■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■Customer Service Dept.

Tel : +82-2-714-2962 Fax : +82-2-714-2963■Address of Region Representative

Im Erlengrund 20, D-46149 Oberhausen, GermanyTel : +49 (0) 208 377 890-0Fax : +49 (0) 208 377 890-55

BIONICS Patient Monitor SeriesOperation Manual

www.ebionics.co.kr

Guardian(BPM-770)Patient Monitor (Ver 1.2)

OPERATION MANUAL

Guardian(BPM-770)Patient Monitor (Ver 1.2)

(FEB. 25. 2013)

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 11Composition 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

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 60Product Specifications 63Product 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

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 breakout from the induced current, and the accuracy of the product and the MRI may be influenced by mutual interference.

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

•��The computerized ECG analysis should be judged by qualified medical professionals, and it should not be the sole basis in determining necessity of treatment for the patient.

NOTE

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

CAUTION

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

WARNING

WARNING

Patient Monitor

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℃, 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 to direct sunlight.

Locations exposed to chemicalor explosive gas.

Disassembling of Product should be done only by the authorized personnel, 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 the installation is completed, otherwise, it can cause a damage to the Product.

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%

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

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

Patient Monitor

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 TemperatureSensor(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

Patient Monitor

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.

D. Our product can be used semipermanently. Please contact our Customer Service dept. or any distributor and then replace the parts, when wasting parts such as battery, LCD or LED and so on have a problem.

• When you keep or operate the product in large temperature difference, product malfunctioning can be happened because of humidity of battery pack. Please operate product after keep it room temperature for three hours.

CAUTION

Patient Monitor

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 Button②� Battery LED ⑧� PRINT START Button③� Power Button ⑨� EXIT Button④� ALARM ON/OFF Button ⑩� MENU Button⑤� SCREEN Button ⑪� ALARM STATUS LED⑥� FREEZE Button

①� PRINT FEED Button ③� PRINT POWER LED②� PRINT ERROR LED

(2) Right Side

① ①⑪

②

②

③�

③

④ ⑤� ⑥ ⑦ ⑧� ⑨� ⑩

Patient Monitor

18 Components of Guardian Components of Guardian 19

Guardian Series

(3) Left Side

①� ECG/RESP Connection Terminal ④� SpO2 Connection Terminal②� IBP Connection Terminal (Option) ⑤� NIBP Connection Terminal③� TEMP Connection Terminal ⑥� CO2 Connection Terminal (Option)

①

④

⑤

⑥

②�

③�

(4) Back Side

①� PORTABLE HANDLE ⑤� Alarm Connection terminal②� ID LABEL / Battery Cover ⑥� LAN PORT③� Grounding Port ⑦� RS-232 PORT④� DC IN ⑧� VGA PORT

①

④ ⑤� ⑥� ⑦� ⑧�

②

③�

Patient Monitor

20 Description of Product Symbols Description of Product Symbols 21

Guardian Series

Composition of Guardian (Accessories) (1) Initial Screen

(Fig1. Main Screen)

①� WAVE Area : Display the graph of patient’s vital sign and condition②� MINI TREND : Display the Trend information of patient③� 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 patient⑤� 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 Patient⑧� HR : Display Heart Rate.⑨� Time : Display the present time⑩� 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.

①�

④�

⑤�

⑥�

⑦�

⑧

⑪� ⑩� ⑨�

②

③

Icon Comments Icon Comments

Type CF Product,Defibrillation protected Alarm On/Off

Type BF Product,Defibrillation protected Screen Change(Screen)

Power stand-by switch Stop Waveforms (Freeze)

Attention, consult accompanying documents

Non Invasive Blood Pressure Manual Measurement(NIBP)

Ground Start Printing (Printer)

SYSTEM Power On/Off Initial Screen (Exit)

Signal On/Off Signal Input

IBP Invasive BloodPressure TEMP 1/2 Temperature 1/2

ECG/RESP Electrocardiofraph/Respirtion SpO2 Oxygen Saturation

NIBP Non Invasive BloodPressure RS-232C Port Use for Program

Upgrade

LAN Port Use for CentralMonitoring VGA Port Screen Transfer

Catalogue number Manufacturer

Serial number Date of manufacture

European CommunityRepresentative

User's Manual operating instructions

Protection against vertically falling drops of water CE Mark

REF

SN

REPEC

0120

Patient Monitor

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

Patient Monitor

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 39Page 44Page 46Page 48Page 51Page 52Page 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

Patient Monitor

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 [%]

SystolicDiastolic

Mean

SystolicDiastolic

Mean

IBP[mmHg]

NIBP[mmHg]

Setting rangeHIGH LOW

10 ~ 300, OFF21 ~ 99, OFF40 ~ 295, OFF30 ~ 285, OFF35 ~ 290, OFF5 ~ 149, OFF40 ~ 295, OFF30 ~ 285, OFF35 ~ 290, OFF

20℃ ~ 49℃, OFF 2% ~ 99%, OFF

OFF, 5 ~ 295OFF, 20 ~ 98OFF, 30 ~ 290OFF, 25 ~ 280OFF, 30 ~ 285OFF, 1 ~ 145OFF, 30 ~ 290OFF, 25 ~ 280OFF, 30 ~ 285

OFF, 10℃ ~ 40℃OFF, 1% ~ 98%

RESP [rpm]

