GIMA B3 Patient Monitor User’s Manual

B3 User’s Manual


33718 MONITOR GIMA SPA B3

Patient Monitor

Rev. 2.0

Rev. 2.0


Table of Contents

B3 User’s Manual ....................................................................................................0

Table of Contents....................................................................................................1

1. BASIC...................................................................................................................7

1.1 CE Standard Information........................................................................................... 8

1.2 Read before Use......................................................................................................... 9

How to Contact Us .........................................................................................................................9

Warranty Period .......................................................................................................................... 10

Warning, Caution, Note................................................................................................................11

General Precaution on Environment........................................................................................... 12

General Precaution on Electric Safety ........................................................................................ 16

Cleaning Applied Parts ............................................................................................................... 18

1.3 Product Components............................................................................................... 20

Product Outline ........................................................................................................................... 20

Principal Characters of Product .................................................................................................. 20

Product Configuration ................................................................................................................. 21

Option Product ............................................................................................................................ 21

Product Body Configuration ........................................................................................................ 22

Accessories................................................................................................................................. 24

Equipment Sign........................................................................................................................... 25

1.4 Function and Key ..................................................................................................... 28

External Function ........................................................................................................................ 28

Operation Key ............................................................................................................................. 28

1.5 Standard Power Supply Application ...................................................................... 30

DC Power.................................................................................................................................... 30

1.6 Battery Power Supply Application ......................................................................... 31

Operation .................................................................................................................................... 31

The Impact of Lithium-Ion Battery Technology on the Battery ................................................... 33

Conditioning Guideline................................................................................................................ 33

Rev. 2.0 1


Storage Guideline ....................................................................................................................... 33

How to Recycle the Battery......................................................................................................... 33

1.7 General Manu Operation ......................................................................................... 34

Screen Composition.................................................................................................................... 34

Menu Selection ........................................................................................................................... 35

Menu Composition ...................................................................................................................... 35

2. PATIENT/DATA MANAGEMENT........................................................................39

2.1 ADMIT........................................................................................................................ 41

ADMIT TYPE............................................................................................................................... 41

CHANGE ADMIT INFO ............................................................................................................... 42

DISCHARGE............................................................................................................................... 43

ADMIT ......................................................................................................................................... 43

HEIGHT....................................................................................................................................... 44

WEIGHT...................................................................................................................................... 44

2.2 ALARM ......................................................................................................................45

Alarm for the Product .................................................................................................................. 46

ALL LIMITS ................................................................................................................................. 47

ALARM PRINT ............................................................................................................................ 47

ALARM VOLUME........................................................................................................................ 48

ALARM LEVEL............................................................................................................................ 48

PARAMETER LEVEL ................................................................................................................. 49

ARRHYTH LEVEL....................................................................................................................... 49

ALARM REVIEW......................................................................................................................... 50

ALARM LIST ............................................................................................................................... 51

SAVING CONDITION ................................................................................................................. 52

NURSE CALL.............................................................................................................................. 53

3. SETUP ................................................................................................................54

3.1 SETUP ....................................................................................................................... 55

DISPLAY ..................................................................................................................................... 55

SET PARA .................................................................................................................................. 56

WAVE SELECT ........................................................................................................................... 56

SET DATE & TIME ...................................................................................................................... 57

SET TIME.................................................................................................................................... 57

Rev. 2.0 2


SET DATE ................................................................................................................................... 58

HR/PR SELECT .......................................................................................................................... 58

SET SWEEP ............................................................................................................................... 59

DEMO ......................................................................................................................................... 59

USER SERVICE ......................................................................................................................... 60

SET UNIT NAME ........................................................................................................................ 60

SET BED NUMBER .................................................................................................................... 61

AC FILTER.................................................................................................................................. 62

SYSTEM ..................................................................................................................................... 63

MAKER SERVICE....................................................................................................................... 63

4. TREND ...............................................................................................................64

4.1 TREND....................................................................................................................... 65

GRAPHIC TREND ...................................................................................................................... 66

TIME PERIOD............................................................................................................................. 67

TABULAR TREND ...................................................................................................................... 68

TIME INTERVAL ......................................................................................................................... 69

TREND WINDOW SETUP.......................................................................................................... 69

TIME PERIOD............................................................................................................................. 70

SET TREND PARA ..................................................................................................................... 71

TREND PRINT ............................................................................................................................ 71

5. ECG ....................................................................................................................72

5.1 Introduction .............................................................................................................. 73

Colors and Standards of Cables ................................................................................................. 73

Position of ECG Connector and Measuring Cable ..................................................................... 73

Attaching Electrodes to the Patient............................................................................................. 74

Choosing an ECG lead for Arrhythmia Monitoring...................................................................... 75

Information on the ECG waveform.............................................................................................. 75

5 Position of 5-Lead .................................................................................................................... 76

Position of 3-Lead Wrier Electrode ............................................................................................. 76

How to Attach the NEONATE Electrode ..................................................................................... 77

5.2 ECG Data Window .................................................................................................... 78

5.3 ECG Data Setup........................................................................................................ 81

TRACE 1 LEAD SELECT ........................................................................................................... 81

Rev. 2.0 3


ALARM LIMIT.............................................................................................................................. 82

ALARM SOUND.......................................................................................................................... 83

QRS VOLUME ............................................................................................................................ 84

DISPLAY ..................................................................................................................................... 84

ECG SPEED ............................................................................................................................... 85

ECG SIZE ................................................................................................................................... 85

HR SOURCE............................................................................................................................... 86

ANALYSIS SETTING .................................................................................................................. 86

6. SpO

2

...................................................................................................................97

6.1 Outline....................................................................................................................... 98

SpO2 Connector Location and Measuring Cable ....................................................................... 98

6.2 SpO2 Data Window .................................................................................................. 99

Signal and Data Validity ............................................................................................................ 100

6.3 SpO

2

Data Setup..................................................................................................... 102

RATE VOLUME ........................................................................................................................ 102

ALARM...................................................................................................................................... 103

ALARM LIMIT............................................................................................................................ 103

ALARM SOUND........................................................................................................................ 104

LEAD FAULT Condition ............................................................................................................ 105

SPO2 Messages ....................................................................................................................... 105

7. RESPIRATION..................................................................................................106

7.1 Outline..................................................................................................................... 107

7.2 Respiration Data Window...................................................................................... 108

7.3 Respiration Data Setup.......................................................................................... 109

RESPIRATION SPEED ............................................................................................................ 109

RESPIRATION...........................................................................................................................110

APNEA DETECT........................................................................................................................110

ALARM....................................................................................................................................... 111

ALARM LIMIT............................................................................................................................. 111

ALARM SOUND.........................................................................................................................112

8. NIBP ................................................................................................................. 113

8.1 Outline..................................................................................................................... 114

Rev. 2.0 4


8.2 NIBP Data Window ................................................................................................. 116

8.3 NIBP Data Setup..................................................................................................... 117

ALARM.......................................................................................................................................117

ALARM LIMIT.............................................................................................................................118

ALARM SOUND.........................................................................................................................119

CUFF SIZE.................................................................................................................................119

UNIT SELECT........................................................................................................................... 120

INTERVAL................................................................................................................................. 120

STAT ......................................................................................................................................... 121

INFLATION ............................................................................................................................... 121

9. TEMPERATURE ...............................................................................................123

9.1 Outline..................................................................................................................... 124

9.2 Temperature Data Window.................................................................................... 125

9.3 Temperature Data Setup........................................................................................ 126

ALARM...................................................................................................................................... 126

ALARM LIMIT............................................................................................................................ 127

ALARM SOUND........................................................................................................................ 128

UNIT SELECT........................................................................................................................... 128

10. PRINT .............................................................................................................129

10.1 Print ....................................................................................................................... 130

Printer and Heat Sensitivity Paper ............................................................................................ 130

Function and Setup Menu......................................................................................................... 131

10.2 Paper Change ....................................................................................................... 134

11. MESSAGE LIST .............................................................................................135

12. DEFAULT SETTING VALUE ..........................................................................136

1. Adult-ICU Mode ........................................................................................................ 136

2. Neonate-ICU Mode ................................................................................................... 138

3. Pediatric-ICU Mode .................................................................................................. 140

13. TROUBLE SHOOTING ..................................................................................142

1. Noise in ECG ............................................................................................................ 142

Rev. 2.0 5


2. SpO2 malfunction .................................................................................................... 143

3. Temp malfunction .................................................................................................... 143

4. NIBP malfunction ..................................................................................................... 144

5. Abnormality in NIBP measurements ...................................................................... 144

6. Failure in battery recharge ...................................................................................... 145

7. Power failure............................................................................................................. 146

8. Periodic noises......................................................................................................... 147

9. Print failure ............................................................................................................... 148

14. SPECIFICATION ............................................................................................127

Ease of use ............................................................................................................................... 128

Additional Function ................................................................................................................... 128

Monitor Environmental Specifications ....................................................................................... 128

Power ........................................................................................................................................ 128

Monitor Performance Specifications ......................................................................................... 128

Graphical and Tabular Trends................................................................................................... 129

ECG capacity ............................................................................................................................ 129

SpO

2

capacity............................................................................................................................ 129

Respiration Performance Specifications ................................................................................... 130

NIBP capacity............................................................................................................................ 130

Temperature Unit Performance Specifications.......................................................................... 130

Accessories Included: ............................................................................................................... 130

Option........................................................................................................................................ 131

Abbreviations and Symbols...............................................................................132

Abbreviations ............................................................................................................... 132

PRODUCT WARRANTY ......................................................................................140

Rev. 2.0 6


1. BASIC

1.1 CE Standard Information

1.2 Read before Use

Warranty Period

Warning, Caution, Note

General Precaution on Environment

General Precaution on Electric Safety

Equipment Connection, Maintenance & Washing Equipment Connection

1.3

Product Components

Product Outline

Principal Characteristics of Product

Product Configuration and Option Product

Product Body Configuration

1.4

Function and Key

External Function

Operation Key

1.5

Standard Power Supply Application

1.6

Battery Power Supply Application

1.7

General Menu Operation

Screen Composition

Menu Selection

Menu Composition

Rev. 2.0


1.1 CE Standard Information

Electromechanical safety standards met:

- EN 60601-1: 1990 + A1:1993 + A2: 1995 Medical Electrical Equipment, Part 1, General

Requirements for Safety.

- IEC/EN 60601-1-2 :2001 Electromagnetic compatibility -Requirements and tests.

- EN 1060-1:1995 Non-invasive sphygmomanometers - Part 1: General requirements

- EN 1060-3:1997 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

- EN ISO 9919:2005 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)

- EN 60601-2-27:2006 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

- EN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

- EN 12470-4:2000 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

- EN 60601-2-49:2001 Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

Rev. 2.0 1.BASIC 8


1.2 Read before Use

The followings are address and phone number for contacting information, services, and product supplies.

How to Contact Us

Purchase

Inquiry

GIMA SPA

VIA MARCONI, 1 – 20060 GESSATE (MI) ITALY

Tel : ++39 02 953854209 Fax : ++39 02 95380056

E-mail : [email protected]

Manufacturer

Bionet Co.,Ltd.

#11F, E&C DREAM TOWER III, 197-33, GURO-DONG, GURO-GU,

SEOUL, SOUTH KOREA (ZIP 152-050)

Overseas sales dept. Tel : +82-2-6300-6418

Service call

Technical support

Web site


Tel : ++39 02 953854209 Fax : ++39 02 95380056


For any technical questions or problems on the equipment, call;


Tel : ++39 02 953854209 Fax : ++39 02 95380056


URL : http://www.gimaitaly.com

URL : http://www.bio2net.com

In the event of malfunction or failure, contact us along with the model name, serial number, and product name of the equipment.

If you need the supply circuit diagram, component list, description and calibration instruction etc. you can contact us we will provide you with it.

Rev. 2.0 1.BASIC 9


Warranty Period

y This product is manufactured and passed through strict quality control and through inspection. y Compensation standard concerning repair, replacement, refund of the product complies with “Consumer’s protection law” noticed by Economic Planning Dept. y We provide a 2-year warranty period for main body, but Accessory provides a 6 months warranty period. y Warranty repair or replacement will be made by GIMA SPA Service Center at no charge for warranty period if properly used under normal condition in accordance with the instructions for use. y Manufacturer or sales agency takes no responsibility for any kind of damage or breakdown that is caused by misuse and failure to maintain the equipment.

