Infinium CLEO User Manual

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CLEO Patient Monitor

USER’S MANUAL

Issued Date: November 20, 2014

User’s manual of CLEO Patient M onitor

Infinium Medical Inc.

Website: www.infiniummedical.com Address: 12151 62nd St North #5

Largo Fl, 33773 USA Toll Free (US call only): 866-918-8434 International: 1-727-531-8434 Fax: 1-727-531-8436

To obt ain infor mation abo ut a warrant y, if any, for this product, cont act Infini um Medica l Inc, Technical Services or your loca l I nf in ium Medical, Inc. representative.

Nellcor is a trademark of NE LLCOR OXIMAX

User’s manual of CLEO Patient M onitor

CONTENTS

SAFETY I NFORMATION ..................................................................................................... 4

INTRODUCTION ................................................................................................................. 7

INTENDED USE ...................................................................................................................... 7

ABOUT THI S MANUAL ......................................................................................................... 7

CONTROLS, INDICATORS, AND SYMBOLS ..................................................................... 8

FRONT AND SIDE PANEL ..................................................................................................... 8

REAR P ANEL .......................................................................................................................... 9

SYMBOLS .............................................................................................................................. 10

DISPLAY SCREEN PARTITION ........................................................................................ 11

SINGLE SPO2 DI S PL AY ....................................................................................................... 12

SINGLE ETC O2 DI S PL AY .................................................................................................... 12

SPO2+ETCO2 DISPLAY ....................................................................................................... 13

SPO2+NBP DISPLAY ............................................................................................................ 13

SPO2 +NBP+ETCO2 DISPLAY ............................................................................................ 14

SPO2+NBP DISPLAY ............................................................................................................ 14

SYSTEM SETUP ............................................................................................................... 15

FACTORY SEVICING SETUP .............................................................................................. 15

SOUND VOLUME ................................................................................................................. 16

ALARM SWITCH .................................................................................................................. 16

MODULE SELECT ................................................................................................................ 16

DEFAULT CONFIG ............................................................................................................... 16

SAVE CONFIG ....................................................................................................................... 16

HOW TO MONITOR .......................................................................................................... 17

ALARM & SOU ND ............................................................................................................. 18

ALARM .................................................................................................................................. 18

SOUND ................................................................................................................................... 19

SPO2 MONITORING ......................................................................................................... 20

SPO2 MONITORING PRINCIPLE ........................................................................................ 20

SPO2 SENSOR INSTALLLATION ....................................................................................... 20

SPO2 WAVEFORM SETUP ................................................................................................... 20

SPO2 P ARAMETER SETUP ................................................................................................. 21

MEASUREMENT LIMITATIONS ........................................................................................ 22

SPO2 ERROR MESSAGES ................................................................................................... 22

NELLCOR INFORMATION .................................................................................................. 24

NIBP MO NITORI NG .......................................................................................................... 25

SUMMARY ON NIBP MO NI TORING ................................................................................. 25

NIBP CUFF FITTING ............................................................................................................ 25

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User’s manual of CLEO Patient M onitor

NIBP MONITORING INITIALIZATION .............................................................................. 26

NIBP PARAMETER SETUP .................................................................................................. 26

NIBP LIST OBSERVATION................................................................................................... 28

MEASUREMENT LIMITATIONS ........................................................................................ 29

NIBP ERROR MESSAGES .................................................................................................... 30

MAINT AI NENCE AND CLEANING .................................................................................... 30

ETCO2 MONITORI NG....................................................................................................... 31

THEORY OF OPERATION .................................................................................................... 31

W ARNINGS, CAUTIONS AND NOTES .............................................................................. 31

ABBREVIATIONS AND TERMINOL OGY ......................................................................... 32

ZEROING THE CO2 MODULE ............................................................................................ 32

P ATIENT AND TUBING PREP ARATION ............................................................................ 33

ETCO2 WAVEF ORM SETU P ................................................................................................ 34

ETCO2 PARAMETER SETUP .............................................................................................. 35

ADVANCED SETUP .............................................................................................................. 36

CALIBRATION ...................................................................................................................... 37

STATUS/ERROR MESSAGES .............................................................................................. 38

MAINTENANCE AND CLEANING ..................................................................................... 38

RECALL DATA ................................................................................................................... 39

PATIENT BASIC INFORMATION SETUP ........................................................................... 39

CLOCK SETUP ...................................................................................................................... 40

HOW T O RECAL L ................................................................................................................ 40

BATTERY OPERATION ..................................................................................................... 43

BATTERY R EC Y CLE ............................................................................................................ 43

DISPOSAL OF DEVICE COMPONENTS ......................................................................... 44

CLEANING ......................................................................................................................... 45

PERIODIC SAFETY CHECKS .......................................................................................... 45

SPECIFICATIONS ............................................................................................................. 46

EMC ................................................................................................................................... 49

ELECTROMAGNETIC IMMUNITY .................................................................................... 49

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User’s manual of CLEO Patient M onitor

FIGURES

Figure 1: Front and Side Panel .................................................................................... 8

Figure 2: Rear View for Main Unit ................................................................................ 9

Figure 3: Single SpO Figure 4: Single EtCO Figure 5: SpO Figure 6: SpO Figure 7: SpO

and EtCO2 Display Screen ................................................................ 13

and NBP Display Screen ................................................................... 13

, EtCO2 and NBP Display Scre en ...................................................... 14

Display Screen ....................................................................... 12

Display Screen ..................................................................... 12

Figure 9: Tree Diagram for System Setup Menu ....................................................... 15

Figure 10: Window for Ether net I P Address Setup .................................................... 15

Figure 1 1: T ree Diagram for Pleth Menu .................................................................... 20

Figure 12: Tree Diagram for SpO

Setup Menu ......................................................... 21

Figure 13: Tree Diagram for NIBP Setup Menu ......................................................... 26

Figure 14: Window for NIBP List Observation ............................................................ 29

Figure 15: Temperature Site and Patient Age ............. Error! Bookmark not defined.

Figure 17: Tree Diagram for EtCO Figure 18: Tree Diagram for EtCO Figure 19: Tree Diagram for EtCO

Wavefor m Set up Menu ..................................... 35

Parameter Setup Menu ..................................... 35

Advanced Setup ................................................ 37

Figure 20: Tree Diagram for Patient Setup ................................................................ 39

Figure 21: Tree Diagram for Clock Setup ................................................................... 40

Figure 22: User Choose and M odule Choose ............................................................ 40

Figure 23: Tabular T r end for S pO Figure 24: Tabular T r end for EtCO

............................................................................. 41

........................................................................... 41

Figure 25: Tabular T r end for NBP ............................................................................... 42

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User’s manual of CLEO Patient M onitor

[WARNING]: CLEO Patient Monitor should not be used as a n apnea monitor.

[WARNING]: MRI Unsafe – DO NOT use in MRI environments.

[WARNING]: CLEO Patient Monitor may not operate effectively on patients who are

experiencing convulsions or tremors.

[WARNING]: D O NOT lift the monitor by the sensor cable, blood pressure hose, or power cord because the cable, lead, or cord could disconnect from the monitor, causing the monitor to drop on t he patient.

[WARNING]: Explosion hazard. DO NOT use the CLEO in the presence of flammable

[WARNING]: CL EO Patie nt M onitor is defibrillator proof. It may remain att ac hed t o the

may be inaccurate during use a nd shortly thereafter.

[WARNING]: CLEO Patient Monitor should only be used o n Adult Patients.

[NOTE]: Before use, please read thi s m anual carefully .

WARNING: CLEO patient monitor is a prescription device and is to be operated by qualified personnel only.

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

SAFETY INFORMATION

This section contains important safety information related to general use of the CLEO Patient Monitor. Other important safety information appears throughout the manual in sections that relate specifically to the precautionary information. Read all text surrounding all precautionary information.

The CLEO can be powered by an internal bat tery that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

A warning message appears on the screen and an audible alarm sounds when the remaining battery power is only enough for 15 minutes of operation. The user should connect the monitor to an external power source to av oid loss of patient monit oring action. External power sources may be connected, disconnected, and reconnected without interrupting the monitor ing action.

patient during defibrillation or while an electrosurgical unit is in use, but the readings

anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitr ous oxide.

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User’s manual of CLEO Patient M onitor

[WARNING]: The CLEO monitor is not intended to be used with Xenon or Helium gasses

[WARNING]: If there is any doubt about the integrity of the protective earth conductor protective conductor is fu lly functional.

[WARNING]: To prevent electrical hazards to all personnel, CLEO Patient Monitor must be properly grounded. The chassis grounding assembly, Universal Switching

DO NOT remove the monitor cover except to replace the

[WARNING]: DO NOT use the CLEO to monitor patients who are linked to heart/lung machines.

[WARNING]: DO NOT touch, press, or rub the display panels with abrasive cleaning

[WARNING]: DO NOT autoclave, ethylene oxide sterilize, or immerse these monitors

[WARNING]: Enclosure leakage current is less than 100 microamperes (µA);

equipment used on the patient at the same time as these monitors.

[WARNING]: To ensure patient sa fety, DO NOT places the monitor in any position tha t might cause it to fall on the p at ient.

[WARNING]: The user must check the equipment prior to use and ensure its safe and proper use.

[WARNING]: To ensure that the leakage current protection remains within the

patient entangl ement or strangulation.

[WARNING]: Disconnect the CLEO and sensors during magnetic resonance imaging or the monitor’s accuracy. Also, to avoid burns, remove the sensors from the patient

before conducting MRI.

(MRI) scanning. Use during MRI could cause burns or adversely affect the MRI image

specifications, use on ly t he p at ient c ables s upp lied with or speci fica lly i ntend ed for use with the CLEO Monitors. Carefully route patient cables to reduce the possibility of

however, always consider additional leakage current that can be caused by other

in liquid. Use the cleaning solution sparingly. Excessive solution can flow into the monitor and cause damage to internal components. Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the monitor. These substances attack the monitor’s materials and device failure can result. Unplug the monitors before cleaning or disinfec t ing.

compounds, instruments, brushes, rough surface materials, or bring them into contact with anything that could scratch the panel.

