Operation Manual. PalmCare plus Handheld Pulse Oximeter (Ver 1.0)

Transcription

1 Operation Manual PalmCare plus Handheld Pulse Oximeter (Ver 1.0)

2 CONTENTS Before using the product Screen configuration Contacts Palmcare plus Basic Operation 23 Product Guarantee Operation Symbols in the Manual MENU SETTING Precautions for use ALARM SETTING Precations for Electrical Safety 9 Initial Display Setting Mode 29 Characteristics and Principles of PalmCare plus 10 Screen Setting Composition of PalmCare plus 11 Sound Setting How to set PalmCare plus - 12 Delete the TREND Precations for Settings Select Language Information of Palmcare Checkpoints Before Use plus Maintenance and Cleaning Trend Funtion PalmCare A f t e r U s e plus Precations for using Measuring of Spo2 42 Components of PalmCare plus- 15 Alarm Function Front & Operation Panel Power & Battery specification R i g h t S i d e AC POWER T o p S i d e Battery Specifications Bottom Side Before Requesting After Service 49 Back Si de Product Specification Description of Product Symbols- 18 2

3 Before Using the Product Thank you for purchasing PalmCare plus(handheld Pulse Oximeter). For safe and efficient operation, please read the manual to learn about the functions of the product before use. Please keep this manual nearby to assist you with operating the functions of the product. The product should be used under the supervision of a medicalrelated certified professional. The product is used for examining patient s abnormal condition. For the safety of the patient, only the components or the accessories recommended by our company should be used. If you connect any accessories to the product that is not specified in the manual, please be sure to notify our company or an agency authorized to distribute our products. Contacts For various services and product information, please feel free to contact our salesperson at the following number. For any questions about use or setup of the product, please contact the following number. Technical Support BIONICS Co,.Ltd Tel: * For reporting defects or abnormalities, please note the model name, product serial number, purchasing date, and abnormal points before contacting us. 3

4 Product Guarantee The product you have purchased comes with a 1-year warranty from the purchasing date covering inferior materials and the manufacturing process. For the disposable products, a warranty is given for 6 months from the purchasing date or 6 months from its first use covering inferior materials and the manufacturing process. This warranty cannot be applied to consumption supplies such as the battery, external cables, cradle and disposable accessories. We are not responsible for any physical, financial and mental loss or damage and direct or indirect expenses caused by, or resultant from, accidental or special circumstances during the use of the product. The warranty is limited to the repair or exchange of the product by the authority of the company or the agency, for problems in materials or the manufacturing process which occurred during use under normal circumstances. The company has no legal responsibility for the confirmation of services, declarations or whole warranty beyond the warranty specified above, which were supplied or will be supplied by the agency or the staff of the company at their own discretion. The user cannot request the company of services, declarations or whole warranty which were supplied or will be supplied by the agency or the staff of the company at their own discretion based on the statements above. The contents of this warranty represent all other warranties indicated or implied, and also represent all kinds of service- related responsibilities of the product sellers for the product they sell. The product was manufactured under strict quality controls and the inspection process of the company. The indemnification standard for product repair and exchange is according to the Economic Planning Board notification Regulation for the indemnification of consumer damage 4

5 Symbols in the Manual Some symbols are used in this manual to help users or patients use this product safely and appropriately and to prevent any risk to patients or damage to materials. Please read and understand all warnings and precautions. Each symbols mean : WARNING The Warning symbol indicates that a dangerous situation may occur resulting in fatal injury or death of the patient, or may incur material and financial damage when the warning is ignored. CAUTION The Caution symbol indicates that a situation may occur resulting in injury or damage to the patient, though not life-threatening, when the caution is ignored. NOTE The Note symbol is used to inform you of important, but not dangerous, information regarding installation, use, and maintenance of the product. Warning Use of this product is prohibited during MRI photographing. A fire may breakout from the induced current, and the accuracy of the product and the MRI may be influenced by mutual interference. All cables should be set properly. Cables and hoses etc. should be kept away from the patient, so that there is no possibility of the patient s neck being entangled in them, and the cables and lines should be well arranged for the safety of the staff in the hospital. The computerized ECG analysis should be judged by qualified medical professionals, and it should not be the sole basis in determining necessity of treatment for the patient. 5

6 Precautions for Use Do not operate or store the equipment under the following environments. 6

7 Standard operational conditions are as follows. - Temperature : 10 ~ 40 (50 ~ 113 ) - Altitude : 70 ~ 106Kpa - Humidity : 30 ~ 85% Standard storage and transportation conditions are as follows. - Temperature : -10 ~ 50 (14 ~ 122 ) - Altitude : 70 ~ 106Kpa - Humidity : 20 ~ 95% 7