Rev. 2.0 1.BASIC 10


Warning, Caution, Note

For special emphasis on agreement, terms are defined as listed below in user’s manual. Users should operate the equipment according to all the warnings and cautions.

Warning

To inform that it may cause serious injury or death to the patient, property damage, material losses against the “warning” sign

Caution

To inform that it may cause no harm in life but lead to injury against the “caution” sign

Note

To inform that it is not dangerous but important “note” sign for proper installation, operation, and maintenance of the equipment.

Rev. 2.0 1.BASIC 11


General Precaution on Environment

- Do not keep or operate the equipment in the environment listed below.

Avoid placing in an area exposed to moist.

Do not touch the equipment with wet hand.

Avoid placing in an area where there is a high variation of temperature.

Operating temperature ranges from 10(C to

40(C. Operating humidity ranges from 30% to 85%.

Avoid exposure to direct sunlight

Avoid in the vicinity of

Electric heater

Avoid placing in an area where there is an excessive humidity rise or ventilation problem.

Avoid placing in an area where chemicals are stored or where there is danger of gas leakage.

Do not disjoint or disassemble the equipment.

We take no responsibility for

it.

Avoid placing in an area where there is an excessive shock or vibration.

Avoid being inserted dust and especially metal material into the equipment

Power off when the equipment is not fully installed.

Otherwise, equipment could be damaged.

Rev. 2.0 1.BASIC 12


CAUTIONS

Before Installation

Compatibility is critical to safe and effective use of this device. Please contact your local sales or service representative prior to installation to verify equipment compatibility.

Defibrillator Precaution

Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the recommended cables and lead wires.

Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation.

Disposables

Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.

Disposal

At the end of its accessories, must be disposed of in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have questions concerning disposal of products, please contact GIMA SPA or its representatives.

Electrocute Precautions

To prevent skin burns, apply electrocute electrodes as far as possible from all other electrodes, a distance of at 15 cm/6 in. is recommended.

EMC

Magnetic and electrical fields are capable of interfering with the proper performance of the device.

For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment or MRI devices are possible source of interference as they may emit higher levels of electromagnetic radiation.

Also, keep cellular phones to other telecommunication equipment away from the monitor.

Rev. 2.0 1.BASIC 13


CAUTIONS

Instruction for Use

For continued safe use of this equipment, it is necessary that the instructions are followed. However, instructions listed in this in no way supersede established medical practices concerning patient care.

Loss of Data

Should the monitor at any time temporarily lose patient data, the potential exists that active monitoring is not being done. Close patient observation or alternate monitoring devices should be used until monitor function is restored.

If the monitor does not automatically resume operation within 60 seconds, power cycle the monitor using the power on/off switch. Once monitoring is restored, you should verify correct monitoring state and alarm function.

Maintenance

Regular preventive maintenance should be carried out annually (Technical inspections). You are responsible for any requirements specific to your country.

MPSO

The use of a multiple portable socket outlet (MPSO) for a system will result in an enclosure leakage current equal to the sum of all individual earth leakage currents of the system if there is an interruption of the MPSO protective earth conductor. Do not use an additional extension cable with the MPSO as it will increase the chance of the single protective earth conductor interruption.

Negligence

GIMA SPA does not assume responsibility for damage to the equipment caused by improperly vented cabinets, improper or faulty power, or insufficient wall strength to support equipment mounted on such walls.

Rev. 2.0 1.BASIC 14


NOTES

Power Requirements

Before connecting the device to the power line, check that the voltage and frequency. Ratings of the power line are the same as those indicated on the unit’s label. If this is not the case, do not connect the system to the power line until you adjust the unit to match the power source.

In U.S.A, if the installation of this equipment will use 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit.

Restricted Sale

U.S.A federal law restricts this device to sale by or on the order of a physician.

Supervised Use

This equipment is intended for use under the direct supervision of a licensed health care practitioner.

Ventilation Requirements

Set up the device in a location which affords sufficient ventilation. The ventilation openings of the device must not be obstructed. The ambient conditions specified in the technical specifications must be ensured at all times.

·Put the monitor in a location where you can easily see the screen and access the operating controls.

·This product is protected against the effects of cardiac defibrillator discharges to ensure proper recovery, as required by test standards. (the screen may blank during a defibrillator discharge but recovers within second as required by test standards.)

Reference Literature

Medical Device Directive 93/42/EEC

EN 60601-1/1990 +A1: 1993 +A2 : 1995 : Medical electrical equipment.

General requirements for safety

EN 60601-1-1/9. 1994 +A1 12.95: General requirements for safety.

Rev. 2.0 1.BASIC 15


General Precaution on Electric Safety

Warning

BM3 OPERATION MANUAL

Check the item listed below before operating the equipment.

NOT

1. Be sure that AC power supply line is appropriate to use. (AC100 - 240V)

2. Be sure that the power source is the one supplied from GIMA SPA.. (DC18V, 2.5A)

3. Be sure that the entire connection cable of the system is properly and firmly fixed.

4. Be sure that the equipment is completely grounded. (If not, there might be the problem occur in the product.)

5. The equipment should not be placed in the vicinity of electric generator, X-ray, broadcasting apparatus to eliminate the electric noise during operation. Otherwise, it may cause incorrect result.

Note

The Equipment should be placed far from generator, X-ray equipment, broadcasting equipment or transmitting wires, so as to prevent the electrical noises from being generated during the operation, When these devices are near the Equipment, it can produce inaccurate measurements. For B3, both independent circuit and stable grounding are essentially required.

In the event that the same power source is shared with other electronic equipment, it can also produce inaccurate output.

Warning

Do not contacts with the patient while operate the machine It may cause serious danger to the users. Use only the provided cable.

Warning

In case the Equipment does not operate as usual or damaged, do not use on patient, and contact to the medical equipment technician of the hospital or the equipment supply division.

Rev. 2.0 1.BASIC 16


Note

B3 is classified as follows:

- B3 classifies as Class

I, BF &

CF concerning electric shock. It is not proper to operate this

Equipment around combustible anesthetic or dissolvent.

- Noise level is B class regarding IEC/EN 60601-1 and the subject of Nose is B level concerning

IEC/EN60601-1-2.

Equipment Connection

Caution

In the hospital, doctors and patients are exposed to dangerous, uncontrollable compensating currents. These currents are due to the potential differences between connected equipment The safety solution to the problem is accomplished with EN60601-1;1993.

Biocompatibility

When used as intended, the parts of the product described in this operator manual, including accessories that come in contact with the patient during the intended use, fulfill the biocompatibility requirements of the applicable standards. If you have questions about this matter, please contact

GIMA SPA. or its representatives.

Maintenance and Washing Equipment Connection

Using various methods can clean B3 and its accessories. Please follow the methods mentioned below to avoid unnecessary damage or contamination to the Equipment.

We do not repair with free of charge regardless of warranty period if it is contaminated or damaged with using dangerous material not designated for washing.

Rev. 2.0 1.BASIC 17


Cleaning Applied Parts

Cables and Leadwires

CAUTION

Do not use acetone or ketone solvents for cleaning; do not use an autoclave or steam cleaner.

Cables and leadwires can be cleaned with a warm, damp cloth and mild soap, or isopropyl alcohol wipes. For more intensive disinfecting (near sterile) Ethylene Oxide (ETO) is acceptable but will reduce the useful lifetime of the cable or leadwire.

CAUTION

The decision to sterilize must be made per your institution’s requirements with an awareness of the effect on the integrity of the cable or leadwire.

Note

The Equipment needs safety inspection once a year. Please refer to user’s guide or service manual for the examine objects.

Please check carefully both frame and sensor, after cleaning the Equipment, Do not use the equipment that is worn out or damaged.

At least once a month, clean and wipe off the frame by using the soft cloth after wetting it with water and alcohol. Do not use lacquer, thinner, ethylene, and oxidizer which may leads damage to the equipment.

Make sure both cables and accessories are free of dust or contaminants, and wipe them off with soft cloth wetted with warm water (40°), and at least once a week, clean them by using the clinical alcohol.

Rev. 2.0 1.BASIC 18


Do not submerge the accessories under any liquid or detergent. Also, make sure any liquid not to penetrate into the Equipment or probe.

Caution

Do not dispose single use probe to any hazard place, Always think about environmental contamination.

Caution

There is back-up battery on board inside system. When users dispose this battery, Please waste proper place for environmental protection.

Warning

Check the electrodes of batteries before changing them.

· Operate B3 with internal electric power supply when unsure of external ground connection or installation occur.

· Remove the 1st Battery when not using equipment for a while without any damage.

For other applied parts such as temperature sensors, pulse oximetry probes, and NBP cuffs, you must consult the manufacturer for cleaning, sterilization, or disinfecting methods.

Rev. 2.0 1.BASIC 19


1.3 Product Components

BM3 OPERATION MANUAL

Product Outline

B3 monitor is a product used for monitoring biological information and occurrence of a patient. Main function ns of the product include displaying information such as ECG, respiration, SpO2, NIBP and temperature on its LCD screen and monitoring parameter, and alarming. It also prints out waves and parameters via a printer.

Principal Characters of Product

B3 is a small-size multifunctional monitoring equipment for a patient designed to an easy usage during movement. It features devices for auto power supply (DC 10V-16V) and DC power supply

(DC 18V) as well as installing its handle to the patient’s bed. The equipment also measures major parameters such as ECG, SpO2, NIBP, temperature and pulse, displaying it on a 7-inch color LCD screen. It also enables users to check waves and parameters and other vital signs of a patient via the 58mm thermal printer and monitor the patient by the remote-controlled alarm system. It also enables to build a central monitoring system by linking devices used for separate patients so that one can monitor several patients at a time.

Warning

Use only the supplement accessories provided by us. Otherwise, patient and user may exposed to danger.

Warning

BEFORE USE — Before putting the system into operation visually inspect all connecting cables for signs of damage. Damaged cables and connectors must be replaced immediately.

Before using the system, the operator must verify that it is in correct working order and operating condition. Periodically, and whenever the integrity of the product is in doubt, test all functions.

Rev. 2.0 1.BASIC 20


Product Configuration

1. Main body of B3 Monitor 1 EA

2. 3-Lead Patient Cable 1EA (3CBL-400, 3WIRE-400)

3. Disposable electrodes 10 EA (ECGSENS-400)

4. NIBP tubing (3M long) 1EA (NBPCBL-400)

5. Adult cuff (25-35 Cm) 1EA (ACUFF-400)

6. SpO2 sensor extension cable (2M) 1EA (SPCBL-400)

7. SpO

2

1

8. DC Adaptor (MW160 made in AULT Co., Ltd.) 1 EA

Option Product

1. Temperature (TEMPSENS-400)

Warning

In order to avoid electrical shock, do not open the cover. Disassembling of the equipment should be done only by the service personnel authorized by GIMA SPA

.

Warning

Users must pay attention on connection any auxiliary device via LAN port or nurse calling. Always consider about summation of leakage current, please check if the auxiliary device is qualified by IEC 60601-1, or consult your hospital biomedical engineer.

Rev. 2.0 1.BASIC 21

Product Body Configuration


Alarm Key

Printer Key

NIBP Key

Function Key

TRIM KNOB Key

Power Key

Rev. 2.0 1.BASIC 22


Rev. 2.0 1.BASIC 23

Accessories

ECG Cable +

Extension Cable


SpO

2

Cable +

Extension Cable

NIBP Cuff+

Extension hose

Temperature sensor (Option)

Rev. 2.0 1.BASIC 24


Equipment Sign

ATTENTION :

Consult accompanying documents

TYPE CF APPLIED PART :

Insulated (floating) applied part suitable for intentional external and internal application to the patient including direct cardiac application. "Paddles" outside the box indicate the applied part is defibrillator proof.

Medical Standard Definition :

F-type applied part(floating/insulated) complying with the specified requirements of IEC 60601-1/UL 2601-1/CSA 601.1

Medical Standards to provide a higher degree of protection against electric shock tan that provided by type CF applied parts.

TYPE BF APPLIED PART :

Insulated (floating) applied part suitable for intentional external and internal application to the patient excluding direct cardiac application. "Paddles" outside the box indicate the applied part is defibrillator proof.

Medical Standard Definition :

F-type applied part (floating/insulated) complying with the specified requirements of IEC 60601-1/UL 2601-1/CSA 601.1

Medical Standards to provide a higher degree of protection against electric shock than that provided by type BF applied parts.