TEMP [℃]EtCO2 [%]

(3) Trends

To check the Trend date for thepatient being measured, push theScreen 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

Patient Monitor

28 How to Use Guardian How to Use Guardian 29

Guardian Series

①

②�

③

(Fig 2. Trend Screen)

①� Parameter name for measurement②� Time of the storage③� 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

Patient Monitor

30 How to Use Guardian How to Use Guardian 31

Guardian Series

Setup MenuLEAD 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 ~ 12

DATE : 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 IISpeed 12.5 mm/sec 12.5 mm/secGain 10 mm/mV 10 mm/mVFilter 1.0 ~ 40 Hz 1.0 ~ 40 Hz

HR > High Limit 150 bpm 200 bpmHR < Low Limit 50 bpm 100 bpm

RESP

APNES Time OFF OFFHigh Limit 30 rpm 100 rpmLow Limit 5 rpm 30 rpm

Size 2.0 Ohm 2.0 OhmSpeed 6.3 mm/sec 6.3 mm/sec

SpO2

High Limit OFF 95 %Low Limit 90 % 80 %

Gain X 2 X 2Speed 12.5 mm/sec 12.5 mm/sec

NIBP

NIBP Mode Manual ManualInterval 60 60

High Alarm Limit 160/90(110) 90/60(70)Low Alarm Limit 90/50(60) 40/OFF(OFF)

IBP

Label ABP ABPScale Optimum OptimumSpeed 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 45Low 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.

Patient Monitor

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

→ PRINTERStep 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 automatically printed 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 (ECG waveform 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

Patient Monitor

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

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 batteryRecharging time : 9 Hours or moreUse time :120 Minutes

C. To ensure the lifecycle and safety of battery, please discharge the battery and then charge perfectly again every six months. Also time-worn battery exceed 24 months should be replaced.

C. Natural lifetime for spontaneous discharge of batteryThe table below shows the lifetime for spontaneous discharge of the battery when the product is unused.

Storage temperature Life for spontaneous discharge0℃ ~ 20℃

21℃ ~30℃

31℃ ~45℃

9 months

6 months

3 months

D. Type of BatteryThe same sort of battery should be used for replacement.- Model : 3S2P(LS18650)- Type : LI-Ion Battery- Manufacturer: BTS Power

E. Time for the Battery exchangeThe 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 use100 % 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

설 명

Patient Monitor

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 the measurement 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

BlackRed

GreenBrown

Attaching siteJust below the clavicle (scapula) near the right shoulder

Just below the clavicle (scapula) near the left shoulderLower area of the left side of the abdomenLower area of the right side of the abdomen

Select the candidate lead for measurement among the 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

Patient Monitor

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 Condition2) 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

Patient Monitor

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 ChangeLEADGAIN

SPEED

FILTER

AREA

ALARM

ST SEGMENTARRHYHMIAPACEMAKER

LEAD I, II, III, aVR, aVL, aVF, V5, 10, 15 mm/mV

6.3, 12.5, 25 mm/sec0.5 ~ 40 Hz0.5 ~ 80 Hz0.05 ~ 40 Hz0.05 ~ 80 Hz1.0 ~ 40 Hz5.0 ~ 20 Hz

50, 60 Hz

High (10 ~ 300bpm) rangeLow (5 ~ 295bpm) range

Alarm ON/OFFDIAGNOSIS ON/OFFDIAGNOSIS ON/OFFDIAGNOSIS ON/OFF

ExplanationChange the ECG Lead on screen

Set the size of ECG waveformSet the speed of ECG waveform

Set the analog and digital filterof the ECG waveform

If there is input, the elimination frequency is set.

Set the upper limit of HRSet the lower limit of HRAlarm operation / restLEVEL check / rest

Arrhythmia check / restDefibrillator 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 the measurement module.

Step 1

Attach the electrodes for respiration measurement by referring to the figures below.

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

Patient Monitor

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 ChangeSPEED

SIZETRACE

6.3, 12.5, 25 mm/sec0.5, 1, 2, 4 OHM, OPTIMUM

ON / OFF

ExplanationSet the speed of RESP waveformSet 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 errors in 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

Patient Monitor

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

1 ~ 120 min

SYS / DIA / MEAN

-

ExplanationSelect automatic or manual

measurement

Select the time interval, when set toautomatic measurement

Indicate measuring value before 30Contact 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

Patient Monitor

46 SpO2 Measurement SpO2 Measurement 47

Guardian Series

Connect the SpO2 probe to the connection terminal of the measurement module.

Step 1

Attach the probe to the finger. (If measured with NBP at the same time, the SpO2 probe should be positioned on the opposite arm. Concurrent use of other medical devices affecting blood flow should be avoided. The probe should be attached at a site that avoids those affected by medical interference.)

