ANGELUS (Ver 2.03) Patient Monitoring System

ANGELUS (Ver 2.03) Patient Monitoring System

CONTENT Contents of Manual 1 Meaning of Symbols used in this manual 2 Section 1. GENERAL 3 1.1 Introduction 4 1.2 Composition of unit 8 1.3 Panel Description 9 1.4 Basic Operation Concepts 13 1.5 General Safety Information 28 Section 2. Preparations 30 2.1 Preparation Flowchart 31 2.2 Installation conditions 32 2.3 Installation of ANGELUS 33 2.4 Power 35 2.5 Basic Operation of ANGELUS 39 2.6 Description of Safety Symbols & Units Symbols 41 Section 3. Changing System Setup Settings 44 3.1Short-cut menu for easy use 45 3.2 List and Explanation of the Setup settings 60 3.3 Angelus System settings 63 3.4 SpO2 Settings 68 3.5 NIBP Settings 69 3.6 Temperature Settings 70 3.7 Trend Settings 72 Section 4. Necessary Settings before Monitoring 73 4.1 Changing Date and Time 74 Section 5. Monitoring Screen 85 5.1 Safety Precautions for Monitoring 87 5.2 Overview 88

Section 6. Alarm Function 89 6.1 What is an alarm 90 6.2 Silencing alarm 90 6.3 Suspending all alarms before occurrence 91 6.4 Alarm Changeable Range 92 6.5 Alarm Type 93 6.6 Alarm Settings 93 Section 7. SpO2 Monitoring 98 7.1 General 99 7.2 Preparing for SpO2 Monitoring 100 7.3 Monitoring SpO2 102 7.4 Changing SpO2 Settings 103 Section 8. NIBP Monitoring 110 8.1 General 111 8.2 Preparing for NIBP Measurement 113 8.3 Measuring and Monitoring NIBP 117 8.4 Error Message on NIBP 118 8.5 Changing NIBP Settings 119 Section 9. Temperature Monitoring 135 9.1 Preparing for temperature monitoring 136 9.2 Changing Temperature Settings 138 Section 10. Maintenance 144 10.1 Battery Pack 146 10.2 SpO2 147 10.3 NIBP 148 10.4 Temperature 150 10.5 Cleaning and Disinfection the unit 150 10.6 Yearly Inspection 151 Section 11. Specification 152

Contents of Manual This section provides a general overview of the unit and how to operate it. If you have not used an Angelus patient monitor before, read this section first. The patient monitor, Angelus, have several connectors for SpO2, NIBP, Temperature. This Manual contains all the information needed to operate our Patient Monitor, Angelus, which has been designed by giving most consideration on users convenience, and it provides exact information on the conditions of the patients including the measured values such as oxygen saturation in blood (SpO2), blood pressure (NIBP) and temperature. This manual is written to help users effectively operate Angelus. Each feature of this unit could be used more effectively, if relevant medical books referenced for clearer understanding of clinical meaning and pathology. In case some problems occur during the operation of our units, please contact local agent. 1

Meaning of Symbols used in this manual Symbols are used to specially emphasize the agreed details as follows. Users need to surely follow all the caution and notes listed in this Manual. In the event that the unit is damaged due to misuse or negligence by a user, the manufacturer or authorized dealers shall not be responsible for any damage or loss to the unit. Warning The title Warning is used to inform the users of possible causes that could inflict injury, death, or properly damage to the patients. Caution The title Caution is used to inform the users of possible causes that could inflict injury to the patients although it might not severe enough to cause deaths. Note The title Note is used to inform the users of items that are of importance in terms of installation, operation, or maintenance of the Unit although the failure does not inflict the bodily harm to the patients. Dangerous warning should never be included under the Note signal. 2

Section 1. GENERAL 1.1 Introduction 1.1.1 General 4 1.1.2 Warranty Period 5 1.1.3 Request for Services 6 1.1.4 How to Contact us 7 1.2 Composition of Unit 8 1.3 Panel Description 1.3.1 Front & Operation Panel 9 1.3.2 LED Indicators 10 1.3.3 Rear Panel 11 1.3.4 Side Panel 12 1.4 Basic Operation Concepts 1.4.1 Screen Displays 13 1.5 General Safety Information 1.5.1 Cautions for Electrical Safety 28 1.5.2 Keeping & Storing Safety 29 3

1.1.1 General 1.1 Introduction Thank you for using Angelus (Patient Monitor). Please read this manual carefully before operating this unit for proper handling and maintenance, and get familiar with all the functions and features of this unit for safe handling and reliable performance. Please, try to fully understand the features and operation and maintenance methods of this unit prior to actual operation by thoroughly and carefully reading this manual. This is the only way to insure safe operation and reliable performance of the unit for a long time. KTMED Inc. only provides the reliable units to our customers. All of assembling, extending, adjusting or repairing of this unit shall be carried out only by the service personnel authorized by our local agent and KTMED Inc. Electrical connection or installation location has to comply with relevant regulations. Operate the unit as directed by this manual. This unit is useful to monitor unconscious or emergency patients. (It measures SpO2, Blood Pressure, and Temperature.) And this unit is restricted to one patient at a time. To insure the safety of patients, use only the parts and accessories recommended by us. In the event that this Unit needs to be used by connecting with other unit that is not listed in this Manual, be sure to notify us or our authorized dealers about this intent. It can be used while moving of patient with battery or DC. 4