Power Supply, and the power cord supplied with the equipment provides for this protection. DO NOT attempt to defeat this protection by modifying the cords or using ungrounded adapters. battery.

arrangement, operate the monitor on internal battery power until the AC power supply

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User’s manual of CLEO Patient M onitor

Caution: W hen connecting the CLEO to any instrument, verify proper operation before clinical use. Both the CLEO and the instrument connected to it must be connected to a grounded outlet. Accessor y equip ments connect ed to this p atient monitor mus t be certifie d according to the respective IEC standards (e.g. IEC 60950 for information technology equipment and IEC 60601-1 for medical electrical equipment). Furthermore all configurations shall com ply with the valid version of t he system standard IEC 60601-1-1.

Any person who connects additional equipment to the signal input or signal output is responsible to ensure the system complies with the requirements of the valid version of the system standard IEC 60601-1-1. If you have any questions, please be free to contact our company or customer service.

To ensure accurate readings, consider the environmental conditions that are present and the condition of the patient. See the appropriate sections of the manual for specific safety information related to thes e c onditions.

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User’s manual of CLEO Patient M onitor

[WARNING]: CLEO Patient Monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with c li ni cal signs and symptoms.

INTRODUCTION

 INTENDED USE  ABOUT THIS MANUAL

INTENDED USE

The purpose and function of the CLEO patient monitor is to monitor basic physiological parameters includi ng

• NIBP(systolic and diastolic)

• SpO

• ETCO

The target populat ion is for adults only It may be used as bedside or portable monitor and be used in all hospitals and

hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a lic ensed healthcare practit ion er.

ABOUT THIS MANUAL

This manual explains how to set up and use the CLEO Patient Monitor. Important safe ty information relating to general use of the CLEO appears before this introduction. Other important safety information is located throughout the text where applicable. Read the

entire manual including the Safety Information section before you operate the monitor.

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User’s manual of CLEO Patient Monitor

No.

Function

Icon

Power Switch

AC ON This LED indicates that the monitor is powered by AC.

DC ON

ates that the monitor is

NIBP Port for the connection with the blood pressure cuff h ose

Oxygen Saturation Sensor Port for Infinium SpO2

Sensor Port for External EtCO2

Air Pipe for Inner EtCO2

Oxygen Saturation Sens or Port for Nellcor

USB Port

10.

Ethernet Port

11.

Alarm Indicator In alarm mode, the alarm indicator

flashes.

CONTROLS, INDICATORS, AND SYMBO LS

 FRONT AND SIDE PANEL  REAR PANEL  SYMBOLS

FRONT AND SIDE PANEL

Figure 1: Front and Side Panel

This LED indic

Transfer data to PC; Upgrade program

Upgrade program

In normal mode, no indicat or lights.

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REAR PANEL

No.

Function

Icon

Battery Access

AC Input and Fuse line power is connected to this monitor, the same type and rating fuse.

100/240V～50/60Hz, 30VA,

Equipotential Grounding

electrical energy to finds its way back to ground.

User’s manual of CLEO Patient Monitor

Figure 2: Rear View for Main Unit

The AC power connection is where facility the AC power fuses must be replaced with

Solve the ground loop and mains problem by designing several alternate courses for

F2AL 250V

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User’s manual of CLEO Patient Monitor

Ty pe BF Applied Part

Manufacture’s Serial Number

Fuse Information Date of Manufacture

Manufacturer

Fragile

This Way Up

Keep Away From Rain

Stacking Limit By Number

General Warning, Caution, Risk Of Danger

Stand-by

condition.

Prescription Only

SYMBOLS

The following symbols ma y appear on the packaging, monitor or in user’s manual:

Contents of the transport package are fra gile therefore it shall be handled with care.

Indicates correct up right position of the transport package.

Transport package shall be kept away from rain.

Maximum number of identical packages which may be s tacked on one another is eight.

Please read the instructions carefully before oper at i ng the product.

To identi fy t he s w itc h or sw it ch position by means of which part of the equipment is switched on in order t o br ing it into the stand-by

To be sold by or on the order of a physician only.

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User’s manual of CLEO Patient Monitor

DISPLAY SCREEN PARTITION

There are six groups for module combination in all. The user can choose what to me asure as required in Module Se l ect M enu. The combination is as below:

 SpO  EtCO  SpO  SpO  SpO  SpO

The display interface is as below :

+ EtCO2

+ NBP

+ NBP + EtCO2

+ NBP

① Single SpO

④ SpO

+ NBP ⑤ SpO2 + NBP + EtCO2 ⑥ SpO2 + NBP

② Single EtCO2 ③ SpO2 + EtCO2

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User’s manual of CLEO Patient Monitor

SINGLE SPO2 DISPLAY

Figure 3: Single SpO2 Display Screen

SINGLE ETCO2 DISPLAY

Figure 4: Single EtCO2 Display Screen

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User’s manual of CLEO Patient Monitor

SPO2+ETCO2 DISPLAY

Figure 5: SpO2 and EtCO2 Display Screen

SPO2+NBP DISPLAY

Figure 6: SpO2 and NBP Display Screen

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User’s manual of CLEO Patient Monitor

SPO2 +NBP+ETCO2 DISPLAY

Figure 7: SpO2, EtCO2 and NBP Display Screen

SPO2+NBP DISPLAY

Figure 8: SpO2, NBP and Display Screen

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User’s manual of CLEO Patient M onitor

System Setup

Factory Setup

Alarm Switch

Default Config

Save Config

Module Select

SpO

Module

Demo Switch

Sound Volume

Upgrade Setup

NBP Module

EtCO2 Module

SYSTEM SETUP

System Setup includes: Factory Setup, Demo Switch, Sound Volume, Alarm Switch, Module Select, Default Co nf ig, Save Config and etc.

Press the button of SETUP to pop the System Setup menu, the tree diagram is as below:

Figure 9: Tree Diagram for System Setup Menu

FACTORY SEVICING SETUP

Servicing engineer use on ly.

1. If input IPSETUP for the password, the “Upgrade Setup” menu item would be

replaced by “IP Address Setup” menu item . And then enter the IP Setup submenu, Patient Monitor will pop out as following:

Figure 10: Window for Ethernet IP Address Setup

If click OK item, the Ethernet IP address setup of the Patient Monitor is set and saved. This IP address is avai lable only when the pat ie nt m onit or i s r e-powered on.

2. If input DEMO… for the password and then open the Demo Switch, you will see the

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User’s manual of CLEO Patient M onitor

[NOTE]

simulation measurement. The Demo mode is for demonstration purpose only. To avoid that the simulated data are mistaken for the monitored patient’s data, you must not change into demo mode during monitoring, otherwise, improper patient monitoring and delayed treatment could result.

This function is for servici ng engineer only.

3. If input UPGRADE for the password, t he Up gr ade Setup Menu will be enable.

This function is for servici ng engineer only.

SOUND VOLUME

Mainly use to adjust the sound to four levels, sep arately they are: I, II, III, IV. Also it can be set to OFF.

ALARM SWITCH

It could be choose ON or OFF. When it is ON, the alarm is enabled, and then you should set the each parameter’s alarm switch in the Parameter Setup. When it is OFF, the alarm is disabled which means a ll a larm is closed.

MODULE SELECT

Choose what module is to open as you want.

DEFAULT CONFIG

If the parameter settings are confused on irrational, you can call the Default Confi g to recover original state. The screen will display a menu to let you confirm the setup.

After return to the above confirmation menu, a message of “Load Successfully!” will display in the message highlight area, showing that the system has begun to work with the new settings.

SAVE CONFIG

You can change monitor settings as required and then save the changed settings. The screen will display a menu to let you confirm the setup:

After return to the above confirmati on menu, a message o f “Sav e succes sfully ” will displa y in the message highlight area, showing that the system and all monitoring parameter settings have been saved ( see each chapter).

Make sure that the chang es ar e suitable for your patient.

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User’s manual of CLEO Patient M onitor

[CAUTION]: Follow local government ordinances and recycle instructions regarding

[CAUTION]: If the CLEO is to be stored for a period of 2 months or longer, notify service

personnel to remove the battery from the monitor prior to storage. Recharge the battery

HOW TO MONITOR

1. According to the parameter needed, connect the correlated sensors to the sockets at

the bottom of the panel;

2. Connect with the power supp ly, press the power switch in the front panel;

3. Power indicator is bright, the display screen enter the ma in screen after 10 seconds;

4. Connect the detector with t he patient;

5. Set monitoring parameters (see chapters be low ) ;

6. Enter the monitoring state.

when the battery has not been rec har ged for 2 or more months.

disposal or recycling of device components, includ in g bat teries.

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User’s manual of CLEO Patient M onitor

Alarm Category

Flashing Rate

High Priority

Two fl ashes in 1 second

Medium priority

One flash in 2 seconds

Low priority

Constant (on) (non-flashing)

ALARM & SOUND

ALARM

When the monitor detects certain conditions that require user attention, the CLEO Patient Monitor enters an alarm st ate. The monitor response is indicated by:

• Visual alarm indicator s

• Aud ib le alarm indicators

ALARM PRIORITY

The monitor’s visual and audible responses to a detected alarm depend on the priority of the alarm; High, Medium, or Low .

A higher priority alarm will super sede a lower priority alarm. The three categories of al ar m s ar e summarized in the followi ng par agraphs.

High Priority

Indicating that immediate OPERATO R res ponse is required: No breath (4 seconds hav e passed with no breath from EtCO

Medium Priority

Indicating that prompt OPERATOR response is r equired: High/Low numeric value limits violated (such as High/Low SpO High/Low Sys./Dia. blood pressure limits violated, High/Low Temperature limits violated, etc.).

