i SENS ISMART300A Blood Gas Analyzer User Manual i Smart 300 Analyzer draft 3
i-SENS, Inc. Blood Gas Analyzer i Smart 300 Analyzer draft 3
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- 1. i-Smart 300 Analyzer user manual draft(3)
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i-Smart 300 Analyzer user manual draft(3)
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| Document ID | 2911252 |
| Application ID | PvrPrIoAAYfuJUaeXONI8A== |
| Document Description | i-Smart 300 Analyzer user manual draft(3) |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 331.81kB (4147670 bits) |
| Date Submitted | 2016-02-25 00:00:00 |
| Date Available | 2016-08-17 00:00:00 |
| Creation Date | 2016-02-19 14:11:33 |
| Producing Software | Microsoft: Print To PDF |
| Document Lastmod | 2016-02-19 14:11:33 |
| Document Title | Microsoft Word - (PN 7983) i-Smart 300 Operators Manual_Draft(3).docx |
| Document Author: | user1 |
Operator’s Manual Software version 1.0.0.0 P/N 7983 Draft July 2015 Copyright © 2015 i-SENS, Inc. All Rights Reserved Operators should read the entire manual before installing and operating the analyzer. Contents Contents Introduction Safety ··························································································· 1-1 Symbols and Terms ············································································· 1-3 Product Description ············································································ 1-5 Installation Installation Requirements ······································································ 2-1 Power Cable Connection ······································································· 2-2 Power-On ······················································································· 2-3 Printer Paper Installation ······································································· 2-5 Cartridge Installation ··········································································· 2-7 Analyzer Settings Screen Menus ··················································································· 3-1 Sample Setup ·················································································· 3-10 QC Setup ······················································································ 3-15 Analyzer Setup ················································································ 3-17 Interface Setup················································································· 3-21 Sample Analysis Patient Samples ················································································· 4-1 QC Samples ···················································································· 4-8 Database Patient Data ····················································································· 5-1 QC Data ························································································ 5-5 Calibration Data ················································································ 5-9 Cartridge Data ················································································· 5-12 Contents Shutdown Analyzer Shutdown ············································································· 6-1 Cartridge Restart ················································································ 6-3 Maintenance Calibration······················································································· 7-1 Cartridge Removal ·············································································· 7-4 System Information ············································································· 7-6 Analyzer Status ············································································· 7-7 Cleaning···················································································· 7-8 Troubleshooting Troubleshooting ················································································· 8-1 Error Code······················································································· 8-6 Specification Operating Specification ····································································· 9-1 ·····································································9-2 Cartridge Specification ····································································· 9-3 Measuring Principles ······································································· 9-4 Analyzer Specification Appendices Appendics A: Sample Collection and Handling ·············································· 10-1 Appendics B: Order Information ····························································· 10-2 Appendics C: Warranty ······································································· 10-3 1. Introduction 1. Introduction Safety ··················································································· 1-1 Symbols and Terms···································································· 1-3 Product Description ··································································· 1-5 1. Introduction Safety General Warnings Use only the provided power cord and adapter. Do not use damaged power cord, adapter, or loose outlet. Never touch the power supply accessories with wet hands. Keep dust away from the outlet and power cord. Do not use or store any hot equipment or flammable material near the analyzer or power supply accessories. Do not allow water or foreign substances to get into the analyzer or power supply accessories. Do not directly look at the red light emitting from the barcode scanner as direct eye exposure to this light can damage vision. General Caution Power cord must be plugged into a grounded outlet. The rear vent of the analyzer must be free of obstruction and not covered by cloth or any other material. Do not install or operate the analyzer in an area where ferromagnetic fields are generated (e.g., the MRI room). Before long term storage of the analyzer, remove the cartridge, turn off the power, and clean any contamination from the analyzer. There are no operator seviceable parts inside the product. Do not disassemble, repair, or modify the product. If electromechanical problems are suspected, call a service engineer to report the problems. When disposing the analyzer and provided electrical accessories, contact your local distributor where you purchased them. You must not discard this electrical/electronic product in domestic household waste. Changes or modifications not expressly approved by i-SENS, Inc. could void the purchaser’s authority to operate the equipment. 