Step 2

For stable measurement, have the patient minimize their movement and band the probe cable with the finger. Care should be taken to not let the banding interfere 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 ChangeGAIN

SPEEDTRACE

x1, x2, x3 OPTIMUM6.3, 12.5, 25 mm/sec

ON / OFF

ExplanationSet the size of SpO2 waveform

Set the speed of SpO2 waveformSet the display of waveform

Patient Monitor

48 Body Temperature Measurement

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

MENU

ECG ▶

SpO2 ▶

IBP ▶

NIBP ▶

RESP ▶

CO2 ▶

ALARM ▶

SETUP ▶

EXIT ▶

ALARM

HR ▶

ST ▶

SpO2 ▶

IBP ▶

NIBP ▶

RESP ▶

TEMP ▶

EtCO2 ▶

+Return

HR

HIGH ▶ 39

LOW ▶ 30

SOUND ▶ ON

+Return

HIGH LIMIT

[Push Encoder]

39

20-49

Connect the temperature sensor to the connection terminal of the measurement module.

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 ChangeHigh limitLow limitON / OFF

20 ~ 49℃

10 ~ 40℃

ON, OFF

ExplanationSet the maximum limit of alarmSet 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

SpO2 Measurement 49

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 the measurement module.

Step 1

In a clean environment, open the package to check if all parts are well connected 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 be removed till the system is full and the foam have been removed. These outlet plugs should always be replaced with other outlet plugs. (A pouch is included in the kit.)

Step 2

Connection of the converter interface cable 1. Hold the backside of the clear cover surrounding the connector, and connect

the converter to the reusable monitor interface. 2. Push the connecter gently into position. If it is well connected, the tap of the

converter 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

Patient Monitor

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

Guardian Series

Priming and TipsStep 5

3. To remove the converter from the cable, push the tap gently inside the clear cover 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 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.

•�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

Patient Monitor

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

CVPICPPAP

Arterial blood pressure

Central venous pressureIntracranial pressure

Pulmonary arterial pressure

Artery group throughout the wholebody (systemic)

Central vein / atrium groupIntracranial 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

Patient Monitor

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

Guardian Series

Set Mode Range for ChangeSPEED

LABEL

* ZEROSCALETRACE

6.3, 12.5, 25mm/sec

ABP, CVP, ICP, PAP

ONOPTIMUM / FIXED

ON / OFF

ExplanationSet the speed of IBP waveformSet the level according to the

measurement site of BP.Change the alarm setting range

according to level.

Adjust the zeropoint of the transducerSet the wave scales

Set the display of waveform

MEDEXMX 9504TMX 95104MX 240MX 800

ExplanationIBP D.P.T Monitor kit

IBP CableIBP ClampIBP 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 GuardianThose 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 CO2A. 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

Patient Monitor

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 buttonB. It is starting Calibration with message “Zero in Progress” on display of EtCO2 WaveC. If the message “Zero In Progress” is disappeared, the Calibration is normally completed.

Massage

Wait For Sensor

Check AdaptorZero Require

ExplanationSelf initialization process of EtCO2 module when power is on(the measurement may be inaccurate during this period)Not connected to the accessoryNeed 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

Patient Monitor

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.

SignThe power of the product is not turned on.

The power of the product turns off suddenly during use.

The power of the product is not 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 magnetism around the product.

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

How to treat

SignThe message “LEAD FAULT” is displayed.

The ECG waveform is not displayed.

Severe noise on thewaveform.

1. Check the ECG cable and ensure that the gel in the electrode 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 of electrode.)

How to treat

▣ Problems in Display

▣ Problems in ECG / Respiration Measurement

Sign

SpO2 measurement is unstable.

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 patientʼs

blood flow. (For example, if the device is connected to the arm being measured for blood pressure, or if the probe is banded 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 is unstable.

1. Check if air has leaked out due to bending or damage of the 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

Patient Monitor

62 Before Requesting After-Sales Service Product Specifications 63

Guardian Series

SignBlood pressure measurement is unstable.

Severe noise or bias in the waveform.

Pour out the contents of the tube carefully and remove the bubble, 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 it up if possible. It should be changed if necessary. To remove this 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 the screen.

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 or if the gear is out of position.

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

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.

Patient Monitor

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 Asystole② Ventricular Tachycardia③ Ventricular Bradycardia④ Ventricular Fibrillation⑤ PVC⑥ R-on-T⑦ Missed Beat⑧ Tachycardia⑨ Bradycardia⑩ Bigeminy⑪ Trigeminy⑫ 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

Patient Monitor

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 Density0~40mmHg

41~70mmHg

71~100mmHg

101~150mmHg

Accuracy±2mmHg

±5% of reading

±8% of reading

±10% of reading

Patient Monitor

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

18) Product specification listed on the manual are subject to change according to the our design change procedure without notice.

Product Warranty

Product Name

Model Code

Manufacture Approval No.

Manufacture Approval Date

Manufacture Serial No.

Warranty Period

Purchase Date

Name ofHospitalAddress

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

OCT. 04. 2012

No. 1936

One year after the purchase date

Date Month Year

Tel) Fax)

BIONICS Co., Ltd.