Low Priority

Indicating that OPER ATOR awareness is required: Module communicates er r or ( such as SpO Sensor off (Such as SpO

sensor disconnect, temperature probe disconnect, etc.)

com error).

)

limits violated,

VISUAL ALARM INDICA T ORS

When an alarm occurs, the CLEO responds with visual alarm indications. The flashing rates for the three categories of alarms are shown. The CLEO uses flashing colors to indicate high and mediu m priority alarm as following Flash ing Rates.

When a low priority alarm occurs, a non-flashing alarm message appears in the message area. If more than one low priority alarm is present, the alarm messages “rotate”. On the CLEO t he alarm led color will chang e to a so lid yellow for a low priority alarm

A medium priority alarm is activated when a parameter is outside its alarm limits, the out-of-limit numeric value and the bell icon in the corresponding Numeric Frame flash at the medium priority rate. Only the numeric frame background color will flash yellow for a medium priority alarm in t he CLEO.

When the high-priority N o breath alarm occurs, the alarm led color will flash red. A non-flashing No breath message appears in the message area and will override any other messages which may be present (there is no message “rotation” in this instance).

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User’s manual of CLEO Patient M onitor

Alarm Category

Encoded Auditory

High Priority

c c c-c c

Medium priority

c c c

Low priority

e C

[NOTE 1]: The characters c,e refer to rel at ive musical pitches an d C is one octave c.

for total of 10 pulses.

[WARNING]: Do not silence the audi ble alarm or decreas e it s volume if patient saf ety

could be compromised.

WARNING: Each time the monitor is used; chec k alarm limits to ensure that they ar e

appropriate for the patient being monitored.

SOUND

ALARM SOUND

Like the mild sound of BEEP. There are four items of Ⅰ, Ⅱ, III and Ⅳ for alarm levels in turn from low to high.

The following encoded auditory alarm signals categorized by alarm condition and priority:

[NOTE 2]: A high priority alar m si gnal is generated with the five pulses, repeat once,

PULSE-TONE

The pulse-tone is a sound of RUB-A-DUB.

KEY BEEPS

The key beep sounds come a lo ng with clicking function ite m s.

MUTE

Click this soft-key to enable or disable all sounds. A symbol of

will display in the

message area. Also the user can s et the Sound Volume t o O FF which disable all sou nds.

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User’s manual of CLEO Patient M onitor

About SpO

、

SaO2

PLETH

Choose Module

Sweep Color

Sweep Speed

[WARNING]

SPO2 MONITORING

 SPO2 MONITORING PRINCIPLE  SPO2 SENSOR INSTALLLATION  SPO2 WAVEFORM SETUP  SPO2 PARAM ETER SETUP  MEASUREMENT LIMITATIONS  SPO2 ERROR MESSAGES  NELLCOR I NFORMATION

SPO2 MONITORING PRINCIPLE

Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous, non-invasive method based on the different absorption spectra of reduced hemoglobin and oxyhemoglobin. It measures how much light, sent from light sources on one side of the sensor , is t rans mitted thr ough p atient t issue ( such as a finger or an ear ), t o a receiver on the other side. The amount of light transmitted depends on many factors, most of which are constant. However, one of these fact ors, the blood flow in t he arteries, varies with t ime, because it is pulsating. By measuring the light absorption during a pulsation, it is possible to derive the oxygen saturation of the arterial blood. Detecting the pulsation gives a PLETH waveform and pulse rate signal.

SpO

□

SaO

□

It is the arterial blood oxy gen saturation lever meas uring by oximeter.

：

It is the oxygen saturation o f art er i al blood

：

Pulse oximeter can ov erest imate the SpO2 value in the presence of HB-CO, Met-HB or dye dilution chemicals.

SPO2 SENSOR INSTALLLATION

1. Insert the plug of SpO2 sensor into the SpO2 socket at the bottom of panel of monitor.

Make sure that the salient of plug must dire ct to the notch of socket when insert ing of unplugging, otherwise t he me asurement will not be reliab le and the sensor connector will be damaged.

2. Wear the finger-pr obe on the f inger; ma ke sure that the fin ger tip is the s ame di rection

as the finger direction indi cated on the probe.

SPO2 WAVEFORM SETUP

Touch the SpO2 Waveform area directly. The tree diagram is as below:

Figure 11: Tree Diagram for Pleth Menu

The menu can finish settings as below:

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CHOOSE MODULE

SpO

Setup

Alarm Switch

SpO

Alarm High

PR Alarm Low

SpO2 Alarm Low

PR Alarm High

PULSE BARGRAPH:

User’s manual of CLEO Patient M onitor

There is one SpO

modules for choice: Nellcor.

More detail please contact with local distributor or se r vice engineer

SWEEP SPEED

Choose from 12.5mm/s to 25.0mm/ s, and t he factory-set is 25 mm/s.

SWEEP COLOR

From Yellow, White, Blue, Red, Green and Cyan for choice, the default-set is Red.

SPO2 PARAMETER SETUP

Touch the SpO2 Parameter area directly. As graph below:

Use red bar graph to express the intensity of the pulse of patient. Pulse bar graph is throbbi ng upon with the pulse.

Figure 12: Tree Diagram for SpO2 Setup Menu

ALARM SWITCH

ON and OFF for choice, the fa ctory–set is ON. If the SpO

value is above or below the SpO2 alarm limit, when the choice is ON, the

alarm is activated; when the choice is OFF, the alarm sound will be forbidden, the alarm indicator will not light and t he r elat iv e alarm paramet er w ill not flas h.

SPO2 ALARM HIGH

The SpO

alarm upper-limit, the range is 50～99 %, and the factory-set is 99%, the

single-step adjust able step- length is 1 %.

SPO2 ALARM LOW

The SpO

alarm lower-limit, the range is 50～99 %, and the factory-set is 85%, the

single-step adjust able step- length is 1%.

PR ALARM HIGH

The PR alarm upper-limit, the range is 30～249 bpm, and the factory-set is 130 bpm, the single-step adjust able step- length is 1 %.

PR ALARM LOW

The PR alarm lower-limit, the range is 30～150 bpm, and the factory-set is 50 bpm, the single-step adjust able step- length is 1%.

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User’s manual of CLEO Patient M onitor

Search Too Long

Search-time of SpO2 is too long

Searching For Pulse. . .

On searching for pulse signal

Sensor Off

Sensor falls off or the finger fails to insert

SpO2 Com Error

SpO2 board has co mmun ication error with

[WARNING]

Prolonged and continuous monitoring may increase jeopardy of unexpected

perfusion or immature dermogram to check the sensor placement by light

DO NOT use SpO2 sensors during magnetic resonance imaging (MRI). Induced the MRI unit may affect the accuracy of the oximetry measurement s.

MEASUREMENT LIMITATIONS

1. The measurement is decided by the pulsating characteristic of blood stream in artery

or arterial blood vessel. The arterial blood stream may decreased to the level which cannot be measured in conditions below:

Shock



Hypothermia



Vasoactive medicines are applied



Anemia



2. The measurement are also decided by the condition how the oxyhemoglobin and

reduced-hemoglobin absorb the light of special wave-length. If there are other material can absorb the same wave-length light, they can cause the measurement false or lower than the actual v alu e of SpO

Carboxyhemoglobin



Methemoglobin



Methylene blue



Carmine indigo



3. The strong light in the environment also can influent measurement. Some suitable

light-tight material t o cover the sensor which ca n improve the measure qua lity.



change of dermal condition such as abnormal sensitivity, rubescence, vesicle, repressive putrescence, and so on. It is especially important for a patient of poor

, for example:

collimation and proper attaching strictly according to changes of the skin. Check regularly the sensor placement and move it when the skin deteriorates. More frequent examinations ma y be required for different patients.



current could potentially cause burns. The sensor may affect the MRI image, and

SPO2 ERROR MESSAGES

PLETH Waveform may di splay messages as below:

PROMPTS EXPLAINATION

into the finger-probe

the mainboard

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User’s manual of CLEO Patient M onitor

Pulse rate measurement is based on the optical detection of a peripheral flow

hange usual arterial

pigmentation may cause erroneous reading s.

NO IMPLIED LICENSE

Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors cables which would, alone, or in combination with this device, fall within t he scope of one or more of the patents relating t o this device.

[WARNINGS]



pulse and therefore may not detect certain arrhythmias. So it should not be used as a replacement or substitute for ECG based arrhyt hm ia analysis.

 CLEO Patient Monitor should be considered an early warning device. As a trend

towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter t o completely understand the patient’s condition.

 Interfering Substances: Carboxyhemoglobin may erroneously increase readings.

The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes or any substance containing dyes that c

MEASUREMENTS

If the accuracy of any measurement does not seem reasonable, first check the patient’ s vital signs by alternate m eans and the check the MS board for proper functioning.

Incorrect measuremen ts may be caused by:

 Incorrect sensor application or use  Significant levels of dysfunctional hemoglobins. (e.g., carboxyhemoglobin or

methemoglobin)

 Intravascular dyes such as indocyanine green or met hykebe blue.  Interfering Substances: Dyes, Nail polish or any substance containing dyes that

change usual blood pigmentation may cause erroneous readings.

 Exposure to excessive illumination, such as surgical lamps (especially ones with

a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material)

 Excessive patient movement.  SpO

is empirically calibrated to functional arterial oxygen saturation in healthy

adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). The monitor cannot measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the

measurement.

SpO

 Venous pulsations may cause erroneous low readings (e.g. tricuspid value

regurgitation).

 Patient suffers from abnormal pulse rhythm.  Motion artifact may lead to inac cur at e measurement s.  Elevated levels of Total Bilirubin may lea d t o inaccurate SpO  With very low perfusion at the monitored site, the readings may read lower than

core arterial oxygen saturation.

 Do not immerse the sensor or patient cable in water or, solvents, or cleaning

solutions (The sensors and connectors are not w at er pr oof).

 Placement of a sensor on an extremity with a blood pressure cuff, arterial

catheter, or intravascular line.

