37
Head Office/Factory 687-5, Sangoan-ri, Hongcheon-eup, Hongcheon-gun, Gangwon-do, Korea (zip.250-804) Tel : +82-33-434-9041 Fax : +82-33-434-9043 Seoul Office/R&D 1406, Masters Tower, 553, Dohwa-dong, Mapo-gu, Seoul, Korea (zip.121-748) Tel : +82-2-714-29602 Fax : +82-2-714-2963 Customer Service Dept. Tel : +82-2-714-2962 Fax : +82-2-714-2963 Address of Region Representative ET MEDICAL DEVICES SPA VIA DE ZINIS 6, 38011 CAVARENO (TN) ITALY Tel : +39 0463 85 01 25 Fax : +39 0463 85 00 88 BIONICS Patient Monitor Series Operation Manual www.ebionics.co.kr

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Page 1: BIONICS Patient Monitor Series Operation Manual BIONICS Patient Monitor Series Operation Manual . OPERATION MANUAL ... as the battery, external cables, sensors, pressure cuff, hose,

Head Office/Factory 687-5, Sangoan-ri, Hongcheon-eup, Hongcheon-gun,Gangwon-do, Korea (zip.250-804)Tel : +82-33-434-9041 Fax : +82-33-434-9043

Seoul Office/R&D1406, Masters Tower, 553, Dohwa-dong, Mapo-gu,Seoul, Korea (zip.121-748)Tel : +82-2-714-2960∼2 Fax : +82-2-714-2963

Customer Service Dept.Tel : +82-2-714-2962 Fax : +82-2-714-2963

Address of Region Representative ET MEDICAL DEVICES SPAVIA DE ZINIS 6, 38011 CAVARENO (TN) ITALY Tel : +39 0463 85 01 25 Fax : +39 0463 85 00 88

BIONICS Patient Monitor SeriesOperation Manual

www.ebionics.co.kr

Page 2: BIONICS Patient Monitor Series Operation Manual BIONICS Patient Monitor Series Operation Manual . OPERATION MANUAL ... as the battery, external cables, sensors, pressure cuff, hose,

OPERATION MANUAL

Guardian(BPM-770)Patient Monitor (Ver 1.0)

(JUL. 29. 2010)

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Before using the product 3

Contacts 3

Product Guarantee 4

Symbols in the Manual 5

Precautions for use 6

Precations for Electrical Safety 10

Characteristics and Principles of Guardian 11

Composition of Guardian 12

How to set Guardian 13

Precations for Settings 13

Checkpoints Before Use 13

Maintenance and Cleaning After Use 15

Components of Guardian 16

Front & Operation Panel 16

Right side 17

Left side 18

Back side 19

Description of Product Symbols 20

Initial Screen 21

How to Use Guardian 24

How to Use 24

Alarms 25

Trends 27

Setup Setting 29

Default Setting 31

Printer setup(Optional) 32

Power & Battery Specifications 34

AC Power 34

Battery Specifications 34

Table of Contents

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ECG Me asurement 36

How to Connect ECG Cable 36

Change of ECG Lead 37

Arrhythmia setting 37

ST SEGMENT setting 39

Respiration Measurement 41

How to measure Respiration 41

Change of Respiratory Mode 42

Blood Pressure Measurement 43

How to Measure Blood Pressure 43

Change of NBIP Mode 44

SpO2 Measurement 45

How to Measure SpO2 45

Change the SpO2 Mode 47

Body Temperature Measurement 48

How to Measure Body Temperature 48

Change of Temp Mode 48

Press Measurement (Optional) 50

Press Setting 50

Change of IBP Mode 55

EtCO2 Measurement (Optional) 57

CO2 Gas Measurement 57

Sidestream CO2 57

CO2 Calibration 59

Before Requesting After - Sale Service 60

Product Specifications 63

Product Warranty 69

Before Using the Product / Contacts 3

Guardian Series

Thank you for purchasing Guardian

For safe and efficient operation, please read the manual to learn about the functions of the

product before use.

Please keep this manual nearby to assist you with operating the functions of the product.

The product should be used under the supervision of a medical- related certified professional.

The product is used for examining patient’s abnormal condition. For the safety of the patient, only

the components or the accessories recommended by our company should be used.

If you connect any accessories to the product that is not specified in the manual, please be sure to

notify our company or an agency authorized to distribute our products.

Before Using the Product

For various services and product information, please feel free to contact our salesperson at the

following number.

For any questions about use or setup of the product, please contact the following number.

Technical Support: BIONICS Co., Ltd. Tel: +82-2-714-2962

※ For reporting defects or abnormalities, please note the model name, product serial number,

purchasing date, and abnormal points before contacting us.

Contacts

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Patient Monitor

4 Product Guarantee Symbols in the Manual 5

Guardian Series

The product you have purchased comes with a 20 month warranty from the purchasing date or

a 2 year warranty from production date covering defective materials. For the accessories such

as the battery, external cables, sensors, pressure cuff, hose, the warranty for them is given for 6

months from the purchasing date.

We are not responsible for any physical, financial and mental loss or damage and direct or

indirect expenses caused by, or resultant from, accidental or special circumstances during the

use of the product. The warranty is limited to the repair or exchange of the product by the

authority of the company or the agency, for problems in materials or the manufacturing process

which occurred during use under normal circumstances.

The company has no legal responsibility for the confirmation of services, declarations or whole

warranty beyond the warranty specified above, which were supplied or will be supplied by the

agency or the staff of the company at their own discretion. The user cannot request the

company of services, declarations or whole warranty which were supplied or will be supplied

by the agency or the staff of the company at their own discretion based on the statements above.

The contents of this warranty represent all other warranties indicated or implied, and also

represent all kinds of service- related responsibilities of the product sellers for the product they

sell.

The product was manufactured under strict quality controls and the inspection process of the

company. The indemnification standard for product repair and exchange is according to the

Economic Planning Board notification “Regulation for the indemnification of consumer

damage”

Product Guarantee

Some symbols are used in this manual to help users or patients use this product safely and

appropriately and to prevent any risk to patients or damage to materials. Please read and

understand all warnings and precautions.

Each symbols mean :

Symbols in the Manual

The “Note” symbol is used to inform you of important, but not dangerous,information regarding installation, use, and maintenance of the product.

Use of this product is prohibited during MRI photographing. A fire may breakoutfrom the induced current, and the accuracy of the product and the MRI may beinfluenced by mutual interference.

All cables should be set properly. Cables and hoses etc. should be kept away fromthe patient, so that there is no possibility of the patient’s neck being entangled inthem, and the cables and lines should be well arranged for the safety of the staff inthe hospital.

The computerized ECG analysis should be judged by qualified medicalprofessionals, and it should not be the sole basis in determining necessity oftreatment for the patient.

NOTE

The “Caution” symbol indicates that a situation may occur resulting ininjury or damage to the patient, though not life-threatening, when thecaution is ignored.

CAUTION

The “Warning” symbol indicates that a dangerous situation may occurresulting in fatal injury or death of the patient, or may incur material andfinancial damage when the warning is ignored.

WARNING

WARNING

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6 Precautions for Use Precautions for Use 7

Guardian Series

Precautions for Use

Do not operate or store the equipment under the following environments.

Avoid the damp locations, and do not operate the equipment withwet hands.

Locations where the temperaturefluctuation is rather big.(Operational temperature range:10~45。C, Moisture level : 30~85%)

Locations where moisture levelcould go up considerably or whereair is not ventilated properly.

Locations where sudden impactor vibration could be received.

Locations close to electricalheating apparatuses.

Locations where exposed todirect sunlight.

Locations exposed to chemicalor explosive gas.

Disassembling of Product should bedone only by the authorizedpersonnel, otherwise we will not beobliged to provide any services at all.

When pulling out the power cord,be sure to grab the plug and pull,out, not the cord.

Do not plug in the power, until theinstallation is completed, otherwise,it can cause a damage to theProduct.

Make sure to prevent dust and especially metal debris, from penetrating in.