1-1 i-Smart 300 Blood Gas Analyzer 1. Introduction Safety, continued Biohazard Caution All materials used in collecting blood and/or other samples from humans should be treated as biohazardous materials with the potential carrying infectious agents capable of producing disease. All biohazardous materials should be handled and disposed of in accordance with applicable rules and regulations of the hospital, laboratory, or other testing facility. Wear appropriate personal protective clothing (lab coat, gloves, goggles, etc.) before operating the analyzer. Be careful not to let the sample and/or collecting tools directly touch the mouth, eyes, mucus membranes, or any area with broken skin. Wash hands after collecting the sample or using the analyzer. Operator’s Manual 1-2 1. Introduction Symbols and Terms Symbols Symbol Description CE mark (In Vitro Diagnostic Directive 98/79/EC) In vitro diagnostics device Consult operating instructions Authorized representative in the European community Serial number Caution: Attention, see operating instructions Manufacturer Temperature limitation Catalogue number Batch code Contains sufficient fortests Use by Biological risk This marking indicates that you must not discard this electrical/electronic product in domestic household waste. Distributors of this product within the EU have taken the necessary step to comply with the Waste Electrical and Electronic Equipment (WEEE), Directive 2002/96/EC. Printer DC power port Off (power) On (power) 1-3 i-Smart 300 Blood Gas Analyzer 1. Introduction Symbols and Terms, continued Terms Term pH Negative log of the hydrogen ion activity pO2 Partial pressure of oxygen pCO2 cNa+ cK+ cCa2+ cClHct Cal Cal 1 Cal 2 QC Warning Caution Operator’s Manual Description Partial pressure of carbon dioxide Concentration of sodium ion Concentration of potassium ion Concentration of calcium ion (ionized calcium) Concentration of chloride ion Hematocrit Calibration 1-Point calibration 2-Point calibration Quality control A statement that alerts the operator to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device. A statement that alerts the operator to the possibility of device malfunction, device failure, damage to the device or damage to other property associated with the use or misuse of the device. 1-4 1. Introduction Product Description Intended Use i-Smart 300 is an automated system that measures pH, pCO2, pO2, cNa+, cK+, cCl-, cCa2+, and hematocrit in whole blood. It is intended for use in a point-of-care setting or laboratory environment. Analyzer Touchscreen Barcode scanner Cartridge door Sampler cover Printer Handle VGA port Serial port LAN port Vent Power switch Power port USB ports i-Smart 300 Analyzer 1-5 i-Smart 300 Blood Gas Analyzer 1. Introduction Product Description, continued Accessories of analyzer Power adapter Power code Printer papers Cartridge Cartridge cover i-Smart 300 Cartridge Operator’s Manual 1-6 1. Introduction This page is intentionally left blank. 1-7 i-Smart 300 Blood Gas Analyzer 2. Installation 2. Installation Installation Requirements ··························································· 2-1 Power Cable Connection ···························································· 2-2 Power-On ············································································· 2-3 Printer Paper Installation ····························································· 2-5 Cartridge Installation ·································································· 2-7 2. Installation Installation Requirements Unpacking Inspect the shipping package of the product for any signs of damage from shipment. Ensure all listed components are included in the package. Environmental Requirements Location indoors 5 ~ 85%, relative humidity Temperature Altitude Humidity 15 ~ 35°C under 3,000 m Note: Electrical Requirements The analyzer should be installed on a horizontal, stable surface in a well-ventilated area without direct sunlight or heat. Allow enough space for the cartridge door of the analyzer to open. Allow at least 10 cm of space from the back of the analyzer for adequate ventilation. This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Volt AC 100 ~ 240 Va.c., grounded electrical supply Frequency 50/60 Hz Amp Power cord 1.5 A 3-wire, approved Power adapter : +24 Vd.c., 2.7 A (Output) 2-1 i-Smart 300 Blood Gas Analyzer 2. Installation Power Cable Connection Caution Check that the power switch is in “ ” (OFF) position. Always connect the power according to the steps described in this manual. Always use a grounded electrical outlet. Use only the power cord and power adapter provided by the manufacture. Electrical plugs and sockets vary by countries. If necessary, use appropriate power plug or power strips to connect the provided power cord to the outlet. Connect Power Cable Operator’s Manual 1. Plug the power cord into the socket of the power adapter. 