Loss of pulse signal can occur in any of the fol lowing situation:

measurements..

 The sensor is too tight.  There is excessive illumination from light sources such as a surgical lamp, a

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User’s manual of CLEO Patient M onitor

bilirubin lamp, or sunlight.

 A blood pressure cuff is inflated on the same extremity as the one with a SpO

sensor attached.

 The patient has hypotension, severe vasoconstriction, severe anemia, or

hypothermia.

 There is arterial occlusion proximal to the sensor.  The patient is in cardiac arrest or is in shock.

SENSORS

 Tissue da m age can be caused by incorr ect application or use of an LNOP® / LNCS®

sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor.

 Do not use damaged LNOP® / LNCS® sensors. Do not use an LNOP® / LNCS®

sensor with exposed optical components. Do not immerse the sensor in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof). Do not sterilize by irradiation, steam, or ethylene oxid e..

NELLCOR INFORMATION

TRADEMA RK A ND LICENSING LABELS

NELLCOR PATEN S

This device is covered under one or more the following U.S. Patents: 4,802,486; 4,869,254;4,928,692; 4,934,372; 5,078,136; 5,351,685; 5,485,847; 5,533,507; 5,577,500; 5,803,910;5,853,364; 5,865,736; 6,083,172; 6,463,310; 6,591,123; 6,708,049; Re.35,122 and international equiv al ents U.S.A internatio nal patents pe nding.

NO IMPLIED LICENSE

Possession or purchase of this device does not convey any express or implied license to use the device with una uthoriz ed rep lace ment p ar t s which wou ld, al one, or in co mbinati on with this device, fall within the scope of on e or m or e of the patents relating to this device.

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User’s manual of CLEO Patient M onitor

[WARNING]

the blood pressure shall be done automatically. The determination should be

place. This could cause tissue damage around the catheter when infusion is slowed or blocked during cuff inflation.

NIBP MONITORING

 SUMMAR Y ON NIBP MONITORING  NIBP CUFF FITTING  NIBP MONITORING INITIALIZATION  NIBP PARAMETER SETUP  NIBP LIST OBSERVATION  MEASUREMENT LIMITATIONS  NIBP ERROR ME S SAG E S  MAINT AIN ENCE AND CLEANI NG

SUMMARY ON NIBP MONITORING

The Non-invasive Blood Pressure (NIBP) module measures the blood pressure using the oscillometric method. It is applicable for adult usage only. There are three modes of measurement available: Manual, Automatic and Stat. E ach mode displays the diastolic and systolic blood pr essure.

 You must not perform NIBP measurements on patients with sickle-cell disease or

under any condition which t he sk in is damaged or expected to be damaged.

 For a thrombasthenia pati ent, it is important to deter mine wheth er measur ement of

based on the clinical evaluat io n.

 Before starting a meas ure ment, ver ify that y ou have select ed a sett ing ap propr i ate

for your patient (adult only)

 DO NOT apply the cuff to a limb that has an intravenous infusion or catheter in

NIBP CUFF FITTING

1. Whether choosing the suitable cuff which match the arm of patient influent much on the accuracy of NIBP measurement. The cuff width recommend by AMERICA HEART SOCIETY is the 40% of upper arm circumference.

2. Apply the blood pressure cuff to the patient ’s arm:

Make sure that the cuff is completely deflated.



Apply the appropriate size cuff to the patient, and make sure that the symbol “φ” is



over the appropriate artery. Ensure that the cuff is not wr apped t oo tightly around the limb. Excessive tightness may cause discoloration and eventual isocheimal of the extremities.

。

3. Make sure that the cuff h as not been twisted.

4. Insert the air pipe into the NIBP socket on the left panel of monitor. Ensure that the

spring block on the left side of socket has been pressed when inserting or unplugging the pipe, otherwise the measurement process will be irregular and the sensor connector will be dam aged.

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User’s manual of CLEO Patient M onitor

NIBP Setup

Choose Color

Pressure Unit

Patient Type

Inflation Mode

Time Interval

NIBP List

STAT

Manual

Auto

Adult

Alarm Switch

Alarm Setup

[WARNING]

 The width of the cuff should be 40% of the limb circumference. The inflatable part

of the cuff should be long enough to encircle 50-80% of the limb. The wrong size of cuff can cause erroneous readings. If the cuff size is in question, then use a larger cuff.

 Make sure that the cuff edge falls within the range of 〈-〉. If does not, change a

more suitable cuff.

 Connect the cuff to the air hose. The cuff chosen for taking the measurement

should be placed at the same lev el as the patient’s h eart . If t his is not possib le y ou should apply the following corrections to the measured values:

NIBP MONITORING INITIALIZATION

After opening the host machine, check the information indicating area before NIBP monitoring, if there is a note of NIBP MODULE SELF-CHECK OK, it shows that the NIBP module operate well, then begin NIBP monitoring, and the NIBP monitoring before this information is invalid; if there is NIBP MODULE SELF-CHECK ERROR, it shows that the NIBP module cannot be proceeded, press the button of START/STOP to give another time of self-checking or machine-opening, if it is also this information, contact with servicing engineer.

NIBP PARAMETER SETUP

Touch the NIBP Parameter Area to pop the NIBP Setup menu.

Figure 13: Tree Diagram for NIBP Setup Menu

This menu can finish settings below :

DISPLAY COLOR

From Y ellow , White, Blue, Red, Green and Cyan for choice, the default-set is Green.

ALARM SWITCH ON and OFF for choice, the factory–set is ON.

If the NIBP value is above or below the NIBP alarm limit, when the cho ice is O N, the a larm is activated; when the choice is OFF, the alarm sound will be forbidden, the alarm indicator will not light and t he r elat iv e alarm paramet er w ill not flas h.

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User’s manual of CLEO Patient M onitor

PRESSURE UNIT mmHg or kPa, the factory–set is mmHg. P ATIENT TYPE ADULT TYPE

In the initiated measurement, inflate the cuff to 180mmHg (24kPa), if the NIBP value cannot be measured, then inflate the cuff to higher than the form value by 50mmHg (6.7kPa), the maximum value cannot exceed 280mmHg (37.3kPa), and the enduring pressure range is 50-280mmHg. The factory–set is ADUL T TYPE.

If this setup is before the NIBP module initiation, information indicating area will give a message of PATIENT TYPE SET ERRO R. Inflating range shown above has been realized on NIBP, NIBP uses this inflation range to make sure the safety of patient.

INFLATION MODE

There are three items for choi ce. Manual, Auto and ST AT.

MANUAL MODE

：

Press the button of START/STOP to begin inflation, the information indicating area display “Manual measuring…” which shows that it is on measurement just the moment . If the NIBP measurement is finished, NIBP parameter area will display values and the information indicating area will give a note of “Manual measuring end!”, then the measurement process finished. If the NIBP value cannot be measured, NIBP parameter area will display error messages and automatically begin three times of measurement again, if the value cannot be measured as well, the information indicating area will give a note of “RETRY OVER” and never measure again. During the measurement, press the button of START/STOP again will stop the NIBP measurement process and the information indicating area will give a note of STOP MANUAL MEASURING.

AUTOMATIC MODE NIBP param eter ar ea w ill disp lay t he co unt d own o f "Aut o measuring.. ." (TIME INTER VAL), so long as reaching the zero point, machine will automatically precede inflating measurement again and again until the mode is changed.

Start a measurement manually. The monitor will then automatically repeat NIBP measurements at the set time interval.

If the NIBP measurement is finished, NIBP parameter area will display values and the information indicating area will give a note of "Auto measuring end！". And then begin another measurement until the mode is changed. If the NIBP value cannot be measured, NIBP parameter area will display error messages and the first measurement automatically begin three times of measurement again, if the value cannot be measured as well, the information indicating area will give a note of “RETRY OVER” and automatically go on the next measurement until the mode is changed. If the button of START/STOP be pressed during any period of countdown, it is immediately begin inflatio n me as urement. During the measurement, press the button of START/STOP again will stop this period of NIBP measurement process and the information indicating area will give a note of "Stop auto measuring", but the automatic measure ment period is continuous.

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User’s manual of CLEO Patient M onitor

Type

SYS UPPER LIMIT

SYS LOWER LIMIT

DIA UPPER LIMIT

DIA LOWER LIMIT

Adult

30~240 Factory-set:150

30~240 Factory-set:100

15~180 Factory-set:90

15~180 Factory-set:50

[NOTE]

graph and trend table, t he parameter will exist f or correlated time length.

[WARNING]

invasive blood pressure measurements in Auto mode may be

warmth and sensitivity. If any abnormality is observed, stop the blood pressure measurements.

Prolonged nonassociated with purport , isocheimal and neuropathy in the limb w earing the cuff. When monitoring a patient, examine the extremities of the limb frequently for normal color,

STAT MODE

In the stat mode, it will measure NIBP continually for three times. And then it will end automatically. Of course, you can press the button of START/STOP to end the measurement manually. Press the button of START/STOP to begin inflation, the information indicating area displa y "STAT measuring..." which shows that it is on measurement just the moment; If the NIBP measurement is finished, NIBP parameter area will display values and the information indicating area well give a note of "STAT measuring end".

If the NIBP value cannot be measured, NIBP parameter area will display error messages and automatically begin three times of measurement again, if the value cannot be measured also, the information indicating area will give a note of “RETRY OVER！”, and then continue another time of me as urement which lasts 5 minutes and then stop. During the measurement, if press the button of START/STOP again, the information indicating area will give a note of "STOP STAT TEST" to stop the NIBP meas ure ment a nd exit from this mode.

The value having been measured will display on the NIBP parameter area for 240 minutes unless a new measurem ent begin dur ing t his period. On the appropri ate tr end

TIME INTERVAL

This setting is used supported by automatic inflation mode. You can input the time interval as you want. The range is 1 min to 4 hours.

ALARM LIMIT SETUP

Limits Patient

(mmHg)

The single-step adjustable length of alarm limit above is 1 mmHg.