Standard operational conditions are as follows.- Temperature : 10℃ ~ 45℃ (50 ~ 113℉)- Altitude : 70 ~ 106Kpa- Humidity : 30 ~ 85%

Standard storage and transportation conditions are as follows.- Temperature : -10℃ ~ 50℃ (14 ~ 122℉)- Altitude : 70 ~ 106Kpa- Humidity : 20 ~ 95%

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Patient Monitor

8 Precautions for Use Precautions for Use 9

Guardian Series

Leakage, heating, ignition or rupture of the battery may cause fire or injury.

- Do not use batteries beyond those specified in this manual.

- Do not short-circuit the battery and do not heat, disassemble, or dispose of it in a fire.

- Do not mix using the used battery with new batteries , different kind of batteries,

other company batteries

- Do not insert batteries with (+) and (-) ends reversed.

When the product is not used for a long time, separate the battery from the

product.

When the product has been moved, make sure to turn it off and arrange the

accessories in order. Injured cords or cables may cause fire or electric shock.

CAUTION

In order to obtain the best results, theses instructions for use are especially

important when applying the specified sensors, and all warnings and cautions

should be obeyed. If the sensors are exposed to excess natural light, we

recommend that you cover the sensors with an opaque material. Excessive light

from operating lamps (especially xenon gas lamps), bilirubin (red-yellow) lamps,

fluorescent lamps and direct sunlight may influence the measurement results.

If results are not available at all or are inaccurate, please check the following:

- If the patient has poor blood flow, attach the sensors to other fingers or toes.

- Check if the sensor is properly placed.

- When the electric operation equipment is used, make sure the sensors are not

positioned close to the cables.

- The Sensor-attached site should be kept clean and not oily. Clean the sensor and

skin if necessary.

NOTE

Interpretation of the measurement value of arterial blood pressure should be

performed by medical professionals.

Arterial blood pressure may be influenced by the patient’s posture, physical

condition and other factors such as a patient’s movement.

The product may not work well when it is kept or operated beyond the

temperature and humidity specified.

Since the use of the inappropriate sensors such as a sensor that is too tightly

wrapped with adhesive tape or use of additional adhesive tape, lack of a periodical

check, or inappropriate setting of sensors may lead to skin injuries and inaccurate

measurement results. The user should read the manual and the precautions

carefully before use.

Premature neonates and patients with chronic pulmonary disease should be

checked for oxygenation levels before starting treatment.

Sensor-attached sites should be checked at least every 8 hours(every 4 hours for

reusable finger sensors on adults). Please check if the sensors are properly

attached, if the skin condition is normal, and if the sensors are well positioned.

Nail polish or calluses may obstruct measurement. Special care is required for

patients with poor blood flow. If the sensor attachment status is not checked

periodically, it may lead to skin injury by extended contact and necrosis from the

pressure. Patients with weak blood flow should be checked every 2 hours

If you want to turn off the Guardian while you’re operating, please use the power

switch where is the front of the product.

CAUTION

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Patient Monitor

10 Precautions for Electric Safety Characteristics and Principles of Guardian 11

Guardian Series

Precautions for Electric Safety

Please check the following points before use.

Is the product supplied with the appropriate power? (100~240VAC)

Are all connecting parts (power cables or the product) properly connected?

Is the product completely grounded? (If not, noise may occur.)

Before turning the power on, is the accessory for measuring the target parameter well connected

to the product?

Characteristics and Principles of Guardian

Guardian is Patient-monitoring equipment. Guardian measures the patient’s ECG, blood pressure

(invasive and noninvasive at two points), end-tidal partial pressure respiration (EtCO2), body

temperature (Temp), oxygen saturation of arterial blood and pulse (SpO2). Information on the

patient’s condition is displayed as numeric values and waveforms.

Guardian provides a variety of information about the patient. The user can choose the functions

they want to use. The vital sign information provided by the product includes ECG, heart rate,

respiratory rate based on respiration, maximum, minimum and mean blood pressure by invasive

and noninvasive methods and percentage of blood oxygen concentration measured by the changes

during a pulse cycle of arterial blood, pulse, and temperature.

The patient’s vital signs and condition are displayed on an LCD screen in realtime. The user can

set alarms or adjust the setting values using the buttons on the front. Guardian provides the basic

vital sign information of the patient to the user.

To prevent electric noise during use, the product should be installed apart from

dynamo, X-ray equipment, broadcast equipment or portable cables. An inaccurate

result may occur when these equipment are placed near the product. Guardian

requires an independent power circuit and a stable earth connection. Sharing power

with other electric equipment may result in inexact results.

NOTE

Guardian classified as follows :

It is a Class I equipment with defibrillation proof, Type CF grade for ECG, Resp,

IBP and BF grade for EtCO2, SpO2, NIBP and Temp.

Please do not use this product near inflammable anesthetics and diluents.

The noise level is “B” Class according to the IEC/EN 60601-1 (Safety of Electric

Medical Product), and the noise redemption is “B” Level according to the IEC/EN

60601-1-2 (Electromagnetic Compatibility Requirements)

Protection grade against water is “IPX 0”

NOTE

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12 Composition of Guardian How to Set Guardian 13

Guardian Series

Composition of Guardian (Accessories) How to Set Guardian

Standard Accessories

Optional

- ECG Cable 3 lead type - TROLLEY (Rolling Cart)

- SpO2 extension Cable - Wall Mount

- DISPOSABLE SpO2 SENSOR - Neonate Cuff

- Clip Type SpO2 sensor (Y-type) - Child Cuff

- Printer Module - Press Measuring Kit (IBP Kit)

- EtCO2 Kit set - Skin Temp. probe

- Electrode (50 PCS / 1SET) - Roll Paper

Main 1 setECG Cable

5 Lead Type (1EA)

SpO2 Finger Probe

(1EA)

Electrode

(5PCS/1set)

NIBP Hose (1EA) Adult Cuff (1EA)

Body Temperature

Sensor(For Rectal use)

(1EA)

Power Cord

Adapter(1EA)

15V 3Ah

Operation Manual

(1EA)

(1) Precautions for Settings

Pay attention when setting Guardian for the following points

- Use Guardian under conditions of 10℃ ~ 45℃ of circumstantial temperature and 30% ~ 85%

humidity.

- Check the connection status of the power cord.

- Do not connect multiple cords to the power supply.

- Place the main body on a flat area.

- If noise occurs, ground the equipment.

- Do not use any electric cords generating connecting noise.

- Take care since the product can be broken by mechanical shock.

- Get rid of dust or inflammable material near the product when setting it up.

(2) Checkpoints before Use

Check the following points before measuring the patient’s condition.

- Make sure there is no mechanical risk.

- Check the lead, power plug, and accessories connected on the outside.

Precautions Before Use ECG

① Do not use product near dynamo, X-ray equipment, broadcast equipment.

② Use disposable electrodes.

③ Do not twist the cable.

④ Attach each Lead properly.

⑤ Keep the patient motionless with comfortable position while measuring.

⑥ Sterilize Lead periodically.

Precautions Before Use SpO2

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14 How to Set Guardian How to Set Guardian 15

Guardian Series

① Do not use product near dynamo, X-ray equipment, broadcast equipment.

② Keep the patient motionless with comfortable position while measuring.

③ Sterilize sensor periodically.

Precautions Before Use Temp

① Do not use product near dynamo, X-ray equipment, broadcast equipment.

② Sterilize sensor periodically.

③ Use disposable hygiene cover.

Precautions Before Use NIBP

① Do not use product near dynamo, X-ray equipment, broadcast equipment.

② Do not twist hose

③ Keep the patient motionless with comfortable position while measuring.

Precautions Before Use IBP

① Do not use product near dynamo, X-ray equipment, broadcast equipment.

② Keep the patient motionless with comfortable position while measuring.

③ Do not twist cable

Precautions Before Use EtCO2

① Do not use product near dynamo, X-ray equipment, broadcast equipment.