8 CAUTION The product may not work well when it is kept or operated beyond the temperature and humidity specified. If you want to turn off the PalmCare plus while you re operating, please use the power switch where is the front of the product. When you keep or operate the product in large temperature difference, product malfunctioning can be happened because of humidity of battery pack. Please operate product after keep it room temperature for three hours. CAUTION Leakage, heating, ignition or rupture of the battery may cause fire or injury. Do not use batteries beyond those specified in this manual. Do not short-circuit the battery and do not heat, disassemble, or dispose of it in a fire. Do not mix using the used battery with new batteries, different kind of batteries, other company batteries When the product is not used for a long time, separate the battery from the product. To ensure the lifecycle and safety of battery, please discharge the battery and then charge perfectly again every six months. Also time-worn battery exceed 24 months should be replaced. When the product has been moved, make sure to turn it off and arrange the accessories in order. Injured cords or cables may cause fire or electric shock. 8

9 Precautions for Electric Safety Prior to operation of the equipment, make sure to check following itmes. 1 Whether power supply is appropriate. (AC100V~AC220V) 2 Whether connections (power line or selected equipment) are properly made to the equipment. 3 Whether Probes are connected before the systems is turned on. CAUTION The equipment should be placed far from generator, X-ray equipment, broadcasting equipment, or transmitting wires, so as to prevent the electrical noises form being generated during the operation, when these devices are near the equipment, it can produce inaccurate measurements, For Palmcare plus, both independent circuit and stable grounding are essentially required. In the event that same power source is shared with other electronic equipment, it can also produce inaccurate output NOTE Palmcare plus is classified as follows; It is a Class II, type-bf against electric shock. Equipments are not suitable for use in presence of a flammable anaesthetic mixture and a solvent. 9

10 Description of Palmcare plus Characteristics and Principles of PalmCare plus PalmCare plus is pulse oximeter for measuring oxygen saturation of arterial blood and plus rate of patient. Data and detected wave are displayed on the front LCD. There are two types of probe to the Plamcare plus. One is reusable probe and the other is disposable probe to apply neonate or pediatric patient as well as single use to adult. There are two principles that pulse oximeter is based on. Oxyhemoglobin and Deoxyhemoglobin differ in spectral absorption, the relative absorption of red and infrared light by bold reflects hemoglobin oxygen saturation. And the changed volume of arterial blood in tissue could be measured during the pulsatile cycle. A pulse oximeter measures the oxygen saturation of arterial hemoglobin by passing red and infrared light emitting diodes(led) in the oximeter sensor serve as light source (ultraviolet rays 660nm and infrared light 960nm); a photodiode serves as the photo detector. Pulse rate and arterial blood oxygen saturation are pleased on a LCD display in the real time. Users can determine the alarm settings and volume as needed via cont 기 key panel on the front. PalmCare plus gives the operator the ability to measure patient basic vital biometric data. 10

11 Composition of PalmCare plus(accessories) Standard Accessories SpO 2 Main 1 set Finger Probe (1EA) Adapter(1EA) DC 5V 2A Operation Manual (1EA) Optional 1 Disposable probe 2 Extension cord 2.4m(8ft) 3 Cradle 4 USB(mini B TYPE) serial cable 11

12 How to Set PalmCare plus (1) Precautions for Settings Pay attention when setting Palmcare plus for the following points - Use Palmcare plus under conditions of of circumstantial temperature and 30% 85% humidity. - Check the connection status of the power cord. - Do not connect multiple cords to the power supply. - Place the main body on a flat area. - If noise occurs, ground the equipment. - Do not use any electric cords generating connecting noise. - Take care since the product can be broken by mechanical shock. - Get rid of dust or inflammable material near the product when setting it up. (2) Checkpoints before Use Check the following points before measuring the patient s condition. - Make sure there is no mechanical risk. - Check the lead, power plug, and accessories connected on the outside. Precautions Before Use 1 Do not use product near dynamo, X-ray equipment, broadcast equipment. 2 Do not twist the cable. 3 Attach each Lead properly. 4 Keep the patient motionless with comfortable position while measuring. 12

13 (3) Maintenance and Cleaning After Use A. Keep the product cleans by cleaning it using a soft cloth at least once a month. Do not use thinner, ethylene, oxidant or lacquer since these may damage the product. B. Keep the accessories clean of dust or foreign materials. For cleaning, use a soft cloth and clinical alcohol. C. Do not soak the accessories in liquid or detergents. Keep the product and accessories out of any liquid. D. For the protection of the environment, please contact the agency you purchased the product from when you wish to discard the Palmcare plus. E. Our product can be used semipermanently. Please contact our Customer Service dept. or any distributor and then replace the parts, when wasting parts such as battery. (4) Precautions for using 1 Precautions for environment ⅰ. Keep it away from wet place or do not use it by wet hands. ⅱ. Temperature range for use 10 ~40, humidity 30%~85%. ⅲ. Avoid areas of high humidity or ventilations problems ⅳ. Keep it away from any electric heater.. ⅴ. Keep it away from direct sunlight. ⅵ. Avoid areas susceptible to large shock or vibration ⅶ. Avoid areas near chemicals or explosive gas. ⅷ. Make sure to not let any dirt or especially metallic objects from going inside the equipment. 2 Precautions for electric safety 13

