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Nonin RespSense II LS1R, Operator'S Manual, Page: 11 / 64

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Nonin RespSense II LS1R Operator'S Manual Download Page 11

5

Guide to Symbols

Guide to Symbols

This chapter describes the symbols that are found on the system components and packaging. 

Table 1. Symbols

Symbol

Description/Function

CAUTION!

Follow Instructions for Use.

CE Marking indicating conformance to EC Directive No. 93/42/EEC 
concerning medical devices.

Authorized representative in the European Community.

Indicates separate collection for electrical and electronic equipment 
(WEEE).

Class II, double insulated

Type BF-Applied Part

IP22

Protected against vertically falling water drops when enclosure is tilted up to 
15 degrees and against access to hazardous parts with a finger per 
IEC 60529.

Green charging indicator (LED)

On/Standby button

Audio Pause button

Power supply input

USB port

Luer lock connector for sample line, Nafion tubing, or cannula

Do not reuse (moisture trap)

Medical prescription required

Manufacturer

Catalogue number

Serial number

Quantity

!

0123

0123 

EC

REP

 

REF

SN

QTY

QTY

Summary of Contents for RespSense II LS1R

Page 1: ...Operator s Manual RespSense II Model LS1R Capnography Monitor 0123 0123 English...

Page 2: ...E mail info nonin com 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 infointl nonin com nonin com MPS Medical Product Servic...

Page 3: ...isture 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...

Page 4: ...d 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 Maintena...

Page 5: ...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 Lo...

Page 6: ...s 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...

Page 7: ...nitored 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...

Page 8: ...g 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...

Page 9: ...ower 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...

Page 10: ...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...

Page 11: ...e collection for electrical and electronic equipment WEEE Class II double insulated Type BF Applied Part IP22 Protected against vertically falling water drops when enclosure is tilted up to 15 degrees...

Page 12: ...6 Guide to Symbols Temperature limitation for storage shipping RoHS compliant China Date of manufacture Country of manufacture Table 1 Symbols Continued Symbol Description Function US US...

Page 13: ...corner of the front panel Next to these buttons there is a small indicator that turns green when the monitor is connected to a power outlet The monitor operates on a fully charged battery for approxim...

Page 14: ...uration includes these non sterile components RespSense II monitor Power supply and plug Single use disposable moisture trap with filter Single use disposable filters qty 3 Adult nasal cannula qty 3 S...

Page 15: ...II Monitor Figure 1 Monitor Features 12 VDC 1 5A 12 VDC 1 5A REF S N 9827 001 04 Nonin Medical Inc Plymouth MN USA MEDICAL EQUIPMENT 0123 0123 Use with Nonin Power Adapters IP22 MASS 865g 5 Front Side...

Page 16: ...rging indicator is lit whenever the device is plugged in Batteries are charged whenever the device is plugged in See Shut Down Modes for information about Standby and Deep Sleep modes 4 Audio Pause Bu...

Page 17: ...monitor to an outlet whenever it is not in use Recharging a fully depleted battery takes approximately 9 hours when using a Nonin specified power supply 9 Speaker WARNING Ensure that all alarm volumes...

Page 18: ...Sample Line 1 Insert the cannula into the patient s nostrils 2 Place the tubing behind each ear 3 Connect the Luer lock fitting to the moisture trap and twist to tighten CAUTION Do not attempt to rep...

Page 19: ...within easy reach When the moisture trap is removed guide marks numbered 1 and 2 and arrows are visible on the back of the monitor These guide marks help the operator insert the moisture trap Replaci...

Page 20: ...monitor 4 To remove the moisture trap and replace the filter use the tab to pull the moisture trap away from the monitor Remove the filter from the moisture trap If the filter is not in the moisture t...

Page 21: ...tor has locked alarm limits see Alarm Lock Mode Screen section The select alarm group screen figure 3 displays after the start up screen On this screen the operator may select alarm limits for a patie...

Page 22: ...Settings are set the alarm limits may be restricted by the Responsible Organization alarm limits 2 Alarm Limits 30kg 66lbs Pressing this icon selects the default alarm limits for patients weighing mor...

Page 23: ...iption 1 Alarm Limits The high alarm limit is always located above the displayed value and the low alarm limit is always located below the displayed value When the parameter readings fall between the...

Page 24: ...centage of battery life remaining Full Partial Battery indicator is green Low Battery indicator flashes yellow Critical Battery indicator flashes red Charging Battery indicator displays a lightning bo...

Page 25: ...e audible alarm volume The minimum alarm value is set on the Responsible Organization Settings screen To set the volume to Off the operator must press OK in the Audible Alarms Off pop up window The au...

Page 26: ...the above items occur on initialization If any do not occur contact Nonin Technical Service for assistance If the clock is not set the message System Time is Not Set displays above the software revis...

Page 27: ...itor After attaching the mounting bracket to the monitor securely clamp the monitor to the pole System Setup 1 Place the monitor in a position so the display can be clearly seen If using the monitor p...

Page 28: ...nction activates approximately 2 minutes after start up The operator can activate the audible alarm before the 2 minutes are up by pressing the Audio Pause button 9 The monitor is ready to use The pat...

Page 29: ...ower right corner of the operating screen press the audible alarm volume icon 2 With each press of the icon the audible alarm volume changes from off to medium to maximum if allowed by the Responsible...

Page 30: ...te the device Access the Configuration Menu 1 Press On Standby to turn the monitor on 2 Start up sequence begins 3 When the Nonin logo start up screen displays press the Nonin logo twice double tap In...

Page 31: ...the factory defaults 1 On the Configuration Menu press Language Units Language Units screen figure 8 displays 2 Press desired language A check mark displays to the left of the selection 3 Press desire...