2. Plug the power adapter into the power port on the back of the analyzer. 3. Plug the power cord into an electrical outlet. 2-2 2. Installation Power-On Caution Remove any attached USB memory device or network cable from the analyzer before turning the power switch on. Turn Power Switch On 2. 3. Facing the back of the analyzer, flip the black power switch on the lower left side, marked “ ” to the “ ” position. The screen will turn on and the analyzer will boot. 4. If the boot is completed, the message of the last shutdown information will appear. 2-3 i-Smart 300 Blood Gas Analyzer 2. Installation Power-On, continued Turn Power Switch On, continued 5. Check that the power cord icon 이 appears at the bottom row of the screen. Note: 6. If the power cord icon does not appear on the screen, check for any loose power connections between the analyzer and the electrical outlet. If no loose power connection is found and the power cord icon still does not appear, call a service engineer immediately. Check the date and time of the analyzer and, if necessary, change date and/or time. Refer to 3. Analyzer Settings Note: Operator’s Manual Changing the date and time of the analyzer is only allowed before cartridge is installed on the analyzer. Once the cartridge is installed, the date and time cannot be changed until the cartridge is removed. 2-4 2. Installation Printer Paper Installation Install Printer Paper 2-5 1. Facing the back of the analyzer, push the PUSH button and flip down the printer cover. 2. Place the paper roll into the paper compartment and place the end of the paper in parallel with the printer slot. i-Smart 300 Blood Gas Analyzer 2. Installation Printer Paper Installation, continued 3. Install Printer Paper, continued Close the printer cover. Note: Operator’s Manual The printer will cut the paper exposed to the outside automatically. 2-6 2. Installation Cartridge Installation Install Cartridge Note: After opening the cartridge, it must be installed directly to the analyzer. 1. Take out the cartridge from the cartridge box. 3. Press Install at the following screen 4. Slide down the lever on the cartridge door, open the cartridge door. 2. 2-7 Press down the cover lock and remove the cartridge cover. i-Smart 300 Blood Gas Analyzer 2. Installation Cartridge Installation, continued Install Cartridge, 5. continued Operator’s Manual Insert the new cartridge into the analyzer, follow the instructions on the screen. 6. Facing the cartridge label, insert the cartridge into the analyzer. 7. Close the cartridge door and slide up the lever on the cartridge door. If the door is properly locked, it will make a clicking sound. 2-8 2. Installation Cartridge Installation, continued Install Cartridge, 8. continued 9. If the RFID tag information of the cartridge is valid, the analyzer will change to the Cartridge Warming-Up screen. The cartridge warming-up will take approximately 25 minutes. Note: 2-9 Once the cartridge cover is removed, be careful with sharp edges of the cartridge parts inside. i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting 3. Analyzer Setting Screen Menus ·················································································· 3-1 Sample Setup·················································································· 3-10 QC Setup ······················································································· 3-15 Analyzer Setup ··············································································· 3-17 Interface Setup ················································································ 3-21 3. Analyzer Setting Screen Menus Ready Screen No. ① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ 3-1 Screen naming Description Analyzer operation schedule Remaining sample number and date of the installed cartridge Current state of interface setup Current state of power connection Current state of and battery recharge level Current date and time of the analyzer Menu access Current state of each sensor: Pressing each button twice will display the latest slope of the sensor. i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting Screen Menus, continued Menu options Operator’s Manual 3-2 3. Analyzer Setting Screen Menus, continued Menu Access 1. Press Menu. The quick menus and the category menus will appear. 2. Press the current screen box at the top right corner to show the current menu options. Note: The Menu button is disabled on the following screens: - Install Cartridge, Remove Cartridge - Introduce Sample, Sample Information, Sample Results - Introduce QC Sample, QC Information, QC Results 3-3 i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting Screen Menus, continued Icons and Buttons Icons and Buttons Description Print results or settings on screen Transmit results to LIS/HIS / Transfer complete Close current screen Go to list screen Go to search screen View result screen Scroll to previous or next page Go to previous or next result screen Operator’s Manual 3-4 3. Analyzer Setting Screen Menus, continued Icons and Buttons, continued Icons and Buttons Description Execute search Run 1-point calibration or 2-point calibration Run QC Accept or discard QC results Add or delete QC lot information Delete entered data on current tab Okay or accept Save Go to previous screen Copy cartridge data to USB memory 3-5 i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting Screen Menus, continued Icons and Buttons, continued Icons and Buttons Description Unselected item Selected item Item that were transmitted to LIS/HIS Selected item that were transmitted to LIS/HIS Show keyboard for data entry Show keyboard for numeric entry Interface was enabled Analyzer is on AC power Battery level Operator’s Manual 3-6 3. Analyzer Setting