14 ⅰ. To avoid electrical noise or disturbance, install the device away from generators, X-ray devices, broadcasting devices and idle wires. Inaccurate reading may show in case above mentioned devices are nearby. ⅱ. Check power supply line of device is proper. ⅲ. Check every connection parts(power line or any optional device) are connected to the device properly. ⅳ. Noise may be made if the device isn t completely grounded. 3 Precautions for using ⅰ. Do not disassemble the device. ⅱ. Do not connect power source before product is installed completely. ⅲ. Do not short-circuit the battery and do not heat, disassemble, or dispose of it in a fire. 4 Precautions for disuse For the protection of the environment, please contact the agency you purchased the product from when you wish to discard the battery. 14

15 Components of Palmcare plus (1) Front & Operation Panel a POWER BUTTON : Power On/Off b MENU BUTTON : Change the setup value c ALARM BUTTON : Alarm sound On/Off d EVT BUTTON: Store the data that specified time. e UP/DOWN BUTTON: Menu UP/DOWN button. f TREND BUTTON : Check the EVENT data g ESC BUTTON: Exit Menu screen h ENTER BUTTON : Select Menu and Alarm value.. 15

16 (2) Right Side a Wrist string attaching part (3) Top side a Finger Probe Connector (4) Bottom Side a Host Interface(USB communication connector) b DC adapter connector 16

17 (5) Back Side a Battery Cover(Battery insertion part) b Cradle Attaching Part. CAUTION In order to avoid electrical shock, do not open the cover. Disassembling of the equipment must be done only an by service personnel who is authorized by BIONICS. 17

18 Description of Equipment Symbols Symbol Description Symbol Description Type BF equipment. Type BF equipment is suitable for intentional external and internal application to the patient, excluding a direct conductive connection to the patient s heart. This symbol means attention during operation. You should pay special attention to the equipment when the equipment is operated in conjunction with other equipment. DC 5V POWER INPUT POWER SWITCH ALARM SOUND ON/OFF UP/DOWN BUTTON MENU BOTTON Event Save BOTTON Trend BOTTON ESC BOTTON ENTER BOTTON OXYGEN SATURATION HEART BEAT RATE PER MINUTE 18

19 Screen Configuration Initial screen is shown after system boot and test for about 3 seconds, if you turn the power on. PalmCare plus offers six kinds of initial screen as the following pictures for the user s convenience, initial screen displayed on pressing power button can be set up differently. Please refer the chapter 6 for how to set up each initial display mode. - Vertical mode initial screen (1)Large Wave Mode (2)Small Wave Mode (3)Pleth Bar Mode (1)Big Wave Mode 1 The domain showing various kinds of icons which describe the current state(information Alarm) of PalmCare plus 2 Measured SpO₂and pulse rate value 3 Big Wave (2)Small Wave Mode 1 The domain showing various kinds of icons which descried the current sate (information Alarm) of Palmcare plus 2 Measured SpO₂and pulse rate value 3 Small Wave (3)Pleth Bar Mode 1 The domain showing various kinds of icons which descried the current sate (information Alarm) of Palmcare plus 2 Measured SpO₂and pulse rate value 3 Pleth Bar 19

20 - Horizontal Mode initial screen (1)Large Wave Mode (2)Small Wave Mode (3)Pleth Bar Mode (1)Big Wave Mode 1The domain showing various kinds of icons which describe the current state(information Alarm) of PalmCare plus 2Measured SpO₂ and pulse rate value 3Big Wave (2)Small Wave Mode 1The domain showing various kinds of icons which describe the current state(information Alarm) of PalmCare plus. 2Measured SpO₂ and pulse rate value 3Small Wave (3)Pleth Bar Mode 1 The domain showing various kinds of icons which describe the current state(information Alarm) of PalmCare plus. 2 Measured SpO₂ and pulse rate value 3 Pleth Bar Each shape and meaning of the icons describing the current state(information alarm) of Palmcare plus is as below.. 20

21 (Table1). Description of Screen Icon ICON Measurement and operation condition How to display Alarm Off fixed Running out battery power Blink every 1seconds Screen select Icon fixed Language select Icon fixed Sound Off fixed Falling out the probe connection (Sensor Off) Searching pulse(in case the probe insert finger at first) Low volume of the blood flow(low Perfusion) High intensity of radiation in light (High Ambient) Falling finger off the probe(no Finger) Blink every 1seconds Blink every 1 seconds Blink every 1 seconds Blink every 1 seconds Blink every 1 seconds 21