NIBP LIST OBSERVATION

Touch the “NIBP List” item area to pop up the NIBP List Tabular.

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User’s manual of CLEO Patient M onitor

[NOTE]: Only after the NIBP value has been measured can it be added to the NIBP the most former data out of the list and be added to the list automatically.

Figure 14: Window for NIBP List Observation

The NIBP list can sav e 260 groups of data.

Data List. NIBP list can sav e 260 groups of data at all, if exceed, the new dat a w ill kick

MEASUREMENT LIMITATIONS

To different patient condit i ons, the oscillometric measurement has certain limitations. The measurement is in search of regular arterial pressure. In those circumstances when the patient’s condition makes it difficult to detect, the measurement becomes unreliable and measuring time increases. The user should be aware that the following conditions could interfere with the measurement, making the measurement unreliable or longer to derive. In some cases, the patient’s condition will make a measure ment impossib le.

PATIENT MOVEMENT

Measurements will be unr eli able or may not be possible if the patient is moving, shivering or having convulsions. These motions may interfere with the detection of the arterial pressure pulses. In additi on, the measurement ti me w ill be pr olonged.

CARDIA C A RRHYT HMIA `S

Measurements will be unreliable and may not be possible if the patient’s cardiac arrhythmia has caused an irregu lar he artbeat . The measur ing ti me thus w il l be pr olong ed.

HEART-LUNG MA C HI NE

Measurements w ill not be possible if the pat ient is connected to a heart-lung machine.

PRESSURE CHANGES

Measurements will be unr eliable and m ay not be po ssible if the p atient’s blood pressure is changing rapidly over the period of time during which the arterial pressure pulses are being analyzed to obtain t he m easurement.

SEVERE SHOCK

If the patient is in severe shock or hypothermia, measurements will be unreliable since reduced blood flow to the peripheries will cause red uced pulsation of the arteries.

HEART RATE EXTREMES

Measurements cannot be made at a heart rate of less than 40 bpm and greater than 240 bpm.

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User’s manual of CLEO Patient M onitor

Patient moving！

Serial error

Pressure < 10 mmHg！

NIBP renew self-check...

Pressure < 1.3 kPa！

NIBP self-check...

Pressure > 325 mmHg！

NIBP self-check error！

Pressure > 43.3 kPa !

NIBP inter error！

Serial overtime！

Patient type error！

Reset error！

Setup patient...

Zero reset error！

NIBP self-check ok!

[NOTE]

DO NOT squeeze t he r ubber t ube on the cuff.

NIBP ERROR MESSAGES

Message indicating area may display messages l ike below：

MAINTAINENCE AND CLEANING

REUSABLE BLOOD PRESSURE CUFF

The cuff can be sterilized by means of conventional autoclaving, gas or radiation sterilization in hot air ovens or disinfected by immersion in decontamination solutions, but remember to remove the bladder if you use this method. The cuff should not be dry-cleaned. The cuff can also be machine-washed or hand-washed; the latter method may prolong the service life of the cuff. Be fore w ashing, remove the latex bladder, and for machine-washing, close the Velcro fastening. Allow the cuff to dry thoroughly after washing, and then reinser t the rubber bag.

To replace the bladder in the cuff, first place the bag on top of the cuff so that the rubber tubes line up with the large opening on the long side of the cuff. Now roll the bag lengthwise and insert it into the opening on the long side of the cuff. Hold the tubes and the cuff and shake the complete cuff until the bag is in position. Thread the rubber tubes from inside the cuff, and out through the small hol e under t he internal flap

Replace the bladder after c lea ni ng and disinfecting the cu ff, as follows:

1. Place the bladder on the top of the cuff, as the figur e shows.

2. Roll the bladder lengthw is e and in sert it int o the larg e openi ng. S ee the figur es below .

3. Hold the hose and the cuff and shake the com plete c uff until the bladder is in position.

4. Thread the hose from insi de t he cuff, and out through the smal l hole under the

internal flap.

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User’s manual of CLEO Patient M onitor

ETCO2 MONITORING

 THEORY OF OPERATION  WARNINGS, CAUTIONS, NOTES  ABBREVIATIONS AND TERMINOLOGY  ZEROING THE CO2 MODULE  P A TIENT AND TUBING PREPARA TION  ETCO2 WAVEFORM SETUP  ETCO2 PARAMETER SETUP  ADVANCED SETUP  CALIBRATION  STATUS/ERROR MESSAGES  MAINTENC E AND CLEACING

THEORY OF OPERATION

Carbon dioxide monitoring system is a sidestream sampling system with a 50 ml/minute low sampling rate, which is used to monitor continuous carbon dioxide and display the End Tidal carbon dioxide (EtCO non-intubated and intubat ed adult p atie nt, using specially designed sampling cannula and on-airway adapter kits. These kits incorporate a filter and the sample cell that provides maximum filtration of fluids and contaminants and protects the system from aspiration of these fluids.

In carbon dioxide monitoring system, infrared light is generated by the sensor and beamed through the sample cell to a detector on the opposite side. CO2 from the patient that is aspirated into the sample cell absorbs some of this infrared energy. The monitor determines CO

concentration in the breathing gases by measuring the amount of light

absorbed by these gases. EtCO mercury (mmHg), percent (%), or kilopascals (kPa). In addition, a CO (capnogram) may be display ed which is a valu able clinic al tool that can be used to assess patient airway integr ity and proper endotrach eal tub e (ETT) plac ement. Respiration rat e is calculated by measuring the time interval between detected breaths.

), inspired CO2 and respiratory rate values of the

is displayed as a numerical value in millimeters of

waveform

WARNINGS, CAUTIONS AND NOTES

WARNINGS

 Explosion Hazard: DO NOT use in the presence of flammable anesthetics or other

flammable gasses.

 Electrical Shock Hazard: Always disconnect the CO2 module before cleaning. DO

NOT use if it appears to have been damaged. Refer servicing to qualified service personnel.

 Failure of Operation: If the CO

manual; DO NOT use it unt il ap pr oved for use by qualified personnel.

 DO NOT position the sensor cables or tubing in any manner that may cause

entanglement or strangulation. Support the carbon dioxide monitoring system airway adapter to prevent stress on t he ET tube.

 Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use

cannula kits and on-airway adapters may compromise functionality and system performance leading to a user or p atient haz ard. Perfor mance is not guar ante ed if an item labeled as single pat ient use is reused.

 Inspect the sidestream on-airway adapters and sidestream sampling kits for damage

prior to use. DO NOT use the sidestream on- airway adapters and sidestream sampling kits if they appear to be damaged or bro ken.

 Replace the sidestream on-airway adapters and sidestream sampling kits if

excessive secretions are observed.

 Monitor the CO2 check waveform (Capnogram). If you see changes or abnormal

module fails to respond as described in this user

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User’s manual of CLEO Patient M onitor

appearance the pat ient and the sampling line. Replace line if needed.

 DO NOT operate the CO

Module when it is wet or has exterior condensation.

 DO NOT apply excessive tension to any cable.  DO NOT use device on patients that can not tolerate the withdrawal of 50 ml/min +/-

10 ml/min from the airway or patients that can not tolerate the added dead space to the airway.

 DO NOT connect the ex haust tube to the ventilator circuit.  DO NOT use for meas ur in g Xenon Gases  DO NOT use for meas ur in g Helium Gases

CAUTIONS

 DO NOT sterilize or immerse the CO  DO NOT store the CO

Module at temperatures less than -40ºF (-40ºC) or greater

module in liquids.

than 158ºF (70ºC).

 DO NOT operate the CO

Module at temperatures less than 32ºF (0ºC) or greater

than 104ºF (40ºC).

 DO NOT stick appen dage into sample receptacle.  Always insert sample cell before inserting the on-airway adapter into the ventilated

circuit.

 Always remove the on-airway adapter from the ventilated circuit before removing the

sample cell.

 Nitrous oxide, elevated levels of oxygen, helium, Xenon, halogenated hydrocarbons,

and barometric pressure can influence the CO

measurement. Levels to be supplied

by the monitor.

NOTES

 After the life cycle of the CO

module and its accessories has been met, disposal

should be accomplished f oll ow ing national and/ or local requirements.

ABBREVIATIONS AND TERMINOLOGY

EtCO2 End tidal carbon di oxide INSP CO

AWRR Air-way r espiration rate

BARO Barometric Pressure

Inspired minimum CO2

ZEROING THE CO2 MODULE

The sample cell zero allows the CO2 Module to adjust to the optical characteristics of the sample cell only when requested.

For optimal accuracy, a CO Module is connected to th e patient monitor.

Before performing a CO patient monitor and the airway adapter type to be used in the circuit should be inserted into the CO residual CO

Module. Care should be taken ensur e that the airway adapter is clear of any

gas. The maximum elapsed time for a CO2 Module zero is 30 seconds.

The typical time for a zero is 15 – 20 seconds. Several CO

Module conditions may also request that a zero be performed. These

requests stem from chang es in the airway adapt er that may indicat e that the sensor is not in optimal measuring condition. When this occurs, the airway adapter should be checked to ensure optical occlusions such as mucus have not obscured the adapter window. If occlusions are found, the airw ay adapter should be cleaned or r eplaced.

Module zero should be performed whenever the CO

Module zero, the CO2 Module should be removed from the

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User’s manual of CLEO Patient M onitor

[WARNING]: Don’t hot plug EtCO2 module, that is make sure that the CLEO is

NOTES:

 System does not allow adapter zero for 20 seconds aft er t he l ast breath is detected.  System does not allow adapter zero if temperature is not stable.  An adapter zero cannot b e per forme d if a s amp le cell is not co nne cted t o the modu le.  For best results, wait 5 minutes to allow the CO

module to warm up before

performing the Sample Cell Zero procedure.

