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SCOMBA-1.1

SpiroCare Operation Manual

Warranty

- This product was made through strict quality control and examination.

- The warranty for this product runs for 4 year. The warranty for accessories runs for 90 days.

- When having troubles during this period, please provide us with the model name, serial

number, date of purchase and a description of the problem you are experiencing.

- Indications for Use
The SPM-300 Spirometer is intended for prescription use only to conduct diagnostic

spirometry testing of adults and pediatric patients in general practice, speciality
physician, and hospital settings.

Caution

Federal law restricts this device to sale by or on the order of a physician

Содержание SpiroCare

Страница 1: ...SpiroCare Operation Manual Ver 1 1 2017 04 14 www ebionet com...

Страница 2: ...ng this period please provide us with the model name serial number date of purchase and a description of the problem you are experiencing Indications for Use The SPM 300 Spirometer is intended for pre...

Страница 3: ...welcomes your enquiries Please contact us In the event of a malfunction or failure contact Service Dept Of Bionet Co Ltd along with the model name serial number date of purchase and explanation of fai...

Страница 4: ...tion due to customer s unskilled installation For offering service when a foreign substance is introduced or mis cleaned by the customer Fee charged 1 The warranty does not cover cleaning adjusting an...

Страница 5: ...r or service agents are not responsible for damage resulting from inappropriate use or carelessness WARNING There may be serious injuries fatal accidents or financial damages if you violate this instr...

Страница 6: ...d humidity range for use are 10 40 C and 30 85 respectively Near electronic heaters High humidity or ill ventilated place Place where excessive shock or vibration may occur Place exposed to flammable...

Страница 7: ...ion proof applied part Degree of protection against harmful ingress of water Ordinary It is not proper to use this product near a flammable anesthetic or solvent Continuous operation IEC EN60601 1 2 E...

Страница 8: ...l findings A qualified physician must verify all computer generated diagnoses WARNING OPERATOR Medical technical equipment such as this system must be used only by qualified and trained personnel WARN...

Страница 9: ...an optional battery pack will not be used or connected to the power line for a period of over six months remove the battery CAUTION BEFORE INSTALLATION Compatibility is critical to safe and effective...

Страница 10: ...oper use of the device Safety Sign To signify that the instruction manual must be read Reading the instruction manual before starting work or before operating equipment General prohibition sign Defibr...

Страница 11: ...cator AC Power Connection Indicator Manufacturer name and address Authorized European representative Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and m...

Страница 12: ...Configuration 23 Front Panel 27 Control Panel 29 Power 30 5 System Installation 31 Precautions For Installation 31 Power Connection 31 Paper Installation 31 System Start 32 Chapter 2 Installing Spiro...

Страница 13: ...tup 97 Chapter 4 Spiro file management 102 1 Display and function 103 2 Data printing 104 3 Data deleting 105 4 System Setup 106 5 Switching menu 108 6 Patient information 109 7 Data search 110 8 Data...

Страница 14: ...SCOMBA 1 1 SpiroCare Operation Manual Chapter 6 System Management 122 1 Maintenance and Cleaning 123 2 Regular Check up 124 3 Trouble Shooting 124 4 Manufacturer Declaration 129 Chapter 7 Specificati...

Страница 15: ...t Overview 2 Indication for use 3 Product Features 4 Product Configuration Basic Components and Accessories Body Configuration Spirometer Configuration Front Panel Control Panel Power 5 System Install...

Страница 16: ...ncy conditions 2 Indication for use The Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients in general practice speciality physic...

Страница 17: ...PC and a hard copy can be retained after printing it out with a general PC printer Unlike competitors mouthpieces screen or turbine modules which needs to be washed and disinfected after each use due...

Страница 18: ...ackage and check the items below are included Also be sure to check for any damage to the body and accessories Basic Components and Accessories Main Body SpiroCare body 1 EA User Manual 1 EA ECG Paper...

Страница 19: ...or signal noise when you use nonstandard or other brand s accessories We strongly recommend you use only the authorized accessories which we supply WARNING How to replace battery Please make sure you...

Страница 20: ...20 135 SCOMBA 1 1 SpiroCare Operation Manual Body Configuration Top view Handle Printer Cover Printer Cover Switch LCD Control Panel...

