iii

Chapter 7 – Environmental Requirements Environmental Requirements Working Environment...37 Storage Environment ...37 Power Requirements ...37

System Specifications Power Data ...38 Battery Data ...38 Physical Data ...38 Operation ...38 Storage...38 Pump ...38 Alarms ...38 Classification ...38 Pulse Oximeter Specifications ...39 SpO2 Accuracy Testing ...39 Capnography Specifications ...40

Manufacturer’s Declaration Manufacturer’s Declaration ...41

Pulse Oximeter Response Time Pulse Oximeter Response Time ...44

Service, Support, Warranty Service, Support, Warranty...45

Quick step with LifeSense LS1-9R To start ...46 Alarm ...46 Battery ...46 When finished ...46

iv

LifeSense

Chapter 1

Indications for Use Contraindications / Warnings

CHAPTER 1 Indications for Use The LifeSense® Model LS1-9R Capnography/Pulse Oximeter monitor indicated for use in simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (ETC02), respiration and pulse rate of well or poorly perfused 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. hospitals, medical facilities, post-operative care, patient transport, home-use, or any emergency medical services and environments.

Safety Messages Contraindications Do not use LifeSense in an MR 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. LifeSense is not intended to be used as a primary diagnostic apnea monitor. 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 NONIN Technical Service. 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 NONIN pulse oximeters. Using other manufacturers’ sensors can result in improper pulse oximeter performance. Only use battery chargers that either are supplied with LifeSense or specified by NONIN. See the Accessories List in Chapter 6. 1

LifeSense

Chapter 1

Warnings

Warnings, continued 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 may affect the performance or accuracy. If the LifeSense fails to respond as described, discontinue use and contact NONIN Technical Service. Use only NONIN recommended accessories and replacement parts. See the Accessories List in Chapter 6. LifeSense displays a LOW BATTERY message when it has approximately 20 minutes of use remaining before it shuts itself off. ETCO2 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. Prior to connecting LifeSense to the battery charger and the power outlet be sure to check that the voltage and frequency rating on the battery charger are the same as the power outlet. If this is not the case, do not connect the monitor and battery charger to the power outlet. 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.

2

LifeSense

Chapter 1

Cautions

Cautions LifeSense should only be operated by trained licenced practitioners. Secure LifeSense with mounting hardware if used in transport vehicles. Do not mount LifeSense directly above the patient. If the monitor is mounted be sure to check it is secured. Always turn off the monitor prior to cleaning the monitor or changing the pulse oximeter sensor or moisture trap and/or filter. Portable and mobile RF communications equipment may interfere with medical electrical equipment. Do not reuse the moisture trap. Do not disassemble the plastic parts of the single-use, disposable moisture trap. Ear Clip and Reflectance SpO2 sensors are not recommended for pediatric or infant / neonatal use. The accuracy of these sensors has not been established for pediatric or infant / neonatal use. 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 specified in this manual. Set or adjust alarm parameters one at a time, not simultaneously. Do not cover or block speaker opening; this may significantly reduce the sound volume. 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.

3

LifeSense

Chapter 1

Cautions

Cautions 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, remove 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 normal range (4.7-6.0 Vol%/KPa or 35-45 mmHG) an internal air leak is possible. Replace the single-use disposable moisture trap and repeat the calibration procedure. If the problem persists contact NONIN Technical Service. 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 damage to the equipment. Avoid rapid temperature change or extreme temperatures. This can cause malfunction. 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 NONIN Technical Service when the battery needs replacing. 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 sample line, moisture trap and filters are “Single-Use Disposable components”. Dispose all components in accordance with your local, state, or national regulations regarding waste management. Do not sterilize or autoclave the monitor or sensors. Do not immerse in liquids. Do not disassemble the plastic parts of the Single-Use, Disposable moisture trap. Never open the monitor housing/case. By opening the case you render your warranty invalid. 4

LifeSense

Chapter 1

Cautions

Cautions, continued 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. 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. Significant levels of dysfunctional hemoglobin may affect SpO2 measurement accuracy. 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. Cardiogreen and other intravascular dyes may affect the accuracy of the SpO2 measurement. The presence of ambient light may affect the accuracy of the pulse oximeter sensor. Each time the system is turned on, a breath must be detected to activate the no-breath alarm. A functional tester cannot be used to assess the accuracy of a pulse oximeter module or sensor.

5

LifeSense

Chapter 1

Equipment Symbols

Equipment Symbols This table describes the symbols that are found on the LifeSense monitor. Symbol Meaning Consult Instructions for Use Type BF applied part. 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. UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1. 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 TrendSense data memory module only.

SpO2

Connection for NONIN-branded PureLight® SpO2 sensor. 6

LifeSense

Chapter 1

General Information

About LifeSense LifeSense offers the healthcare professional 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 single-use disposable 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 NONIN. 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 be operated on battery for approximately 8 hours, 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.

7

LifeSense

Chapter 1

General Information

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 licenced practitioners.