PATIENT AND TUBING PREPARATION

MODULE MOUNTING

a. Put the CO b. Check that monitor i s swit ched of f，Insert the plug of CO sensor socket marked with EtCO

module into the bracket of the r ear panel of the monitor.

sensor into t he cor responding

icon on the left panel of monitor.

powered off before Insert the connector of CO2 sensor into EtCO2 socket. Otherwise the CO

module may be damaged by power supply from EtCO2 socket of CLEO.

CONNECTI NG THE SAMPLE KIT

a. The sample cell of the sampling kit must be inserted into the sample cell receptacle of the CO

Module as shown in following figure. A “click” will be heard when the sample cell

is properly inserted.

b. Connect the CO

tubing to Nasal and Nasal/Oral Sidestream Kits.

c. Inserting the sample cell into t he r eceptacle automatically starts t he sampling pump. Removal of the sample cell turns t he sample pump off. d. To remove the sa mp lin g kit sample cell from the sample cell receptacl e, press down on the locking tab and pu ll th e s ample cell from the sample cel l receptacle.

DIRECTIONS For use of single patient use nasal and nasal/oral sidestream kits

CAUTION: The Nasal and Nasal/Oral Cannula kit s are intended for sin gle pati ent use. Do

NOT reuse or steriliz e the cannula kit as system perf or m ance will be compromised.

1. Verify that the cannula kit is clean, dry and undamaged. Replace the cannula kit if necessary.

2. Insert the sample cell into the sample cell receptacle as shown in above figure on connecting the Sample Kit section. A “click” will be heard when properly inserted.

3. Perform a sample cell zer o if pro mpted by the host system.

4. Place the nasal cannula kit s ont o t he patient as shown in fo llowing figure.

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User’s manual of CLEO Patient M onitor

[CAUTION]:

been use.

5. Some patients are prone to mouth breathing. The Oral/Nasal sampling cannula

should be used on these p at ients, a s most, i f not all o f the CO mouth. If a standard nasal CO EtCO

number and capnogr am will be substantia lly lower than actual.

6. When using the Nasal or Oral/Nasal CO

sampling cannula is used with these patients, the

sampling kits with oxygen delivery, place

is exhaled thr ough th e

the cannula on the patient as show n above and then att ach the oxy gen supply tubing to the oxygen delivery system and set the prescribe d oxygen flow.

7. If the oral/nasal cannula is used, the oral sampling tip may need to be trimmed to

adequately fit the patient ( see fo llowing figure). Place the cannula onto the patient as shown in above figure. Observe the length of the oral cannula tip. It should extend down past the teeth and be positioned in the mouth opening. Remove the cannula from the patient if the tip n eeds t o be t r immed.

 DO NOT cut the oral cannula tip when the cannula is on t he patient.  Remove the sampling kit sample cell from the CO2 Module Inlet Port when not

: FLOW RATE

Conditions that can cause a c hange in Flow Rate:

 Water, mucou s or ot her patient contaminate has entered the sa mp le tubing.  The sample tubing is cr imped or pin che d so th at t he sa mp le flow rate has decr ease d.  The exhaust port of the CO

module is obstructed.

 The sample line is damaged.  The sample line has been cut, or split, causing the flow rat e to increase.

ETCO2 WAVEFORM SETUP

Touch the EtCO2 Waveform Area to pop the menu of EtCO2 Waveform Setup, s ee graph below:

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User’s manual of CLEO Patient M onitor

ETCO

Waveform

Setup

Waveform Scale

Sweep Color

Sweep Speed

EtCO2 Setup

Alarm Switch

EtCO2 Alarm High

EtCO2 Alarm Low

awRR Alarm High

awRR Alarm Low

Apnea Delay

EtCO2 Unit

Zero Setup

Oxygen

Anesthetic

BARO.

Advanced Setup

Zero Gas Type

Start Zeroing

EtCO2 Period

Balance Gas

Gas Temp

Figure 15: Tree D iagram for EtCO

WAVEFORM SCALE

Use this setting to adjust the amplitude measurement (size) of the displayed EtCO waveform scale manually. The label will be displayed in the screen. There are two items for choice: 0～75 mmHg, 0～150 mmHg.

SWEEP SPEED

From 6.25 mm/s, 12.5 mm/s and 25 mm/s for choice, the factory-set is 6.25mm/s.

SWEEP COLOR

From Y ellow , White, Blue, Red, Green and Cyan for choice, the default-set is Cyan.

Waveform Setup Menu

ETCO2 PARAMETER SETUP

Touch the EtCO2 Parameter Area to pop the menu of EtCO2 Parameter Setup, see tree diagram below:

Figure 16: Tree D iagram for EtCO2 Parameter Setup Menu

ALARM SWITCH ON and OFF for choice, the factory–set is ON.

If the EtCO

or awRR value is above or below the alarm limit, when the choice is ON, the

alarm is activated; when the choice is OFF, the alarm sound will be forbidden, the alarm indicator will not light and t he r elat iv e alarm paramet er w ill not flash.

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User’s manual of CLEO Patient M onitor

[NOTE]: During the CO2 module warm-up period after the mo nitor is pow ered on, the

ETCO2 ALARM HIGH

The range is 20～100 mmHg，an d t he fa c t or y-set is 60 mmHg.

ETCO2 ALARM LOW

The range is 1～95 mmHg，and the factory-set is 15 mmHg.

A WRR A LA R M HIGH

The range is 10～150 mmHg，an d t he fa c t or y-set is 30 mmHg.

AWRR ALARM LOW

The range is 5～100 mmHg，an d t he fa c t or y-set is 5 mmHg. The single-step adjustable length of alarm limit above is 1 mmHg.

ASPHYXIA DELAY

This setting is used to set the no breaths detected time-out. This time-out is the time period in seconds following the last detected breath at which the CO

module will signal

no breaths detected. The monitor will a larm if t he pa tient has stop ped bre athin g for longer than the preset apnea tim e. The setting range is 10～60 seconds，and the fact ory-set is 10 seconds.

ETCO2 UNIT

mmHg, kPa or percent (%), the factory –set is mmHg.

ETCO2 PERIOD

This setting is used to set the calculation period of the EtCO value is the highest peak CO

value of all ends of expirations (end of breaths) over the

value. The end-tidal CO2

selected time period. If less than two breaths exist in the selected time period, the value will be the maximum EtCO

value for the last two breathes.

This setting has 1 breath, 10 seconds and 20 seconds for choice, the factory–set is 1 breath.

ZERO SETUP

Zero steps refer to “Zeroing the CO

Module” section detailed.

Complete the zero procedure by press “Start Zeroing” item. During zeroing, a message of “EtCO

Zero Started” will be display on t he message area.

monitor will perform an automatic zero calibration. The maximum elapsed time for a

Module zero is 30 seconds. The typical time for a zero is 15 – 20 seconds.

ZERO GAS TYPE

When performing a zero on room air, this setting should be set to room air (the default). Only change to nitrogen (N

) when performing a zero on 100% N2 gas. This is provided

for use in a laboratory environ m ent .

ADVANCED SETUP

Pick “ADVANCED SETU P” it em to call up the related menu:

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User’s manual of CLEO Patient M onitor

EtCO

Setup

Oxygen

Anesthetic

BARO

Advanced Setup

Balance Gas

Gas Temp

[NOTE]: At 700 mmHg of pressure, the correct CO2 value is 35.0 mmHg.

Figure 17: Tree Diagram for EtCO2 Advanced Setup

SET GAS COMPENSATIONS

The measurement of CO The barometric pressure as well as the presence of O agents in the gas mixture needs to be compensated for by the CO

is affected by temperature, pressure, and gas compensations.

, N2O, helium, and anesthetic

module in order to

achieve its stated accuracy. The instrument settings for these parameters should be set when initially connecting to the CO

module and whenever there is a change in the

conditions at the pat ient airway. In the CO

module, the temperature of the gas in the airway also effects the CO2

measurement. It is necessary to adjust the instrument setting for the gas temperature to achieve the maximum accur acy for the CO

module.

OXYGEN COMPENSATION

The setting range is 0～100 %. The factory–set is 16 %.

BALANCE GAS

There are room air, N

O and Helium items to choose.

ANESTHETIC A G ENT (Not Cleared for USA)

Use this setting to correct for the compensation of the gas mixture administered to the patient. Anesthetic agent is ignored when t he balance gas is set to helium. The setting range is 0.0～20.0 %. The factory –set is 0.0 %.

BAROMETRIC PRESSURE

This setting is used to set current Bar ometric Pressure. The setting range is 400～850 mmHg. The factory –set is 760 mmHg.

GAS TEMPERATURE

This setting is used to set temperature of the gas mixture. This setting is useful when bench testing using static gasses where the temperature is often room temperature or below. The setting range is 0～50℃. The factory –set is 35℃.

CALIBRATION

No routine user calibratio n required.

Safety lock-outs:  System does not allow sample cell zero for 20 seconds after the last breath is

detected.

 System does not allow samp le cell zero if temperature is not stable.  An adapter zero cannot be performed if a sample cell is not connected to the

module.

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User’s manual of CLEO Patient M onitor

Messages

Descriptions

Sensor Off

The CO2 sensor is not connected

Sensor Warm Up

One of the following conditions exist:

Source Current unsta ble

Sensor Over Temp

Make sure sensor is not exposed to extreme heat (heat lamp, etc.). If error persists, r et urn sensor to factory for servicing.

Sensor error

Check that the sensor is properly plugged in. Reinsert or reset the sensor if necessary. If error persists, return sens or t o factory for servicing.

Sensor Zeroing. . .

A z er o is cur rently in progress.

Zero Required

To clear, check airway adapter and clean if necessary. If this

ct the error, perform an adapter zero. If you must adapter zero more than once, a possible hardware error may exist.

Check Sampling Line

To clear, clean if sampling line mucus or moisture is seen. If the sampling line is clean, perform a zero.

CO2 Out of Range

The value being calculated is greater than the upper CO2 limit (150 mmHg, 20.0 kPa, or 19.7 %). The maximum value output is the upper CO2.