1.1.2 Warranty Period Our Units are produced through out strict quality control, management, packed, and transported to insure the best installation. So you are recommended to do not transport or move the unit without KTMED s packing as you wishes. If not, it can be damaged by delivery. The warranty period for this unit is specified to be 2 years. (But accessories are specified to be one year.) Please contact with KTMED for service. When it malfunctions during the course of normal operation while under the Warranty Period, it will be repaired without any cost to the consumer at our company. We recommend that you have to check regular calibrations at least 24 months. In this case, please contact with KTMED. Clinical accuracy characteristics (manufacturer of the unit) are available from KTMED. When it malfunctions during the warranty period, please inform the service personnel on basic facts, such as model name, unit No., purchase date, and the brief description of the problem. If the defects in units or workmanship for two years from the purchased date, manufacturer will repair or replace your unit with new or rebuilt parts without any charges except below cases, 1 2 3 4 After warranty period Defects from operating or handling carelessness Defects from a natural calamity Defects from repair or disassembled the unit by unauthorized person 5

1.1.3 Request for Services The services for KTMED Inc. units can be performed only by the personnel authorized by the Customer Service Dept. of KTMED or our local agent. In the event that the unit is serviced or tried to be serviced by an unauthorized third party during the warranty period, the warranty shall be nullified. The local agent is obliged to provide the services requested by the customers. When any abnormalities are found in the unit or a danger to bodily harm exists, the unit has to be repaired fast and adequately by authorized personnel. At time of unit malfunctions, please take following steps. Immediately contact our local agent which provides the repairing services for us as a Contractor. Please be prepared to inform the receiver about the manufacturer s label, serial number, date of original purchasing and brief description of malfunction or enquiry before making call. KTMED or local agent will make available on request circuit diagrams, component part lists, descriptions, calibration instructions or other information which will assist your appropriately qualified technical personnel to repair those parts of unit which are designated by KTMED Inc repairable. The customer is responsible for any freight charges, when unit is shipped to KTMED Inc. for servicing (this includes all customs charges). Our local agent will first try to analyze and solve the problem while talking to you on the phone if possible. 6

1.1.4 How to Contact us Contact us at following phone No. and address for various services and unit supplies. We are at your service all the time. Do not hesitate to call us any inquiries at all. KTMED Inc. Tel: +82-2-2108-7890 Fax: +82-2-2108-7894 E-Mail: master@ktmed.com Service Request When request for repairing service, please find out the unit s model name, unit serial No. and brief description of problem in advance, and then contact our Customer Service Dept. 7

1.2 Composition of unit 1 Angelus main unit: 1ea 2 Power cord (110V /220V): 1ea 3 NIBP cuff for Child: 1ea 4 NIBP cuff for adult: 1ea 5 NIBP cuff hose: 1ea 6 SpO2 reusable sensor for adult: 1ea 7 SpO2 extension cable: 1ea 8 IV pole clamp: 1ea 8

1.3 Panel Description 1.3.1 Front& Operation panel This section provides an overview of the operator controls, indicators and symbols. Detailed use of each control is described in other sections of this manual. 1 Malfunction Big LED 2 3 Digit Dual Color FND 3 LED indicators 4 4 Digit FND 5 10 BAR LED 6 Speaker 7 [Start/ Stop] button 8 [Trend] button 9 [[Setup/ Menu] button 10 [Esc/silence] button 9

1.3.2 LED indicators LOW BATTERY: When batteries are low, the LOW BATTERY indicator will be steadily illuminated and audio-able alarm goes off. With connecting AC power, alarm will be stop automatically NO SIGNAL: When SpO2 sensor can not read the finger or pulse rate, the NO SIGNAL will be steadily illuminated. In this case, condition of SpO2 sensor and patient should be checked. ALARM SILENCE: When alarm sound occurs, press this button, and then alarm sound doesn t go off. FINGER FAULT: The FINGER FAULT is steadily illuminated until SpO2 sensor recognizes and read the finger signal. SENSOR FAULT: The SENSOR FAULT is steadily illuminated until SpO2 sensor is connected with ANGELUS correctly. ADULT: When NIBP is set in adult mode, the ADULT is steadily illuminated. NEONATE: When NIBP is set in neonate mode, the NEONATE is steadily illuminated. 10

1.3.3 Rear panel 1 IV Pole Clamp Holder 2 Internal Battery Cover 3 Battery Cover Fixing Bolt 4 Description of Specifications 5 Earth 6 External AC power Input Source 7 Hand Holder 11

1.3.4 Side panel 1 Hand Holder 2 IV POLE CLAMP HOLDER 3 SpO2 SENSOR Socket 4 NIBP Air Coupler 5 Temperature Sensor Socket 12

1.4 Basic Operation Concepts 1.4.1 Screen displays Following are the screens available on the Angelus. For details about the individual screens see the appropriate section. The shadow of the previous screen may remain for a few minutes after changing the screen. Check the following items in the unit and measuring sensors, before operating the unit. Check whether there exists any mechanical danger. Inspect the cable which connects to outside, and power cord, and accessories. Check whether the unit and sensors are connected exactly. 13

1 Initial screen If you press located on the front of the unit, the unit will turn itself on. If you press once more, the unit will turn itself off. When turning on the unit, version information with melody will be displayed for a few seconds as below picture. If the unit is not turned on or indicates low battery on the LED of status LED with an alarm sound, the unit needs to be recharged with an AC power source. After the initial display, the unit is ready to measure SpO2, Pulse Rate, Blood Pressure, and Temperature. Angelus Ver. 2.03 The unit indicates pulse rate, SpO2, blood pressure, temperature numerical value If the unit is not turned on or battery lamp on red with alarm sound, the unit needs to be recharged with an AC power source. 2 Display when you press the Setup/Menu button 1) Press [Set up] button for more than 2 seconds and press [Up/Down] button to change the set values. 14

2) In this mode, these UP/DOWN, Confirm, Esc/silence buttons are used for setting the unit s parameters. [UP/DOWN] buttons are used for scrolling the menu. [Confirm] button is used for selecting one of them. [Esc/silence] button is used for ESC button to exit. 3 Set up the System Volume 15

Further information can fully be explained in the System volume set up in section 3.3.1. 16