Rev. 2.0 1.BASIC 25


Ground

Printer

Serial Port

LAN Port

AUX Connector Port

DC Input Indicator

Battery Operation Indicator

DC Input Connector

Rev. 2.0 1.BASIC 26


NIBP

Temperature

Function

Power on

Power off

Respiration

ECG

Heart Pulse

Rev. 2.0 1.BASIC 27


1.4 Function and Key

External Function

The front panel of this product consists of an LCD screen and five function keys and one trim knob.

Operation Key

1. Power : Switches on and off the Power.

2. Function Key

3. Blood Pressure：Manually completes measuring blood pressure.

4. Printer：Prints out the waves selected from the menu until the key is pressed to stop.

5. Alarm： Stop alarm sound.

First press stops the current alarm for one minute

Second press stops the all alarm for five minutes.

Third press makes the alarm back to the original setting.

6. Trim Knob：This key is used to select menu by turning it clock or anticlockwise to move cursors.

Rev. 2.0 1.BASIC 28


MAIN

MENU

PREV

MENU

ALL ALARM

LIMITS

NURSE

CALL:

ON

ALARM

PRINT:

ON

ALARM

LEVEL

ALARM

VOLUME:

OFF

ALARM

REVIEW

Rev. 2.0 1.BASIC 29


1.5 Standard Power Supply Application

DC Power

DC Power LED is lighted on when the DC Power is plugged into the inlet at the back of the product.

A press of power key makes the machine ready for use.

Warning

This equipment must only be connected to a supply mains with protected earth.

Rev. 2.0 1.BASIC 30


1.6 Battery Power Supply Application

Battery power can be supplied for enabling a portable use or a use during DC power failure.

Operation

1. Battery Power LED is lighted on when the machine is in use.

2. The DC/battery power is only sustainable for 1 hour.

3. Battery is automatically charged when the machine is connected to DC Power Supply. Battery

LED is lighted on after blinking.

4. The charging status of the batteries is displayed with 5 green boxes, each indicating a different charging

. ( 0% -> 25% -> 50% -> 75% -> 100%) z Battery: LS1865L2203S1PMXZ(11.1V - 2200mA, Li-ion)

The Lithium-Ion battery is a rechargeable battery containing Lithium-Ion cells. Each battery contains an integrated electronic fuel gauge and a safety protection circuit.

5. The discharge condition of battery is indicated with on of 5 yellow boxes, each box showing a different level of charge available.

.

(100% -> 75% -> 50% -> 25% -> 0%)

Rev. 2.0 1.BASIC 31


When the battery power remains 25%, the message of “Low Battery” is displayed. The power is automatically cut off after 5 minutes from the appearance of the message. The machine will no longer operate when the “Low Battery” indication is on. Charge the batteries with the power adaptor, which GIMA SPA. provided.

-Battery charging time: More than 6 hours

-Continuous battery use time: Lowest 1 hour to highest 2 hours continuous use (buffering)

Warning

Check the electrodes of batteries before charging them.

6. Battery status indication: When battery is apart from equipment and out of order, it is shown by a red `X' as shown below.

7. Automobile power supply: When an automobile power uses 12V~15V, the battery indication disappears and the ”CAR” indication is active.

Display of automobile power

Note

Battery is not charged when the automobile power is used.

Rev. 2.0 1.BASIC 32


The Impact of Lithium-Ion Battery Technology on the Battery

The following are the key points you should know about Lithium-Ion battery technology:

The battery will discharge on its own, even when it is not installed in a monitor. This discharge is the result of the Lithium-Ion cells and the bias current required for the integrated electronics.

By the nature of Lithium-Ion cells, the battery will self-discharge.

The self-discharge rate doubles for every 10°C (18°F) rise in temperature.

The capacity loss of the battery degrades significantly at higher temperatures.

As the battery ages, the full-charge capacity of the battery will degrade and be permanently lost. As a result, the amount of charge that is stored and available for use is reduced.

Conditioning Guideline

the battery in the monitor full charged and discharged every six months and condition it using the battery charger.

Storage Guideline

Store the battery outside of the monitor at a temperature between 20°C to 25°C (68°F to 77°F).

When the battery is stored inside a monitor that is powered by an AC power source, the battery cell temperature increases by 15°C to 20°C (59°F to 68°F) above the room’s ambient temperature. This reduces the life of the battery.

When the battery is stored inside a monitor that is continuously powered by an AC power source and is not powered by battery on a regular basis, the life of the battery may be less than 12 months.

GIMA SPA. recommends that you remove the battery and store it near the monitor until it is needed for transport.

How to Recycle the Battery

When the battery no longer holds a charge, it should be replaced. The battery is recyclables. Remove the old battery from the monitor and follow your local recycling guidelines.

WARNING

EXPLOSION HAZARD —

DO NOT incinerate the battery or store at high temperatures. Serious injury or death could result.

Rev. 2.0 1.BASIC 33


1.7 General Manu Operation

Screen Composition

Real Time Wave

Window

Parameter

Windows

Menu Select Window

Real Time Wave Window：Displays measured results by up to three waves.

Menu Select Window：Menus appear when they are activated..

Parameter Window：Measured and setup data are displayed in five windows.

Rev. 2.0 1.BASIC 34

Menu Selection


Turn or press the knob.

When the Trim Knob Key is turned, menus are selected in the order indicated above. The above screen shows that the MORE menus is selected. The menus move to the right in the order of MORE

MENU

→ ECG → NIBP →SpO

2

→ RESP → TEMP. An inactivated window is jumped off.

Menu Composition

More Menu Window

When the additional menu is selected it will set and cancel the functions.

Rev. 2.0 1.BASIC 35


Numerical value sign widow

This window displays a measured parameter, function setup, and the boundary of parameter values.

Parameter value

Breathing rate

Menu selection by using Trim Knob key

As the key is turn to the right, the menu selection moves clockwise. As the key is turn to the left, the menu selection moves counterclockwise. The menu selection is activated when you depress Trim

Knob key.

Menu selection with arrows

Upward Movement: Turns the Trim Knob key to the left.

Downward Movement: Turns the Trim Knob key to the right.

Selection is made by pressing the Trim Knob key. One comes out of the menu after the selection.

Rev. 2.0 1.BASIC 36


When moving the within quadrilateral, the letter reverses, and the numeric value reflects immediately.

MAIN

MENU

PREV

MENU

QRS VOLUME :

> OFF

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Word feature menu

The following figure shows the screen where the word sequence menu is activated within the word sequence correction menu. Here, the cursor moves over the words when the Trim Knob key is turned in the clockwise direction.

The above figure shows how the cursor moves on the screen. The cursor moves according to the direction the Trim Knob Key is turned. Press the Trim Knob key if you want to change a letter currently on the screen.

The above figure shows how the cursor is selected to change a letter. Right-hand turning of the Trim

Knob Key makes it possible to select in the order of 0-9,A-Z, and a blank, while left-hand turning makes the movement in the opposite direction. Once a letter or a number is selected, the screen comes back to the condition where the same process of selection can be made. One may move to

Rev. 2.0 1.BASIC 37


the menu item in the left of the screen to end the process, which is completed by pressing Trim

Knob Key. After completion, the screen comes back to the earlier picture.

Operation menu

The setup value changes without a selection when the menu is moved.

Rev. 2.0 1.BASIC 38


2. PATIENT/DATA MANAGEMENT

2.1 ADMIT

CHANGE ADMIT INFO

DISCHARGE

HEIGHT

WEIGHT

2.2 ALARM

ALL LIMITS

ALARM PRINT

ALARM VOLUME

ALARM LEVEL

ARRHYTH LEVEL

ALARM REVIEW

ALARM LIST

SAVE ALARM LEVEL

NURSE CALL

Rev. 2.0


Additional setups are made foe each parameter function. One can make an overall setup for the entire monitor system.

Rev. 2.0 2. PATIENT/DATA MANAGEMENT 40

2.1 ADMIT

CHANGE ADMIT INFO

DISCHARGE

HEIGHT UNIT

WEIGHT UNIT


ADMIT TYPE

Set the exercise environment of equipment in discharge status.

ADU : ADULT ICU // PED: PEDIATRIC ICU // NEO : NEONATE ICU



CHANGE ADMIT INFO

Last and first name (11 letters for each), sex (male or female), date of birth, weight, height, and patient ID (13 characters)



DISCHARGE

Patient information and all numbers change to standard, and the screen displays, “ALL ALARMS

OFF ADMIT PATIENT TO ACTIVE ALARMS.”

ADMIT


HEIGHT

Unit of height is set as Cm / Inches.


WEIGHT

Unit of weight is set as Kg / LBS.



2.2 ALARM

Alarm is divided into two, alarm for the patient’s condition and for the product’s condition.

The patient’s alarm sounds when the diagnostic functions (ASYSTOLE, VTAC/VFIB, and VTAC) are detected. Each alarm sound differs in order in order and volume according to the levels of HIGH,

MEDIUM, LOW and MESSAGE.

HIGH

-5

≡

300

≡

MEDIUM

-3

≡

300

≡

LOW

-1 ≡ 300 ≡

300

≡

MESSAGE

: Alarm sounds

≡ 300 ≡

: Number flashes

: Waves are printed out

≡

: Alarm lamp flashes



Alarm for the Product

The machine gives alarm sounds for its system with a related message flashing.

LOW -1

≡

ALARM LIMITS：The machine enables one to see and change the limits of alarm for all parameter functions.

ALARM PRINT：with an ON/OFF setup, the related information is printed out whenever an alarm is given.

ALARM VOLUME：volume of each alarm can be adjusted in 10 step.

ALARM LEVEL：Priority of each parameter alarm can be set up.

ALARM REVIEW： Shows the priority order information for all alarms of each measurement.

NURSE CALL： Set the ON/OFF feature of the NURSE CALL.

MAIN

MENU

PREV

MENU

ALL ALARM

LIMITS

NURSE

CALL:

ON

ALARM

PRINT:

ON

ALARM

LEVEL

ALARM

VOLUME:

OFF

ALARM

REVIEW

It is able to see all the alarm range and change of measurement function.


ALL LIMITS

MAIN

MENU

PREV

MENU

ALL ALARM

LIMITS

NURSE

CALL:

ON


ALARM

PRINT:

ON

ALARM

LEVEL

ALARM

VOLUME:

OFF

ALARM

REVIEW

ALARM PRINT

Set ON/OFF functions automatically. When the alarm is activated the corresponding information is printed on heat sensitive paper.



ALARM VOLUME

Set the alarm volume to be set at 10 grades.

MAIN

MENU

PREV

MENU

ALL ALARM

LIMITS

NURSE

CALL:

ON

ALARM

PRINT:

OFF

ALARM

LEVEL

MAIN

MENU

PREV

MENU

ALARM VOLUME :

ALARM LEVEL

Set the order of priority in each alarm.

MAIN

MENU

PREV

MENU

ALL ALARM

LIMITS

NURSE

CALL:

ON

>

OFF

10%

20%

30%

40%

50%

ALARM

PRINT:

ON

ALARM

LEVEL

MAIN

MENU

PREV

MENU

PARAMETER

LEVEL

ARRHYTH

LEVEL

60%

70%

80%

90%

VOLUME:

REVIEW

100%

ALARM

OFF

ALARM

ALARM

VOLUME:

OFF

ALARM

REVIEW


PARAMETER LEVEL


ARRHYTH LEVEL

One can set up priorities when he or she uses the alarm for the diagnostic function.



ARRHYTHMIA ALARM LEVELS

RETURN

ASYSTOLE

VTAC/VFIB

VTAC

ALARM LEVEL

HIGH

HIGH

HIGH

ALARM REVIEW

After an alarm is triggered the alarms and data wave pattern can be reviewed. Set up for priority of each parameter alarm.

MAIN

MENU

PREV

MENU

ALL ALARM

LIMITS

NURSE

CALL:

ON

ALARM

PRINT:

ON

ALARM

LEVEL

ALARM

VOLUME:

OFF

ALARM

REVIEW



ALARM LIST

When an alarm activates, this shows the order of the alarms.