Screen Menus, continued Keyboards The analyzer offers following keyboards for data entry. Alphabetic Keyboard Numeric & Special Character Keyboard Date and Time Entry Keyboards 3-7 i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting Screen Menus, continued Keyboards, continued Operator’s Manual Numerical Keyboard 3-8 3. Analyzer Setting Screen Menus, continued LCD Brightness When the analyzer has not been in use for more than 10 minutes, the screen turns to screensaver. Note: The screensaver does not apply to the Sample Results screen and the QC Results screen. Message A message box on the screen informs following information: A current task that is about to begin or in-progress. An error that needs an attention or action. Voice Guide In addition to message boxes, the analyzer plays sound playbacks for following operations: Blood sample introduction Cartridge removal 3-9 Action to take in operating the analyzer, such as introducing sample or replacing cartridge. QC sample introduction Cartridge installation Cartridge data copy Battery alarm:: “The battery is low” i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting Sample Setup Reference Ranges Operator’s Manual 1. Go to Menu > Setup (Setup menu is protected by password.) > Reference Ranges Setup. The following screen will appear. 2. Press each box and enter low and high limits of the reference range for each parameter. 3-10 3. Analyzer Setting Sample Setup, continued Reference Ranges, continued Note: To delete the entered data, press Current Tab Clear. Before saving the setup, the analyzer will validate the entered values to confirm that: - Values for both low and high limits are entered. 3. 3-11 - Low limit value is lower than high limit value. If any of the entered values are not valid, the analyzer will not save the setup and ask to correct the invalid value at the setup screen. Press Save to save the setup and go back to the main screen. To exit to main screen without saving the changed setting, press Close. i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting Sample Setup, continued Reference Ranges, continued Note: Patient reference ranges should be established by individual institutions. The reference ranges in the table below are shown only as general guidelines. Parameter Unit Reference Range pCO2 mmHg 35.0 ~ 48.0 cNa+ mmol/L 136 ~ 145 cCa2+ mmol/L 1.15 ~ 1.35 Hct 35 ~ 51 pH pO2 cK+ cCl- Operator’s Manual mmHg mmol/L mmol/L 7.350 ~ 7.450 83 ~ 108 3.4 ~ 4.5 98 ~ 106 3-12 3. Analyzer Setting Sample Setup, continued Critical Limits 1. Go to Menu > Setup (Setup menu is protected by password.) > Critical Limits Setup. The following screen will appear. 2. Press each box and enter low and high values of the critical limits range for each parameter. Note: 3. 3-13 To delete the entered data, press Current Tab Clear. Before saving the setup, the analyzer will validate the entered values to confirm that: - Values for both low and high limits are entered. - Low limit value is lower than high limit value. If any of the entered values are not valid, the analyzer will not save the setup and ask to correct the invalid value at the setup screen. Press Save to save the setup and go back to the main screen. To exit to main screen without saving the changed setting, press Close. i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting Sample Setup, continued Critical Limits, continued Operator’s Manual Note: High limit value is high than high limits of the reference range. Low limit value is low than low limits of the reference range. 3-14 3. Analyzer Setting QC Setup QC Lot Setup 3-15 1. Go to Menu > Setup (Setup menu is protected by password.) > QC Setup. The following screen will appear. 2. Select the empty list on the left column. Entry tabs to enter QC lot information is activated on the right side as follow. 3. Press each entry tab, and enter QC lot information using the keyboard. i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting QC Setup, continued QC Lot Setup, continued 4. Press Add after entering QC lot information. The entered QC lot will be added to the list on the left column. Note: Continue to select the empty list on the left column and add desired QC lot information. 5. 6. To delete the previously saved QC lot information, press the desired QC lot on the left column and press Delete. To modify the previously saved QC lot information, delete the saved QC lot on the left column and newly add the modified QC lot. Note: Operator’s Manual The newly added or modified QC lot is shown in bold. 7. Press Save to save the setup and go back to the main screen. To exit to main screen without saving the changed setting, press Close. 3-16 3. Analyzer Setting Analyzer Setup Date and Time 1. Go to Menu > Setup (Setup menu is protected by password.) > Analyzer Setup. The following screen will appear. Note: Changing the Time, Date and Date Format of the analyzer is only allowed before cartridge is installed on the analyzer. Once the cartridge is installed, the time, date and date format cannot be changed until the cartridge is removed. 2. 3-17 Press Date Format box and select the desired date format from the drop-down list. i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting Analyzer Setup, continued Date and Time, continued Operator’s Manual 3. Press Date box and enter the current date using the keyboard. 4. Press Time box and enter the current local time using the keyboard. 3-18 3. Analyzer Setting Analyzer Setup, continued Volume 3-19 1. To adjust the volume, press Volume. or button of the Speaker 2. To turn off sound playback, press Mute. To turn to maximum volume, press Max. i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting Analyzer Setup, continued LCD Brightness 1. To adjust the LCD brightness, press or button of the LCD Brightness. Brightness can be adjusted in 15 steps. Note: To turn to minimum or maximum brightness, press Min or Max. 2. Operator’s Manual Press Save to save the setup and go back to the main screen. To exit to main screen without saving the changed setting, press Close. 