4 Set up the Alarm Alarm Sound Volumes Alarm Interval Further information can fully be explained in the Alarm set up in section 3.3.2 and Alarm settings in section 6.6. 17

5 Set up the Time Year Month Date AM/PM 18

Hour Minute Second Further information can fully be explained in the Changing Date and Time in section 4.1. 19

6 Set up the Alarm Limit Pulse rate alarm limit - High limit - Low limit Further information can fully be explained in the Changing the Pulse rate Alarm limit in section 7.4.1 20

SpO2 alarm limit - High limit - Low limit Further information can fully be explained in the Changing the SpO2 Alarm limit in section 7.4.2. 21

NIBP alarm limit - Systolic high limit - Systolic low limit 22

- MAP high limit - MAP low limit 23

- Diastolic high limit - Diastolic low limit Further information can fully be explained in the Changing the NIBP Alarm limit settings in section 8.5.3. 24

Temperature alarm limit - Temperature high limit - Temperature low limit Further information can fully be explained in the Changing the Temperature Alarm limit in section 9.2.2. 25

7 Set up the Blood Pressure (NIBP) NIBP Mode or Further information can fully be explained in the Selecting the cuff type in section 8.5.1. NIBP Interval Further information can fully be explained in the Selecting the interval time in section 8.5.2. NIBP Cuff Exhaust 26

or Further information can fully be explained in Selecting the Exhaust type in section 8.5.4. 8 Set up the Temperature Temperature Unit Further information can fully be explained in the Changing the temperature unit in section 9.2.1. 27

1.5 General Safety Information 1.5.1 Cautions for Electrical Safety Before operation of the Unit, make sure to check following items: Never use this unit in the presence of any flammable anesthetic gas, concentrated oxygen or hyperbaric oxygen. Failure to follow this warning may result in explosion. Never use the unit in a high-pressure oxygen medical care tank. Failure to follow this warning may cause explosion or fire. Whether power supply is appropriate.(ac 100~240V, 50/60Hz) Confirm it before connecting to an outlet. Whether connections (power line or selected unit) are properly made to the unit. Whether the unit is properly grounded. Inaccurate measurement may occur when the sensor sites are exposed to excessive amounts of patient movement. To ensure patient safety, the user should use only the parts and accessories are supplied or recommended by KTMED Inc. If other company s sensors are used for Angelus, it may damage to the monitor. Note The Unit should be placed far from generator, X-ray unit, broadcasting unit, or transmitting wires, so as to prevent the electrical noises from being generated during the operation. When these units are near the unit, it can be inaccurate measurements. 28

1.5.2 Keeping & Storing Safety Please read this manual carefully before operating. Don t operate or store the Unit under the following environments. Store the damp location, and operate the Unit with wet hand. The place where the unit is exposed to direct sunlight. The place where the unit is closed to electrical heating apparatuses. The place where the temperature fluctuation is rather big. (The temperature falls below -20 C or exceed 60 C.) The place where moisture level could go up considerably or where air is not ventilated properly. (Humidity is above 75 %.) The place where the unit is exposed to excessive shocks or vibrations. The place where the unit is exposed to chemical or explosive gas. Disassembly of Unit should be done only by the authorized personnel; otherwise, we will not be obliged to provide any services at all. Make sure that this unit prevents dust and especially metal debris from penetrating in. The place where the atmospheric pressure falls below 70KPa (700mbar) or exceed 106KPa (1060mbar). The place where the unit is exposed to heavy density oil vapor. The place where the unit is exposed to salty atmosphere. If this unit is used with other electrical unit such like ultrasound surgical at the same time, it maybe breakdown. Use sensor and cable that have connected with unfit voltage or damaged ones. Use while testing of MRI or CT etc, it is harmful to patient and might be occurred unreasonable results. Standard operation conditions are as follows. Temperature: 0 ~ 50 C Humidity: 10~ 95% Standard storage and transportation conditions are as follows. Temperature: -20~ 60 C Humidity: 10~ 95% 29

Section 2. Preparations 2.1 Preparation Flowchart 31 2.2 Installation conditions 32 2.2.1 Warnings 32 2.2.2 Cautions 32 2.3 Installation of ANGELUS 33 2.3.1 Power connection 33 2.3.2 Connection of Measuring Sensor with Accessory 34 2.4 Power 35 2.4.1 AC or DC Power Source Selection 35 2.4.2 External Power 36 2.4.3 Internal Power 37 2.4.4 Power Source 38 2.4.5 Battery Specifications 38 2.5 Basic Operations of ANGELUS 39 2.5.1 How to Operate ANGELUS 40 2.6 Description of Safety Symbols & Unit Symbols 41 30

2.1 Preparation Flowchart You may not need to do all these. 1) Install the unit and do the procedures in section 2. 2) Check or change any initial settings on the Setup screen. These items usually do not need to be changed. Refer to Section 3. 3) Check or change the necessary settings before monitoring in section 4. Date and time System setup (Sound Volume) 4) Prepare the unit (SpO2 sensors, NIBP cuffs, Temp sensors, etc.) for monitoring individual parameter and check or change the settings for each parameter. Refer to section 7, section 8, and section 9. 31

2.2 Installation conditions 2.2.1 Warnings Never use this unit in the presence of any flammable gas, concentrated oxygen or hyperbaric oxygen. Failure to follow this warning may result in explosion. Connect only the specified instruments to the connector or connectors marked by following the specified procedure. Otherwise, electrical leakage current may harm the patient and operator. 2.2.2 Cautions Avoid collision when moving the monitor on a cart. Strong impact may damage the monitor. Avoid location where the monitor is sprinkled with liquids. Avoid direct sprinkling, spray or moist air from inspirator or a humidifier. If fluids are accidentally spilled on the unit, take the unit out of service and check for damage. Avoid exposing the unit to direct sunlight. And do not place the unit in dusty area. Connect the power cord to an AC outlet which can supply enough AC current to the monitor. The unit can not function properly with low current. Do not place the unit in an MRI examination room. The monitor may not function properly, or noise from the unit may interfere with the MRI. And do not use an electrical blanket. It may affect monitoring. When there is any problem on the unit, turn off the power immediately and disconnect the power cord from the AC outlet. Take the Monitor out of service and check for damage. 32