22 Function of the buttons Each buttons on the PalmCare plus services more than two use according to the screen. The use meaning for each screen is as below chart. Button Display Mode Initial Screen Initial Screen Initial Screen Initial Screen TREND Screen Initial Screen TREND Screen Initial Screen Initial Screen Initial Screen Alarm Screen Commonness for all kind of the screens. Meaning and Operation Move to SETUP(Environment Set up) Screen Alarm On/Off Save the current measured value (Spo2 & HR) in Trend Log Up / Increase the value on setting up the Alarm range Page Up(previous page) Down / Decrease the value on setting up the Alarm range Page Down(Next page) Show Time-based TREND data(spo2 & HR) and move screen. ESC(Moving to initial screen) ENTER (Input or select) Change the setting value on Alarm screen. Power On/Off 22

23 Palmcare plus Basic Operation (1) OPERATION Step 1 Please press the power button in front- lower of the equipment. The power is to be impressed and Palmcare plus automatically starts the self-test. (You can see the BIONICS logo on the screen during self-test) Step 2 Screen will be displayed the value and waves of patient after attaching the finger probe. Step 3 if you want to change the setting value, please press the MENU ( ) button. Also if you want to examine the Trend Data, please press the TREDN ( ) button. NOTE Push and hold the power button for 1~2 seconds when power off. Power off automatically when no inputting data for 1 minute when battery mode. 23

24 Environment Setting of Equipment Menu Setting You can set the all menu pushing MENU button ( ) Step 1 If you press MENU button ( ) on the initial screen of Palmcare plus, the environment setting mode will be shown as below. Press MENU ( ) Button. Step 2 Press the ENTER ( ) button and enter setup screen you want, after making reverse turn item you want by using UP/DOWN ( / ) button. Step 3 In case you want to return to the initial screen, press ECS ( ) Button. 24

25 Alarm Setting The below screen will be shown if you press ENTER ( ) button, after making reverse the item 1. Alarm Setting on the environment setting screen of Palmcare plus. (Alarm setting screen) Step 1 Step 2 The change of the setting value can be controlled by the UP/DOWN ( / ), the item moving can be controlled ENTER ( ) button. The SETUP screen can be returned if you press the ECS ( ) button after completed inputting Alarm setting. If you press continuously UP/DOWN ( / ) button, the value is increased or decreased continuously after about one second and the value is increased or decreased by one for each on time pressing the UP/DOWN button. The changed alarm range will be displayed on The LCD as soon as you set up new alarm range. Please refer the below chart for the allowable adjustment range of this. Setting Default Range value HI LOW HI LOW HR LOW+1 ~ ~ HI-1 SpO₂ LOW+1 ~ 100, OFF 1 ~ HI-1 Suspend Time 1 Min 1 Min / 2 Min / 3 Min, OFF The LOW+1 in the chart means low limit value +1, the HI-1 means high limit value -1. For example, if low limit value for HR is 55, the HI value range for HR can be adjusted as some numbers between 56 to 299.On the contrary, if high limit value for HR is 150, the LOW value range for HR can be adjusted as some numbers between1 to

26 The value range for SpO2 also can be applied of the same rule of setting up HR value. The only difference is the high limit value can be OFF This OFF means the measured SpO2 value beyond the high limit range will not be checked for alarm. High Pulse Rate Alarm Limit Adjust Mode After selecting HR high (the digits in right side of the colon is reversed) on the alarm setting screen, you can change the value as you want by UP/DOWN. ( / ) button and then press ENTER button. Now, you can adjust the high pulse rate alarm limit like this Low Pulse Rate Alarm adjust Mode After selecting HR Low (the digits in right side of the colon is reversed) on the alarm setting screen, you can change the value as you want by UP/DOWN ( / ) button And then press ENTER button. Now, you can adjust the low pulse rate alarm limit like this. High SpO₂Alarm Limits Adjust Mode After selecting SPO2 High ( the digits in right side of the colon is reversed) on the alarm setting screen, you can change the value as you want by UP/DOWN ( / ) button and then press ENTER button. Now, You can adjust the high oxygen saturation alarm limit like this 26

27 Low SpO₂Alarm Limits Adjust Mode After selecting SPO2 Low ( the digits in right side of the colon is reversed) on the alarm setting screen, you can change the value as you want by UP/DOWN ( / ) button and then press ENTER button. Now, you can adjust the low oxygen saturation alarm limit like this. Information Alarm ON/OFF Information Alarm is a kind of sound alarm ringing when a probe has slipped off or when a probe connector is pulled off from the Palmcare plus. At this time, this is an item to decide wether this information alarm will activate (setting on) or will not (setting off). After selecting Info Alarm ( the on/off in right side of the colon is reversed) on the alarm setting screen, you can select on/off as you want by UP/DOWN ( / ) button and then press ENTER button. Now, you can adjust how to turn on or off the information alarm like this. 27