II

10-JAN-2007 12:23

ALARM REVIEW

III

< RETURN

ECG

SPO2

RESP

SpO2

ECG

ECG

ECG

SPO2

SPO2

RESP

RESP

ECG

TIME

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

John

PVC (0/min): 0

ST(mm): 0.0

100

50

BPM

P mmHg

KIND

ASYSTOLE

LOW

HIGH

MESSAGE1

MESSAGE2

MESSAGE3

MESSAGE4

MESSAGE5

MESSAGE7

MESSAGE8

MESSAGE9

X2

X1

Ver.4.00BHCDDC

X4

150

60

S

ADT

09:30

1 hr

2:10

%SpO2

100

90

30

10

37.0

35.0

RPM

‘C

30S

(93)



IIII

100

50

150

60

S

III

< RETURN

ASYSTOLE

80BPM 99%SpO2 150RPM

ECG

SPO2

RESP

ECG

ECG

ECG

SPO2

SPO2

RESP

RESP

ECG

22:21:10

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

02/23 22:22:60

22:22:12

ASYSTOLE

LOW

HIGH

MESSAGE1

MESSAGE2

MESSAGE3

MESSAGE4

MESSAGE5

MESSAGE7

MESSAGE8

MESSAGE9

22:22:14

09:30

1 hr

2:10

37.0

35.0

SAVING CONDITION

This determines the order in which triggered alarms are saved.



NURSE CALL

When an alarm is triggered, this activated the NURSE CALL function.

MAIN

MENU

PREV

MENU

ALL ALARM

LIMITS

NURSE

CALL:

ON

ALARM

PRINT:

ON

ALARM

LEVEL

MAIN

MENU

PREV

MENU

ALL ALARM

LIMITS

NURSE

CALL:

OFF

ALARM

PRINT:

ON

ALARM

LEVEL

ALARM

VOLUME:

OFF

ALARM

REVIEW

ALARM

VOLUME:

OFF

ALARM

REVIEW



3. SETUP

3.1 SETUP

DISPLAY

DEMO

USER SERVICE

MAKER SERVICE

Rev. 2.0


3.1 SETUP

DISPLAY : screen set menu

USER SERVICE : This is the menu to set the connection used to interface with an external computer

MAKER SERVICE : This is the basic adjustment menu used to adjust the features of this product.

DISPLAY

SET PARA：Measurement function selected.

WAVE SELECT：Set wave pattern source at the bottom of the WINDOW with LARGE

PARAMETER MODE.

SET DATE & TIME: Set and change date and time.

HR/PR SELECT：Set and select HR/PR source.

COLOR SELECT: Set screen display color.

SET SWEEP: Set speed of ECG, RESP WAVE DISPLAY

MAIN

MENU

PREV

MENU

SET PARA

SET

SWEEP:

25mm/s

WAVE SELECT:

ECG

SET

DATE & TIME

HR/PR SELECT:

ECG

Rev. 2. 0 3.SETUP 55


SET PARA

Select measurement function to use

MAIN

MENU

PREV

MENU

SET PARA

SET

SWEEP:

25mm/s

WAVE SELECT:

ECG

SET

DATE & TIME

HR/PR SELECT:

ECG

WAVE SELECT

Select waveform to display in large parameter display.

MAIN

MENU

PREV

MENU

SET PARA

SET

SWEEP:

25mm/s

WAVE SELECT:

ECG

SET

DATE & TIME

HR/PR SELECT:

ECG

Rev. 2.0 3.SETUP 56


MAIN

MENU

SET PARA

PREV

MENU

SET

SWEEP:

25mm/s

SET DATE & TIME

It has sub menu to set date and time.

MAIN

MENU

SET PARA

PREV

MENU

SET

SWEEP:

25mm/s

SET TIME

Set time of equipment.

MAIN

MENU

PREV

MENU

SET TIME

COLOR

SELECT:

GREEN

WAVE SELECT:

ECG

SET

DATE

>

SET

DATE & TIME

SPO2

RESP

HR/PR SELECT:

ECG

SET

DATE & TIME

HR/PR SELECT:

ECG

MAIN

MENU

PREV

MENU

SET

TIME:

10:58:01

Rev. 2. 0 3.SETUP 57


SET DATE

Set date of equipment

MAIN

MENU

PREV

MENU

SET TIME

SET

DATE

MAIN

MENU

PREV

MENU

SET

DATE:

06-DEC-2007

HR/PR SELECT

This menu is used to set the source that detects heart and pulse rate.

The source can select among ECG and SPO2.

MAIN

MENU

PREV

MENU

SET PARA

SET

SWEEP:

25mm/s

WAVE SELECT:

ECG

SET

DATE & TIME

HR/PR SELECT:

ECG

Rev. 2.0 3.SETUP 58


SET SWEEP

Set speed of drawing wave signal pattern in this widow.

MAIN

MENU

PREV

MENU

SET PARA

SET

SWEEP:

25mm/s

WAVE SELECT:

ECG

SET

DATE & TIME

HR/PR SELECT:

ECG

MAIN

MENU

PREV

MENU

SET

SWEEP:

DEMO

Set ON/OFF DEMONTRATION of equipment.

> 6.25 mm/s

12.5 mm/s

25 mm/s

50 mm/s

SET

DATE & TIME

HR/PR SELECT:

ECG

Rev. 2.0 3.SETUP 59


USER SERVICE

The user is able to set the communication parameters, power supply filter, and patient’s age.

SET UNIT NAME

Set up for Equipment name.

MAIN

MENU

PREV

MENU

SET UNIT

NAME:

█

Rev. 2.0 3.SETUP 60

SET BED NUMBER

Set up for patient bed number.

Allowable setters are from 1 to 255.


Rev. 2.0 3.SETUP 61


AC FILTER

AC FILTER is function where you can set power supply frequency. This feature is required because power supply frequency can be different from one country to another. . (The selectable frequencies are 50Hz and 60Hz.)

Rev. 2.0 3.SETUP 62


SYSTEM

System able to change and verify Equipment version information and system information

MAKER SERVICE

Maker service is a menu is used by manufacturers.

Rev. 2.0 3.SETUP 63


4. TREND

4.1 TREND

GRAPHIC TREND

TABLE TREND

TREND WINDOW SETUP

Rev. 2. 0 64


4.1 TREND

TREND shows saved data graphically displayed with numeric values.

Real-time data recording duration is 1 minute. Amount of saving time is for this data will be saving for 128hours.

: Move to main screen

: Move within the tables

: Move up to other analysis function

: Move down to other analysis function

: Time period set menu

Rev. 2.0 4.TREND 65


GRAPHIC TREND

Wave Data can be stored and seen according to section.

Rev. 2.0 4.TREND 66


TIME PERIOD

One can set up and store data and time that one can see in a screen.

Rev. 2.0 4.TREND 67


TABULAR TREND

One can see the stored data at the time previously set up.

Rev. 2.0 4.TREND 68

TIME INTERVAL

One can store data and set up time.


TREND WINDOW SETUP

Set the trend display window that will show the real time wave window.

Rev. 2.0 4.TREND 69


MAIN

MENU

PREV

MENU

II

10-JAN-2007 12:23

II

SpO2

RR II

TIME PERIOD

Set visible time period in a screen.

MAIN

MENU

TIME

PERIOD:

30MINS

PREV

MENU

John

PVC (0/min): 0

HR

ST

NIBP

%SpO2

RR

TEMP

ST(mm): 0.0

100

50

BPM

P

300 mmHg

0

-99.9

300

0

100

X2

0

128

150

60

S

ADT

09:30

1 hr

2:10

%SpO2

100

90

RPM

0

45.0

30

10 30S

15.0

‘C

12:00

Ver.4.00BHCDDC

37.0

35.0

(93)

SET TREND

PARA

TIME

PERIOD:

> 30MINS

60MINS

90MINS

3HRS

6HRS

12HRS

Rev. 2.0 4.TREND 70


SET TREND PARA

Set parameter for display in a screen.

MAIN

MENU

TIME

PERIOD:

30MINS

PREV

MENU

SET TREND

PARA

TREND PRINT

Graphic: select the number which selects a graphic trend and press print to prints the selected trend.

Table: select the table number to be print and press print to receive print all the data in the selected patient admit (Admit) table.

Rev. 2.0 4.TREND 71


5. ECG

5.1 Outline

Color and Name for Each Cable Size

ECG Connector Location and Measurement Cable

5 Lead Electrode Attached Location

3 Lead Electrode Attached Location

Method to Attach Electrode to Baby

5.2 ECG Data Window

5.3 ECG Data Setup

TRACE 1 LEAD SELECT

ALARM LIMIT

ALARM

QRS VOLUME

ECG SIZE

HEART RATE SOURCE

ECG SPEED

ANALYSIS SETTING

Rev. 2. 0 72


5.1 Introduction

It calculates the heart rate with 3 or 5 leads ECG signal acquisition and perform the alarm according to the setting value.

Colors and Standards of Cables

Leadwire

AHA

Color code

AHA

Label

IEC

Color code

IEC

Label

Right arm White RA Red R

Left arm Black LA Yellow L

Right leg

Left leg

Green RL Black

Red LL

N

Green F

V1(precordial) Brown V1 White C1

AHA：American Heart Association (U.S.A. standard)

IEC：International Electro technical Commission (Europe standard)

Position of ECG Connector and Measuring Cable

ECG connecter +detect cable

Rev. 2.0 5.ECG 73


Attaching Electrodes to the Patient

1. Shave exess hair. With a piece of cotton pad moistened with alcohol, clean the patient’s skin where the electrodes should be mounted. Avoid wrinkled or uneven skin areas. Wipe off the alcohol with a dry cotton pad.

2. Open the electrode package and take out the electrode.

3. Remove the backing paper from the electrode. Be careful not to touch the adhesive side.

4. Attach the disposable electrode to the previously cleaned skin. Avoid wrinkled and uneven skin areas.

5. The electrode lead which is connected to the monitor onto the electrode.

6. Fasten the electrode lead to the skin with surgical tape with an extra length of wire between the tape and the electrode. This prevents body movement from moving the electrode lead.

Note

9 To maintain good contact between the electrode and skin, check that the paste of the disposable electrode is not dry.

9 When contact of the disposable electrode becomes poor, replace the electrode with a new one immediately. Otherwise, contact impedance between the skin and electrode increase and the correct ECG cannot be obtained.

9 If the contact is bed before the expiration date on the package, replace the electrode with a new one.

9 To obtain a stable ECG waveform rub the skin with “skin Pure” skin preparation gel or tincture of Benzion.

9 Shall use only the CE certified disposable electrode.

Rev. 2.0 5.ECG 74


Choosing an ECG lead for Arrhythmia Monitoring

It is very important to select a suitable lead for arrhythmia monitoring.

Guidelines for non-paced patients:

9 QRS should be tall and narrow(recommended amplitude > 0.5mV)

9 R wave should be above or below the baseline (but not bi-phasic)

9 T wave should be smaller than 1/3 R-wave height.

9 The P-wave should be smaller than 1/5 R-wave height.

For paced patients, in addition to the above,:

9 Not wider than the normal QRS

9 The QRS complexes should be at least twice the height of pace pulses.

9 Large enough to be detected, with no re-polarization.

To prevent detection of P-waves or baseline noises as QRS complexes, the minimum detection level for QRS complexes is set at 0.15mV. Adjusting the ECG wave size on the monitor display(gain adjustment)does not affect the ECG signal which is used for arrhythmia analysis. If the

ECG signal is too small, you may get false alarms for asystole.

Information on the ECG waveform

When ECG signal is 80bpm T-wave duration is 180ms, and the QT interval is 350ms.

Rev. 2.0 5.ECG 75

5 Position of 5-Lead


Position of 3-Lead Wrier Electrode

Rev. 2.0 5.ECG 76


How to Attach the NEONATE Electrode

Rev. 2.0 5.ECG 77


5.2 ECG Data Window

Heart Rate Alarm Limit:

Decides the QRS limits, and gives an alarm if a value is over the limits.

QRS: Detects QRS, and flashes when QRS is detected.

Pace Detector

Indicators:

Detects and displays the patient’s pace maker and flashes.

Heart Rate:

Displays heart rate per minute.

Note

ECG Wave Display is always on when the cable is connected.

The heart rate is calculated by a moving average. The monitor detects 8 consecutive beats, averages the R-R intervals of the latest 8 beats and uses this average to calculate the current heart rate. When a new beat is detected, the heart rate is recalculated using the latest 8beats. The heart rate display is updated every 3 seconds.

Heart rate meter updates a new heart rate for a step increase or decrease in 10 seconds maximum.

When ventricular tachycardia is detected, the alarm set in 5 seconds maximum.

Check that the delay time of the output signal (alarm trigger 80ms maximum) is within the range of the connected equipment.

Rev. 2.0 5.ECG 78


Safety Precautions

Warning

CABLES — Route all cables away from patient's throat to avoid possible strangulation.

CONDUCTIVE CONNECTIONS — Extreme care must be exercised when applying medical electrical equipment. Many parts of the human/machine circuit are conductive, such as the patient, connectors, electrodes, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device. Such contact would bridge the patient's isolation and cancel the protection provided by the isolated input. In particular, there must be no contact of the neutral electrode and ground.