3-20 3. Analyzer Setting Interface Setup Option Setup Note: 1. Go to Menu > Setup (Setup menu is protected by password.) > Interface Setup. The following screen will appear. 2. Check Sample, QC, Cal 1, and/or Cal 2 to transmit. 4. Select Serial from Sending Method. 3. 3-21 Make sure that network cable(s) is appropriately connected to the analyzer before starting interface setup. Select Auto or Manual from Auto & Manual Send to automatically or manually transmit the data. i-Smart 300 Blood Gas Analyzer 3. Analyzer Setting Interface Setup, continued Serial Setup 1. 2. 3. 4. 5. 6. Operator’s Manual Press Baud Rate and select the desired option from the dropdown list. Default is 9600. Press Data Bit and select the desired option from the drop-down list. Default is 8. Press Stop Bit and select the desired option from the drop-down list. Default is ONE. Press Parity and select the desired option from the drop-down list. Default is None. Press Handshake and select the desired option from the dropdown list. Default is None. If serial setup is completed, press Save to save the setup and return to the previous screen. To exit to main screen without saving the changed setting, press Close. 3-22 3. Analyzer Setting This page is intentionally left blank. 3-23 i-Smart 300 Blood Gas Analyzer 4. Sample Analysis 4. Sample Analysis Patient Samples ········································································ 4-1 QC Samples ············································································ 4-8 4. Sample Analysis Patient Samples Introduce Sample Note: Sample analysis is available only when the analyzer is in Ready state. When the analyzer is not in Ready state, the sampler cover cannot be lifted because it is locked. 1. Check that the analyzer is in Ready state. 2. Lift up the sampler cover. The following message will appear. Note: 4-1 To cancel a patient sample, lower the sampler cover to the original position before pressing Aspirate. Once Aspirate is pressed, the sample analysis cannot be cancelled. i-Smart 300 Blood Gas Analyzer 4. Sample Analysis Patient Samples, continued Introduce Sample, continued 3. For a syringe sample, immerse the end of the sampler probe into the sample container. Note: Be careful not to introduce air bubbles, clots, or foreign substances along with sample to the analyzer. 4. For a capillary sample, lift the sampler cover all the way up. Carefully insert the capillary into the septum. Note: Operator’s Manual Do not allow any gap between the capillary and the septum to avoid air flow in with the sample. 4-2 4. Sample Analysis Patient Samples, continued Introduce Sample, continued 4-3 5. If the sampler probe is adequately immersed in the sample, press Aspirate to begin aspiration. 6. The “Aspirating sample... Please wait” message will appear. 7. If the aspiration is completed, the “Remove sample now” message will appear. Remove sample from sampler probe. 8. Wait a second until the “Close sampler cover ” message will appear. 9. Lower the sampler cover to close. i-Smart 300 Blood Gas Analyzer 4. Sample Analysis Patient Samples, continued Enter Sample Information Operator’s Manual 1. Once the sampler cover is closed, the Sample Information screen will appear. 2. If the sample information is available in barcode, scan the barcode using the barcode scanner that is located in front of the analyzer. 3. To manually enter the sample information, press each of the input boxes and enter the sample information using the screen keyboard. 4-4 4. Sample Analysis Patient Samples, continued View Sample Results 1. When the sample analysis is completed, the sample results will appear at the Measured Quantity tab of the Sample Results screen. 2. The result values will appear in blue color if the reference ranges have not been setup in the analyzer. 3. If the reference ranges have been setup in the analyzer and a result is within the reference range, the value will appear in blue color. Note: 4-5 If a result is above reference range, the value will appear in blue color along with an up arrow If a result is below reference range, the value will appear in red color along with a down arrow i-Smart 300 Blood Gas Analyzer 4. Sample Analysis Patient Samples, continued View Sample Results 4. If any result falls outside of the Critical Limit, the value will appear in red color. The phrase will be accompanied by a double arrow or , to indicate above the upper limit or below the lower limit. 5. If the drift error of a sensor has occurred, the corresponding result will be accompanied by “D” in red color. 6. 7. 8. If any result falls outside of the reportable range, the corresponding result will not be reported. Instead “R” will appear in red color. If the slope error of a sensor has occurred, the corresponding result will not be reported. Instead “S” will appear in red color. Select the Calculated Quantity tab. The calculated values will appear. Note: Operator’s Manual If a value cannot be calculated, the value will not be reported. Instead “C” will appear in red color. 4-6 4. Sample Analysis Patient Samples, continued View Sample Results 9. Press Print to print out the results. A printout similar to following will be printed. Note: If the analyzer is on battery power, the printout is only available in more than 50% battery levels. 10. If the analyzer has been set to auto print, the analyzer will print the results as soon as they are reported. 