② Keep the patient motionless with comfortable position while measuring

③ Do not twist cable

(3) Maintenance and Cleaning After Use

A. Keep the product cleans by cleaning it using a soft cloth at least once a month. Do not use

thinner, ethylene, oxidant or lacquer since these may damage the product.

B. Keep the accessories clean of dust or foreign materials. For cleaning, use a soft cloth and

clinical alcohol.

C. Do not soak the accessories in liquid or detergents. Keep the product and accessories out of any

liquid.

Maintenance and Cleaning after using ECG

① Sterilize Lead periodically after using

② Discard the disposable electrodes in designated locations.

③ Store the cable without twisting.

Maintenance and Cleaning after using SpO2

① Sterilize the Probe periodically after using.

② Store the cable without twisting.

Maintenance and Cleaning after using Temp

① Sterilize the Probe periodically after using.

② Discard the disposable covers in designated locations.

③ Store the cable without twisting.

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16 Components of Guardian Components of Guardian 17

Guardian Series

Components of Guardian

(1) Front & Operation Panel

① AC Power LED ⑦ NIBP START/STOP Button

② Battery LED ⑧ PRINT START Button

③ Power Button ⑨ EXIT Button

④ ALARM ON/OFF Button ⑩ MENU Button

⑤ SCREEN Button ⑪ ALARM STATUS LED

⑥ FREEZE Button

① PRINT FEED Button ③ PRINT POWER LED

② PRINT ERROR LED

(2) Right Side

① ①⑪

④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩

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18 Components of Guardian Components of Guardian 19

Guardian Series

(3) Left Side

① ECG/RESP Connection Terminal ④ SpO2 Connection Terminal

② IBP Connection Terminal (Option) ⑤ NIBP Connection Terminal

③ TEMP Connection Terminal ⑥ CO2 Connection Terminal (Option)

(4) Back Side

① PORTABLE HANDLE ⑤ Alarm Connection terminal

② ID LABEL / Battery Cover ⑥ LAN PORT

③ Grounding Port ⑦ RS-232 PORT

④ DC IN ⑧ VGA PORT

④ ⑤ ⑥ ⑦ ⑧

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20 Description of Product Symbols Description of Product Symbols 21

Guardian Series

Composition of Guardian (Accessories)

Icon Comments Icon Comments

Type CF Product,Defibrillation protected Alarm On/Off

Type BF Product,Defibrillation protected

Screen Change(Screen)

Stop Waveforms(Freeze)

Non Invasive BloodPressure Manual

Measurement (NIBP)

Start Printing (Printer)

Initial Screen (Exit)

Signal Input

Temperature

Oxygen Saturation

Use for ProgramUpgrade

Screen Transfer

Power stand-by switch

Attention, consultaccompanying documents

Ground

SYSTEM PowerOn/Off

Signal Output

Invasive BloodPressureIBP

ECG/RESP

NIBP

LAN Port

TEMP

SpO2

RS-232CPort

VGA Port

Electrocardiograph /Respiration

Non Invasive BloodPressure

Use for CentralMonitoring

(1) Initial Screen

(Fig1. Main Screen)

① WAVE Area : Display the graph of patient’s vital sign and condition

② MINI TREND : Display the Trend information of patient

③ FiCO2(Fractional concentration of carbon dioxide in inspired gas) : Display the Fractional

concentration of carbon dioxide in inspired gas of patient.

④ RR, TEMP : Display the respiration and temperature value of patient

⑤ IBP : Display the Invasive Blood pressure of patient.

⑥ NIBP : Display the Non Invasive Blood Pressure of patient.

⑦ SpO2 : Display the Oxygen Saturation of Patient

⑧ HR : Display Heart Rate.

⑨ Time : Display the present time

⑩ Each Measurement Mode Icons : Display the measurement and Lead off etc.(Refer to next

page <Table 1 : Explanation of Screen Icons >)

⑪ Patient Information : Use to set the room and bed of patient.

⑪ ⑩ ⑨

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22 Description of Product Symbols Description of Product Symbols 23

Guardian Series

(A) (B)

(D) (C)

Icon Meaning How to display

ECG Lead Fault & Lead off Flickers at 1-second interval

Arrhythmia Detect Flickers at 1-second interval

Pacemaker Detect Flickers at 1-second interval

No Finger & No Sensor Flickers at 1-second interval

On NIBP measuring Flickers at 1-second interval

NIBP measurement Error Flickers at 1-second interval

NIBP Over Pressure Flickers at 1-second interval

NIBP Auto pressurization Fixed. Fixed.

IBP1 Lead Fault Flickers at 1-second interval

Temp1 Lead Fault Flickers at 1-second interval

Alarm OFF Fixed when Alarm OFF is set.

Alarm Suspend: Automaticallycancelled after 2 minutes. Flickers at 1-second interval

Printing Flickers at 1-second interval

Waveform stop Flickers at 1-second interval

AC in use Fixed.

Battery in use Fixed.

(Table 1) Explanation of Screen Icons

Guardian provides 4 different screens to use “Screen” button.

4 screens are as follows.

A. Full Parameters Screen (Main Screen)

B. 1 (ECG Wave) and 6(ECG, SpO2, NIBP, RR, TEMP, CO2) Parameters Screen

C. 1 (ECG Wave) and ALARM Occurrence Information Screen

D. TREND Screen

NOTE

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24 How to Use Guardian How to Use Guardian 25

Guardian Series

How to Use Guardian

(1) How to Use

Turn on the main power switch at the back of the product. Check the light-on

status of the AC LED in the front, and push the power switch 1~2 seconds to

turn it on.(If any problems occur, refer to the “How to solve the problems”

section in the manual )

If you want to change the setting value etc. during use, push the Menu button

to change the setting values per each measurement parameter

When the measurement sensor is connected to the patient, the information to

the patient is displayed as values and waveforms on the LCD screen.

Refer to the table below for the details of how to measure each parameter.

- ECG measurement Page 39

Page 44

Page 46

Page 48

Page 51

Page 52

Page 59

- Respiration measurement

- Blood pressure measurement

- SpO2 measurement

- Body temperature measurement

- IBP (Press) measurement(optional)

- EtCO2 measurement(optional)

Step 1

Step 2

Step 3

Step 4

(2) Alarms

Different alarms are provided in Guardian for the sake of the user’s convenience. Please read

carefully the contents of this section in order to learn how to interpret and react appropriately to

the alarms.

High Alarm

- The High alarm will sound when the measurement values exceed the proper range.

- In High alarm, 5 alerting sounds ring for 2 seconds, for a total of 10 times. After 8 seconds,

the alerting sounds are repeated.

Information Alarm

- The information alarm rings to notify you of any announcements or if there has been an error

measurement.

- The information alarm sounds like a chime bell, and rings at an interval of 5 seconds to alert

the user.

- The information alarm rings for the following situations:

a. If there is a failure in the NIBP measurement or overpressure.

b. At Lead fault or Lead off during measurement.

c. If the finger is not attached to the finger probe during measurement of SpO2.

d. If the battery is low.

- When the information alarm rings, it can be cancelled by operating the function switch or

Menu switch. (The Exit switch is recommended.)

The alarms in the product conform to the international standard “EN 475:1995”

- A High alarm and Information alarm were adopted in Guardian

We recommend that you listen to the alarms before using the product.

NOTE

Push the Power button 1~2 seconds when turn it off and then “Power off”

massage will be displayed.