DEFIBRILLATION — Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result.

To avoid the risk of serious electrical burn, shock, or other injury during defibrillation, all persons must keep clear of the bed and must not touch the patient or any equipment connected to the patient.

After defibrillation, the screen display recovers within 10seconds if the correct electrodes are used and applied in accordance with the manufacturer’s instructions.

ECG cables can be damaged when connected to a patient during defibrillation. Check cables for functionality before using them again.

The peak of the synchronized defibrillator discharge should be delivered within 60ms of the peak of the R wave. The signal at the ECG output on the patient monitors is delayed by a maximum of 30ms.

If the ECG waveform on the screen is too unstable to synchronize with the patient’s heart beat because of the following reason, remove the cause of an alarm, message, or unstable ECG, and then use a stable ECG lead for synchronization.

9 ECG electrode is detached or broken. Lead wire is detached or broken.

9 Lead wire moves. AC interference, EMG noise or noise from ESU is superimposed.

9 Connection cable is broken or has a short circuit. Connector has poor contact.

Rev. 2.0 5.ECG 79


INTERFACING OTHER EQUIPMENT — Devices may only be interconnected with each other or to parts of the system when it has been determined by qualified biomedical engineering personnel that there is no danger to the patient, the operator, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected devices, the user must contact the manufacturers concerned (or other informed experts) for proper use. In all cases, safe and proper operation should be verified with the applicable

Manufacturer’s instructions for use, and system standards IEC 60601-1-1/EN 60601-1-1 must be complied with.

Electrosurgery Unit

9 Electrosurgical units(ESU) emit a lot of RF interference. If the monitor is used with an

ESU,RF interference may affect the monitor operation.

9 Locate the monitor as far as possible from the ESU. Locate them on opssite sides of the operating table, if possible.

9 Connect the monitor and ESU to different AC outlets located as far as possible from each other.

9 When using this monitor with an electrosurgical unit, its return plate and the electrodes for monitoring must be firmly attached to the patient. If the return plate is not attached correctly,it may burn the patient’s skin where the electrodes are attached.

Rev. 2.0 5.ECG 80


5.3 ECG Data Setup

A setup window appears at lower part of the screen when the Trim Knob Key is pressed in the ECG

Parameter Window.

Selection is made by pressing the Trim Knob Key, while movement across the menu is performed by turning the key either clock or anticlockwise.

TRACE 1 LEAD SELECT

Select channels from I to V in ECG

Rev. 2.0 5.ECG 81

ALARM LIMIT

Alarm Limit is 0 ~ 300.


Rev. 2.0 5.ECG 82

ALARM SOUND

Set ON/OFF of ECG alarm sound.


MAIN

MENU

PREV

MENU

ALARM

LIMIT

ALARM

SOUND

Rev. 2.0 5.ECG 83


QRS VOLUME

Move the Key to select a volume rate from OFF, 10% to 100%.

DISPLAY

Set the sweep speed and waveform size.

MAIN

MENU

LEAD SELECT :

II

PREV

MENU

DISPLAY

ANALYSIS

SETTING

ALARM

QRS VOLUME :

OFF

Rev. 2.0 5.ECG 84


ECG SPEED

ECG speed is 25 mm/s.

Speed is changeable to 6.25, 12.5, 25, 50mm/s.

MAIN

MENU

SWEEP SPEED :

25 mm/s

ECG SIZE :

X1

PREV

MENU

HR

SOURCE:

ECG

ECG SIZE

The size is changeable to X0.5, X1, X2, X4.

Rev. 2.0 5.ECG 85


HR SOURCE

MAIN

MENU

SWEEP SPEED :

25 mm/s

PREV

MENU

ECG SIZE :

X1

HR

SOURCE:

ECG

MAIN

MENU

SWEEP SPEED :

25 mm/s

PREV

MENU

HEART RATE

SOURCE:

>

ECG

SPO2

AUTO

ANALYSIS SETTING

Analysis setting divided to 3 menus.

ECG FILTER：One may select from three frequency types for WAVE FILTER.

MONITOR 0.5Hz ~ 40Hz

MODERATE 0.5Hz ~ 25Hz

MAXIMUM 5Hz ~ 25Hz

DIAGONOSIS is

MAIN

MENU

LEAD SELECT :

II

PREV

MENU

DISPLAY

ANALYSIS

SETTING

ALARM

QRS VOLUME :

OFF

Rev. 2.0 5.ECG 86


PACE：Sets up ON/OFF to indicate that the patient has PACE.

The PACE menu option enables/disables the pacemaker detection program.

Be aware of the following when monitoring a patient with a pacemaker.

Warning

FALSE CALLS—False low heart rate indicators or false asystole calls may result with certain pacemakers because of electrical overshoots.

MONITORING PACEMAKER PATIENTS—Monitoring of pacemaker patients can only occur

Rev. 2.0 5.ECG 87


with the pace program activated.

PACEMAKER SPIKE—An artificial pacemaker spike is displayed in place of the actual pacemaker spike. All pacemaker spikes appear uniform. Do not diagnostically interpret pacemaker spike size and shape.

PATIENT HAZARD—A pacemaker pulse can be counted as a QRS during asystole in either pace mode. Keep pacemaker patients under close observation.

PACEMAKER PATIENTS

. Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter

ALARMS

. Keep pacemaker patients under close surveillance.

ARRHYTH：Sets up ON/OFF to indicate detection of diagnosis (ASYS, VTAC/VFIB, VTAC).

The Analysis algorithm simultaneously uses leads I, II, III, and the V lead for ECG and arrhythmia analysis.

ASYSTOLE: Ventricular asystole occurs whenever the displayed heart rate drops to zero.

VTAC/VFIB: Ventricular fibrillation occurs when the ECG waveform indicates a chaotic ventricular rhythm With an average heart rate greater than or equal to 200beats per minute.

VTAC: Ventricular tachycardia occurs when a run of six or more ventricular beats is detected

With an average heart rate greater than or equal to 150beats per minute.

ST SETTING : ST signal and setting related ST menu.

Rev. 2.0 5.ECG 88


ST ANALYSIS: ON/OFF ST analysis signal.

MEASUREMENT CONDITION: ST measurement condition setting

MAIN

MENU

ST ANALYSIS :

ON

MEASUREMENT

CONDITION

PREV

MENU

ST

ALARM LIMIT

ST

ALARM LEVEL

Rev. 2.0 5.ECG 89


ST ALARM LIMIT: ST alarm limit range setting

Rev. 2.0 5.ECG 90


ST ALARM LEVEL: ALARM LEVEL setting

PVC SETTING: PVC ON/OFF and ALARM limit range setting

Rev. 2.0 5.ECG 91


PVC ANALYSIS: Decision maker to display PVC value sign with ON/OFF

PVC ALARM LIMIT: Set alarm indicate to PVC

Rev. 2.0 5.ECG 92


PVC ALARM LEVEL: Set PVC ALARM LEVEL

Warning

Display Hart Beat Equipment Signal

Hart Beat equipment signal displays when the PACE mode is. the signal appears series form.

The signal size or form are meaningless clinically

Number Of Heart Beat

Attention to the patient with heart beat equipment. The heart beat equipment can show heart beat even during arrhythmia continuously. Therefore, do not depend on heart beat alarm excessively.

Rev. 2.0 5.ECG 93


CAUTION

FDA POSTMARKET SAFETY ALERT

The United States FDA Center for Device and Radiological Health issued a safety bulletin

October 14, 1998. this bulletin states “that minute ventilation rate-adaptive implantable pacemakers can occasionally interact with certain cardiac monitoring and diagnostic programmed rate.”

The FDA further recommends precautions to take into consideration for patients with these types of pacemakers. These precaution for patients with these types of pacemakers. These precautions include disabling the rate responsive mode and enabling an alternate pace mode. For more information contact:

Office of Surveillance and Biometrics, CDRH, FDA

1350 Packard Drive, Mail Stop HFZ-510 Rockville, MD 20850 U.S.A

NOTE

ECG monitoring with patients in non-invasive trans coetaneous pacemakers may not be possible due to large amounts of energy produced by these devices. Monitoring ECG with an external device may be needed.

Rev. 2. 0 5.ECG 94


WARNINGS

VENTRICULAR ARRHYTHMISAS

The arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect a trial or supra ventricular arrhythmias. Occasionally it may incorrect identify the presence or absence of an arrhythmia. Therefore, a physician must analyze the arrhythmia information in conjunction with other clinical findings.

SUSPENDED ANALYSIS

Certain conditions suspend arrhythmia analysis. When suspended, arrhythmia conditions are not detected and alarms associated with arrhythmias do not occur. The messages which alert you to the conditions causing suspended arrhythmia analysis are : ARR OFF,

ARRHYSUSPEND, LEADS FAIL, ALARM PAUSE, ALL ALARMS OFF, and DISCHARGED.

Trouble shooting

Problem :

Inaccurate heart rate and/or false a systole.

Solution :

Check ECG signal from patient:

1. Check/adjust lead placement.

2. Check/perform skin preparation.

3. Check/replace electrodes.

Check amplitude of ECG waveform:

1. Select ECG parameter label.

2. Select DISPLAY LEAD,

3. Scroll through all ECG leads and check for 0.5mV amplitude at normal (1X) size. (at least

0.5mV amplitude is required for QRS detection.) for borderline signals, validate on a graph.

4. If amplitudes are low, electrodes may need to be repositioned or replaced.

Rev. 2.0 5.ECG

95


Problem :

False ventricular calls.

Solution :

Check ECG signal from patient: (the chest lead may exhibit polarity changes which may occasionally cause an inaccurate call.)

1. Check/adjust lead placement.

2. Check/perform skin preparation.

3. Check/replace electrodes. (if chest lead is a problem, move the chest lead to another chest position or leg position.)

Problem :

Inaccurate pacemaker detection

Solution :

Use pacemaker processing:

1. Select ECG parameter label.

2. Display the lead of ECG with the greatest amplitude in the top waveform position.

3. Select ANALYSIS SETTINGS.

4. SELECT DETECT PACE.

Rev. 2.0 5.ECG

96


6. SpO

2

6.1 Outline

SpO

2

Connector Location and Measuring Cable

6.2 SpO2 Data Window

6.3 SpO2 Data Setup

SWEEP SPEED

RATE VOLUME

ALARM

ALARM LIMIT

Rev. 2. 0 97


6.1 Outline

SPO2 monitoring is a noninvasive technique used to measure the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the probe passes through the tissue and is converted into an electrical signal by the photodetector in the probe. The monitor processes the electrical signal and displays on the screen a waveform and digital values for SpO2 and pulse rate. It detects SpO2 in the way of transmitting the red and infrared rays into the capillary vessel to take the pulsation. Also perform the alarm function according to the setting value.

SpO2 Connector Location and Measuring Cable

SpO

2

connector

SpO

2

Measuring Cable

Note

The signal input is a high-insulation port and it is defibrillator proof ( )

The insulated input ensures patient safety and protects the device during defibrillation and electrosurgery.

Rev. 2.0 6.SpO2

98


6.2 SpO

2

Data Window

SpO

2

Alarm Limit： Indicates an SpO

2 alarm limit

SpO

2

Strength indicators：

Indicates SpO

2

Strength in a bar graph.

Oxygen Concentration in the

Blood(SpO2 value)

: Indicates %SpO

2

in numbers.

The current SPO2 value and the derived pulse rate (RATE) are displayed. The block sets indicate the strength of the signal (twenty block bars indicate the strongest signal). The SPO2 measurements are averaged over a 6-second period of time.

The monitor display is updated every second.

The SPO2 monitoring features are found in the SPO2 menu. These features include alarm limit adjustment, display of RATE, and RATE volume.

Note

SpO

2

WAVE SIZE is changed automatically.

Rev. 2. 0 6.SpO2 99


Signal and Data Validity

It is extremely important to determine that the probe is attached to the patient correctly and the data is verifiable. To make this determination, three indications from the monitor are of assistance—signal strength bar, quality of the SPO2 waveform, and the stability of the SPO2 values. It is critical to observe all three indications simultaneously when ascertaining signal and data validity.

Signal Strength Bar

The signal strength bar is displayed within the SPO2 values window. This bar consists of 20 blocks set depending on the strength of the signal. Proper environmental conditions and probe attachment will help to ensure a strong signal.