11. To transmit the results to the LIS/HIS, press Send. 12. Press Close to save the results and exit to main screen. 13. The analyzer will go through Rinse and Cal 1 process before returning to the Ready state for a next sample. 4-7 i-Smart 300 Blood Gas Analyzer 4. Sample Analysis QC Samples Introduce QC Sample 1. Press Menu and select Run QC. The following screen will appear. 2. Press Yes. The following screen will appear. Note: The Run QC menu will be available only when the QC lot(s) has been setup at QC Setup menu. 3. Operator’s Manual When the “Lift sampler cover for QC sampling” message appears, lift up the sampler cover. 4-8 4. Sample Analysis QC Samples, continued Introduce QC sample, continued 4. When “Position QC sample for aspiration” message appears, immerse the end of the sampler probe into the QC sample and press Aspirate. 5. The “Aspirating QC sample... Please wait” message will appear. Note: 4-9 To cancel QC sample, lower the sampler cover to the original position before pressing Aspirate. Once Aspirate is pressed, the sample analysis cannot be cancelled. i-Smart 300 Blood Gas Analyzer 4. Sample Analysis QC Samples, continued Introduce QC sample, continued Operator’s Manual 6. If the aspiration is completed, the “Remove QC sample now” message will appear. Remove QC sample from the sampler probe. 7. Wait a second until the “Close sampler cover” message will appear. 8. Push down the sampler cover to the original position. 4-10 4. Sample Analysis QC Samples, continued Enter QC Information 4-11 1. Once the sampler cover is closed, the QC Information screen will appear. 2. Select the QC lot of the QC sample. 3. If necessary, enter Operator ID and QC Comment using the screen keyboard. 4. Press OK. QC Results screen will appear. i-Smart 300 Blood Gas Analyzer 4. Sample Analysis QC Samples, continued View QC Results 1. When the QC sample analysis is completed, the QC results will appear at the QC Results screen as following. Note: If a result is within the QC range, the value will appear in blue color. Operator’s Manual If a result is above the QC range, the value will appear in red color along with an up arrow If a result is below the QC range, the value will appear in red color along with a down arrow 2. Press Accept or Discard to accept or discard the QC results. The state will switch from Pending to Accepted or Discard. 4-12 4. Sample Analysis QC Samples, continued View QC Results, 3. continued Press Print to print out the results. A printout similar to following will be printed. Note: 4. 5. 4-13 If the analyzer is on battery power, the printout is only available in more than 50% battery levels. To transmit the results to the LIS/HIS, press Send. Press Close to save the results and exit to main screen. i-Smart 300 Blood Gas Analyzer 5. Database 5. Database Patient Data··················································································· 5-1 QC Data ······················································································· 5-5 Calibration Data ············································································· 5-9 Cartridge Data ··············································································5-12 5. Database Patient Data Last Patient Results 1. Go to Menu > Sample >Last Sample Results. The following screen will appear. Note: The same screen can be accessed through Menu > Last Sample Results. 2. To view the screen of the next patient sample results or the previous patient sample results, press Next Results or Prev Results. 3. 4. 5. Sample Results List 5-1 1. To go to the list of patient sample results, press List. To transmit the results to the LIS/HIS, press Send. Press Close to exit to main screen. Go to Menu > Sample > Sample Results List. The following screen will appear. i-Smart 300 Blood Gas Analyzer 5. Database Patient Data, continued Sample Results List, continued Operator’s Manual 2. 3. The latest patient sample data are listed on the top. Use Page UP or Page Down to scroll the list of patient results. To view a patient sample results, select a desired row from the list. 4. To view more the desired sample results, press View Result. The corresponding patient sample results screen will appear. 5. To search patient sample results, press Search on the Sample Results List screen. Refer to the Sample Results Search section below. 5-2 5. Database Patient Data, continued Sample Results List, continued 5-3 6. To transmit patient sample results to the LIS/HIS, select desired results from the list and press Send. 7. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer 5. Database Patient Data, continued Sample Results Search 1. Go to Menu > Sample > Sample Results Search. The following screen will appear. Note: Search criteria for patient results are as following: From & To Sample Type Patient ID Sample ID Patient Last Name Patient First Name Operator ID 2. Enter desired search criteria in appropriate boxes. 4. To go to the list of patient results, press List. 3. 5. Operator’s Manual Press Search. The searched patient results will appear. Press Close to exit to main screen. 5-4 5. Database QC Data Last QC Results 1. Go to Menu > QC > Last QC Results. The following screen will appear. 2. Press List to go to the list of QC results. 4. To transmit the results to the LIS/HIS, press Send. 3. 5. QC Results List 5-5 To view the screen of the next QC results or the previous QC results, press Next Results or Prev Results. Press Close to exit to main screen. 1. Go to Menu > QC > QC Results List. The following screen will appear. 2. The latest QC results are listed on the top. Use Page Up or Page Down to scroll the list of QC results. i-Smart 300 Blood Gas Analyzer 5. Database QC Data, continued QC Results List, continued Operator’s Manual 3. To view a QC results screen, select a desired row from the list and press View Result. 