NOTE

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26 How to Use Guardian How to Use Guardian 27

Guardian Series

How to set the alarm

To change the alarm setting, push the Menu button once to select “Alarm”

▶ Alarm Range

Step 1

Parameter

ECG [bpm]

SpO2 [%]

Systolic

Diastolic

Mean

Systolic

Diastolic

Mean

IBP[mmHg]

NIBP[mmHg]

Setting rangeHIGH LOW

10 ~ 300, OFF

21 ~ 99, OFF

40 ~ 295, OFF

30 ~ 285, OFF

35 ~ 290, OFF

5 ~ 149, OFF

40 ~ 295, OFF

30 ~ 285, OFF

35 ~ 290, OFF

20℃ ~ 49℃, OFF

2% ~ 99%, OFF

OFF, 5 ~ 295

OFF, 20 ~ 98

OFF, 30 ~ 290

OFF, 25 ~ 280

OFF, 30 ~ 285

OFF, 1 ~ 145

OFF, 30 ~ 290

OFF, 25 ~ 280

OFF, 30 ~ 285

OFF, 10℃ ~ 40℃

OFF, 1% ~ 98%

RESP [rpm]

TEMP [℃]

EtCO2 [%]

(3) Trends

To check the Trend date for the

patient being measured, push the

Screen button three times

1. The saved Trend Date can

bechecked using the Menu button

by moving it to the left or right.

2. Trend Date is saved from the right

to the left

For the sake of the user’s convenience, the function of Alarm On/Off functions

are added to each parameter. The state of Alarm On/Off does not affect the setting

values of the alarm.

NOTE

Guardian Trend Data provides 4320 data in total at an interval of 1minute for 72

hours.

NOTE

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28 How to Use Guardian How to Use Guardian 29

Guardian Series

(Fig 2. Trend Screen)

① Parameter name for measurement

② Time of the storage

③ Standard bar

(4) SETUP Setting

The setting of the basic default value, print setting, volume adjustment and language selection

can be changed at the user’s convenience.

Setup is as follows.

To change the SETUP setting, push the Menu button once to select SETUP

▶ By operating as detailed above, you can change the setting of each SETUP menu.

Step 1

If you are moving the MENU button to the left or right fast, function of the

searching is going to be fast.

NOTE

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30 How to Use Guardian How to Use Guardian 31

Guardian Series

Setup Menu

LEAD TYPE 3 LEAD/5 LEAD Select ECG Lead Cable

TRACEECG1,ECG2

SpO2,IBPRESP,EtCO2

Select Wave displayed on thescreen.

NUMERICSpO2

IBP,NIBPRR/TEMP,EtCO2

Select parameter displayed onthe screen.

TRAND TRACE/TIME Indicate TREND on first screen.

BED NUMBER 0~99 Input the BED number

PATIENT NAME Input the patient name

PATIENT

SOUND

Adult / Neonate

HR,ST LEVELSpO2

IBP,NIBPRESP/TEMP

EtCO2

Select the adult or neonate

Setup the existence of Soundwhen parameter alarm occurs

DATE / TIME

YEAR : 2000 ~ 2050MONTH : 1 ~ 12DATE : 1 ~ 31HOUR: 0 ~ 23

MINUTE : 0 ~ 59

Input the date/ time

LANGUAGE

ENGLISH ,SPANISHGERMAN, ITALIANFRANCE, CHINESEPOLISH,RUSSIAN

CZECH

Select the language

SOUND VOL.

PRINTER

0 ~ 7

Refer to Page 35 : Printer Settings

Set Beep Sound

Initialize

DEMO

EXECUTE

ON / OFF Setup the Demo

NETWORK

NURSECALL

Setup the Network

ON / OFF Setup the wire remote buzzer

Range of change Explanation

Parameter

ECG

Lead II II

Speed 12.5 mm/sec 12.5 mm/sec

Gain 10 mm/mV 10 mm/mV

Filter 1.0 ~ 40 Hz 1.0 ~ 40 Hz

HR > High Limit 150 bpm 200 bpm

HR < Low Limit 50 bpm 100 bpm

RESP

APNES Time OFF OFF

High Limit 30 rpm 100 rpm

Low Limit 5 rpm 30 rpm

Size 2.0 Ohm 2.0 Ohm

Speed 6.3 mm/sec 6.3 mm/sec

SpO2

High Limit OFF 95 %

Low Limit 90 % 80 %

Gain X 2 X 2

Speed 12.5 mm/sec 12.5 mm/sec

NIBP

NIBP Mode Manual Manual

Interval 60 60

High Alarm Limit 160/90(110) 90/60(70)

Low Alarm Limit 90/50(60) 40/OFF(OFF)

IBP

Label ABP ABP

Scale Optimum Optimum

Speed 12.5 mm/sec 12.5 mm/sec

High Alarm Limit 150/120(130) 90/60(70)

Low Alarm Limit 80/60(70) 55/OFF(35)

TEMPHigh Alarm Limit 39℃ 39℃

Low Alarm Limit 30℃ 36℃

EtCO2High Alarm Limit 45 45

Low Alarm Limit 10 10

Range of change Explanation Explanation

(5) Default setting

The default settings of the values can be used, without the need of changing the setting values of

each parameter.

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32 Printer Setup (Optional) Printer Setup (Optional) 33

Guardian Series

Printer Setup (Optional)

The patient’s information can be printed out using the printer.

To change the printer setup, push Menu button to select SETUP

PRINTER

Step 1

▶ By operation as detailed above, you can select the function of the Printer mode.

Setting Mode

SYNC

MODE

SOURCE

SIZE

Alarm / Manual

Wave+Trend / Wave / Trend

ECG2/SpO2/IBP/RESP

120 ~ 300mm(To be adjusted at 15mm unit)

When “Alarm” is selected, the date is automaticallyprinted out if the data is out of range.

Print the waveform and Trend Data / waveform only /Trend Data only.

Select the waveform to be printed out (ECGwaveform is printed out as a basic factor.)

Select the length of printed paper.

Range of change Explanation

<Ex :Trend printing>

<Ex:Wave printing>

Do not print greater than consecutive 3 times

There is possibility of fire, Do not use printing for 5min. after consecutive 3 times

of printing

CAUTION

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34 Power & Battery Specifications Power & Battery Specifications 35

Guardian Series

Power & Battery Specifications

Both AC and DC power is used for Guardian. Basically, AC power is used and a rechargeable

battery is available for portable use.

1. AC Power (110 ~ 240 VAC)If the AC power is connected to the main body of the product, a light-green color lights up on

the AC LED on the front. If the product is not being used, the power changes automatically to

the recharging mode.

Battery 상태 설 명

Battery full

After use for 50 ~ 60 minutes

Requiring recharging

Low Battery requiring recharging

2. Battery SpecificationsWhen the AC power is disconnected and the switch is turned on, the power is supplied using

the battery, signaled by the orange light on the battery LED.

A. Signs for Battery

B. Time for 1ea of battery

Recharging time : 9 Hours or more

Use time :120 Minutes

C. Natural lifetime for spontaneous discharge of battery

The table below shows the lifetime for spontaneous discharge of the battery when the product

is unused.

Storage temperature Life for spontaneous discharge

0℃ ~ 20℃

21℃ ~ 30℃

31℃ ~ 45℃

9 months

6 months

3 months

D. Type of Battery

The same sort of battery should be used for replacement.

- Model : 3S2P(LS18650)

- Type : LI-Ion Battery

- Manufacturer: BTS Power

E. Time for the Battery exchange

The lifetime of the battery gets shorter if it is not 100@ recharged for use

The battery is recharged when AC power is confirmed.

Charge / Discharge ration Number for use

100 % Charge / discharge

50 % Charge / discharge

30 % Charge / discharge

1200 times

500 times

200 times

During operation using AC power, noise may occur in the waveform. If this is the

case, ground the product soundly.

An AC power connection in a wet or damp area may cause electric shock or fatal

damage to the product.

There are more chance to get fire or heating to use printer constantly. Please do

not use 5 minutes after using 3 consecutive times.

CAUTION

When the battery is disconnected, all data (Trend, Setup values and time etc.) are

saved in the memory within Guardian for about 3 days. If the product is kept off

of the battery for more than 3 days, all the data may be deleted.

CAUTION

For the protection of the environment, please contact the agency you purchased

the product from when you wish to discard the battery.

Contact the agency you purchased battery in case battery should be changed.

CAUTION

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36 ECG Measurement ECG Measurement 37

Guardian Series

ECG Measurement

(1) How to Connect the ECG Cable

Connect the ECG cable to the ECG/RESP connection terminal of themeasurement module.