8

LifeSense

Chapter 2

Description of Components

Chapter 2 Description of Components A standard LifeSense set-up consists of a monitor, single-use, disposable moisture trap with filters, NONIN-branded PureLight® finger clip sensor (8000AA), nasal cannula (Ref 5814-001), and battery charger (5783-000). 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 No

1 2

1.

2.

5

3

3.

4

5

4.

5.

9

Name Description Audible Icon for selecting alarms off Alarm (disables audible alarms by silence Icon setting all lower limits to 0) Alarms on Icon

Icon for selecting alarms on. Default if no icon is chosen.

≤ 30kg or ≤ 66 lbs. Icon

Icon for selecting default alarm limits for patients weighing ≤ 30kg or ≤ 66 lbs. Only available if alarms on icon is chosen on previous screen.

> 30kg or >66lbs. Icon

Icon for selecting default alarm limits for patients weighing >30kg or >66lbs. Only available if alarms on icon is chosen on previous screen.

LifeSense version

Shows LifeSense version. If error occurs during startup, an error number will be shown here and the monitor will alarm.

LifeSense

Chapter 2

Description of Components

2) Operating Screen 3 1

2

4

5

6 9

7 10

11 8

12 14

13 15

17

16 18

3) Trend Page Screen

19

25

20 21 22

23 24

10

LifeSense

Chapter 2

Description of Components

Screen Icons and Display Descriptions No

Name

1.

LCD Display

2.

3.

4.

5.

Limit Settings

Up/Down Bar

Charge Indicator

Audible Alarm Pause Button

Description 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. 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. 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 charging. When there is no outlet power connected the indicator will remain off. 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.

6. ON/OFF Button

Note: depressing this button > 1 second will turn the monitor off. When enabled the audible pulse beep (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 percent (%) oxygen saturation (% SpO2). The SpO2 value is updated on the display every 1.5 seconds. 11

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.

Alarm Symbols 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.

Trend Icon

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

15.

Pulse Oximetry Plethysmograph

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

16.

Plethysmograph Scale Factor

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

17.

Respiration Graph

Displays a graph of the CO2 in expired air (capnograph).

18.

Battery Indicator

Displays the battery status. See Chapter 6 for more information.

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

25.

Trend Time

Timescale is presented in half hour segments. The total trend time is approximately 4 hours of volatile internal memory. Real time data can be collected using the TrendSense memory module for download to a PC. 12

LifeSense

Chapter 2

Description of Components

Monitor Rear View The moisture trap, filter and equipment label are located on the rear side of LifeSense. The items on the rear side of the monitor are shown in the figure below. Names and descriptions of each component are listed in the table below. 3

2 1

4

No Name

1.

Single-use, Disposable Moisture Trap and Filter

Description The moisture trap located on the back of the monitor, clicks into position as illustrated above. Numbers 1 and 2 act as guide marks. 1.) Slide the moisture trap into position. 2.) Push it down. Push tab out to remove. The moisture trap and filter are single-use, disposable components and should be replaced after each patient use. The filter fits into the moisture trap and protects the monitor from moisture.

2.

Attachment Holes

Dedicated holes for attachment of a mounting bracket. See the Accessories List in Chapter 6 for part number if a mounting fitting is required. 2 mm screws can be used if there is a need to attach the monitor in a fixed position.

3.

Luer Lock

Luer lock connector for attaching sample line.

Equipment Label

The label contains model number, serial number, manufacturing date, manufacturer, UL-mark, “Read operator’s manual” symbol and the Applied Part symbol. Every LifeSense device has a unique serial number for identification. See Chapter 1, Equipment Symbols for description of the different symbols.

4.

13

LifeSense

Chapter 2

Description of Components

Monitor Right Side View Outputs and connections are located on the right hand side of the monitor as shown in the figure below. Detailed specification of connections is listed in Chapter 7, “Specification”. Names and descriptions of each component are listed in the table below.

1 2 3

No

Name

Description For patient data transfer from LifeSense to a PC.

1.

TrendSense Serial NOTE: Use only TrendSense with LifeSense Interface Output Capnography/Pulse Oximeter Systems.

2.

Power Inlet

Power inlet for the battery charger that is connected to the power outlet. Only use NONIN specified chargers.

SpO2 Connector

PureLight® pulse oximeter sensor connection for measuring oxygen saturation. Pulse oximeter sensors to be used with the device are specified under “Accessories” in Chapter 6. No other sensors may be used.

3.

WARNING

Use only NONIN-branded PureLight® pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications of NONIN pulse oximeters. Using other manufacturers’ sensors can result in improper pulse oximeter performance. 14

LifeSense

Chapter 2

Description of Components

Replacing the Single-Use, Disposable Moisture Trap and Filter Caution: The moisture trap and filters are Single-use, disposable components and a new one must be used for each patient and be disposed of after use. Caution: Do not reuse the moisture trap. Do not disassemble the plastic parts of the single-use, disposable moisture trap.

• Place the filter in the moisture trap as shown in arrow 1. • Connect the moisture trap into position as shown by arrow 2. • Then press the moisture trap into position, by pushing the tab, as shown by arrow 3. • To remove the moisture trap and replace the filter, reverse the three steps as described above.

1

2

3

15