4. The corresponding QC results screen will appear. 5-6 5. Database QC Data, continued QC Results List, continued 5-7 5. To transmit patient sample results to the LIS/HIS, select desired results from the list and press Send. 6. To search QC results, press Search on the QC Results List screen. Refer to the QC Results Search section below. 7. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer 5. Database QC Data, continued QC Results Search 1. Go to Menu > QC > QC Results Search. The following screen will appear. Note: Search criteria for QC results are as following: From & To QC Lot Either Accepted or Discarded QC results only or all results Operator ID 2. Enter desired search criteria in appropriate boxes. 4. To go to the list of QC results, press QC List. 3. 5. Operator’s Manual Press Search. The searched QC results will appear. Press Close to exit to main screen. 5-8 5. Database Calibration Data Cal 1 Results 1. Go to Menu > Calibration > Cal 1 Results. The following screen will appear. 2. To view the screen of the next Cal 1 results or the previous Cal 1 results, press Next Results or Prev Results. 3. To transmit the results to the LIS/HIS, press Send. 5. To go to the list of calibration, press List. 4. To print out the results, press Print. Note: If the analyzer is on battery power, the printout is only available in more 6. 5-9 than 50% battery levels. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer 5. Database Calibration Data, continued Cal 2 Results 1. Go to Menu > Calibration > Cal 2 Results. The following screen will appear. 2. To view the screen of the next Cal 2 results or the previous Cal 2 results, press Next Results or Prev Results. 3. 4. To transmit the results to the LIS/HIS, press Send. To print out the results, press Print. Note: If the analyzer is on battery power, the printout is only available in more 5. 6. Operator’s Manual than 50% battery levels. To go to the list of calibration, press List. Press Close to exit to main screen. 5-10 5. Database Calibration Data, continued Calibration List 1. Go to Menu > Calibration > Calibration List. The following screen will appear. 2. The latest Cal 2 results are listed on the top. Use Page Up or Page Down to scroll the list of Cal 2 results. 3. To view a Cal 2 results screen, select a desired row from the list and press View Result. 4. 5. 5-11 To transmit the results to the LIS/HIS, press Send. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer 5. Database Cartridge Data Cartridge Data Copy 1. Go to Menu > Status > Cartridge Data. The following screen will appear. 2. The latest cartridge data will appear on the top. Page Down to scroll the list of cartridge data. 3. 4. 5. 6. 7. Operator’s Manual Use Page Up or Select desired cartridge data and press Copy. The following screen will appear. Insert an USB memory into any of available USB ports on the analyzer. The “Data copy in progress. Please wait” message will appear along with the copy progress bar. When the data copy is completed, the “Cartridge data copy has completed. Remove USB memory” message will appear. Remove the USB memory from the USB port. 5-12 5. Database This page is intentionally left blank. 5-13 i-Smart 300 Blood Gas Analyzer 6. Shutdown 6. Shutdown Analyzer Shutdown··········································································· 6-1 Cartridge Restart ·············································································· 6-3 6. Shutdown Analyzer Shutdown Caution The power of the analyzer should be turned off according to the shutdown procedure as described in this manual. Failure to follow the described shutdown procedure can cause damage to the data or the analyzer. To disconnect the power cables from the analyzer, first unplug the power cord from the outlet. Then, unplug the adapter from the analyzer. The cartridge cannot be removed once the shutdown process begins or after the analyzer is turned off. Shutdown Analyzer 6-1 1. Go to Menu > Shutdown Analyzer. The following screen will appear. 2. Press Yes to continue. The following message will appear. i-Smart 300 Blood Gas Analyzer 6. Shutdown Analyzer Shutdown, continued Shutdown Analyzer, continued Operator’s Manual 3. Wait until the analyzer completes a power cycle and the following screen appears. 4. Wait until the progress circle reaches 100%. 5. Facing the back of the analyzer, flip the black power switch on the lower left side, marked “ ”, to the “ ” position. 6-2 6. Shutdown Cartridge Restart Power Recovery When the analyzer recovers from power interruption, the cartridge inside the analyzer can be continuously used, only if: The analyzer was analyzing a sample when the power was interrupted and the power returns within 20 minutes. The analyzer was analyzing a QC sample when the power was interrupted and the power returns within 1 hour. 1. When the analyzer recovers from power interruption with the cartridge inside, one of following Cartridge Restart screens will appear. 2. The Cartridge Restart from power recovery will take about 10 minutes. 3. 6-3 The analyzer was in Ready state or in process of calibration when the power was interrupted and the power returns within 1 hour. After the Cartridge Restart, the analyzer will return to the Ready state. i-Smart 300 Blood Gas Analyzer 7. Maintenance 7. Maintenance Calibration ······················································································ 7-1 Cartridge Removal ············································································ 7-4 Analyzer Information ········································································ 7-6 Analyzer Diagnosis ··········································································· 7-7 Cleaning ························································································· 7-8 7. Maintenance Calibration Run Cal 7-1 1. Go to Menu > Run Cal 1. The following screen will appear. 