Quality of SPO2 Waveform

Under normal conditions, the SPO2 waveform corresponds to (but is not proportional to) the arterial pressure waveform. The typical SPO2 waveform indicates not only a good waveform, but helps the user find a probe placement with the least noise spikes present. The figure below represents an

SPO2 waveform of good quality.

Good Quality SPO2 Waveform

If noise (artifact) is seen on the waveform because of poor probe placement, the photodetector may not be flush with the tissue. Check that the probe is secured and the tissue sample is not too thick.

Pulse rate is determined from the SPO2 waveform which can be disrupted by a cough or other hemodynamic pressure disturbances. Motion at the probe site is indicated by noise spikes in the normal waveform. (See the figure below.) It has been noted that letting the patient view the SPO2 waveform enables them to assist in reducing motion artifact.

SPO2 Waveform with Artifact

Rev. 2.0 6.SpO2 100


Stability of SPO2 Values

The stability of the displayed SPO2 values can also be used as an indication of signal validity.

Although stability is a relative term, with a small amount of practice one can get a good feeling for changes that are artifactual or physiological and the speed of each. Messages are provided in the

SPO2 values window to aid you in successful SPO2 monitoring.

WARNING

In the monitoring of patients the coincidence of adverse conditions may lead to a disturbed signal going unnoticed. In this situation artifacts are capable of simulating a plausible parameter reading, so that the monitor fails to sound an alarm. In order to ensure reliable patient monitoring, the proper application of the probe and the signal quality must be checked at regular intervals.

Rev. 2.0 6.SpO2 101


6.3 SpO

2

Data Setup

ALARM LIMIT： Menu in which SpO

2 limits are set up.

SWEEP SPEED: speed SpO2 Waveform display setting menu

RATE VOLUME：Menu in which RATE VOLUME is set up

RATE VOLUME

Move the KEY to select the volume from OFF to 100%.

When the ECG volume rate is set, it turns OFF automatically.

Rev. 2.0 6.SpO2 102


ALARM

Two menus: ALARM LIMIT, ALARM provided in the alarm menu

ALARM LIMIT

Number setting of alarm value of %SpO

2 is

0 ~ 100

1. Move the mark to select from RETURN, SpO

2 or SpO

2

-R, and press.

2. After pressing at SpO

2

, move the cursor right or left to LOW, and press.

3. Once the color is changed, move the cursor again to the selected value and press.

4. Place the cursor to HIGH and press, when the color changes, move the cursor again to select the targeted value, and press. Finally move to SpO

2 and press.

(You may decide to perform the process in the opposite order, LOW to HIGH, to have the same result.)

5. After pressing at SpO

2

-R, move the cursor right or left to LOW, and press.

6. Once the color is changed, move the cursor again to the selected value and press.

7. Place the cursor to HIGH and press, when the color changes, move the cursor again to select the targeted value, and press. Finally move to SpO

2

-R and press.

8. With the selection of RETURN the user gets out of the menu.

Rev. 2.0 6.SpO2 103


ALARM SOUND

Warning sound or message displays configuration menu when an alarm is triggered.

Rev. 2.0 6.SpO2 104


LEAD FAULT Condition

When using a reusable finger probe, there is a system alarm to alert you when the probe is off the

Monitor. The monitor defaults this “ LEAD FAULT” condition as a System Warning alarm. however,

You can set it as a System ALARM LEVEL in Monitor Defaults.

SPO2 Messages

Below is a list of system status alarm messages which may be displayed in the SPO2 parameter window during monitoring.

CHECK PROBE

Reusable finger probe is off the patient. Check the probe. The factory default for this alarm is

MESSAGE ALARM.

PULSE SEARCH

Detection by the monitor of a repeatable pulse has ceased. Check the patient and the probe site.

POOR SIGNAL

The SPO2 signal is too low. No SPO2 data is displayed. This can be due to a low patient pulse, patient motion, or some other interference. Check the patient and the probe.

LOST SIGNAL

SPO2 data continues to be displayed, but the quality of the signal is questionable. Check the patient and the probe.

Rev. 2.0 6.SpO2 105


7. RESPIRATION

7.1 Outline

Respiration Connector and Measuring Cable

7.2 RESPIRATION Data Window

7.3 RESPIRATION Data Setup

Respiration Size

Alarm Limit

Rev. 2. 0 7. RESPIRATION 106


7.1 Outline

Respiration via ECG Lead II electrode makes the skin area of the chest enlarged, causing changes in the resistance of skin. Through this it calculates respiration value per minutes and performs the alarm function according to limit value.

Position of

Detected

Lead

II

Respiration Connector and Measuring Cable

Respiration Connecter

Respiration

Measuring Cable

Rev. 2.0 7.RESPIRATION 107


7.2 Respiration Data Window

Breathe indicator:

Indicates the detected breath

Respiration alarm limit:

Indicates respiration limits. minute.

Apnea Limit Setting: Apnea limit sign

Breathing Number: Displays the number of respiration per



7.3 Respiration Data Setup

ALARM: Respiration alarm setting menu

RESP SIZE: A menu to setup Wave Display

SWEEP SPEED: A menu to setup Wave Display of speed

APNEA DETECT: A menu to setup APNEA alarm display

RESPIRATION SPEED

Wave pattern speed is 25 mm/s.

MAIN

MENU

ALARM

PREV

MENU

APNEA DETECT

ON

SWEEP

SPEED:

6.25m m / s

12.5 m m / s

25 m m / s


RESPIRATION

Set wave pattern size X2~ X10.


APNEA DETECT

Deciding function of activating Apnea Alarm

MAIN

MENU

ALARM

SWEEP

SPEED

25mm/s

PREV

MENU

APNEA DETECT

ON

RESP

SIZE

X 2



ALARM

Alarm menu provide ALARM LIMIT and ALARM.

ALARM LIMIT

Alarm Limit of Respiration Numeric Value is 5 ~ 150bpm

Alarm Limit of RESPIRATION APNEA Numeric Value is 3 ~ 30sec.

1. Move the mark to select RETURN, RESP or RESP-A, and press.

2. After a press in RESP, move the cursor right or left to LOW, and press.

3. After the color changed, move the cursor right or left to the selected value, and press.

4. Place the cursor to HIGH, and press. When the color has changed, move the cursor again to select the value and press. Move to the RESP and press again. (You may decide to perform the process in the opposite order, LOW to HIGH, to have the same result.)

5. Once RESP-A is pressed, move to LOW and press.

6. When the color has changed, move the cursor to select the value, and press.

7. A press in the HIGH position, the color changes. Then move the cursor to select the value and press. Move again to RESP-A, and press.

8. Select RETURN to get out of the window.



ALARM SOUND

Warning sound or message displays activation setting when Respiration ALRAM occurs.



8. NIBP

8.1 Outline

NIBP Connector Location and Cuff

8.2 NIBP Data Window

8.3 NIBP Data Setup

ALARM LIMIT

ALARM

CUFF SIZE

UNIT SELECT

INTERVAL

STAT

INFLATION

Rev. 2. 0 7. RESPIRATION 113


8.1 Outline

This function is to measure minimum, Maximum and average blood pressure by using Oscillometric method

Position of NIBP Connecter and cuff

NIBP Connector

Note

As the value of NIBP can vary according to the age and sex of a patient, the user needs to set up right data in Parameter Menu before measurement.

WARNING

Noninvasive blood pressure monitoring is not recommended for patients with hypotension, hypertension, arrhythmias or extremely high or low heart rate. The software algorithm cannot accurately compute NIBP or patients with these conditions.

Rev. 2.0 8.NIBP 114


Note

As the value of NIBP can vary according to the age and sex of a patient, the user needs to set up right data in parameter Menu before measurement. Tubes between the cuff and the monitor are not kinked or blocked.

The air pad should be exactly over the branchial artery. Tubing is immediately to the right or left of the branchial artery to prevent kinking when elbow is bent.

The maintenance is performed every 2 years.

Check the following list devise to operates properly and safety at all times.

1. Check for proper cuff size.

2. Check for residual air left in the cuff from a previous measurement.

3. Make sure cuff is not too tight or too loose.

4. Make sure cuff and heart are at same level, otherwise hydrostatic pressure will offset the NIBP value.

5. Minimize patient movement during measurement.

6. Watch for pulses paradox us.

7. Check for leak in cuff or tubing.

8. Patient may have a weak pulse.

Rev. 2.0 8.NIBP 115


8.2 NIBP Data Window

Alarm Limit：Indicates alarm limit of blood pressure.

Measurement time

Indicates the completion time of measuring

Interval Time: Indicates

Interval time when measures the blood pressure periodically

S：

Indicates the level of systolic limits.

Measure time:

Indicates the schedule counter time of measuring

Systolic pressure：

Indicates the maximum limit of blood pressure

Diastolic blood pressure：Indicates the minimum limit of blood pressure

Mean Value： Indicates mean blood pressure

Rev. 2.0 8.NIBP 116


8.3 NIBP Data Setup

ALARM： A menu to set the Alarm

CUFF SIZE：A menu to select cuff size

UNIT SELECT: A menu to select the pressure unit

INTERVAL ：A menu to set Interval time when measures the blood pressure periodically

STAT: a menu to set activation of 5 minute spontaneous monitor mode

INFLATION: Initial Pressurization setting menu

ALARM

The alarm provides ALARM LIMIT and ALARM.

Rev. 2.0 8.NIBP 117


ALARM LIMIT

Alarm setting Numeric Value of Systolic, Diastolic, and mean pressure is 10 ~ 360mmHg.

1. Move the mark to select one from RETURN, NIBP-S, NIBP-M, or NIBP-D, and press.

2. Press the key at NIBP-S, and move to LOW, and press again.(The user gets the same result regardless of the LOW-HIGH, or HIGH-LOW order.)

3. When the color has changed, move it again to select a target value, and press.

4. Press the key at HIGH. When the color has changed, move to the right to select a target value, and press.

5. Set up or revise the values of NIBP-M and NIBP in the same way as above.

6. With the selection of RETURN, the user can get out of the window.

Rev. 2.0 8.NIBP 118


ALARM SOUND

The menu which decide activate of warning sign and message display when the respiration alarm is on.

CUFF SIZE

The user can select a CUF between ADULT and NEONATAL.

Rev. 2.0 8.NIBP 119


UNIT SELECT

It is a function to set blood pressure measurement unit.

The blood pressure measurement unit provides mmHg and kPa.

INTERVAL

This menu is used for selecting intervals when measures the blood pressure automatically.

Select a target interval from 1min, 2, 3, 4, 5, 10, 15, 20, 30, 1hour, 2, 4, 8.

Rev. 2.0 8.NIBP 120


MAIN

MENU

PREV

MENU

INTERVAL:

> OFF

1MIN

2MINS

3MINS

4MINS

5MINS

10MINS

15MINS

30MINS

60MINS

90MINS

2HRS

4HRS

8HRS

STAT

5 minute monitoring mode activates spontaneously when STAT mode is on.

INFLATION

It is a function for pressurization pressure.

Numeric value is 80, 100, 120, 140, 160, 180, 200, 220, and 240.

Rev. 2.0 8.NIBP 121


Warning

Pay attention to not to block connecting hose when you put cuff on patient.

Rev. 2.0 8.NIBP 122


9. TEMPERATURE

9.1 Outline

Temperature Connector and Measuring Cable

9.2 Temperature Data Window

9.3 Temperature Data Setup

ALARM LIMIT

UNIT SELECT

Rev. 2. 0 9.TEMPERATURE 123


9.1 Outline

This function is used to indicate the changes of resistance generated by the changes of temperature in numbers. The function involves the process of transferring the changes into electric signals.

Temperature Connector and Measuring Cable

Temperature Connector

Temperature

Measuring Cable

Note

Temperature probe is correctly positioned and fixed to do not disconnect on the patient.

Temperature cable is attached to the monitor.

Rev. 2. 0 9.TEMPERATURE 124


9.2 Temperature Data Window

Unit：

Displays temperature unit.

Alarm limit on the least low temperature ：

Indicates temperature limits

Temperature：

Displays temperature.

Note

The minimum measuring time required to obtain accurate readings at the specific body site is at least 3 minutes.

Rev. 2.0 9.TEMPERATURE 125


9.3 Temperature Data Setup

ALARM： Temperature measurement alarm set

UNIT: Temperature measurement unit set

ALARM

Alarm menu provide ALARM LIMIT and ALARM.



ALARM LIMIT

Setting numeric value is 15.0 ~ 45.0 .