Step 1

To change the printer setup, push Menu button to select SETUPStep 2

<If 5 leads are attached> <If 3 leads are attached >

Lead Color of electrode

RA (R)

LA (L)

LL (F)

RL (N)

V (C)

White

Black

Red

Green

Brown

Attaching site

Just below the clavicle (scapula) near the rightshoulder

Just below the clavicle (scapula) near the leftshoulder

Lower area of the left side of the abdomen

Lower area of the right side of the abdomen

Select the candidate lead for measurement amongthe chest leads

(2) Change of ECG Lead▶ To change the setting of the ECG Lead waveform, push the Menu button to obtain the

pull-down menu below.

(3) Arrhythmia SettingArrhythmia in ECG has the function which judges the abnormality of the heart cardiac

ventricle.

BIONICS diagnosis program A can detect the below 3 kinds of Arrhythmia which can be fatal

on patient’s life

With the use of an electric pacemaker, do not touch the patient, table, or other

equipment.

Check if the ECG cable is damaged before taking the ECG measurement. (A

damaged ECG cable cannot protect the patient.)

Do not use disposable electrodes. (They may cause noise.)

WARNING

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38 ECG Measurement ECG Measurement 39

Guardian Series

Asystole (ASY)

Ventricular Tachycardia (V-TAC)

Ventricular Fibrillation (V-TAC/V-FIB)

BIONICS diagnosis program B can detect the below kinds of Arrhythmia except the above

mentioned 3 types

Asystole

Ventricular Tachycardia

Ventricular Bradycardia

Ventricular Fibrillation

PVC

R-on-T

Missed Beat

Tachycardia

Bradycardia

Bigeminy

Trigeminy

Couplet

(4) ST SEGMENTThe value of ST Level can fall or rise unusually in case myocardial infarction occurs . It is

clinically necessary to observe the value of ST Level in all of LEAD. BIONICS ST Level

program measures each value of ST Level of LEAD I and LEAD II. LEAD I is fixed for

Channel 1 and LEAD II is fixed for Channel 2. The unit for ST Level is mV and in ascending

case, it is expressed as + sign, in descending case, it is expressed as - sign.

1) ST Level Condition

2) ST Level program of Bionics gets the value of ST Level on the basis of -78ms(ISO)

and +109ms(ST) with R peak as the center

ST Point Range of Change

Datum point for ST Level measurement

ST Point

J Point + 0ms

J Point + 30ms

J Point + 40ms

J Point + 50ms

J Point + 60ms

J Point + 80ms

Arrhythmia diagnosis program is designed to detect the abnormality of the

ventricular. However, it may occur not to judge exactly the existence of

Arrhythmia. Therefore, in case Arrhythmia is detected, the judgment of the

clinical specialist is positively necessary

WARNING

In case of measurement Arrhythmia, it is principle to fix LEAD at LEAD II of the

channel 1.

WARNING

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40 ECG Measurement Respiration Measurement 41

Guardian Series

▶ By operating as detailed above, you can select each function of the ECG mode.

Setting Mode Range of Change

LEAD

GAIN

SPEED

FILTER

AREA

ALARM

ST SEGMENT

ARRHYHMIA

PACEMAKER

LEAD I, II, III, aVR, aVL, aVF, V

5, 10, 15 mm/mV

6.3, 12.5, 25 mm/sec

0.5 ~ 40 Hz

0.5 ~ 80 Hz

0.05 ~ 40 Hz

0.05 ~ 80 Hz

1.0 ~ 40 Hz

5.0 ~ 20 Hz

50, 60 Hz

High (10 ~ 300bpm) range

Low (5 ~ 295bpm) range

Alarm ON/OFF

DIAGNOSIS ON/OFF

DIAGNOSIS ON/OFF

DIAGNOSIS ON/OFF

Explanation

Change the ECG Lead on screen

Set the size of ECG waveform

Set the speed of ECG waveform

Set the analog and digital filter

of the ECG waveform

If there is input, the eliminationfrequency is set.

Set the upper limit of HR

Set the lower limit of HR

Alarm operation / rest

LEVEL check / rest

Arrhythmia check / rest

Defibrillator check / rest

<Sites for 3 leads attachment> <Sites for 5 lead attachment>

Respiration Measurement

Changes in the chest impedance resulting from the patient’s respiration is measured and displayed

as a waveform and the values will appear on the screen.

(1) How to Connect the ECG Cable

Connect the ECG cable to the ECG/Res connection terminral of themeasurement module.

Step 1

Attach the electrodes for respiration measurement by referring to the figuresbelow.

Step 2

Respiration is measured with the ECG and HR etc., using the ECG cable.

Do not judge the patient’s condition only with the respiratory value and the

waveform.

NOTE

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42 Respiration Measurement Blood Pressure Measurement 43

Guardian Series

Blood Pressure Measurement

(1) How to Measure Blood Pressure

(2) Change the Respiration Mode▶ To change the setting of respiratory waveform, push the Menu button to

select RESP.

▶ By operating as detailed above, you can select each function of the RESP mode.

Setting Mode Range for Change

SPEED

SIZE

TRACE

6.3, 12.5, 25 mm/sec

0.5, 1, 2, 4 OHM, OPTIMUM

ON / OFF

Explanation

Set the speed of RESP waveform

Set the size of RESP waveform

Set the display of waveform

Connect the gray hose to Guardian as shown below.Step 1

Wrapping the cuff to tight or too loose on the measuring site may cause errorsin the value.

Step 2

The Alarm setting for Apnea can be set up in ALAR → RESP → APNEA by

MUNE button

■ APNEA Alarm Range : OFF, 10 ~ 60 seconds (Adjustable by 1 sec. unit )

NOTE

Check if the cuff and hose are damaged before measuring blood pressure. A

damaged apparatus may cause inaccurate results.

A patient’s movement during measurement may cause inaccurate results.

Choose the cuff type which is appropriate to the patient.

NOTE

Do not use the NIBP Cuff for other purposes except blood pressure measurement.

Blood pressure cannot be measured on the upper arm of the patient, in case the

artificial infusion set or catheter is inserted.

WARNING

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44 Blood Pressure Measurement SpO2 Measurement 45

Guardian Series

(2) Change of NIBP Mode▶ To change the setting of NIBP mode, push the Menu button to select NIBP.

▶ By operating as detailed above, you can select each function of the NIBP mode.

Set Mode Range for Change

AUTO

INTERVAL

LIST

CALIBRATION

ON / OFF

2 ~ 120 min

SYS / DIA / MEAN

-

Explanation

Select automatic or manualmeasurement

Select the time interval, when set toautomatic measurement

Indicate measuring value before 30

Contact to the agency.

SpO2 Measurement

The concentration of oxygen saturation means the saturation level of hemoglobin which can

transport the oxygen of the arterial blood. The current transport level for the capacity of

hemoglobin to transport the oxygen is expressed as a percentage.

(1) How to Measure SpO2

After measurement NIBP, if the “EXIT” button is pressed, the measured value is

disappeared on the display. (The measured value is normally saved in the Trend)

NOTE

While the MRI is used, measurement using the sensor may cause severe burning.

If this occurs during normal use, remove the product immediately from the

patient.

Do not place the probes at the site where the arterial catheter or the venous

infusion set is connected.

For neonates, measurement should be made outside the incubator using the

disposable sensor. (Humid conditions in the incubator may affect the

measurement, resulting in inappropriate data.)

NOTE

Strong light interferes with accurate measurement. In this case, cover the sensor

with an opaque material.

For patients with thick or dark skin, or with weak blood flow and weak signs, the

oxygen concentration level may appear lower than it is.

In patients with abnormalities in the peripheral nervous system including

hypothermia, hypovolemia, hyperdynamia of vessels or reduction in heart rate, the

vital signs may not read properly due to these abnormalities.

In patients with an abnormal increase in oxyhemoglobin or methemoglobin, the

data for SpO2 will not be accurate.

Check if the sensors release light, if the sensors are positioned properly opposite,

and if the light release to the patient’s tissue.