Page 32: ...y the organization Once a PIN is saved the alarm limits become restricted to the high and low limits on the Responsible Organization Settings screen 1 On the Configuration Menu press Responsible Organ...

Page 33: ...g Default Alarm Volume The default alarm volume is Maximum Set the Default Alarm Volume 1 Access the Responsible Organizations Settings screen 2 In the Default Alarm Volume field press one of the volu...

Page 34: ...cel New PIN NOTE The operator is required to enter a new 4 digit PIN the first time the Responsible Organization Settings screen is accessed or after restoring factory defaults The PIN which may be se...

Page 35: ...Time Date Time screen figure 10 displays 2 To select a field press the up or down arrow for that field The field highlights 3 Tap the up arrow to increase the value tap the down arrow to decrease the...

Page 36: ...n is accessed through the Configuration Menu see Access the Configuration Menu 1 On the Configuration Menu press Alarm Lock Mode Alarm Lock Mode screen figure 11 displays 2 To lock the alarm limits pr...

Page 37: ...concerning waste materials 1 Attach a calibration apparatus to the moisture trap 2 Press On Standby to turn on the monitor 3 Access the Configuration Menu 4 Press Calibration Calibration screen figure...

Page 38: ...times d Verify the EtCO2 reading on the display A reading of 33 43 mmHg 4 4 5 7 kPa is considered normal This should agree with the device accuracy claims found in the Capnography Specifications sect...

Page 39: ...default settings or the last used alarm limits All parameters have built in limits that cannot be exceeded CAUTION Set or adjust only one parameter at a time Table 5 Alarm Limit Settings Alarm Limit A...

Page 40: ...can render the alarm system useless CAUTION The monitor is equipped with automatic barometric pressure compensation End tidal pCO2 values displayed are calculated based on an atmospheric pressure of...

Page 41: ...Pause button temporarily silences audible alarms for 2 minutes The operator can reactivate the audible alarm before the 2 minutes are up by pressing the button again The intended operator s position...

Page 42: ...m limit RR high limit flashes red 2 times per second RR Low Limit displays when respiration rate is below the low alarm limit RR low limit flashes red 2 times per second No breath is detected for appr...

Page 43: ...99 040 Europe Low Priority Alarms Low priority alarms do not have an audible alarm Table 8 Inoperable Alarms Message Error Code Probable Cause NO CAPNO E04 No communication from capnography unit SPEAK...

Page 44: ...like an endless loop tape When the memory is full the monitor begins overwriting the oldest data with new data Download Patient Data USB Drive Requirements Formatted with FAT32 file system Compatible...

Page 45: ...the operating screen 4 Once the data download is complete the Download Memory Complete pop up window displays See Clear Memory If the USB drive is disconnecting during the download the USB Drive Failu...

Page 46: ...nt readings alarm limits and volume and _cw capnography waveform data The _pt file contains placeholder values and is not used with RespSense II NOTE The patient data and capnography waveform data fil...

Page 47: ...re including the latest monitor software revision Bit Capno_Status Description Bit Sys_Status Description 23 Reserved 7 Alarm Silence 22 Reserved 6 Low Batt 21 Reserved 5 Reserved 20 Reserved 4 Reserv...

Page 48: ...he system configuration Adding devices to or disconnecting devices from the system Updating or upgrading equipment connected to the system Issues resulting from user initiated system changes may inclu...

Page 49: ...the monitor should be verified using 5 CO2 gas The calibration apparatus gas valve and 5 CO2 verification gas are available from Nonin see Accessories Please contact Nonin Technical Service if monitor...

Page 50: ...uations for all parameters 9 Visually verify the zero point of the CO2 graph is not elevated CAUTION After exposing the monitor to an environment outside of normal room temperature humidity conditions...

Page 51: ...d into the moisture trap Moisture trap is not properly seated in the monitor Verify the moisture trap and filter are properly inserted in the monitor by creating an occlusion 1 Using a finger cover th...

Page 52: ...sage area The patient has stopped breathing for 30 seconds or longer Check the patient Sample line is not properly applied to the patient Verify sample line placement Sample line or Nafion tubing is n...

Page 53: ...line connector and visually inspect the sample line for signs of damage Check Nafion tubing connection If the problem persists contact Nonin Technical Service An error code appears in the display area...

Page 54: ...ss icon If the brightness does not change contact Nonin Technical Service Incompatible USB or USB Device Failure error displays USB flash drive is full Delete unnecessary data from the flash drive or...

Page 55: ...uzer Glide 8 GB USB flash drive SanDisk P N SDCZ60 008G A46 Capno Report Converter Patient data management software for LifeSense II and RespSense II Monitor Mounting Bracket Connector that enables ad...

Page 56: ...Valve for Verification Gas Reusable gas valve and tubing for controlling the flow from the verification gas Calibration Apparatus Used for 0 point calibration Moisture Trap with Filter 10 packages ea...

Page 57: ...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 h...

Page 58: ...AUTION 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 CAUTION Por...

Page 59: ...e that it is used in such an environment RF Emissions CISPR 11 Group 1 This device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any...

Page 60: ...V for common mode 1 kV differential mode 2 kV for common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations...

Page 61: ...be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 Professional Transport 20 V...

Page 62: ...ce According to Frequency of Transmitter Rated Maximum Output Power of Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 7 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7...

Page 63: ...nded use 10 minutes to warm from 40 C to ambient temperature of 20 C 19 minutes to cool from 70 C to ambient temperature of 20 C Applied part temperature will not exceed 41 C as measured during a cont...

Page 64: ...EtCO2 CO2 reading reaches its steady state accuracy within 10 minutes after power up From maximum storage temperature monitor reaches steady state accuracy 19 minutes after power up Calculated Update...

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