2.3 Installation of Angelus 2.3.1 Power Connection Put the power cord into the power cable of Angelus. (Put the power cord to No. 6) Select the power source between an external AC and DC. When you use an external AC power source, connect power cord to AC INPUT located at the rear of the unit. In the case of an external DC power source, connect the power, 12~24V 3A, to its connector of the rear part. 33

2.3.2 Connection of Measuring Sensor Connect the relevant parameter sensors to the appropriate connector. If you want to know further information, refer to section 7, 8, and 9. Warning Only use the SpO2 sensors, NIBP cuffs, Temperature probes supplied with the unit. If not, it may cause some form of harmful effects to the patient or its user. For more detailed information concerning this situation, please contact KTMED or local agent. 34

2.4 Power 2.4.1 AC or DC Power Source Selection The unit can operate on either battery or AC power. Select the power source between an external AC and DC. When you use an external AC power source, connect power cord to AC INPUT located at the rear of the unit. In the case of an external DC power source, connect the power, 12~24V 3A, to its connector of the rear part. For example, when transferring a patient, the unit automatically switches to battery power. The battery is charged when the power cord is plugged into an AC outlet and the AC current is supplied to the monitor. The battery is also charged during monitoring. The monitor can operate for about 2 hours with a fully charged battery pack when: Charged and used in normal temperature (about 25 ) Recorder is not used No alarm occurs No NIBP measurement 35

2.4.2 External Power Warning Only use the provided power cord. Using other power cords may result in electrical shock or other injury to the patient and operator. When the provided power cord cannot be used, operate the monitor on battery power. 1 Power Connection Put the power cord into the power cable of Angelus. (You put the power cable to No.6) Connect the provided power cord to the AC SOURCE connector on the rear panel of the unit and plug the cord into an AC outlet. When the AC power is supplied to the unit, the AC power lamp on the front panel lights and a buzzer sounds. 36

2.4.3 Internal power Angelus has a battery pack which is composed of 6 pieces of the NIMH, 1.2V. This unit can be operated about 2hours with a fully charged battery. When you connect the unit with a direct DC power source, the batteries are automatically charged. It takes about 6 hours to fully recharge a battery. There would be nothing happened even if the unit is connected to DC power with fully charged batteries at the same time. The condition of the internal power source is indicated by battery lamp. Battery pack is charged fully, green light comes on. While battery pack is discharged, red light comes on. If you want to recharge batteries, use a DC power source. If battery pack is recharged enough time, but red light still comes on, then the battery pack should be replaced. You have to contact to KTMED or local agency. Replacement internal of batteries Battery pack is fixed with a connector Note You should use the batteries supplied by KTMED only. Normally, the battery should be changed at least every year. 37

2.4.4 Power Source 1 AC power source When you connect AC power to the unit, the lamp on the front panel will be blinking. Use AC 100~240V, 50/60Hz. If the unit is supplied out of these ranges of power, the unit might be damaged. AC power is supplied to the unit, the green LED AC power light in the front panel is turned on. And when the unit is not in use, it is automatically changed to auto recharge mode. 2 DC power source This unit is possible to be used in a car with DC power. Connect DC power with DC INPUT connector on the bottom side. In this case, Power should be DC 12~ 24V, 3A. 2.4.5 Battery Specifications When the unit is turned on while AC power is cut off, the power is supplied from the battery and the LED battery power indicator at the upper section of the unit is turned on. In case battery power is running out. When the battery capacity goes below 12V, the alarm maybe go off, and battery lamp will blink for a few minute, and then the power will be turned off. Therefore, AC power has to be supplied soon in order to prevent the power shortage. Recharging period: It takes about 6 hours. Continuous Operation Time per full recharge: 2hours. 38

2.5 Basic Operations of Angelus Followings are the screens available on the Angelus. For details about the individual screens, see the appropriate section. Check the following items in the unit and measuring sensors, before operating the unit. Check whether there exists any mechanical danger. Inspect the cable which connects to outside, and power plug, and accessories. Check whether the unit and sensor is connected exactly. 39

2.5.1 How to operate Angelus Note: If you press [Setup/Menu] button more than 2 seconds, you can start System mode. If you want to use short-cut menu, press [setup/menu] button as usual. Also, if you want to know short-cut menu, refer to the Short-cut menu for easy use in section 3.1. 1) If you press located on the front of the unit, the unit will turn itself on. If you press once more, the unit will turn itself off. 2) If you want to change the set values while in use, use [Setup] button, [Up/Down] button, and [Confirm] button to change the set values. 3) The unit should be connected with the measuring sensor. 4) If the unit is not turned on or indicates low battery on the LED of status LED with an alarm sound, the unit needs to be recharged with an AC power source. After the initial display, the unit is ready to measure SpO2, Pulse Rate, Blood Pressure and Temperature. 40

2.6 Description of Safety Symbols & Unit Symbols The International Electro-technical Commission (IEC) has established a set of symbols for medical electrical unit regarding connections or warnings of potential hazards. The classification and symbols are shown below; Symbol Description Attention, consult ACCOMPANYING DOCUMENTS Date of manufacture Serial Number Type BF Equipment Equipotential terminal Power stand-by button Defibrillation-Proof Type BF applied parts Temp SpO2 Alarm SET UP Body Temperature connector Oxygen Saturation connector Alarm Button for changing to system setup 41