28 Alarm Suspend Time value setting Alarm suspend time value means not to make any alarm sound during the set time. In other words, the user can make not to activate the alarm sound for a while. The time can be adjusted as 1MIN/2MIN/3MIN/OFF If the event caused the alarm will not be terminated during the set time, the alarm sound will activate again. The alarm will not ring if you set the Suspend Time as OFF, even though the alarm occurs As this shape icon ( ) s displayed on the LCD of the initial screen during Suspend time, you can find out that the current alarm is suspended state. After selecting Suspend Time( the value in right side of the colon is reversed) on the alarm setting screen, you can adjust suspending time as you want by UP/DOWN button ( / ) and then press ESC button to return to the initial screen of the environment setting. 28

29 Initial Display Setting Mode (Display Mode) Step 1 You can enter to the initial display setting mode if you press ENTER button ( ), after making a reverse the item 2. DISPLAY MODE on the environment setting (SETUP) screen. Making a reverse the item 2.Display Mode by UP/DOWN button. Press ENTER ( ) button Step 2 You can use UP/DOWN ( / ) for the item moving, and ENTER ( ) button for your choice. 29

30 Step 3 You can return automatically to the SETUP screen if you choose the mode by ENTER button. And if you want to cancel the selection and return to the SETUP screen, you can go back to the SETUP screen with ESC( ) button. The initial display mode of PalmCare plus is Vertical Large Wave. 1 Horizontal Large Wave 2 Horizontal Small Wave 3 Horizontal Pleth Bar 4 Vertical Large Wave 5 Vertical Small Wave 6 Vertical Pleth Bar 30

31 Screen Setting (Vertical/Horizontal) Step 1 You can enter to the initial display setting mode if you press ENTER button ( ), after making a reverse the item 3. LCD VIEW on the environment setting (SETUP) screen. Making a reverse the item 3.LCD VIEW by ENTER button. Press ENTER ( ) button 단계 2 You can use UP/DOWN ( / ) button for the item moving, and ENTER ( ) button for your choice. (1)Horizontal (2)Vertical 31

32 Step 3 You can return automatically to the SETUP screen if you choose the mode by ENTER button. And if you want to cancel the selection and return to the SETUP screen, you can go back to the SETUP screen with ESC( ) button. 32

33 Sound Setting (Sound High/Low/Off) The sound ON/OFF set up is used for the Heart Beating Sound (Peak Sound), buttons sound which can be heard on pressing the buttons and turning on/off the sound. Step 1 You can enter to the High/Low/Off setting mode if you press ENTER button ( ), after making a reverse the item 4.Sound Volume on the environment setting (SETUP) screen. button. Making a reverse the item 4.Sound Volume by UP/DOWN Press ENTER( ) button Step 2 You can use UP/DOWN ( / ) button for the item moving, and ENTER ( ) button for your choice. i. 1.Sound Off : Volume Off. ii. 2.Sound Low : Low volume. iii. 3.Sound High : High volume. 33

34 Step 3 You can return automatically to the SETUP screen if you choose the mode by ENTER button. And if you want to cancel the selection and return to the SETUP screen, you can go back to the SETUP screen with ESC( ) button. The initial Sound Mode of PalmCare plus is set as on.. As this shape icon is displayed on the LCD of the initial screen, if you set the sound off, you can find out that the current sound is OFF state. 34

35 Delete the TREND This item is used to delete all of the trend data which is saved in the internal memory of Palmcare plus. Step 1 You can enter to the TREND DELETE setting mode if you press ENTER button ( ), after making a reverse the item 5.TREND DELET on the environment setting (SETUP) screen. Making a reverse the item 5.TREND DELETE by pressing UP/DOWN button. Press ENTER( ) button Step 2 You can use UP/DOWN ( / ) button for the item moving, and ENTER ( ) button for your choice. Step 3 You can return automatically to the SETUP screen if you choose the mode by ENTER button. And if you want to cancel the selection and return to the SETUP screen, you can go back to the SETUP screen with ESC( ) button. 35

36 CAUTION Please take a note that all of the trend data saved in the inside of Palmcare can be deleted, if you select YES 36

37 Select Language This item is used to select language of PalmCare plus. Step 1 You can enter to the Select Language setting mode if you press ENTER button ( ), after making a reverse the item 6.Select Language on the environment setting (SETUP) screen. Making a reverse the item 6. Select Language by pressing UP/DOWN button. Press ENTER ( ) button Step 2 You can use UP/DOWN ( / ) button for the item moving, and ENTER ( ) button for your choice. i. 1.English Lan : Select English ii. 2.French Lan : Select French iii. 3.Germeny Lan : Select Germeny vi. 4.Italian Lan : Select Italian. v. 5.Spain Lan : Select Spain. 37