Check Airway Adapter

To clear, clean airway adapter if mucus or moisture is seen. If the adapter is clean, perfo r m a z er o.

Pump Life Exceed

The manufacturer st ated pump life has been exceeded. Service may be required if Pneumatic System Error is present and can no longer be cleared.

Sensor Setup. . .

The CO2 sensor is setting process.

EtCO2 Zero Error: Sensor Not Ready .

The CO2 sensor is not ready for a EtCO2 Zero

EtCO2 Zero Error: Breath Detected.

Breaths have been detected by the CO2 module within the last 20 seconds while a CO2 module zero was attempt ed.

STATUS/ERROR MESSAGES

Sensor under temperature Temperature not stable

does not corre

MAINTENANCE AND CLEANING

SCHEDULE

The CO calibrated flow meter ever y 12 months.

CLEANING

Cleaning the Sidestrea m On-Airway Adapt ers and Sidestrea m Sam pling Kit s: Sidestream on-airway ada pters and sidest ream sam pling kits are s ingle pat ient use. T reat in accordance with hospital protocols for handling single patient use devices.

Module flow rate accuracy should be verified by direct measurement using a

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User’s manual of CLEO Patient Monitor

Patient Setup

Sex

Blood

Age

[NOTE]: Once the user chooses the method of YES to exit from the Patient Inf ormation Setup, all information of patient will be refreshed a nd the trend data will be r enovated.

[NOTE]: The Patient Monitor displays physiological data and stores them in the trends

can clearly identify your patient, on recordings, r eports and networking devices.

[NOTE]: If you set the same ID with previous patient , the measure ment dat a record wil l be saved following after the previous data with same I D.

RECALL DATA

 PATIENT BASIC INFORMATION SETUP  CLOCK SETUP  HOW TO RECALL

PATIENT BASIC INFORMATION SETUP

The user can set by t ouching the pat ient ID ar ea at the top left corner t o pop up patient setup menu. You can have settings as below. CLEO Patient Monitor can save five groups patient in formation for recall in total.

Figure 18: Tree Diagram for Patient Setup

Set the ID number of patient. The ID number for each patient is different and unique. The user can input 12 characters at mo s t .

SEX Set the patient gender, the default setting is MALE. BLOOD

Set the blood type of patient. It can be：N/A(unknown type) , A , B , O , AB , RH+ , RHand so on, the default setting is N/A.

AGE

Set the age of patient. The range is 0 ~120, the de f ault setting is 25.

as soon as a patient is con nected. This a llows y ou to monitor a patie nt that is no t saved information yet. However, it is recommended that you fully admit a patient so that you

- 39 -

User’s manual of CLEO Patient Monitor

Clock Setup

Year/Month/Day

Time

CLOCK SETUP

In order to review data easily and intuitively, you should have set a right time. Touch the time area at the top right corner to pop up time setup menu. You can have settings as below:

Figure 19: Tree Diagram for Clock Setup

The value of year, month, day, hour and minute can be set. System will amend the internal clock according t o the new settings.

Once the system time realigned, the trend data will renew correspondingly. On entering the master screen, please checks whether the monitor time and the current time are consistent, if not, please correct them.

HOW TO RECALL

In Recall menu, choose a user f irstly and then choose which parameter is to r eview.

Figure 20: User Choose and Module Choose

The parameter value in tabular format could be review if the relevant module is ON. The parameter record wi ll b e saved every two seconds.

10 groups of measurement value are listed every page and 300 groups in total. Once the recall memory has stored 300 groups of data, the oldest recall data will be overwritten by new data.

These data will be listed follow the order of from new to former and the time is displaying at the scale-of-24 hour s. The p ara meter na me is dis play on th e top of c hart a n d the i nval id data will not display. The invalid data will not display.

- 40 -

SPO2 REVIEW

User’s manual of CLEO Patient Monitor

The SpO

History Data review is as below:

ETCO2 REVIEW

The EtCO

History Data review is as below:

Figure 21: Tabular Trend for SpO2

Figure 22: Tabular Trend for EtCO2

- 41 -

User’s manual of CLEO Patient Monitor

NBP REVIEW

The NBP History Data review is as below:

Figure 23: Tabular Trend for NBP

- 42 -

User’s manual of CLEO Patient Monitor

[NOTE]: Whenever the monitor is connected to AC power, the battery is being charged. Therefore, it is recommended that the monitor remain connected to AC

time.

[NOTE]: As the battery is used and recharged over a period of time, the amount of

[CAUTION]: If the CLEO is to be stored for a period of 2 months or longer, notify [WARNING]: DO NOT disassemble batteries, or put them into fire, or cause them to

short circuit. They may ignite, explode, or leak, causi ng per sonal injury.

BATTERY OPERATION

CLEO Patient Monitor is designed to operate on one rechargeable Lithium ion battery whenever AC power supply is interrupted. A symbol is displayed in the upper right quart er of the screen to indicate the status of recharging, in which the color part represents the electric energy of the battery.

A new, fully charged battery will provide about 3 hour of monitoring time under the following conditions: no audible alarms, no analog or serial output devices attached, and no backlight. The charge and discharge cycles life of the battery is about 300 times.

When operating on battery, the monitor will shut off automatic ally when t he elect ric energy is low. When the electric energy is lower than 25% of total power capacity, the battery signal will change red. Connect the monitor t o AC p ower at this moment can recharge the battery while operating. If keep operating on the battery, the monitor will shut off automatically upon exha ustion of the battery.

power when not in use. This will make available a fully charged battery for use at any

time between the onset of the low battery alarm and the instrument shut-off may become shorter. If the backlight is turned of f during a low batter y condition, it cann ot be t urned b ac k on. It is recommended that the internal battery is replaced by qualified service personnel

service personnel to remove the battery from the monitor prior to storage. Recharge the battery when it has not been char ged for 2 or more months.

BATTERY RECYCLE

When a battery has visual signs of damage, or no longer holds a charge, it should be replaced. Remove the old battery from the Patient Monitor and recycle it properly. To dispose of a battery, follow local laws for proper disposal.

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User’s manual of CLEO Patient Monitor

DISPOSAL OF DEVICE COMPONENTS

Follow local governing ordinances and recycling instructions regarding disposal or recycling of device compo nents, including batteries.

- 44 -

User’s manual of CLEO Patient Monitor

[WARNING]: Do not spray, pour, or spill liquid on CLEO, its accessories, connectors,

CLEANING

To clean the CLEO, dampen a cloth with a commercial, nonabrasive cleaner and w ipe the exterior surfaces lightly. Do not allow any liquids to come in contact with the power connector or switches. Do not allow any liquids to pe netrat e con nectors or ope nin gs in th e instrument. For cables, sensors, and cuffs, follow the cleaning instructions in the directions for use that acc om pany these accessories.

PERIODIC SAFETY CHECKS

It is recommended that the following checks be performed every 24 months.

• Inspect the equipment fo r mec hanical and functional da m age.

• Inspect the safety relevant labels for legibility.

switches, or openings in the chassis. Do not immerse the CLEO or its accessories in liquid or clean with caustic or abr asiv e c l eaners.

- 45 -

SPECIFICATIONS

SAFETY

Meet the requirement of EN60 601 series, CE markin g ac cor ding to MDD93/42/EEC

Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

Ty pe of Protection:

Class I (on AC power) Internally Powered (on battery power)

Degree of Protection:

Ty pe BF - Applied part

Steriliz at i on or Disinfection methods:

70% isopropyl alcohol solution or a nonstaining disinfectant.

Operation Mode:

Continuous Operation

Protection Against Ingress of Liquid’s:

IPX0

APPLICATION

Adults

Physical Dimensions & Weight

Base Unit:

120×125×195 mm

Weight:

900 g

PEFORMANCE SPECIFICATIONS

Display:

5.0 Inch(Diagonal)Color TFT

Resolution:

480×RGB×270

Trace:

2 Waveforms

Waveforms

PLETH, EtCO2

Indicator:

Alarm Indicator Power Indicator

Trend time:

10 mins

Nellcor SPO2

Standard:

ISO 9919

ASpO2:

Anti-motion SpO2

Measuring Technology:

Light absorption method

SpO2 Measurement Rang e:

0～100 %

SpO2 Accuracy:

70～100 %: ±2 % 0～69 % : Undefined

PR Measurement Range:

30～250 bpm

PR Accuracy:

±2 bpm(non-motion) ±3 bpm (motion)

SpO2 Alarm Limit:

Upper Limit : 50～99 %，

Lower Limit : 50～99 %

SpO2 Probe:

Red Light LED Wavelength: 660±5 nm

Infrared Light LED Wav e lengt h: 940±10 nm

Refreshing Rate:

1 s

Option T ype:

Nellcor (See the modules’ relative technical specifications)

Operating and Storage Temperature

Operating Temperature

-31oF – 158oF

NIBP

Standard:

EN 60601-2-30/IEC 60601-2-30, EN 1060-1, EN 1060-3, EN 1060-4, SP10

Measuring Technology:

Automatic Oscillating Measurement

Cuff Inflating:

<30 s（0～300 mmHg，Standard Adult Cuff）

Measuring Period:

AVE<40 s

Mode:

Manual, Auto, STAT

User’s manual for CLEO Patient Monitor

32oF – 113oF Storag e Temperature

- 46 -

User’s manual for CLEO Patient Monitor

Measuring Interval in AUTO Mode:

1min～4h

Resolution:

1mmHg

Overpressure Protection:

Adult Mode 280 (mmHg)

Alarm Limit:

SYS 30～240 mmHg DIA 15～180 mmHg

CO2

Mode of Sampling:

Sidestream

Measurement technology:

Infrared Absorption

Principle of Operation:

Non-dispersive infrared (NDIR)

Frequency St able Ther mopile

Initialization Time:

Warmup less than 10 seconds

CO2 Measurement Range:

0 to 150 mmHg, 0 to 19.7%, 0 to 20 kPa

CO2 Calculation Method:

BTPS (Body Temperature Pressure Saturat ed)

Response Time:

Rise Time 300 ms Total System Response Time (secs) 4

CO2 Resolution:

0～69 mmHg: 0.1 mmHg 70～150 mmHg: 0.25 mmHg

CO2 Accuracy:

0 – 40 mmHg ±2 mmHg (<5%)

Above 80 BPM ±10% of read ing

CO2 Stability:

r four hours shall not

Long term drift: Accuracy specification will be maintained over one y ear

CO2 Noise:

RMS noise of the sensor is less t han or equ al to

0.25 mmHg at 5% CO2

Sampling Rate:

100 ml/min +-15% of set value

Operating: 5º to 50ºC, 10 to 90% RH,

<90% RH,

Waveform, and parameters respiratory rate,

NETWORKING

Wired Networking:

Industry Standard: IEE E 802.3 wired network

Proprietary High Efficiency IR Source, no moving parts

Capnogram, displayed in less than 4 seconds, at an ambient temperature of 25°C,

41 – 76 mmHg ±5% of reading (5-10%) 76 – 150 mmHg ±8% of reading (10-20%)

Short term drift: Drift ove exceed 2 mmHg maximum

Compensations Barometric pressure Calibration Zero calibration based on time and t emp eratur e

or as well as on-demand No routine user CO2 calibration required.