KTMED s model Angelus is classified as; Ordinary unit without protection against ingress of water. Unit not suitable for use in presence of a flammable anesthetic mixture by standard of IEC 60601-1(Safety of Electric Medical Unit) Unit that complies with class B for noise-emission, Level B for noise-immunity, per standard of IEC60601-1-2 (Electromagnetic Compatibility Requirements) Applied parts : BF applied parts. Protection against harmful ingress of water: ordinary IPXO. Degree of safety in the presence of flammable anesthetics mixture with air or with oxygen or with nitrous oxide. Not suitable for use in the presence of a flammable anesthetics mixture with air or with oxygen or with nitrous oxide. 42

Section 3. Changing System Setup Settings 3.1 Short-cut menu for easy use 45 3.1.1 NIBP Set up with [Confirm] button 45 3.1.1.1 Selecting the NIBP cuff type 45 3.1.1.2 Changing the NIBP Interval time 46 3.1.2 Alarm Limit set up with [Setup] button 47 3.1.2.1 Changing Pulse rate Alarm Limit 47 3.1.2.2 Changing SpO2 Alarm Limit 49 3.1.2.3 Changing NIBP Systolic Alarm Limit 51 3.1.2.4 Changing NIBP Diastolic Alarm Limit 53 3.1.2.5 Changing NIBP Mean Alarm Limit 55 3.1.2.6 Changing Temperature Alarm Limit 57 3.1.3 Alarm Silence 59 3.1.4 System Menu 59 3.2 List and Explanation of the Setup settings 60 3.2.1 List of all settings 60 3.2.2 Menu button 60 3.3 ANGELUS SYSTEM Settings 63 3.3.1 System Volume Setup 64 3.3.2 Alarm Setup 66 3.3.3 Clock Setup 67 3.4 SpO2 Settings 68 3.5 NIBP Settings 69 3.6 Temperature Settings 70 3.6.1 Changing the temperature unit 70 3.7 Trend Settings 72 3.7.1 View mode 72 3.7.2 Erase mode 72 43

This section explains how to change setting after the unit is installed and before monitoring. The initial setting on the Setup screen must be changed before monitoring. Change these settings while monitoring interrupts monitoring. All other settings can be changed at any time without interrupting monitoring. This section also explains how to initialize the system. This procedure returns all settings to the factory default settings and deletes all stored data memory. 44

3.1 Short-cut Menu for easy use If you want to use short-cut menu, press [setup/menu] button as usual. These are 2 short-button menus for easy manipulation. We use existing menu buttons for this operation. 3.1.1 NIBP Set up with [Confirm] button Users can setup the NIBP Mode and NIBP Interval easily. For manipulation, the users should use [Confirm] button and [Up/Down] button. 3.1.1.1 Selecting the NIBP cuff type 1) Press the [Confirm] button, the Angelus NIBP Adult menu is displayed. 2) Press the [Up/Down] button, then select Adult or Neonate. 3) Press the [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 45

3.1.1.2 Changing the NIBP Interval time 1) Press [Confirm] button one more time, NIBP Interval menu is displayed. 2) Press the [Up/Down] button, then choose appropriate value. (Interval time range: Off(0)/1/3/4/5/10/15/30/45/60/90/120/240 minute) 3) Press the [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 46

3.1.2 Alarm Limit set up with [Setup] button Users can setup Alarm Limit in each parameter easily. For manipulation, the users should use [Setup] button and [Up/Down] button. When the users press [Setup] button, the Pulse Alarm Limit (High) menu is displayed. If the users press this button step by step, Pulse Alarm Limit (Low) is displayed. The next is SpO2 High/Low, and the last is temperature. In other words, manipulation process is step by step. 3.1.2.1 Changing Pulse rate Alarm Limit 1) Press [Setup] button continuously until Pulse rate high Limit menu is displayed. 2) Press the [Up/Down] button, then choose appropriate value from 26 to 255. 47

3) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 4) Press [Setup] button continuously until Pulse rate low Limit menu is displayed. 5) Press the [Up/Down] button, then choose appropriate value from 25 to 254. 6) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 48

3.1.2.2 Changing SpO2 Alarm Limit 1) Press [Setup] button continuously until SpO2 high Limit menu is displayed. 2) Press the [Up/Down] button, then choose appropriate value from 36 to 100. 3) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 49

4) Press [Setup] button continuously until SpO2 low Limit menu is displayed. 5) Press the [Up/Down] button, then choose appropriate value from 35 to 99. 6) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 50

3.1.2.3 Changing NIBP Systolic Alarm Limit 1) Press [Setup] button continuously until NIBP Systolic high Limit menu is displayed. 2) Press the [Up/Down] button, then choose appropriate value from 31 to 300. (In case of neonate mode, alarm limit become from 16 to 150) 3) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 51

4) Press [Setup] button continuously until NIBP Systolic low Limit menu is displayed. 5) Press the [Up/Down] button, then choose appropriate value from 30 to 299. (In case of neonate mode, alarm limit become from 15 to 149) 6) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 52

3.1.2.4 Changing NIBP Diastolic Alarm Limit 1) Press [Setup] button continuously until NIBP Diastolic high Limit menu is displayed. 2) Press the [Up/Down] button, then choose appropriate value from 31 to 300. (In case of neonate mode, alarm limit become from 16 to 150) 3) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 53

4) Press [Setup] button continuously until NIBP Diastolic low Limit menu is displayed. 5) Press the [Up/Down] button, then choose appropriate value from 30 to 299. (In case of neonate mode, alarm limit become from 15 to 149) 6) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 54

3.1.2.5 Changing NIBP Mean Alarm Limit 1) Press [Setup] button continuously until NIBP Mean high Limit menu is displayed. 2) Press the [Up/Down] button, then choose appropriate value from 31 to 300. (In case of neonate mode, alarm limit become from 16 to 150) 3) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 55