CAUTION

The automatic measurement mode (AUTO pressing) is cancelled in the following cases:

■When the blood pressure measurement fails 3 consecutive times.■When overpressure occurs. (Cuff pressure over 280 mmHg)■When the power is On/Off.

When the automatic measurement mode is cancelled, the user should reset the

AUTO pressing to let it operate normally.

WARNING

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46 SpO2 Measurement SpO2 Measurement 47

Guardian Series

Connect the SpO2 probe to the connection terminal of the measurementmodule.

Step 1

Attach the probe to the finger. (If measured with NBP at the same time, theSpO2 probe should be positioned on the opposite arm. Concurrent use of othermedical devices affecting blood flow should be avoided. The probe should beattached at a site that avoids those affected by medical interference.)

Step 2

For stable measurement, have the patient minimize their movement and bandthe probe cable with the finger. Care should be taken to not let the bandinginterfere with blood flow.

Step 3

(2) Change of SpO2 Mode▶ To change SpO2 mode, push the Menu button to select SpO2.

▶ By operating as detailed above, you can select each function of the SpO2 mode.

Set Mode Range for Change

GAIN

SPEED

TRACE

x1, x2, x3 OPTIMUM

6.3, 12.5, 25 mm/sec

ON / OFF

Explanation

Set the size of SpO2 waveform

Set the speed of SpO2 waveform

Set the display of waveform

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48 Body Temperature Measurement Body Temperature Measurement 49

Guardian Series

Body Temperature Measurement

Changes in impedance according to the change in the patient’ s body temperature is perceived by

the temperature sensor, and then displayed numerically on the screen after a series of calculations.

(1) How to Measure Body Temperature

MENUECG ▶

SpO2 ▶

IBP ▶

NIBP ▶

RESP ▶

CO2 ▶

ALARM ▶

SETUP ▶

EXIT ▶

ALARMHR ▶

ST ▶

SpO2 ▶

IBP ▶

NIBP ▶

RESP ▶

TEMP ▶

EtCO2 ▶

+Return

HRHIGH ▶ 39LOW ▶ 30SOUND ▶ ON+Return

HIGH LIMIT[Push Encoder] 39 20-49

Connect the temperature sensor to the connection terminal of the measurementmodule.

Step 1

(2) Change of TEMP Mode▶ To change TEMP mode, push the Menu button to select Alarm

▶ By operating as detailed above, you can select each function of the TEMP mode.

Set Mode Range for Change

High limit

Low limit

ON / OFF

20 ~ 49℃

10 ~ 40℃

ON, OFF

Explanation

Set the maximum limit of alarm

Set the minimum limit of alarm

Alarm ON, OFF

The temperature sensor provided with the product is of the rectal type.

The temperature sensor should be sterilized before application to another patient.

NOTE

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Press Measurement (Optional) 51

Guardian SeriesPatient Monitor

50 Press Measurement (Optional)

Press Measurement (Optional)

(1) Press Setting

A transducer which can be protected from electric shock and electrical impulses should be used. It

can be used during the electric operation of the device.

During defibrillation of a patient, the measurement values may be inaccurate. After defibrillation

and a continuous normal state, accurate measurement values will return.

Composition of Monitoring Accessories

Connect the monitor interface cable to the press connection terminal of themeasurement module.

Step 1

In a clean environment, open the package to check if all parts are wellconnected and if the handle of the stopcock is positioned properly.All side ports of the stopcock are protected by the outlet plugs and may not beremoved till the system is full and the foam have been removed. These outletplugs should always be replaced with other outlet plugs. (A pouch is includedin the kit.)

Step 2

Connection of the converter interface cable

1. Hold the backside of the clear cover surrounding the connector, and connectthe converter to the reusable monitor interface.

2. Push the connecter gently into position. If it is well connected, the tap of theconverter connecter will fit the slot of the reusable connecter snugly.

Step 3

Only the transducer specified by the company can be used.

NOTE

Do not reuse the disposable transducer.

WARNING

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52 Press Measurement (Optional) Press Measurement (Optional) 53

Guardian Series

Blood pressure for a liquid infusion line over 300mmHg requires an infusion of more than

3cc per hour. In this case, the blood pressure must not exceed 15psi (775mmHg). A

protective function is set in the flush device, which prevents overpressure of the converter

by making the liquid bypass the device. If a more precise control of fluid volume is

required, it is necessary to connect the infusion pump around the flush device.

Priming and TipsStep 5

3. To remove the converter from the cable, push the tap gently inside the clearcover and then separate the reusable interface cable.

Hold both sides of the flush operator and pull upward gently.Do not revolve the operator and take care not to put the power on one side.

Step 4

Priming should be done slowly! - Slow priming will lessen the effort to remove air bubbles

afterward.

Prime using gravity! - Pressing may result in leakage of liquid or bubbles by forcing the liquid to

flow into the system. If small bubbles flow too slowly inside the system, lift up the supply bag.

1 inch corresponds to 2mmHg, and the primed 4-feet line gives a pressure of about 100mmHg if it

is completely spread out The solution bag should be placed at a higher position than the converter

and the pressing tube, in order for priming using gravity.

1. Twist the sterilized solution bag lightly using a drip chamber spike.

2. Open the roller clamp and remove the air inside the bag completely by squeezing using an

infusion set or an 18-gauge needle inserted into the injection port in the back. By emptying the

back this way, it can prevent air input into the patient’s body.

3. Before inputting the solution into the infusion set, push both sides and fill the drip chamber

partially.

4. Operate the flush device gently. Since air rises from the bottom, make sure that the solution is in

the bottom at all times.

5. Prime the side ports and the plug of the zero point stopcocks in the converter using a door-lock

plug. <Caution: The stopcocks of the converter or the outlet should be locked before connecting

the door-lock plug.>

6. Check if bubbles are present in the monitoring system. To check the presence of invisible

bubbles, rap it lightly.

Transducer Connecting piece Monitor Interface Cable

Do not use the blood pressure monitoring kit with the nonseparated blood

pressure monitor. Do not twist the cable. Reusable interface cable cannot be

sterilized by autoclaving.

NOTE

If a fast flush is performed on the patient, the user should check carefully for the

presence of foam and particulate matter. If a large volume is flushed by force, a

short flush with an increase rate less than 2cc is recommended to avoid central

embolism.

CAUTION

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54 Press Measurement (Optional) Press Measurement (Optional) 55

Guardian Series

7. Add pressure to the system up to 300mmHg using C-fusor or the clear cuff. Flush the system

for 2~3 seconds. Check for the presence of air bubbles which may result from a fast flush. Now,

the system is ready for zero point setting and measuring. Place the stopcock in a 90 degree

position to let it off state.

Be sure to never position it at 45 degrees. A wrong setting of the stopcock handle may cause

infection, bleeding, or air embolisms in the patient.

Adjustment of Zeropoint of the ConverterStep 6

1. Place the zeropoint port at the area of the right atrium, the middle of the axilla, and the fourth

intercostals area, and then place the converter and the kit in a proper operating site. Some

version of the blood pressure conversion kit is provided with the patient’s IV rod or the

accessories needed for various settings.

2. Lock the zeropoint stopcock (toward OFF) and release the converter according to the air

pressure.

3. Conduct zeroing by pushing the zeroing button of the module or select zeroing-one from the

menu in the IBP setting menu.

If the fix plate is used, fix it as below.

ABP

CVP

ICP

PAP

Arterial blood pressure

Central venous pressure

Intracranial pressure

Pulmonary arterial pressure

Artery group throughout the wholebody (systemic)

Central vein / atrium group

Intracranial group

Pulmonary artery group

(2) Change of IBP Mode▶ To change IBP mode, push the Menu button.

< Table for labels according to the site of measurement> >

Care should be taken not to let air bubbles inside the 3-way outlet stopcock or the

cannula reflush into the patient. To check, confirm if the monitoring line is fully

filled with liquid before connecting the monitoring line and let a small volume of

blood flow through the cannula.