38 Step 3 You can return automatically to the SETUP screen if you choose the mode by ENTER button. And if you want to cancel the selection and return to the SETUP screen, you can go back to the SETUP screen with ESC( ) button. 38

39 Information of Palmcare plus Palmcare plus displays the simple information of this equipment on the LCD like the manufacturer of Palmcare plus, Program version/name and etc. Step 1 You can check the information of Palmcare plus by pressing the ENTER button ( ) after making a reverse the item 7.Device Info. Making a reverse the item 7.Device Info by Up/Down button. Press ENTER ( ) button Step 2 You can use UP/DOWN ( / ) button for the item moving, and ENTER ( ) button for your choice. Brightness : LCD Brightness auto control setting. i. ON : If there is no key input, do setting Back Light is controlled automatically after 30 seconds (Auto Dim out). ii. OFF : If there is no key input, do not setting Back Light is controlled automatically after 30 seconds. Step 3 You can go back to the previous (SETUP screen) if you press ESC ( ) button. 39

40 Trend Function PalmCare plus Palmcare plus can show you the value at each time in the trend form which has been measured for1hr, 12hr, 24hr, 48hr and 72hr of the patients oxygen saturation (SpO2) and Pulse Rate (HR) That s to say, you can examine and print the long-term change and the previous data of the measurement value of the patient (However, the printing is possible only in case of attaching the printer on Palmcare plus. Trend Information Check Step 1 If you want to examine the trend information on the initial screen, please press TREDN button ( ) then the following Trend printing screen will be seen on the LCD. Press the TREND ( ) button 40

41 It indicates the type of the trend being displayed on the curren screen. 2 Time(hour: minute-it starts at 00:00) for initial trend saving time 3 Saved SpO₂value 4 Save HR Value 5 Event data which is saved by the user 6 Data mark which is saved by Medium Priority Alarm 7 Data mark which is saved by High Priority Alarm Step 2 You can examine the Trend Data by pressing the UP/DOWN button ( / ). Whenever pressing the TREDN button( ) one time, you can check Trend information as below 다. 1 hour SpO2/ Pulse Rage Trend - mean value of the 1 minute unit 12 hours SpO2/ Pulse Rage Trend - mean value of the 5 minutes unit 24 hours SpO2/ Pulse Rage Trend - mean value of the 10 minutes unit 48 hours SpO2/ Pulse Rage Trend - mean value of the 20 minutes unit 72 hours SpO2/ Pulse Rage Trend - mean value of the 30 minutes unit Step 3 You can go back to the initial screen if you press ESC button ( completing trend examination. ) after 41

42 Measuring of SpO₂ Preparation before Measuring SpO₂ Step 1 Plug in the SpO₂probe to SpO connection port on upper side of Palmcare plus. 1 Spo2 probe connection port Step 2 Turn the power on by pressing the power button ( ) PalmCare plus. Attaching of Probe Step 1) Clean the area of the body to be measured by using alcohol. Step 2) Attach the probe to a finger as shown on the following drawing. (When measuring NIBP, SpO2 probe is attached to the other arm than the one that NIBP is measured. Do not use with other medical instruments that can affect the blood flow, and do not attach the probe where medical interference can be generated.) Step 3) Be sure that red light of the probe is on, the sensor gives out the light, the both sides of the probe faces rightly Step 4) For a stable SpO2 measurement, movement of body should be restricted, and band the probe cable on the finger. When banding the probe cable, make sure it does not hinder with blood flow. Step 5) Make sure to check the skin condition in the attached location and the sensor whether they are facing each other in a proper way, every 2 to 3 hours. If skin condition changes, change the attaching location. SpO₂Finger Finger Banding 42

43 CAUTION (How to apply SpO₂finger probe) Make sure that you should carefully handle the sensor and cable. Non-careful use of the probe may cause harm the sensitive sensor. Be sure that the cable is protected against sharp things. If a patient suffers from a fever or a disorder in peripheral circulation system, then the temperature of the skin goes up by 2 or 3 degrees. If the values for Oxyhemoglobin or Methemoglobin of a patient are increased abnormally, the SpO2 data are not reliable. The disposable sensor should not be re-used for the same patient on the same or different part of the body. In order to reuse disposable sensor, you should sterilize it WARNING Using an SpO2 probe during MR imaging can cause severe burns. To minimize this risk, ensure that the cable is positioned so that no inductive loops are formed. If the probe does not appear to be operating properly, remove it immediately from the patient. Never apply an SpO2 probe at ambient temperatures higher than 37 Do not use disposable probe on patients who have allergic reactions to the adhesive Avoiding the probe placed on any extremity with an arterial catheter, or intravascular venous infusion line. Make sure the sensor emitter light and is directly opposite each other and that all of the light from the emitter passes through the patient s tissue. For Neonatal patients, make sure the disposable probe should be used outside the incubator. (The humid atmosphere inside the incubator can cause inaccurate measurements.) 43