Temperature and Humidity

non-condensing Storage: -40º to 70ºC,

non-condensing

Water Resistance (sensor ) IPX4 – Splash-proof (When gas dryer line is

connected to input)

Output Data

inspiratory CO2, PetCO2, Ti, Te

Balance gas compensat io n. Patient Population Adult Power requirements

480mW (typical with pump on)

1600mW (extreme status)

- 47 -

User’s manual for CLEO Patient Monitor

RJ45 interface and USB port

POWER

Source:

External AC Power and Internal Battery

AC Power:

100/240 VAC, 50/60 Hz, 150V

Battery:

Rechargeable Lithium ion battery, 7.2 V/2000

Operating time after the first alarm of low

Number of Batteries: 1

ENVIRONMEN T AL SPECIFICATIONS

Temperature:

Operating: 5～40 °C Storage: -10～45 °C

Humidity Range:

Operating: ≤80% Storage: ≤80%

mAh

Operating time under the normal condition:

3 hrs

battery: 10 mins

Charge Time: 8 hrs

Operating Time: 3 hrs

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User’s manual for CLEO Patient Monitor

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic

6 kV contact

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast

2 kV for power

output lines

2 kV for power

output lines

Mains power quality should be that of a typical commercial or hospital

Surge

1 kV

2 kV

1 kV

2 kV

Mains power quality should be that of a typical commercial or hospital

Voltage dips, short interruptions and voltage variations on power supply

<5 % UT1 (>95 % dip in UT) for 0.5

(60 % dip in UT) for 5

(30 % dip in UT) for 25

(>95 % dip in UT) for 5 sec

<5 % UT2 (>95 % dip in

(60 % dip in UT)

(30 % dip in UT)

(>95 % dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital

Patient Monitor requires continued

operation during power mains

Patient Monitor be power ed fro m an

Power frequency

IEC 61000-4-8

Power frequency magnetic fields should be at levels characteristic of a typical

environment.

EMC

The product is in radio-interference protection class A in accordance with EN55011. The product complies with the requirement of standard EN60601-1-2:2007 “Electromagnetic Compatibility - Medical Electrical Eq ui pment”.

ELECTROMAGNETIC IMMUNITY

This section constitutes the guidance and CLEO Patient Monitor’s declaration regarding electromagnetic immunity. The CLEO Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the CLEO Patient Monitor should assure that it is used in such an environment.

discharge (ESD) IEC 61000-4-2

transient/burst IEC 61000-4-4

IEC 61000-4-5

input lines IEC 61000-4-11

8 kV air

supply lines 1 kV for input /

differential Mode



differential Mode

cycle 40 % UT

cycles 70 % UT

8 kV air

supply lines 1 kV for input /

differential Mode



differential Mode

UT) for 0.5 cycle 40 % UT for 5 cycles 70 % UT

environment.

environment. If the user of t he CLEO

interruptions. it is recommended that the CLEO uninterruptible power sup ply or a battery.

cycles <5 % UT

(50/60 Hz) magnetic field

3 A/m

Note:

UT is the a. c. mains voltage prior to application of the test level.

for 25 cycles <5 % UT

3 A/m

- 49 -

location in a typical comm er ci al o r ho spi tal

User’s manual for CLEO Patient Monitor

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

150 kHz to 80

80 MHz to 2.5

Portable and mobile RF communications equipment should be used no closer to

Patient Monitor, including cables, than the recommended separation distance calculated from the

he frequency of the

 



 



5.3

 



 



5.3

 



 



Where P is the maximum output power rating of the transmitter in watts (W)

cording to the transmitter manufacturer

and d is the recommended separation

magneti c site

survey, a should be less than the range.b Interference may occur in the

vicinity of equipment marked with the

[NOTE 1]: At 80 MHz and 800 MHz, the higher fre quency range applies.

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

broadcast cannot be predicted theoret ically with accur acy . To assess the elect ro magnet ic env iron ment due t o fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field

Monitor is used exceeds the applicable RF

Patient Monitor should be obser ved to verify normal operation.

such as reorienting

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

Only ISA CO tested at 20 V/m

3 Vrms MHz 3 V/m

80%AM@2Hz GHz

20 V/m

80%AM@1kH z

GHz

3 Vrms

3 V/m

20 V/m

any part of the CLEO

equation applicable to t transmitter.

Recommended sep ar at i on distance:

80 MHz to 800 MHz

800 MHz to 2.5 GHz

ac distance in meters (m). Field strengths from fixed RF transmitters,

as determined by an electro

[NOTE 2]: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorptio n and reflection from str uctures, objects and people.

a. telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV

strength in the location in which the CLEO Patient compliance level above, T he CLEO If abnormal performance is observed, additional measures may be necessary, or relocating the CLEO Patient Monitor. b. Over the frequency ran ge 150 kHz to 80 MHz, field strengths should be less than 3V/m.

- 50 -

compliance level in each frequency

following symbol:

User’s manual for CLEO Patient Monitor

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Recommended separation distances between portable and mobile RF communications

The CLEO Patient Monitor is intended for use in an electromagnetic e nvironment in which radiated

Rated maximum

Separat i on dista nce according to frequency of transmitter [m]

150 kHz to 80 MHz

 



 



5.3

80 MHz to 800 MHz

 



 



5.3

800 MHz to 2.5 GHz

 



 



0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above, the recommended separation

in meters (m) can be estimated using the equation applicable to the frequency of the

(W) according

At 80 MHz and 800 MHz, the separation distance for the higher frequency range

These guidelines may not apply in all s ituations. Electro magnet ic propagat ion is a ffected

by absorption and reflecti on from structures, objects and people.

equipment and t he CLEO Patient Monitor

RF disturbances are contr oll ed. The customer or the user of the CLEO Patient Monitor can help prevent electromagnetic interference by maintain ing a minimum distance bet ween portable and mobile RF communications equipment (transmitter s) and the CLEO Patient Monitor as recommended below, acc or din g t o the maximum output power of t he com m unications equipment

output power of transmitter [W]

distance d transmitter, where P is the maximum output power rating of the transmitter in watts to the transmitter manufa cturer. [NOTE 1]: applies. [NOTE 2]:

- 51 -

Infinium CLEO User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

SAFETY INFORMATION

INTRODUCTION

INTENDED USE

ABOUT THIS MANUAL

CONTROLS, INDICATORS, AND SYMBO LS

FRONT AND SIDE PANEL

REAR PANEL

SYMBOLS

DISPLAY SCREEN PARTITION

SINGLE SPO2 DISPLAY

SINGLE ETCO2 DISPLAY

SPO2+ETCO2 DISPLAY

SPO2+NBP DISPLAY

SPO2 +NBP+ETCO2 DISPLAY

SPO2+NBP DISPLAY

System Setup

FACTORY SEVICING SETUP

SOUND VOLUME

ALARM SWITCH

MODULE SELECT

DEFAULT CONFIG

SAVE CONFIG

HOW TO MONITOR

ALARM & SOUND

ALARM

ALARM PRIORITY

VISUAL ALARM INDICA T ORS

SOUND

ALARM SOUND

PULSE-TONE

KEY BEEPS

MUTE

SPO2 MONITORING

SPO2 MONITORING PRINCIPLE

SPO2 SENSOR INSTALLLATION

SPO2 WAVEFORM SETUP

CHOOSE MODULE

Alarm Switch

PR Alarm Low

SpO2 Alarm Low

PR Alarm High

SWEEP SPEED

SWEEP COLOR

SPO2 PARAMETER SETUP

SPO2 ALARM HIGH

MEASUREMENT LIMITATIONS

SPO2 ERROR MESSAGES

NO IMPLIED LICENSE

[WARNINGS]

MEASUREMENTS

SENSORS

NELLCOR INFORMATION

TRADEMA RK A ND LICENSING LABELS

NELLCOR PATEN S

NO IMPLIED LICENSE

NIBP MONITORING

SUMMARY ON NIBP MONITORING

NIBP CUFF FITTING

Alarm Switch

NIBP MONITORING INITIALIZATION

NIBP PARAMETER SETUP

DISPLAY COLOR

INFLATION MODE

TIME INTERVAL

ALARM LIMIT SETUP

NIBP LIST OBSERVATION

MEASUREMENT LIMITATIONS

PATIENT MOVEMENT

CARDIA C A RRHYT HMIA `S

HEART-LUNG MA C HI NE

PRESSURE CHANGES

SEVERE SHOCK

HEART RATE EXTREMES

NIBP ERROR MESSAGES

MAINTAINENCE AND CLEANING

REUSABLE BLOOD PRESSURE CUFF