1. Move the mark to select either RETURN or TEMP, and press.

2. After pressing the cursor at TEMP, move it to LOW, and press.

3. When the color has changed, move the cursor again to select a target value, and press.

4. Move the cursor to HIGH and press. After the color has changed, move the cursor again to select a target value, and press. (One may choose HIGH first to get the same result.)

5. Select RETURN to get out of the menu.



ALARM SOUND

The menu which decide activate of warning sign and message display when the respiration alarm is on.

UNIT SELECT

Able to select unit with °C, °F.



10. PRINT

10.1 Print

Printer and Heat Sensitivity Paper

Function and Setup Menu

10.2 Paper Change

Rev. 2. 0 10.PRINT 129


10.1 Print

Printer and Heat Sensitivity Paper

A printer used to print data onto thermal paper, this product is offered as an option.

Size of the thermal paper roll: 580mm wide x 380mm in diameter any thermal paper of same size can be used for the printer.

Side View of Printer

Rev. 2.0 10.PRINT 130


Function and Setup Menu

MAIN

MENU

PREV

MENU

PRINTER

SPEED:

25mm/s

WAVE

FORM2:

SPO2

1. Press the PRINT Key for continuous printing.

2. Select Printing Speed 25, 50 mm/s.

WAVE

FORM3:

RESP

WAVE

FORM1:

ECG

MAIN

MENU

PREV

MENU

PRINTER

SPEED:

50mm/s

WAVE

FORM3

WAVE

FORM1

WAVE

FORM2

3. Set up ALARM PRINT in the MORE menu to activate ALARM during printing.

ALARM ALARM PRINT ON

4. Data is printed in a selected wave form along with personal information of the patient.

3 channels select 3 parameters to print.

PRINTER

ECG, RESP, SPO2

Rev. 2.0 10.PRINT 131


MAIN

MENU

PREV

MENU

PRINTER

SPEED:

50mm/s

WAVE

FORM2:

SPO2

WAVE

FORM1:

> ECG

SPO2

RESP

OFF

MAIN

MENU

PREV

MENU

WAVE

FORM2:

> ECG

SPO2

RESP

OFF

WAVE

FORM1:

ECG

Rev. 2.0 10.PRINT 132

MAIN

MENU

PREV

MENU

WAVE

FORM3:


> ECG

SPO2

RESP

OFF

WAVE

FORM1:

ECG

Rev. 2.0 10.PRINT 133


10.2 Paper Change

1

Open the window of the printer.

2

Insert the paper roll offered with the product into the printing unit. Place the roll in a proper way so that the printed paper can roll out upwards.

3

Press the printer window until it is properly shut. Inaccurate shutting may cause failure in printing.

Rev. 2.0 10.PRINT 134


11. MESSAGE LIST

Function

ECG

SpO

2

Message

LEAD FAULT

CHEK PROBE

LEAD FAULT

Details

Cable is not properly connected.

Patient’s finger is off the probe.


RESP

NIBP

TEMP

LEAD FAULT

APNEA


APNEA gives an alarm.

INFLATION FAILURE CHECK CUFF

Cuff hose is not properly connected.

Cuff pressure is putting on excessively.

OVER PRESSURE

Cuff is bent, preventing deflation.

DEFLATION FAILURE

OVER TIME CUFF PRESSURE

Measure time exceeds the preset Level.

Measure signal absent

MEASUREMENT ERROR

LEAD FAULT Cable is not properly connected.

ALARM

ALARM VOL.OFF

SILENCED

ALARM PAUSE 5MIN

Alarm volume is off.

Alarm key is pressed once

Alarm key is pressed twice

TREND

PRINT

NO PATIENT DATA

NO PAPER

No patient’s data input.

No paper in the printer

SETUP BATTERY LOW Low battery

Rev. 2.0 11. MESSAGE LIST 135


12. DEFAULT SETTING VALUE

1. Adult-ICU Mode

Alarm level

Asystole 0

Vfib/VTac 0

V Tach 0

NIBP 0

SpO

2

0

SpO

2

-Rate 0

RR 0

RR-Apnea

T(

ْ C)

0

0

Parameter Limits

Low High

HR 50

NIBP-S 80

150

200

NIBP-M 40

NIBP-D 20

SpO

2

90

SpO

2

-Rate 50

RR(RESP) 10

140

120

100

150

30

RR-Apnea 0

T(

ْ C/ْ

F)

20

30.0/42.0 86.0/107.6

Rev. 2. 0 12. DEFAULT SETTING VALUE 136


Display

Patient Age

Color format

Adult

Color

Primary ECG II

Arrhythemia Off

Detect Pace

Print Waveform2

Off

Off

Print Waveform3

Alarm Print

NIBP Auto

NIBP Cuff Size

Off

On

Off

Adult

RR(RESP) Lead

Alarm Volume

QRS Volume

Pulse Volume

ECG Lead Fault

SpO

2

Probe Off

Units for Height

Units for Weight

Temperature Units

NIBP Limit Type

ECG Filter

II

50%

Off

Off

Low Alarm

Low Alarm cm kg

ْ C

Systolic

Monitoring

Rev. 2.0 12. DEFAULT SETTING VALUE 137


2. Neonate-ICU Mode

Alarm level

Asystole 0

Vfib/VTac 0

V Tach 0

NIBP 0

SpO

2

0

SpO

2

-Rate 0

RR 0

RR-Apnea

T(

ْ C)

0

0


Low High

HR 90 200

NIBP-S 40

NIBP-M 30

100

70

NIBP-D 20

SpO

2

88

SpO

2

-Rate 90

RR(RESP) 15

60

100

200

100

RR-Apnea 0

T(

ْ C/ْ

F)

15

30.0/42.0 86.0/107.6



Display

Patient Age

Color format

0~2 years

Color

Primary ECG II

Arrhythemia Off

Detect Pace

Print Waveform2

Off

Off

Print Waveform3

Alarm Print

NIBP Auto

NIBP Cuff Size

Off

On

Off

Neonate

RR(RESP) Lead

Alarm Volume

QRS Volume

Pulse Volume

ECG Lead Fault

SpO

2

Probe Off




NIBP Limit Type

ECG Filter

II

50%

Off

Off

Low Alarm

Low Alarm cm kg

ْ C

Systolic

Monitoring



3. Pediatric-ICU Mode

Alarm level

Asystole 0

Vfib/VTac 0

V Tach 0

NIBP 0

SpO

2

0

SpO

2

-Rate 0

RR 0

RR-Apnea

T(

ْ C)

0

0


Low High

HR 70 180

NIBP-S 60

NIBP-M 40

160

120

NIBP-D 30

SpO

2

90

SpO

2

-Rate 70

RR(RESP) 10

100

100

180

50

RR-Apnea 0

T(

ْ C/ْ

F)

20

30.0/42.0 86.0/107.6



Display

Patient Age

Color format

Adult

Color

Primary ECG II

Arrhythemia Off

Detect Pace

Print Waveform2

Off

Off

Print Waveform3

Alarm Print

NIBP Auto

NIBP Cuff Size

Off

On

Off

Adult

RR(RESP) Lead

Alarm Volume

QRS Volume

Pulse Volume

ECG Lead Fault

SpO

2

Probe Off




NIBP Limit Type

ECG Filter

II

50%

Off

Off

Low Alarm

Low Alarm cm kg

ْ C

Systolic

Monitoring



13. TROUBLE SHOOTING

1. Noise in ECG

- Gel is dry

- Electrodes does not stick well to skin

The patient’s skin Yes is extremely dry

No

The electrode is Yes in poor condition

No

The cable (lead wire) Yes is disconnected

No

Repair the ECG B/D

Apply ECG gel or water to the area of contact then use the electrode

Replace the electrodes

(Use CE compatible products)

Replace lead wires

Rev. 2. 0 13. TROUBLE SHOOTING 142


2. SpO

2

malfunction

Connectors of the equipments are in bad condition?

The extension cables Yes

are disconnected

No

The Finger probe is Yes

in bad condition?

No

Repair the ECG B/D

Replace extension cables

Replace the finger probe

3. Temp malfunction

The probe is Yes in bad condition?

No

Repair the Temp B/D

Replace the probe

Rev. 2.0 13. TROUBLE SHOOTING 143


4. NIBP malfunction

Are leaks from the hose Yes connector of cuff

No

Repair the NIBP B/D

5. Abnormality in NIBP measurements

Replace the hose of cuff

The patient moved Yes

while measuring

No

Make sure the patient stay still during diagnosis

The measurements Yes

appear lower

No

There is a delay Yes in measuring

No

Repair the NIBP B/D

Loosen the cuff during diagnosis

Tighten the cuff during diagnosis



6. Failure in battery recharge

( the battery does not fully recharge in 6 hours or more)

The output voltage of Yes the adapter is 18V

No

The battery voltage Yes is lower than 5V

No

Repair the power B/D

Replace the adapter

(the battery will not be changed at the rate lower than 17V)

Replace the battery



7. Power failure

The adapter connector Yes is in bad condition

No

The output voltage of the Yes adapter is lower than 18V

No

Repair the power B/D

“Admit” has been Yes selected in the menu

Execute the “admit:” function

(No data will be stored during battery discharge)

No

The Digital B/D (dig) Yes

Battery has been lower than 3V

Replace the battery (3volt)

No

Repair the Dig B/D



8. Periodic noises

Yes All alarm has been

turned off

No

Display lead fault Yes

Turn functions not in use off message appears

(Mode-Display-Set para)

No

The printer Yes function abnormally

No

Repair the accompanying

Equipment

Replace the printer



9. Print failure

The paper tray cover Yes is properly shut

No

The printing face of Yes paper has been reversed

No

Repair the printer and printer B/D

Shut the cover tight

Reverse the paper face



14. SPECIFICATION

Ease of use

Customization

Special Features

Monitor Environmental Specifications

Power adaptor

Monitor Performance Specifications

Graphical and Tabular Trends

SpO2 Performance Specifications

Respirations Performance Specifications

NIBP Performance Specifications

ECG Performance Specifications

Temperature Unit Performance Specifications

Accessories included

OPTION

Rev.2.0 14.SPECIFICATION 127


Ease of use

· Battery operation

· Attached printer

· Table and graphic trend

· Nellcor SpO

2 sensor interchanges

Additional Function

· Able to use auto mobile power supply

· LAN Connection

Monitor Environmental Specifications

· Operating Temperature： 15°C to 30°C (59°F to 86°F)

· Storage Temperature： - 10°C to 60°C (14°F to 140°F)

· Humidity： 20% to 95% RH

· Operating Attitude： 70(700) to 106Kpa(1060mbar)

Power

· AC 100-240V (50/60Hz)

· Adapter 18 V, 2.5 A

Monitor Performance Specifications

· Screen： 7” TFT LCD (800×480)

· Indicators

- Up to 3 wave patterns

- 3 levels of alarm sound

- Visual alarm

- Pulse sound

- handle flashing

- Battery status

- LED external power supply LED

· Interfaces

- Vehicles power supply：12 to 16 V DC, 3A max.

- Generating power for LAN, Wireless LAN : 5.0V max 0.9A

· Battery



- Li-ion battery

- Battery status display

- Operating time：2hours(with fully charged Battery)

· Thermal Printer(Optional)：internal printer

- Speed：25, 50 mm/sec

- Paper width：58 mm

Graphical and Tabular Trends

· Table Trend

- Memory Storage：128 hours

- Data Interval：1 minute

- Display Interval：1MIN, 5, 15, 30, 1HR

· Graphical Trend

- Display Period：30MINS, 60, 90, 3HRS, 6, 12

ECG capacity

· Lead :

· pulse rate range：

3,5

30 to 300 bpm

· Bandwidth：

· Display Sweep Speed：

· ECG size (Sensitivity)：

· Lead-off Detection with display indicator

· Pace maker Detection Mode

· Differential Input Impedance：

· XCommon Mode Rejection Ratio：

0.5 Hz to 40 Hz

2 5mm / sec

0.5, 1, 2, 4 mV/cm

> 5 M

Ω

> 90 dB at 50 or 60 Hz

· Defibrillator Discharge： < 5s

SpO

2

capacity

· Saturation Range：

· Pulse Rate Range：

· SpO

2 accuracy：

0% to 100% oxygen proportion

30 to 254 bpm

70% to 100% ±2 digits, 0% to 69% unspecified



· Sensor

· Minimum Signal:

Amplitude

Red 660nm, 2mW (typical)

Infrared 905nm, 2-2.4mW (typical)

0.05% modulation (Low

perfusion level performance and limitation validation using

FLUKE Index 2 Oximetry Simulator)

Respiration Performance Specifications

· Range： 5 to 120 breaths/min

· Accuracy： ±3

· Display Sweep Speeds：25mm/sec

NIBP capacity

· Technique： Oscillometric

· Measurement mode:

- Manual：

- Auto：

· Pressure Display：

Single Measurement automatic Intervals of 1MIN, 2, 3, 4, 5, 10, 15, 20, 30, 1HR, 2, 4, 8

0 to 300 mmHg

· Blood Pressure Measurement Range:

- systolic ： 60 to 250 mmHg

- Mean Arterial Pressure ：40 to 235 mmHg

- Diastolic： 30 to 220 mmHg

Temperature Unit Performance Specifications

· Range ： 15°C to 45°C (59°F to 113°F )

· Accuracy ：

· Sensor :

25°C to 45°C ± 0.1°C, 15°C to 24°C±0.2°C

YSI 400 Series compatibility

Accessories Included:

· 3Lead patient cable(3CBL-400, 3WIRE-400)

· Electrodes(ECG SENS - 400)

· NIBP tubing, 3m long( NBPCBL-400)

· adult cuff, 25-35 Cm (ACUFF-400)

· SpO

2 extension cable 2m (SPCBL-400)

1 EA

10 EA

1 EA

1 EA

1 EA



· SpO

2

sensor (SPASENS – 400)

· DC adapter, 18VDC, 2.5A (MW160 Made in AULT Co., Ltd.)