CAUTION

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56 Press Measurement (Optional) EtCO2 Measurement (Optional) 57

Guardian Series

Set Mode Range for Change

SPEED

LABEL

* ZERO

SCALE

TRACE

6.3, 12.5, 25mm/sec

ABP, CVP, ICP, PAP

ON

OPTIMUM / FIXED

ON / OFF

Explanation

Set the speed of IBP waveform

Set the level according to themeasurement site of BP.

Change the alarm setting rangeaccording to level.

Adjust the zeropoint of the transducer

Set the wave scales

Set the display of waveform

MEDEX

MX 9504T

MX 95104

MX 240

MX 800

Explanation

IBP D.P.T Monitor kit

IBP Cable

IBP Clamp

IBP Plate

▶ By operating as detailed above, you can select each function of the IBP mode.

* Adjust the zeropoint of the transducer : In order to obtain accurate results, make sure to adjust

the zeropoint of the transducer before measuring the patient.

** Fixed : Basic value according to the established label (ABP:0~200, CVP:0~50, ICP:0~50,

PAP:0~50)

*** Optimum : Scale of waveform is automatically adjusted regardless of the level.

<Composition of IBP KIT >

EtCO2 Measurement (Optional)

(1) CO2 Gas MeasurementNot only Mainstream CO2 but also Sidestream CO2 can be installed in Guardian

Those Mainstream/ Sidestream CO2 provides the function of ETCO2, the respiratory CO2, the

function to measure respiration rate.

The display and menu about EtCO2 are automatically reconstituted depending on attachment

or detachment CO2 module.

(2) Sidestream CO2

A. Connect one side of the gas outlet to the gas outlet of Guardian and the other side to the air

elimination system of the hospital.

B. Open the spring-type door and connect the filterline appropriately to the equipment. The

other end is then connected to the patient.

C. Respiratory rate is automatically changed during measuring EtCO2. The calculated value of

the chest impedance change is shown in case of stop measurement.

The maximum sampling rate of the nose tube is 50mL/min. The product should

not applied to patients who may experience respiratory distress by the vacuum

flow level.

To prevent infection of the medical staff by the patient’s respiration sample, the

outlet of Guardian should be connected to the air elimination system of the

hospital.

WARNING

The gas inspiring vacuum pressure (negative pressure) of the gas elimination

system should not exceed the pump outlet standard of Guardian, 1mmHg.

Excessive pressure will display the message of “OCCULSION” and it may

damage the Guardian product pump. During zeroing, the air elimination system

should be operating.

WARNING

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58 EtCO2 Measurement (Optional) EtCO2 Measurement (Optional) 59

Guardian Series

D. If GUARDIAN senses proper respiratory movement, it displays the level of EtCO2,

inspired CO2, and respiration rate.

E. The respiratory waveform and data of EtCO2 is displayed. If the waveform does not appear,

set the Menu --> EtCO2 ---> TRACE --> ON.

F. If necessary, the size of the CO2 waveform can be adjusted by using the menu.

(3) CO2 CALIBRATIONThe accuracy validation for the CO2 should be performed once a year or when the

measurement results are not accurate.

A. Select EtCO2 --> Calibration by pressing MENU button

B. It is starting Calibration with message “Zero in Progress” on display of EtCO2 Wave

C. If the message “Zero In Progress” is disappeared, the Calibration is normally completed.

Massage

Wait For Sensor

Check Adaptor

Zero Require

Explanation

Self initialization process of EtCO2 module when power is on(the measurement may be inaccurate during this period)

Not connected to the accessory

Need the Calibration

* During Measurement mode

Massage

Zero In Progress

Explanation

Progressing the CALIBRATION

* During Calibration mode

Connection of all tubes should be safe, and the nose cannula should be kept away

from the CO2-present area during the warming up period (including the outlet of

the ventilator and the respiration of the user).

Range for Measuring : 0 ~ 150bpm

NOTE

For the best accuracy, a warm-up of about 20 minutes is required.

NOTE

Refer to the following diagrams during the EtCO2 measurement.

NOTE

CO2 waste and CO2 filter should be treated as fatal biological materials for the

human body.

CAUTION

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60 Before Requesting After-Sales Service Before Requesting After-Sales Service 61

Guardian Series

Before Requesting After-Sales Service

This section shows how to treat simple problems encountered during use.

Please check the following points before requesting after-sales service.

Sign

The power of the product isnot turned on.

The power of the product turnsoff suddenly during use.

The power of the product isnot turned on.

The waveform is not normal.

1. Check if the AC power is supplied..2. Press and hold the power button for 2 seconds

1. Check if the power is off due to battery release.2. Check if AC power is supplied to the product.

1. Press the power button during 1~2 seconds2. Check if “Power off” message is shown in display.

1. Check if there is any equipment with a strong magnetismaround the product.

2. Check if the cable connection is stable.3. Check if the product is grounded.

How to treat

Sign

The message “LEAD FAULT”is displayed.

The ECG waveform is notdisplayed.

Severe noise on thewaveform.

1. Check the ECG cable and ensure that the gel in theelectrode is not dry.

2. Try using another ECG cable.

1. Check if the cable connection is stable.2. Check if the ECG cable is damaged.

1. Check if the electrode attached to the patient is stable.2. Check if the disposal electrode is one provided by the

company. (Noise may occur according to the kind ofelectrode.)

How to treat

▣Problems in Display

▣Problems in ECG / Respiration Measurement

Sign

SpO2 measurement isunstable.

1. Check if the probe is affected by strong light in the area.2. Check if the connection is normal; if the red light of the

sensor flickers or does not turn on, it is an inferior probe.3. Check if there are any factors interfering with the patient’s

blood flow. (For example, if the device is connected to thearm being measured for blood pressure, or if the probe isbanded on the finger for too long a time.)

4. Check if the probe is properly positioned to the patient.5. Check if the patient is shaking their finger or pressing the

probe.6. Check if the probe is damaged.

How to treat

Sign

NIBP measurement isunstable.

1. Check if air has leaked out due to bending or damage ofthe NIBP cuff or hose.

2. Check if the proper type of cuff is used for the patient.3. Check if the posture of the measurement site is proper.4. Check if the patient moves during measurement.5. Check if the cuff is attached too loose or too tight.

How to treat

▣Problems in SpO2 Measurement

▣Problems in NIBP Measurement

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62 Before Requesting After-Sales Service Product Specifications 63

Guardian Series

Sign

Blood pressure measurementis unstable.

Severe noise or bias in thewaveform.

Pour out the contents of the tube carefully and remove thebubble, then shorten the tubing length.

Do not shake or touch the connection area of the IBP sensor.

How to treat

▣Problems in IBP Measurement

Sign

Check Adaptor

The wave and value of EtCO2 is not displayed

The Filterline is not connected to the main body.Connect the Filterline.

Check if the sampling line and filter is obstructed, and clean itup if possible. It should be changed if necessary. To removethis message, disintegrate the filterline and then reconnect it.

How to treat

▣Problems in EtCO2 Measurement

Sign

No printing.

Noise during printing.

1. Check if the message “PRINTER” is displayed on thescreen.

2. Check if the power LED lights up on the printer.3. Check if the paper is set normally.4. Check if the printer door is closed.

1. Check if the roller is contaminated with foreign materials orif the gear is out of position.

2. Check if the problem is due to a paper jam (change thepaper)

How to treat

▣Problems in EtCO2 Measurement(Optional)

Product Specifications

1) Measurement parameters- ECG, NIBP, SpO2, Respiration, IBP, Temp, EtCO2

- PROCESSING PARAMETERS :

HR, NIBP(Systolic/Diastolic/Mean pressure), SpO2 Saturation, Pulse rate, Respiration, IBP,

Temp, EtCO2

2) Monitor Performances specifications- TFT Color LCD Display

- Waveform Display Method : Scroll

- Display Size : 7 inch

- Resolution : VGA (800X480)

- Sweep Speed : 6.3, 12.5, 25mm/sec

- Display waveform Time : 4 sec

- Waveform Freeze : Function of waveform freeze

- Waveform Display : ECG, SpO2, IBP, Respiration , EtCO2

- Waveform Traces : 6 Traces

- Measurement Value Display : Heart Rate, SpO2, Pulse Rate,

NIBP, IBP, Temp, Respiration

EtCO2, FiCO2

3) ECG Measurement- ECG Lead : 3 lead / 5 lead( I, II, III, aVR, aVL, aVF, V )

- Input : Installed the circuit for protecting from the high frequency electric potential of ESU,

Defibrillator and so on.