44 Alarm Function Palmcare plus is designed to provide various kinds of alarm for users convenience. Users must read following carefully and treat proper manner in the situation of alarm occurrence. About the Alarm 1 High Priority Alarm The high priority alarm is set off only when a measured value is extremely abnormal. For example, in the event pulse rate goes up higher than 180 or goes down lower than 40, the high priority alarm will go off regardless of set alarm limits. It is recommended to actually listen to the alarm sound in advance for fast and accurate recognition.. 2 Medium Priority Alarm The medium priority alarm goes off when a measured value goes over the set alarm limits. It is recommended to actually listen to the alarm sound in advance for fast and accurate recognition. Medium priority alarm works in connection with the oxygen saturation and pulse rate. If the oxygen saturation and pulse rate exceeds the alarm limits, it becomes to activate. 3 Information Alarm Information Alarm informs the matters which the user should keep or the abnormality occurrence during measuring by alarming NOTE We are recommended to hear the each alarm sound with your own ears before use the equipment, because to express the sound is very hard. Alarms for Each Mode 1 Standard Mode The high priority alarm makes a sound 5 times in the period of 2 seconds, and then after interval of 10 seconds, it makes a sound again 44

45 5 times in 2 seconds. This alarm sound has a rhythm specified by the international standards. The medium priority alarm makes a 3 times in the period of 2 seconds and then after interval of 24 seconds, it makes a sound 3 times in 2 seconds. If the information alarm goes off, it means that incidences as follow have occurred. i. Heart beating : The pitch of beep sound will vary in accordance with oxygen saturation value changes. ii. In case the battery capacity is running out: when inside battery is used instead of outside power source (DC adapter), the information (warning) alarm will go off to alert the user, when the battery is running out. iii. In case of Measuring failure: When a sensor has slipped off, or when a probe connector is pulled off from the equipment, or when sensor is malfunctioning, the information alarm will go off. 2 Visual Alarm To provide the fast recognition at a glance by the users, all the displayed values that caused the alarm will be set to blink continuously Alarm Occurrence In the event the alarm occurs, the measured value changed red color and you can heard the alarm weaning sound at the same time. 45

46 Power & Battery Specifications PalmCare plus can be operated DC power. It can be operated while on the move by getting the power from the internal battery which ca be used again by recharging with the DC adapter. DC Adapter Power In case battery power is running out, it is automatically recharged if you connect DC adapter to Palmcare plus to the outlet. 1. USB (mini B Type) Communication connector 2. DC Adapter connector Battery Power The internal battery supplies the sources of electricity, if you separate the Dc adapter from Palmcare plus. - Recharging period : 1Houres 1H/2 Min(1CELL),3 hours (2CELL) - Continuous operating time : 3 hours(1cell: 1130mAh)- Standard 6hours (2CELL: 2260mAh)-Optional NOTE In case battery power is running out, battery shaped icon ( ) will blink at the upper portion of the LCD screen before about 5 minutes of the power shortage. And the power can be immediately turned off according to the using parameter. Therefore, DC power has to be supplied at once. For the effective use of battery, Palmcare plus has the power saving mode it turn off the LCD back light after 3 seconds and also turn off the all functions of Palmcare plus after 30 seconds, if the user does not operate any button or measures. (However, if he starts operating any button or measurement within 30 seconds, the LCD back light turns on again) But it will not turn off the power if the AC adapter is connected. 46

47 Both AC and DC power is used for PalmCare plus. Basically, AC power is used and a rechargeable battery is available for portable use. 1. AC Power (110~240VAC) If the AC power is connected to the main body of the product, If the product is not being used, the power changes automatically to the recharging mode. A. Type of Adaptor - Model : JMW110KA0500M03 Input : 100~240V~, 50~60Hz - Output : 5V(DC), 2Amps - Manufacturer: BridgePower Corp. CAUTION During operation using AC power, noise may occur in the waveform. If this is the case, ground the product soundly. An AC power connection in a wet or damp area may cause electric shock or fatal damage to the product. When you connect the adapter will charge the battery automatically 2. Battery Specifications When the AC power is disconnected and the switch is turned on, the power is supplied using the battery. A. Signs for Battery Battery status Description Battery full After use for 70 ~ 80 minutes Requiring recharging Low Battery requiring recharging B. Time for 1ea of battery 47