Страница 21: ...BA 1 1 SpiroCare Operation Manual Front View Printer Cover Switch Rear View Protective Ground Terminal Power Switch AC Power Connection Port Fuse 250V 5A High breaking type USB Port Spirometry port RJ...

Страница 22: ...oCare Operation Manual Left Side View Handle Right Side View Patient Cable Connection Port NOTE To avoid an expected electric shock do not open the equipment cover or disassemble the equipment Refer s...

Страница 23: ...at fixes mouthpiece 2 Upper cover lock Part that locks upper cover fixing the mouthpiece 3 Action lamp Lamp showing action status green 4 Connection conductor Conductor connected to serial cable conne...

Страница 24: ...ver Upper cover that fixes mouthpiece 2 Upper cover lock Part that locks upper cover fixing the mouthpiece 3 Connection conductor Conductor connected to serial cable connection hole in the back of the...

Страница 25: ...e of spirometer handle 1 Upper cover Upper cover that fixes the mouthpiece 2 Connection conductor Conductor connected to serial cable connection hole in the back of the main body 3 Mouthpiece insertio...

Страница 26: ...r Upper cover that fixes the mouthpiece 2 Upper cover lock Part that locks upper cover fixing the mouthpiece 3 Connection conductor Conductor connected to serial cable connection hole in the back of t...

Страница 27: ...27 135 SCOMBA 1 1 SpiroCare Operation Manual Front Panel During device boot up you can see the system version and the company name Rotary key Power status Battery status Button Graphic Display Window...

Страница 28: ...atus or AC power connection status Menu to measure Forced volume Vital Capacity FVC Menu to measure Slow Vital Capacity SVC Menu to measure Maximum Voluntary Ventilation MVV Patient information input...

Страница 29: ...attery is on and shows your current battery charging status A red light indicator lets you know that the battery is charging and a green light indicator lets you know the batter is fully charged Green...

Страница 30: ...by choosing to set successive function for about 360 min at 25mm s and 10mm mV or in the absence of ECG record it is possible to record a max of 200 ECGs Display Battery Power Status Battery Fully Ch...

Страница 31: ...al memory even when it is off Prevent any shock or excessive force that may cause damage to the device Place the device away from any dust or flammable materials Power Connection The equipment needs e...

Страница 32: ...t the system version and the company name will be displayed when switched on and then the initial menu selection will show on the screen as in the figure below You can move to the main page of the cho...

Страница 33: ...33 135 SCOMBA 1 1 SpiroCare Operation Manual Chapter 2 Installing Spirometer 1 Connecting Spirometer Handle 2 Installing Mouthpiece...

Страница 34: ...he power switch located on the right side of the handle to up position 2 Installing Mouthpiece To start spirometer measurements mouthpiece should be inserted in spirometer handle Start by first pressi...

Страница 35: ...e Operation Manual 2 Insert Mouthpiece into a groove made in open side 2 3 Close upper cover by giving it a little pressure on top 3 Caution Mouthpiece is designed for single use Do not close cover wh...

Страница 36: ...Patient Information 3 FVC Forced Vital Capacity TEST FVC Test FVC PRE POST Bronchodilator Comparison Test 4 SVC Slow Vital Capacity TEST 5 MVV Maximum Voluntary Ventilation TEST 6 Calibration 7 System...

Страница 37: ...the Spirometer area to shift to Spirometer measurement mode Menu screen of Spirometer To activate the function of the selected item turn the rotary key on the menu screen of the spirometer above and...

Страница 38: ...as Age Gender Height and Race which are indicated as in their input fields must be entered because they are essential for the diagnosis of the pulmonary function To enter the Patient ID and other inf...

Страница 39: ...t and numbers appears on the screen If you turn the rotary key to the right cursor moves consecutively from left top to right bottom Letters or numbers on which the cursor is placed are highlighted on...

Страница 40: ...Manual Keyboard Entering Name Enter the name of the patient in the same way as in ID entry Entering Age After selecting Age the number entry keypad titled Edit Age as seen below will appear Press OK k...