4) Press [Setup] button continuously until NIBP Mean low Limit menu is displayed. 5) Press the [Up/Down] button, then choose appropriate value from 30 to 299. (In case of neonate mode, alarm limit become from 15 to 149) 6) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 56

3.1.2.6 Changing Temperature Alarm Limit 1) Press [Setup] button continuously until Temperature high Limit menu is displayed. 2) Press the [Setup] button, and then choose appropriate value from 15.1 to 45. (In the temperature display LED) 3) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 57

4) Press [Setup] button continuously until Temperature low Limit menu is displayed. 5) Press the [Setup] button, and then choose appropriate value from 15.0 to 44.9. (In the temperature display LED) 6) Press [ESC] button or 10 seconds later (automatically), setup is stored and returned to the measuring mode. 58

3.1.3 Alarm Silence Although the measurement value is out of alarm limit, if users don t want to use Alarm sound, the users can disable Alarm sound. However, if there is an error in the sensor or system, the alarm sound is on. a) Alarm On Setup Press [Alarm Silence] button for 2 seconds. Then, Alarm LED is flashed. In this mode, the alarm sound is not generated even if the measurement value is out of alarm limit. b) Alarm On Setoff Press [Alarm Silence] button for 2 seconds. Then, flashed Alarm LED is off. In this mode, the alarm sound is returned to normal mode. 3.1.4 System Menu Press the Setup button for 2 seconds, you can enter System Menu. In this mode, users can setup all parameters described in the manual. Note: If you want to use short-cut menu, press [setup/menu] button as usual. If you press [Setup/Menu] button more than 2 seconds, you can start System mode. Further information can fully be explained in the SpO2 monitoring in section 7, NIBP monitoring in section 8, Temperature monitoring in section 9. 59

3.2 List and Explanation of the Setup Settings 3.2.1 List of all settings Various parameters are user selectable from set up menu. The menu of ANGELUS is constructed as below explanation. The first menu is categorized as Angelus System, SpO2 Setup, NIBP Setup and Temperature Setup. Under each category, the user can set up the parameters. 3.2.2 Menu button We have 4 menus for setting the unit s working parameters. If you press [Setup/Menu] button more than 2 seconds, you can see the menu mode. In this mode, these [Up/Down], [Confirm], [Esc/silence] buttons are used for setting the unit s parameters. [Up/Down] buttons are used for scrolling the menu. [Confirm] button is used for selecting one of them. [Esc/silence] button is used for ESC button to exit. The menu button allows to you: 1 Angelus SET: There are three modes. System volume: Adjust the Angelus sound volume. Alarm Setup: Adjust the alarm volume. Clock Setup: Clock setup the same way as on a typical watch. 2 NIBP SET: There are adult and neonate modes. You can choose according to the patient age. Furthermore, it can be chosen interval time, alarm limit value, and exhaust type. MODE: There are adult and neonate modes. You can choose a proper type for each patient. INTERVAL: Adjust the NIBP interval time of automatic NIBP measurement. Systole: Adjust the Systolic blood pressure alarm limit values. Diastole: Adjust the Diastolic blood pressure alarm limit values. MAP: Adjust the Mean of blood pressure alarm limit values. Exhaust: Choose linear or step type. 60

3 SpO2 SET: You can adjust the SpO2 value and pulse rate alarm limit values. Pulse rate limit: Adjust the pulse rate alarm limit value. SpO2 limit: Adjust the SpO2 alarm limit value. 4 Temperature SET: There are Celsius and Fahrenheit modes. You can choose a desired mode. Furthermore, it can be chosen alarm limit value. Temperature unit: Choose Celsius or Fahrenheit. Temperature limit: Adjust the Temperature alarm limit value. 61

List of all settings Menu Sub menu 1 Setup/Menu Angelus SET SpO2 SET NIBP SET Temper ature SET Sub menu 2 Sub menu 3/Value Value System Volume 0~9 Alarm Setup Alarm volume 0~9 Alarm Interval 1~60 Clock Setup Year 0~99 Month 1~12 Date 1~31(29,30) Hour 1~12 Minute 0~59 Second 0 Pulse rate limit High limit 26~255 LOW limit 25~254 SpO2 limit High limit 36~100 LOW limit 35~99 NIBP mode ADULT/NEONATE NIBP Interval OFF(0)~ 60 Systole High limit(neonate) 16~150 LOW limit(neonate) 15~149 High limit(adult) 31-300 LOW limit(adult) 30-299 MAP High limit(neonate) 16~150 LOW limit(neonate) 15~149 High limit(adult) 31-300 LOW limit(adult) 30-299 Diastole High limit(neonate) 16~150 LOW limit(neonate) 15~149 High limit(adult) 31-300 LOW limit(adult) 30-299 Celsius High limit 15.1~45.0 LOW limit 15.0~44.9 Fahrenheit High limit 59.1~113.0 LOW limit 59.0~112.9 62

3.3 Angelus SYSTEM settings Set up Variation range Comments System 0/1/2 9 Adjustment of system volume volume Alarm 1/2 9 Adjustment of alarm volume volume Alarm Off(0)/1/ 59/60 Adjustment of alarm interval time/minute Interval Clock Year: 00~99 Month: 1~12 Date: 1~31 Adjustment of Clock AM/PM Hour: 1~12 Minute: 0~59 Second: 0 Esc/Silence EXIT Return to the previous screen Angelus system setup MAP Angelus System System volume Alarm set up Clock set up 1. To select desired mode, press up/down button. 2. Then press confirm button. 63

3.3.1 System Volume Set up System volume setup MAP System volume 0~9 1. To select desired volume level, press up/down button. 2. Then press confirm button. 1) Press Setup/Menu button, and using [Up/Down] button, move to Angelus System mode, then press [Confirm] button as below picture. 2) To select System volume mode, using [Up/Down] button then press [Confirm] button. 64

3) Using [Up/Down] button, set the volume level from 0 to 9, then press [Confirm] button. 65