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64 Product Specifications Product Specifications 65

Guardian Series

- Frequency Filter : High frequency noise remove filter / Install the

50/60Hz power noise remove filter

- Input Impedance : Greater than 5 M ohm(50/60Hz)

- Input for Initial Electric currency : Below 50 ㎂

- CMRR : Greater than 120dB

- Frequency Bandwidth : 0.5 ~ 40 Hz, 0.5Hz ~ 80Hz, 0.05Hz ~ 40Hz, 0.05Hz ~ 80Hz,

1.0Hz ~ 40Hz, 5.0Hz ~ 20Hz,

- Gain : 5, 10, 15 mm/mV

- QRS Sensing Range : -0.5mVpp ~ + 5mVpp

- ST-Level : -0.1mV ~ +0.1mV(High limit : 0.01mV~0.99mV,

Low Limit : -0.99mV~ 0.01mV)

- Alarm Setting Range : High Alarm Limit : 10~300bpm ,

Low Alarm Limit : 5~295bpm

- ARRHYHMIA Detect

① Asystole

② Ventricular Tachycardia

③ Ventricular Bradycardia

④ Ventricular Fibrillation

⑤ PVC

⑥ R-on-T

⑦ Missed Beat

⑧ Tachycardia

⑨ Bradycardia

⑩ Bigeminy

⑪ Trigeminy

⑫ Couplet

4) Heart RATE- Measurement Range : 20 ~ 300bpm

- Accuracy : ±2bpm (Measurement value)

- Alarm Range : High alarm limit - 10 ~ 300, OFF, Low alarm limit - 5 ~ 295

5) SpO2, Pulse Oximetery- Measurement Range : 20 ~ 100%SpO2

- Accuracy : 70 ~ 100% SpO2 : ±2%

50 ~ 69% SpO2 : ±3%

0 ~ 49% SpO2 : Unspecified

- Alarm Range : High limit - 21 ~ 99%, OFF SpO2

Low limit - OFF, 20 ~ 98% SpO2

- Pulse Measurement Range : 20 ~ 300bpm

- Pulse Measurement Accuracy : ±2 bpm

6) Non-invasive Blood Pressure Measurement- Measurement Method : Oscillometric, Automatic measurement

- Display Value : Systolic, Diastolic, Mean Pressure

- Measurement Range :

- Accuracy: 0~200mmHg : ±3mmHg , 200~270mmHg : ±4mmHg

- Range: 0~300mmHg

- Alarm Range

- Auto Pressure: Manual, Automatic (2~120 minutes interval)

- Measurement Sensitivity : 1mmHg

7) Respiration- Measurement Range : 2 ~ 150 rpm

- Accuracy : ±2 rpm

- Measurement Sensitivity : 1rpm

- Alarm Range : High limit : 5~149 / Low limit : 1~145

Display

NIBP[mmHg]

Systolic

Diastolic

Mean

SYSTOLIC 60~270mmHg 50~130mmHg

MEAN 45~255mmHg 40~120mmHg

DIASTOLIC 40~245mmHg 30~100mmHg

PRESSURE ADULT NEONATE

High

40 ~ 295, OFF

30 ~ 285, OFF

35 ~ 290, OFF

Low

OFF, 30 ~ 290

OFF, 25 ~ 280

OFF, 30 ~ 285

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66 Product Specifications Product Specifications 67

Guardian Series

8) IBP (Invasive Blood Pressure) - Optional- Measurement Range : -40 ~ 360mmHg

- Accuracy : ±2mmHg

Measurement Sensitivity : 1mmHg

- Alarm Range : ABP standard

9) Temperature- Measurement Range : 10 ~ 50℃

Measurement Sensitivity : 0.1℃

- Accuracy : ±0.1℃

- Alarm Range : High alarm limit - 20.0℃ ~ 49.0℃, OFF

Low alarm limit - 10.0℃ ~ 40.0℃

10) EtCO2 : End-Tidal CO2 - Optional- Transducer Type: Mainstream / Sidestream CO2 Sensor

- Range: 0~150mmHg

- Temperature: Normal temperature 0~45℃

- Accuracy :

- Alarm Setting Range : High limit: 2~99mmHg , Low limit : 1~98mmHg

11) Printer - Optional- Print Method : Thermal

- Type : Internal

- Paper Width : 57 mm

- Valid Width : 120 ~ 300mm

12) Trend- Parameter : Heart Rate, SpO2, Pulse Rate, NIBP, IBP , Temperature, EtCO2

- 72 Hours (1 minute step : Saving Data 4,320ea)

13) Interface- RS-232C port

- LAN Port (Central Monitor)

- VGA Port (Display Transferring)

14) Physical Specifications- Size: 205 x 207 x 147mm (WxDxH)

- Weight: 2.4Kg(Include battery)

- Power Requirement: AC 100~240V , 50/60 Hz, 90VA(MAX)

- Battery: LI-Ion, 11.1V, 4400mAh

15) Operating Environment- Temperature : (Operating : 10℃ ~ 45℃ / Storage : -10℃ ~ 50℃)

- Humidity : (Operating : 30 ~ 85% / Storage : 20 ~ 95%)

- Atmospheric Pressure : (Operating : 70 to 106 kPa / Storage : 70 to 106kPa)

Display

IBP[mmHg]

Systolic

Diastolic

Mean

High

40 ~ 295, OFF

30 ~ 285, OFF

35 ~ 290, OFF

Low

OFF, 30 ~ 290

OFF, 25 ~ 280

OFF, 30 ~ 285

CO2 Density

0~40mmHg

41~70mmHg

71~100mmHg

101~150mmHg

Accuracy

±2mmHg

±5% of reading

±8% of reading

±10% of reading

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68 Product Specifications Product Warranty 69

Guardian Series

16) Standard Accessories- 5lead ECG cable 1 ea

- Adult NIBP cuff 1 ea

- Gray hose 1 ea

- Power cord 1 ea

- Adaptor 15V 3Ah 1 ea

- Disposable Electrode (5pcs/set) 1 set

- SpO2 Sensor (Reusable) 1 ea

- Battery 11.1V 4.4Ah(built-in) 1 ea

- Temp. sensor(Rectal type) 1 ea

- User Manual 1 ea

17) Optional Accessories- 3lead ECG Cable

- Extension Cable for SpO2 sensor

- IBP module kit

- Printer Module

- Roll Paper

- EtCO2 Kit set (In case of EtCO2 installation)

- Disposable Electrode (50 PCS/1SET)

- Battery

- TROLLEY (=Rolling Cart)

- Wall Mount

- Skin Temp Probe

- Disposable SpO2 sensor

- Y-type SpO2 sensor (Clip type)

- Neonate NIBP Cuff

- Child NIBP Cuff

Product Warranty

Product Name

Model Code

Manufacture Approval No.

Manufacture Approval Date

Manufacture Serial No.

Warranty Period

Purchase Date

Name ofHospital

Address

Name

Tel

Thank you for using Guardian

This product is a medical device.

Only the products that have Passed our extensive and thorough quality tests are

offered to our customers

Our policies on repairing, exchange and refund complies with “Regulation on

Consumer Protection & Compensation Standards” issued by Economic

Planning Board of Korea

Name of Distributor

Name of Manufacture

CustomerInformation

Patient Monitor

BPM-770 (BRAND NAME : Guardian)

No. 10-646

JUL. 05. 2010

No. 1936

One year after the purchase date

Date Month Year

Tel) Fax)

BIONICS Co., Ltd.