Страница 41: ...entry space Entering Weight The Number Entry window appears if Weight is selected Enter the Patient s weight and select OK Pressing the OK button after entry is complete saves the entered information...

Страница 42: ...s implementation of input methods you need to verify the scanner is supported by Bionet Input methods supported by Bionet International standards USB Products below are tested and confirmed by Bionet...

Страница 43: ...Care Operation Manual 3 FVC Forced Vital Capacity TEST FVC Test Select FVC by turning the rotary key or touch At this time the patient information must be entered beforehand to ensure diagnosis based...

Страница 44: ...44 135 SCOMBA 1 1 SpiroCare Operation Manual When you select the FVC menu the screen shifts to the FVC Test screen following the test preparation process as shown in the figure below...

Страница 45: ...Spirometer handle is not connected or power is turned off on the handle This message is also displayed in the same way during the SVC Test and MVV Test At this time touch Exit by hand or press it usin...

Страница 46: ...st measurement is ready if the Spirometer handle is connected normally The measurement begins if the Start button is pressed and the patient begins to breathe into the mouthpiece To ensure accuracy me...

Страница 47: ...ient to inhale as much as possible 3 Exhale as fast and much as possible Forced expiration Make sure the patient exhales as fast as possible until he or she reaches the point where no more exhalation...

Страница 48: ...hale again 5 Press the Stop button If you take breaths in above mentioned orders a graph showing the result of normal breaths appears in small size If you go ahead with step 2 to 4 a big graph is draw...

Страница 49: ...eration Manual Result screen Press Stop button by using rotary key or touchscreen to signal the machine that measurement is finished After pressing the button the following screen showing the result o...

Страница 50: ...Result screen menu New The machine begins to take a new measurement This is used for starting another new test upon completion of measurement If you click Yes the screen for a new measurement will app...

Страница 51: ...ote You should avoid connecting or disconnecting a USB device while printing out as it could cause the printer module to rattle VT The measured result will be presented as a VT graph The measured resu...

Страница 52: ...asurements the machine will show the main screen At this time select Yes to save the data or No to cancel If Yes is selected 1 A message appears requiring the entry of Patient ID if the Patient ID was...

Страница 53: ...e box asking whether the patient information is to be deleted appears 4 The main screen of Spiro is displayed NOTE The following messages will appear when the memory is full Message appeared after sav...

Страница 54: ...54 135 SCOMBA 1 1 SpiroCare Operation Manual FVC Test Pint Form...

Страница 55: ...Data List menu to check the data indicated as FVC based on the entered ID type of the patient 3 Select the saved FVC data of the patient from the Post Medication Test List and then select Spiro from...

Страница 56: ...the results of the test conducted twice before and after the administratrion of medicine Note If test needs to be performed twice i e before and after medication set up as Setup SPIRO FVC Post On befo...

Страница 57: ...57 135 SCOMBA 1 1 SpiroCare Operation Manual FVC Test Print Form...

Страница 58: ...u and press rotary key or touch the touchscreen the machine will begin to take a SVC measurement Make sure for the patient to put the mouthpiece into his or her mouth and take breaths in following man...

Страница 59: ...measurement 1 Take normal breaths at least four times or more If the machine senses four or more normal breaths it beeps 2 Exhale as much volume as possible to the end slowly RV level 3 Inhale as much...

Страница 60: ...al breath while taking a big breath according to step 2 to 3 a big graph would be re drawn on screen Speed in the positive side F L s of the screen indicates exhalation and that in the negative side i...

Страница 61: ...e measurement is finished a graph V T showing change in volume of lungs to passage of time is drawn like the screen shown below Like in FVC test there are three menus New Print and Exit on the bottom...

Страница 62: ...62 135 SCOMBA 1 1 SpiroCare Operation Manual SVC Test Print Form...

Страница 63: ...e Operation Manual 5 MVV Maximum Voluntary Ventilation TEST If you select MVV in the initial menu and press rotary key or touch the touchscreen the following screen appears Press Start to begin taking...

Страница 64: ...ion Manual Make sure for the patient puts the mouthpiece into his or her mouth and then perform MVV measurement in the following manner It is not possible to take an accurate MVV measurement unless th...