3.3.2 Alarm Set up When an alarm sounds, you need to identify the alarm. And act appropriately, according to the cause of the alarm. Identify which monitor is in alarm Check the patient s condition Identify the cause of the alarm Silence the alarm, if necessary When alarm condition id eliminated check that the alarm reset Alarm setup MAP Alarm set up Alarm volume Alarm interval 1~9 Off(0)~60 1. To select desired mode, press up/down button. 2. Then press confirm button. 3. To select desired value, press up/down button. 4. Then press confirm button. Further information can fully be explained in the Alarm volume setup in section 6.6.1, Alarm interval time setup in section 6.6.2. 66

3.3.3 Clock Set up You can set the date and time to be displayed on the screen. Once it has been set, the internal clock retains the setting even when the system is turned off. Clock setup MAP Clocksetup Year Month Date AM/PM Hour Minute Second 00~99 1~12 1~31 AM/PM 1~12 0~59 00 1. To select desired mode, press up/down button. 2. Then press confirm button. 3. To select desired value, press up/down button. 4. Then press confirm utton. Further information can fully be explained in the Changing date and time in section 4.1. 67

3.4 SpO2 Settings When the ANGELUS is first powered on, the alarm limits are set to the factory default values. The following table lists alarm limit range for the SpO2 value and pulse rate. Parameter High Low SpO2 Value 36-100 35-99 Pulse Rates 26-255 25-254 To change an existing alarm limit, perform the following procedures should be performed. SpO2 Setup MAP Angelus SpO2 Pulse Alarm limit SpO2 Alarm limit 1. Press setup/menu button more than 2 seconds. 2. To select desired mode, press up/down button. 3. Then press confirm button. Further information can fully be explained in the SpO2 Monitoring in section 7. 68

3.5 NIBP Settings When you adjust the cuff type, NIBP measuring interval time, and cuff exhaust type, you should use this mode. Set up Selection Range Comments Mode Adult/ neonate Cuff type Exhaust Linear/Step Exhaust type Interval Off(0)/1/2/3/ 60min Set up the time interval when measured automatically Esc/Silence EXIT Return to the previous screen NIBP Setup MAP Angelus NIBP Mode 1. Press setup/menu button more than 2 seconds. 2. To select desired mode, press up/down button. Interval Systole Alarm Limit Diastole Alarm Limit Mean Alarm Limit Exhaust Further information can fully be explained in the NIBP Monitoring in section 8. 69

3.6 Temperature settings Temperature can be monitored by attaching the probe to the patient and using the TEMP connector in the monitor. Temperature setup MAP Angelus Temperature Unit Alarm Limit(c) Alarm Limit (F) Celsius High Limit High Limit Fahrenheit Low Limit Low Limit 1. To select desired mode, press up/down button. 2. Then press confirm button. 3.6.1 Temperature unit type Set Up Selection Comments Range Celsius Celsius Scale for the measuring temperature, in which water freezes at 0 degrees and boils at 100 degrees. It is represented by the symbol C. Fahrenheit Fahrenheit Scale for the measuring temperature, in which water freezes at 32 degrees and boils at 212 degrees. It is represented by the symbol F. Esc/Silence EXIT Return to the previous screen 70

Temperature Unit setting MAP Temperature Unit Celsius Fahrenheit 1. To select desired unit mode, press up/down button. 2. Then press confirm button. Further information can fully be explained in the Temperature Monitoring in section 9.. 71

3.7 Trend Settings Trend function allows users to check the stored data on a patient as well as the longterm variation of patient data, showing the long-term trend of patient s condition at any time. (But, printout is possible only when a printer is equipped.) Press [TREND] button which on the below side of front panel. After selecting TREND section, there are two modes. (View, Erase modes) Set up Selection Range Comments View If you want to see the trend mode, you choose this mode Erase CANCEL/ DONE If you want to erase the measurement record, you choose done. If not, you choose cancel. Exit EXIT Return to the previous screen 3.7.1 View mode To select a View mode, pressing [Up/Down] button then pressing [Confirm] button. DONE/CANCEL mode will be displayed on the screen. Select DONE mode to finish setting up TREND. If you want to see the stored data, press [Up/Down] button. 3.7.2 Erase mode When monitoring the patient is no longer required, delete the data. The patient data on the review screens are deleted, when you choose ERASE mode. 1) After selecting TREND section, press [confirm] button. After selecting TREND mode, press [Up/Down] button. ERASE mode will be displayed on the screen. Selecting DONE mode can delete measurement record. 72

Section 4. Necessary Settings before Monitoring 4.1 Changing Date and Time 74 4.1.1 Year 74 4.1.2 Month 75 4.1.3 Date 77 4.1.4 AM/PM 78 4.1.5 Hour 80 4.1.6 Minute 81 4.1.7 Second 83 73

4.1 Changing Date and Time When the monitor turns on, the current time is displayed in the lower right corner of the screen. 4.1.1 Year 1) Press [Setup/Menu] button more than 2 seconds. Using [Up/Down] button, move to Angelus System mode. Then press [Confirm] button. Following menu will appear on the screen for setting up year of the unit. 2) Using [Up/Down] button, move to Clock Setup mode. Then press [Confirm] button. 3) To select the value for desired the YEAR by pressing [Up/Down] button, press [Confirm] button to complete the setup. 74

4) Using [Up/Down] button, set year from 01 to 99. Then press [Confirm] button. 4.1.2 Month 1) Press [Setup/Menu] button more than 2 seconds. Using [Up/Down] button, move to Angelus System mode. Then press [Confirm] button. Then following menu will appear on the screen for setting up month of the unit. 75

2) Using [Up/Down] button, move to Clock Setup mode. Then press [Confirm] button. 3) To select the value for desired the Month by pressing [Up/Down] button, then press [Confirm] button to complete the setup. 4) Using [Up/Down] button, set month from 1 to 12. Then press [Confirm] button. 76