48 Recharging time: 1H 1H/2Min,3H(OP MODE),(2H,4H)(POWER OFF) Use time : 180 Min,360 MIN CAUTION When the battery is removed, all data can be reset. Only in case the product is kept for long time, Remove the battery from the product B. Natural lifetime for spontaneous discharge of battery The table below shows the lifetime for spontaneous discharge of the battery when the product is unused. Storage temperature Life for spontaneous discharge 0 ~ 20 9 months 21 ~ 30 6 months 31 ~ 45 3 months D. Type of Battery The same sort of battery should be used for replacement. - Model : 1S1P(ICP523450)/ Type : LI-Ion / Manufacturer: ENERWIZ E. Time for the Battery exchange The lifetime of the battery gets shorter if it is not 100% recharged for use. Charge / Discharge ration Number for use 100 % Charge / discharge 1200 times 50 % Charge / discharge 500 times 30 % Charge / discharge 200 times 48

49 CUATION For the protection of the environment, please contact the agency you purchased the product from when you wish to discard the battery. Contact the agency you purchased battery in case battery should be changed. To ensure the lifecycle and safety of battery, please discharge the battery and then charge perfectly again every six months. Also time-worn battery exceed 24 months should be replaced. Before Requesting After Service This chapter explains the solutions to simple problems occurred during the operation. One might feel lost sometimes while operating the equipment. You don t need to call the service man every time you feel lost. It just might be a simple operational problem. Before you call for help, check the following points. Problem Cannot turn the Power on. Solution 1. In case of the battery is discharged. - Connect DC adapter. 2. Please check the connection of the switch, it happens when the switch junction is imperfect. The red light in the sensor is extinguished. The wave does not display normally. 1. Please check the connection of the probe, it happens when the probe junction is incomplete. 2. Please replace the probe, it happens for the defective probe. 1. Please check the connection of the probe, it happens when the probe is put in infirmly. For repair, contact our Customer Service Dept, or A/S receptions. 49

50 Product Specification Display TFT COLOR LCD Resolution : 320 X 240 Pixels Graphic wave form 10 level vertical bar graph Numeric Data Display : Current Oxygen Saturation, Pulse Rate Display Mode: Horizontal or Vertical display Indicators Low Battery Icon SpO₂No Sensor, No Finger Icon SpO₂Pulse Search Icon Low Perfusion Icon Alarm ON/Off Icon Screen Mode Icon Language Mode Icon Sound Mode Icon High Ambient Icon Measurement Range SpO₂Saturation: 0 ~ 100 % HR : 30 ~ 300 BPM Alarm Limits Range 50

51 Setting Default Value Range HI LOW HI LOW HR LOW+1 ~ ~ HI-1 SpO₂ LOW+1 ~ 100, OFF 1 ~ HI-1 Accuracy SpO₂ : 70 ~ 100 % (1%step) : ±2% Under 70 % : unspecified Pulse Rate : 30 ~ 300 BPM : ±2% or ±2 bpm Power Consumption Manufacturer: BridgePower Corp. Model : JMW110KA0500M03z 100~240VAC, 50/60 Hz DC 5V Adaptor Battery Lithum-ion 3.7V 1CELL (1130mAh) Option 2CELL(2260mAh) 3hours on a full charge (1CELL) 6hours on a full charge (2CELL) Output USB mini Port: SpO₂, Pulse Rate Interface : USB mini B Type Temperature Range Operating : 50 ~ 113 (10 ~ 40 ) Storage: 14 ~ 122 (-10 ~ 50 ) Humidity Range Operating : 30% ~ 85% non condensing Storage : 20% ~ 95% non condensing 51

52 SpO₂Sensor Adult finger probe SpO₂extension cable (Optional : 2.4m(8ft)) Trend Memory Oxygen Saturation and Pulse rate Memories (72 hours maximum) Physical Dimension 165mm(H) X 70mm(W) X 30mm(D) 1CELL 200 g 2CELL 250 g Standard Accessories Finger Probe 5V, 2.0A DC Adapter Optional Accessories USB mini B Type Cable Disposable Probe Cradle Extension cable of SpO₂ (2.4m / 8.4ft) Product specification listed on the manual are subject to change according to the our design change procedure without notice. 52

53 Product Warranty Product Name Model Code Pulse Oximeter PalmCare plus Manufacture Approval No. No Manufacture Approval Date JAN Manufacture Serial No. No Warranty Period One year after the purchase date Purchase Date Date Month Year Customer Information Name of Hospital Address Name Tel Tel) Fax) Name of Distributor Name of Manufacture BIONICS Co., Ltd. Thank you for purchasing PalmCare plus. This product is under thorough quality management and complied with strict test. This product can be repaired, replaced or refunded in accordance with Customer s Damage Compensation Regulation noticed by Economic Planning Board. This product is medical equipment. Date : FEB. 15,

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