Страница 65: ...take measurement of vital capacity 2 Instruct the patient to breathe as fast and much as possible MVV 3 After a specified measurement time T MVV has passed the machine concludes the measurement and sh...

Страница 66: ...rement is automatically completed 12 seconds after the predetermined duration of measurement T MVV and the results are displayed on the screen MVV respiratory cycle FB and Total Ventilation TV are com...

Страница 67: ...67 135 SCOMBA 1 1 SpiroCare Operation Manual MVV Test Print Form...

Страница 68: ...68 135 SCOMBA 1 1 SpiroCare Operation Manual 6 Calibration Select CAL from the sub menu and press the Rotary key or tab to the CAL field to see the Calibration Main menu screen as below...

Страница 69: ...irometer to the main body 2 Connect the mouthpiece installed in the spirometer handle to mouth of syringe Insert it tightly to prevent any leakages 3 Press start button If the machine is ready for the...

Страница 70: ...ibration Correction can be made by pressing the Start button once you are ready for correction The screen below appears if the syringe handle is moved back and forth To ensure accurate correction move...

Страница 71: ...the menu to apply Calibration result to the device Select Exit from the menu to end Calibration and exit to the top menu Note It is recommended that the revision of the lung capacity measuring instrum...

Страница 72: ...72 135 SCOMBA 1 1 SpiroCare Operation Manual Calibration Print Form...

Страница 73: ...em Setup menu consists of Basic Setup Network Setup Hospital Setup Spiro Setup Calibration Setup and Service Setup and you can change the setting at each window The main page shows Basic Setup After f...

Страница 74: ...en Start Option Unit Date Type and Device Name menus Setup date and time After selecting System Setup click the Basic button to focus on the Date item By using the touch screen or rotating the rotary...

Страница 75: ...nates for setting calibration will appear as shown below Follow the instructions shown on the screen and then the coordinates will be set up Please input the information in the right place otherwise t...

Страница 76: ...Rumanian Russian Spanish and Turkish Select the language you want to use and click the OK button and then you can use the service in the chosen language Note Patient information previously entered wi...

Страница 77: ...You can set up the index page shown at the time of initial boot up according to the common dialog When clicking the Start Option button a small menu window will appear and you can select the initial...

Страница 78: ...Manual Units This menu is to select the units for height and weight of the patient When you click Units button cm kg or Inch Lbs will be shown If you select Inch Lbs unit the patient s height informat...

Страница 79: ...the selected date format is seen on the output Device Name Setup Device Name refers to the name of the device The user can input the name of the device in order to distinguish devices on PC easily De...

Страница 80: ...e selected as Wired or Wireless in Net Device setup The automatic IP DHCP or fixed Manually can be selected through the Configure If the Configure is setup as automatic IP DHCP the Device IP Subnet Ma...

Страница 81: ...MS Server of Bionet or PACS Server After selecting the type of interlocking server select the Setting button an appropriate setup window to the choice of server will be displayed Note When setting up...

Страница 82: ...the PC If no IP of the intended BMS Server to connect is shown on the input box choose Search button to conduct an additional search If no IP of the intended BMS Server to connect is shown on the inpu...

Страница 83: ...screen for related settings such as the AE Title IP and Port of SpiroCare Worklist Server and Store Server will appear When the input window of each item is selected the keyboard window will appear e...

Страница 84: ...ul the Verify Success message will appear when it has failed Verify C Echo Failed will appear Set the PACS option by pressing the More button when connection to the server is confirmed Spiro Exam Code...

Страница 85: ...st screen will re appear automatically by using the Exam button after selecting the patient to measure or by using the NETWORK key or AUTO key after selecting the patient to measure RGB Format Select...

Страница 86: ...JPEG PDF or RAW after checking the format supported by the PACS Server Retry Count Select the number of Retransmission attempts when a communication error occurs during transfer of data to the PACS Se...

Страница 87: ...le it should be selected according to the character set in order to present contents such as patient information by language when transferring a DICOM file to the PACS Server Upon the completion of ea...

Страница 88: ...Setup Network and Set the Device as Wireless When selection is done properly the Survey button on the bottom will be activated 3 Select the Search button to search for the AP The AP is to be searched...