4.1.3 Date 1) Press [Setup/Menu] button more than 2 seconds. Using [Up/Down] button, move to Angelus System mode. Then press [Confirm] button. Then following menu will appear on the screen for setting up date of the unit. 2) Using [Up/Down] button, move to Clock Setup mode. Then press [Confirm] button. 77

3) To select the value for desired the Date by pressing [Up/Down] button, then press [Confirm] button to complete the setup. 4) Using [Up/Down] button, set date from 1 to 31. Then press [Confirm] button. 4.1.4 AM/ PM 1) Press [Setup/Menu] button more than 2 seconds. Using [Up/Down] button, move to Angelus System mode. Then press [Confirm] button. Then following menu will appear on the screen for setting up AM or PM of the unit. 78

2) Using [Up/Down] button, move to Clock Setup mode. Then press [Confirm] button. 3) To select between AM and PM, by pressing [Up/Down] button. Then press [Confirm] button to complete the setup. 79

4.1.5 Hour 1) Press [Setup/Menu] button more than 2 seconds. Using [Up/Down] button, move to Angelus System mode. Then press [Confirm] button. Then following menu will appear on the screen for setting up hour of the unit. 2) Using [Up/Down] button, move to Clock Setup mode. Then press [Confirm] button. 80

3) To select the value for desired the Hour by pressing [Up/Down] button, then press [Confirm] button to complete the setup. 4) Using [Up/Down] button, set hour from 1 to 12. Then press [Confirm] button. 4.1.6 Minute 1) Press [Setup/Menu] button more than 2 seconds. Using [Up/Down] button, move to Angelus System mode. Then press [Confirm] button. Then following menu will appear on the screen for setting up minute of the unit. 81

2) Using [Up/Down] button, move to Clock Setup mode. Then press [Confirm] button. 3) To select the value for desired the Minute by pressing [Up/Down] button, then press [Confirm] button to complete the setup. 4) Using [Up/Down] button, set minute from 0 to 59. Then press [Confirm] button. 82

4.1.7 Second 1) Press [Setup/Menu] button more than 2 seconds. Using [Up/Down] button, move to Angelus System mode. Then press [Confirm] button. Then following menu will appear on the screen for setting up second of the unit. 2) Using [Up/Down] button, move to Clock Setup mode. Then press [Confirm] button. 83

3) To select the value for desired the Second by pressing [Up/Down] button, then press [Confirm] button to complete the setup. 4) Using [Up/Down] button, set second only 0 Then press [Confirm] button. 84

Section 5. Monitoring Screen 5.1 Safety Precautions for Monitoring 87 5.1.1 Using an Electro Surgery Unit 87 5.1.2 Using a Defibrillator 87 5.2 Overview 88 5.2.1 Monitoring Screen 88 5.2.2 Trend mode (Review Screen) 88 85

This section explains how to monitor the patient s data. Before monitoring the patient: Prepare the patient and equipment Before monitoring a new patient, follow the flowchart Preparation in section 2 Read the safety precautions in the Safety Precautions for Monitoring in section 5.1 In this section: Overview gives general information for all monitoring. 86

5.1 Safety Precautions for Monitoring Before beginning monitoring, observe the following safety precautions and the safety precautions in section 7, 8, 9 for SpO2, NIBP, and Temperature monitoring parameters. 5.1.1 Using an electro surgery Unit Warning Electrosurgical units (ESU) emit a lot of RF interference. If the unit is used with an ESU, RF interference may affect the monitor operation. Place the unit as far as possible from the ESU. Locate them on opposite sides of the operating table, if possible. Connect the monitor and ESU to different AC outlets located as far as possible from each other. 5.1.2 Using a Defibrillator Warning To avoid the risk of serious electrical burn, shock, or other injury during defibrillator, all users must keep clear of the bed and must not touch the patient or any equipment connected to the patient. If you draw out sensor or extension cable indifferently, these are broken or had short circuit. 87

5.2 Overview 5.2.1 Monitoring screen When you first begin monitoring, a monitoring screen appears. The monitoring screen displays value for Pulse rate, SpO2, Blood pressure, and Temperature parameter. Any time you press the button on the front panel, the monitoring screen appears. The parameters on the monitoring screen depend on the measured parameter. When the monitor is turned on, it enters Setup mode while the monitor is waiting for the probe to be attached to the patient. The SpO2, NIBP, Temperature monitoring starts when the sensors are connected to the connector on the monitor and sensors are attached to the patient. 5.2.2 Trend mode (Review screen) The trend displays the stored data. You can display a stored data of the past hours on the trend window, the list of vital sign data on the screen. 88

Section 6. Alarm Function 6.1 What is an alarm 90 6.2 Silencing alarm 90 6.3 Suspending all alarms before occurrence 91 6.4 Alarm Changeable Range 92 6.5 Alarm Type 93 6.6 Alarm Settings 93 6.6.1 Alarm volume Setup 94 6.6.2 Alarm Interval Time Setup 96 89

6.1 What is an alarm Angelus provides some alarm functions for the users. Users are recommended to carefully read this manual to understand and respond appropriately when the alarm goes off. Alarm informs error or information. When the monitor detects an abnormal patient condition, it can change an alarm sound, alarm lamp indication (malfunction lamp or power lamp). You can set each individual alarm condition. There are several types of alarm. The different alarm types are fully explained in the Alarm Types section. 6.2 Silencing alarm Several alarms occur together and if the [ESC/Silence] button is pressed, all alarms are silenced. When a SpO2 alarm, NIBP alarm, Pulse rate alarm, and Temperature alarm are silenced, the alarm resumes after the alarm silenced ends. When an alarm other than a vital signs alarm is silenced, the alarm indication dose not resume after the alarm silence ends. 90