Option

· Temperature sensor (skin) (TEMPSENS-400)

· Printer Paper (PAPER-400)

· 5 lead patient cable (5CBL-400, 5WIRE-400)

1 EA

1 EA



Abbreviations and Symbols

Abbreviations and symbols which you may encounter while reading this manual or using the monitor are listed below with their meanings.

Abbreviations

A

AaDO2

A

amps alveolar arterial oxygen gradient

ABG

AC arterial blood gas alternating current

ACCV

ACC VENT

ADT

ANT

AR

AO2 (aO2) accelerated ventricular adult anterior arterial oxygen saturation argon

ARRYTH arrhythmia

ART

ASYS arterial asystole

Auto, AUTO automatic

AUX Auxiliary a–vO2

AVF

AVG

AVL

AVR arterial venous oxygen content difference left foot augmented lead average left arm augmented lead right arm augmented lead

B

BE

BGMY

BP

BP 1

BP 2

BPM

BRAD base excess bigeminy blood pressure blood pressure connector 1 blood pressure connector 2 beats per minute bradycardia

Rev. 2.0 132


BSA

BT body surface area blood temperature

Celsius calibration calculation calculations arterial oxygen content cardiac computation constant cubic centimeter critical care unit effective dynamic compliance channel cardiac index centimeter cardiac output, carbonmonoxide carbon dioxide carboxyhemoglobin

C

C

CAL

CALC

CALCS

CaO2

CARD

CC cc, CC

CCU

CEd

CH

CI cm, CM

CO

CO2

COHb

COMM

CP

CS

CvO2

CVP

CPLT

CPP communication cardiopulmonary couplet cerebral perfusion pressure central station mixed venous oxygen content difference central venous pressure

D

D

DC diastolic direct current

DDW Direct Digital Writer

DEFIB, Defib defibrillator

DES

DIA

DISCH dyn desflurane diastolic discharge dyne

Rev. 2.0 133


E ea–vO2 eCaO2

ECG eCvO2

EMC

EMI

ENF

E

expired estimated arterial venous oxygen content difference estimated arterial oxygen content electrocardiograph estimated mixed venous oxygen content eg for example electromagnetic compatibility electromagnetic interference enflurane eO2CI eO2DI eO2R eQs/Qt estimated oxygen consumption estimated oxygen delivery estimated oxygen extraction ratio estimated shunt fraction

Esopho

ESU esophageal electrosurgical cautery unit et al and others

EtCO2, ETCO2 end-tidal carbon dioxide

ETO

EX, Exp

Ethylene Oxide expired

F

F

FEM

FiO2

FR

Fahrenheit femoral fraction of inspired oxygen

French (catheter size)

G

g gram

GTT/CC, gtt/cc drops per cubic centimeter

H

HAL

Hb

HbO2

HCO3

HE

Hgb

HR halothane hemoglobin oxyhemoglobin bicarbonate helium hemoglobin heart rate, hour

Rev. 2.0 134


L

LA

LAT

LBS

LCD

LD

LED

LL

LVSWI

HT

Hz

I

IABP

ICP

ICU ie

IN

Inc

INF

INIT

Inj, INJECT

Insp

IRRG

ISO

ISU

IT

IV kg, KG kPa

M mean, m height hertz

I

inspired intra-aortic balloon pump intracranial pressure intensive care unit that is inspired incorporated infusion, inferior initialization injectate inspired irregular isoflurane inlet select unit injectate temperature intravenous

K

kilogram kilopascal

L

liter, left left arm, left atrial lateral pounds liquid crystal display lead light emitting diode left leg left ventricular stroke work index

M

minute meter

Rev. 2.0 135


MAP

MCG

MetHb

MG

MIN, mL

MM, mm

MM/S mean arterial pressure micrograms methemoglobin milligrams min minute milliliter millimeters millimeters per second

MMHG, mmHg millimeters of mercury

MRI magnetic resonance image

MTR

MUNITS motor milliunits mV

MV millivolt minute volume

N2

N2O

NBP

NC

NET

NS

O2

OR

PA

PaCO2

PAD

PaO2

Pa/FiO2

PAM

PAO2

PAUS

PAW

NEO, Neo

N

nitrogen nitrous oxide noninvasive blood pressure non-capture neonatal network non-sense

O

oxygen operating room

P

pulmonary artery partial pressure of carbon dioxide in arterial pulmonary artery diastolic oxygenation ratio pulmonary artery mean pressure partial pressure of oxygen in arterial blood alveolar pressure pause pulmonary artery wedge pressure

Rev. 2.0 136


PBAR

PCO2

PEAKP

PED

PEEP pH

PIP

PO2

PPLAT

PT-RR

PULM

PVC

PvO2

PVR

PVRI

PWR

QA

QRS

Qs/Qt

QTY

R

RA

RESP

RHb

RHY

RL

RM

RMT ALM

RMT VID

RR

RTFC

RVSWI barometric pressure partial pressure of arterial carbon dioxide end inspiratory pressure pediatric positive end expiratory pressure hydrogen ion concentration peak inspiratory pressure partial pressure of arterial oxygen plateau pressure patient respiration rate pulmonary premature ventricular complex partial pressure of oxygen in mixed venous pulmonary vascular resistance pulmonary vascular resistance index power

Q

quality assurance interval of ventricular depolarization shunt fraction quantity

R

rate, right right arm, right atrial respiration reduced hemoglobin rhythm right leg respiratory mechanic remote alarm remote video respiration rate artifact right ventricular stroke work index

Rev. 2.0 137


S

SaO2 sec

SOL

SP

SPEC

SpO2

SUM

S

systolic arterial oxygen saturation second solution special spectrometer arterial oxygen saturation from pulse oximetry summation

SV

SvO2

SVR

SVRI stroke volume mixed venous oxygen saturation systemic vascular resistance systemic vascular resistance index

SYNC, Sync synchronization

SYS systolic

T

T1

T2 temperature site 1 temperature site 2

TACH tachycardia

Temp, TEMP temperature

TGMY

TIR

TMP

TV trigeminy technical information report temperature tidal volume

U

UAC

UVC umbilical artery catheter umbilical venous catheter

V

V

V

VAC

VBRADY

VBRD precordial lead volt volts AC (alternating current) ventricular bradycardia ventricular bradycardia

Rev. 2.0 138


–

#

%

±

&

°

>

<

VENT

V-Fib, VFIB

VID

VNT ventilator ventricular fibrillation video ventilator

VT

VTAC ventricular tachycardia ventricular tachycardia

V-Tach, V-TACH ventricular tachycardia

VOL volume

WT

X

W

weight

X

multiplier when used with a number (2X), denotes invalid data when used in place of a value on the display 12SL 12-lead ECG analysis and degree(s) greater than less than minus number percent plus or minus

Rev. 2.0 139


PRODUCT WARRANTY

Product Name

Model Name

Approval

Number

Approval Date

Serial Number

Warranty Period

Date of Purchase

Customer

Section

2 year from date of purchase

Hospital Name :

Address :

Name :

Phone :

Patient Monitor

B3

Sales Agency

Manufacturer

* Thank you for purchasing B3.

* The product is manufactured and passed through strict quality control and through inspection.

* Compensation standard concerning repair, replacement, refund of the product complies with

“Consumer’s Protection Law” noticed by Economic Planning Dept.

Rev. 2.0 140


Manufactured by -

Bionet Co., Ltd :

#11F, E&C DREAM TOWER III, 197-33, GURO-DONG,

GURO-GU, SEOUL, SOUTH KOREA

Tel : +82-2-6300-6418 / Fax : +82-2-6300-6425

Distributor by -

GIMA SPA


Tel : ++39 02 953854209 Fax : ++39 02 95380056


EC Representative -

MGB Endoskopische Gerate GmbH Berlin

Schwarzschildstr. 6, 12489 Berlin, Germany

TEL : +49(30)63927010 / FAX : +49(30)63927011

After Sales Service Center -

GIMA SPA


Tel : ++39 02 953854209 Fax : ++39 02 95380056


Model Name : B3

Rev. 2.0 141


GIMA warranty conditions

Congratulations for purchasing a GIMA product.

This product meets high qualitative standards both as regards the material and the production.

The warranty is valid for 12 months from the date of supply of GIMA.

During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defected parts due to production reasons. Labor costs and personnel traveling expenses and packaging not included.

All components subject to wear are not included in the warranty.

The repair or replacement performed during the warranty period shall not extend the warranty.

The warranty is void in the following cases: repairs performed by unauthorized personnel or with non-original spare parts, defects caused by negligence or incorrect use.

GIMA cannot be held responsible for malfunctioning on electronic devices or software due to outside agents such as: voltage changes, electro-magnetic fields, radio interferences, etc.

The warranty is void if the above regulations are not observed and if the serial code (if available) has been removed, cancelled or changed.

The defected products must be returned only to the dealer the product was purchased from.

Products sent to GIMA will be rejected.

Disposal

Disposal: The product must not be disposed of along with other domestic waste.

The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment.

For further information on recycling points contact the local authorities, the local recycling center or the shop where the product was purchased. If the equipment is not disposed of correctly, fines or penalties may be applied in accordance with the national legislation and regulations.

BIONET Co., Ltd. #1101, E&C Dream Tower III, 197-33, Guro-Dong, Guro-Gu, 152-848 Seoul - Korea

MGB Endoskopische Geräte GmbH Berlin, Schwarzschildstr. 6, 12489 Berlin - GERMANY

Rev. 2.0 142

GIMA B3 Patient Monitor User’s Manual

Assistant Bot

B3 User’s Manual

33718 MONITOR GIMA SPA B3

Patient Monitor

Rev. 2.0

Table of Contents

1. BASIC

1.1 CE Standard Information

1.2 Read before Use

1.3

1.4

1.5

1.6

1.7

1.1 CE Standard Information

Electromechanical safety standards met:

1.2 Read before Use

How to Contact Us

Warranty Period

Warning, Caution, Note

General Precaution on Environment

CAUTIONS

Before Installation

Defibrillator Precaution

Disposables

Disposal

Electrocute Precautions

EMC

CAUTIONS

NOTES

Power Requirements

Restricted Sale

Supervised Use

Ventilation Requirements

Reference Literature

General Precaution on Electric Safety

Equipment Connection

Biocompatibility

Maintenance and Washing Equipment Connection

Cleaning Applied Parts

Cables and Leadwires

1.3 Product Components

Product Outline

Principal Characters of Product

Product Configuration

Option Product

Product Body Configuration

Accessories

Equipment Sign

Ground

Printer

Serial Port

LAN Port

AUX Connector Port

DC Input Indicator

Battery Operation Indicator

DC Input Connector

NIBP

Temperature

Function

Power on

Power off

Respiration

ECG

Heart Pulse

1.4 Function and Key

External Function

Operation Key

1.5 Standard Power Supply Application

DC Power

1.6 Battery Power Supply Application

Operation

The Impact of Lithium-Ion Battery Technology on the Battery

Conditioning Guideline

Storage Guideline

How to Recycle the Battery

1.7 General Manu Operation

Screen Composition

Menu Selection