Страница 89: ...t that time the security key input window will appear if the Encrypt field is On Note The user should set the AP Search and Security Key in order to use the wireless network If there is no security se...

Страница 90: ...attempted and the message describing the connection status will appear 7 When the message reporting a proper connection appears click the Close button When connection is successful the wireless icon o...

Страница 91: ...e name of the AP wireless network SSID If it is entered in Korean or other languages Mojibake or illegible characters can appear Hospital Setup When selecting the Hospital menu at the left side of the...

Страница 92: ...among Morris Knudson ECCS Korea CJK or Pereira In addition the contents of each Formula is explained as the below Ethnicity Formula Area North America Morris Polgar Prediction formula widely used in...

Страница 93: ...the point of 1 second from the start If blowing with a slightly weak force at the initial point and then blowing hard spirometry calculates 1 second forced vital capacity at the point 1 second from th...

Страница 94: ...VC graph format If it will be set up as All the all graphs of three times test are printed And if it will be set up as BEST the best one graph of three times test are printed Note In case of doing an...

Страница 95: ...nspection all details of the drug test could be set If it is set up as ON the post inspection could be executed and if it is set up as OFF the post inspection is not going to be executed Note Please s...

Страница 96: ...page Calibration Setup page will show up at the right side When selecting items such as Pressure Humidity Temperature and Syringe Size by using Rotary switch or tabbing the number keypad input window...

Страница 97: ...een is selected the other Setup screen related to User Security Set and Manufacture Set will appear At User Security Set setup it is possible to change Factory Setting and User Password At Manufacture...

Страница 98: ...zed values are as follows Contents Setting Value Gain 10mm mV Speed 25mm s Start Option Main Unit Height cm Weight kg Date Type YYYY MM DD Patient Info File Delete Device Name SpiroCare Net Device Wir...

Страница 99: ...nd KOR language 60Hz For other languages 50Hz Low Pass Filter 150Hz EMG Filter Off ECG Store Yes Print Out Yes Export None Diagnosis Professional ST Level Auto V Channel None Long Time Off Arrhythmia...

Страница 100: ...100 135 SCOMBA 1 1 SpiroCare Operation Manual Data Erase All data in Files and Worklist will be deleted...

Страница 101: ...Manual Change PW User Password can be configured User Password is the number entered for Factory and Data Erase The password should be a 4 digit number NOTE The default User Password is 1234 If you fo...

Страница 102: ...1 1 SpiroCare Operation Manual Chapter 4 Spiro file management 1 Display and function 2 Data printing 3 Data deleting 4 System Setup 5 Switching menu 6 Patient information 7 Data Search 8 Data transfe...

Страница 103: ...t page among total 20 pages 1 Page contains 24 lines of Data If Rotary is selected the focus will be moved to Data list Button to skip to the previous page Button to skip to the next page Button to ch...

Страница 104: ...us can be found on Print button When there is no patient information you want to select please press or button or the Search menu to move to other pages Menu direction Rotary Key s right spin Print De...

Страница 105: ...the Select button one data will be deleted but if you press the All button all data in the list will be deleted In order to help the user not to make a mistake when deleting the data a message shown...

Страница 106: ...e Spiro When you click the menu Retain will be set up and when clicking the menu again Delete will be set up Default is set as Delete Delete To set up the patient information is deleted when you move...

Страница 107: ...data in the PC connected with the equipment USB To save the data in the external USB Memory When clicking the Method button a small line window will show up and it will disappear when selecting Manua...

Страница 108: ...o select the user s options after the data has transferred Yes To delete the data after it has transferred No To not delete the data after it has transferred NOTE If Format menu has only EKG FVC SVC M...

Страница 109: ...selecting a saved data at the Spiro file management page by using a rotary key or a touch screen the focus will appear at the data list Press the Info button Then you will see a Patient Information wi...

Страница 110: ...l see a Patient Search window as shown below If you rotate the rotary key the search condition button will have focus Press the Find button after inputting the information about ID Name Date or Age Wh...

Страница 111: ...When pressing the NETWORK key a message will show up asking which menu you want to select If you transfer a selected data a message with progress speed or other information will be shown as below If...

Страница 112: ...s up without having LAN cable connected the network function may not work properly In this case enter System Network OK then press NETWORK button to attempt running the network function again Please r...

Страница 113: ...window prompting you to select one of them will appear If the external device is not connected to SpiroCare the error message will be shown as below If you select the Selected menu in the Import File...

Страница 114: ...e Operation Manual If you select the All menu in the Import File List screen a system message with progress speed will be shown as below After receiving all data from the external device a system mess...

Страница 115: ...15 135 SCOMBA 1 1 SpiroCare Operation Manual Chapter 5 Spiro worklist management 1 Display and function 2 Spiro Test 3 Data deleting 4 System Setup 5 Switching menu 6 Patient information 7 Data search...

Страница 116: ...first page among total 20 pages 1 Page contains 24 Data If Rotary is selected the focus will be moved to Data list Button to skip to the previous page Button to skip to the next page Button to check...

Страница 117: ...on the control panel If there is no data in the page the focus can be found on Exam button When there is no patient information you want to select please press or button or the Search menu to move to...

Страница 118: ...the Select button one data will be deleted but if you press the All button every data in the list will be deleted In order to help the user not to make a mistake when deleting the data a message show...

Страница 119: ...em Setup When clicking the Setup button at the Spiro data worklist management page you will see the worklist System Setup window as shown below Note The steps for Network Hospital and Service Setting...

Страница 120: ...ransmit when moving to other main screen ECG skip to ECG main screen FILE skip to File Management screen Spiro skip to spirometry measurement screen 6 Patient information When selecting saved data at...

Страница 121: ...l see a Patient Search window as shown below If you rotate the rotary key the search condition button will have focus Press the Find button after inputting the information about ID Name Date or Age Wh...

Страница 122: ...122 135 SCOMBA 1 1 SpiroCare Operation Manual Chapter 6 System Management 1 Maintenance and Cleaning 2 Regular Check up 3 Trouble Shooting 4 Manufacturer Declaration...

Страница 123: ...ake sure there is no liquid in the product or the cable Disposal of your old appliance 1 When this crossed out wheeled bin symbol is attached to a product it means the product is covered by the Europe...

Страница 124: ...y not be closed properly Please close the cover and print again When using the battery power there was a beep for more than 3 times and a message came as shown below The battery is low Please connect...

Страница 125: ...nt ID Please enter patient ID When you implement AUTO or NET button without patient ID Please enter patient ID in patient information window to implement 5 Wrong password Please re enter your password...

Страница 126: ...eck lan cable network setting and relevant program When there is failure of network connection Please check LAN cable connection network setting server PC s networking and related S W programs 16 File...

Страница 127: ...e stop the use of printer for at least one minute and try again 29 Printer Paper empty When the printing paper is completely out Please put new roll of printing paper for use 30 Printer Printer not re...

Страница 128: ...test protocol goes wrong Re test with right test protocol of FVC SVC and MVV 38 Examination Zeroing Fail When the zeroing of spirometer handle is failed React the test 39 Examination Start Fail When i...

Страница 129: ...ot likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The SpiroCare is suitable for use in all establishments other than domestic and may be used in domestic...

Страница 130: ...V line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions a...

Страница 131: ...quation applicable to the frequency of the transmitter Recommended separation distance Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 80 MHz to 800 MHz 800 MHz to 2 5 GHz where P is the maxim...

Страница 132: ...ted RF disturbances are controlled The customer or the user of the SpiroCare can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communicatio...

Страница 133: ...hod Prediction equation Morris Polgar Knudson ITS ECCS Quanjer Korea CJK Pereira Sample rate 200 samples sec Flow impedance 0 2 mbar s l at 12 l s Measuring accuracy Complies with ATS American Thoraci...

Страница 134: ...eriod 1 year from the date of purchase Date of purchase yyyy mm dd Customer Hospital Address Name Contact No Seller s Name Manufacturer s Name This product is a medical machine This product meets the...

Страница 135: ...U S A sales service representative Bionet America Inc 2691 Dow Ave Suite B Tustin CA 92780 U S A Toll Free 1 877 924 6638 Fax 1 714 734 1761 e mail support bionetus com Website www bionetUS com Europ...

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