2. Go to Menu > Run Cal 2. The following screen will appear. i-Smart 300 Blood Gas Analyzer 7. Maintenance Calibration, continued Cal 1 Auto Repeat If the drift error of a sensor has occurred in the previous Cal 1, the analyzer will automatically repeat Cal 1 up to three times. Cal 2 Auto Repeat If the slope error of a sensor has occurred in the previous Cal 2, the analyzer will automatically repeat Cal 2 up to two times. While the Cal 2 repeat is in progress, the “Drift error has occured. Cal 1 is in progress. Please wait...” message will appear. While the Cal 2 repeat is in progress, the “Slope error has occured. Cal 2 is in progress. Please wait...” message will appear. If the same sensor fails in Cal 2 three times in succession, the sensor state will appear as Operator’s Manual on the main screen. 7-2 7. Maintenance Calibration, continued Sensor State 7-3 1. State of each sensor will appear as okay in blue background, drift error in yellow background or slope error in red background at the main screen based on the results of the last calibration. 2. Press the Sensor State icon twice quickly. The last slope and the allowable slope range of the sensor will appear. i-Smart 300 Blood Gas Analyzer 7. Maintenance Cartridge Removal Caution Treat the used cartridge as biohazard material. Dispose of the used cartridge in accordance with the laboratory’s established procedures for disposing of biohazardous materials. Before removing the used cartridge, wear appropriate personal protective clothing to protect from biohazard materials. Remove Expired Cartridge 1. The analyzer will automatically display the Cartridge Expired screen in one of following situations: 2. Press Remove to remove the current cartridge. The following screen will appear. 3. Remove the cartridge in accordance with the instructions on the screen. To install a new cartridge, refer to the Cartridge Installation (2. Installation) section. 4. Operator’s Manual The uselife of the cartridge has expired. All tests of the cartridge have been used up. The analyzer has been without power for more than the allowable time limit to restore the cartridge. 7-4 7. Maintenance Cartridge Removal, continued Remove Cartridge in Use 1. Go to Menu > Remove Cartridge to remove a cartridge in use. The following screen will appear. Note: To cancel the cartridge removal, press No. 2. Press Yes. The following screen will appear. 3. Remove the cartridge in accordance with the instructions on the screen. 4. 7-5 The removed cartridge cannot be reused. To install a new cartridge, refer to the Cartridge Installation (2. Installation) section. i-Smart 300 Blood Gas Analyzer 7. Maintenance System Information 1. Go to Menu > Status > System Information. The following screen will appear. 2. The following information will appear: Software Version and Firmware Version Cartridge: Serial Number, Lot Number, Installation Date & Time, Expiration Date & Time, Age Calibration Information Note: Operator’s Manual The information of the removed cartridge is not shown. 3. Press Close to exit to main screen. 7-6 7. Maintenance Analyzer Status 1. Go to Menu > Status > Analyzer Status. The following screen will appear. 2. The following information will appear: Raw Signals Measuring temperature Analyzer temperature Battery level 3. 4. States of Cartridge installation, Cartridge door, and Sampler cover Press Run Cal 1 or Run Cal 2 to initiate Cal 1 or Cal 2 on the current screen. Press Close to exit to main screen. Note: 7-5 If the cartridge is properly installed, Cartridge, Cartridge Door, and Sampler Cover states will appear as Yes. The Service Mode is for service engineers ONLY and protected by password. i-Smart 300 Blood Gas Analyzer 7. Maintenance Cleaning Caution Wear appropriate personal protective clothing to prevent infection when cleaning. Clean the analyzer after use or periodically. Do not spray cleaning solution directly onto the analyzer. Do not allow cleaning solution to enter the analyzer. Do not use force to wipe the screen. Prepare 0.5% hypochlorite cleaning solution immediately before use. Dispose of all waste after cleaning in accordance with the laboratory’s established procedures for disposing of biohazardous materials. Cleaning Procedure Use 0.5% hypochlorite cleaning solution. 1. Note: To prepare 0.5% hypochlorite solution, mix 1 part of Clorox and 9 parts of water. 2. Dampen a soft cloth with the cleaning solution. 4. Allow to air-dry for about 10 minutes. 3. 5. Operator’s Manual Commercial Clorox contains approximately 5% sodium hypochlorite. Using a dampened soft cloth, wipe sampler cover, screen, and other contaminated areas on the analyzer. Using a soft cloth dampened with water, wipe the analyzer. Using a dry cloth, dry the surface of the analyzer. 7-8 7. Maintenance This page is intentionally left blank. 7-9 i-Smart 300 Blood Gas Analyzer 8. Troubleshooting 8. Troubleshooting Troubleshooting ··············································································· 8-1 Error Code ······················································································ 8-6 8. Troubleshooting Troubleshooting Guideline If the problems described below are encountered during installation and/or operation of the analyzer, try the suggested solutions as described in this manual. If the problem persists, please call a service engineer for further assistance. Barcode Scanner When scanning barcode, the scanner does not emit the red light: 1. 2. 3. Screen Move the barcodes to be scanned in front of the marking “ BARCODE SCAN”. If there does not show a red light beam, press the “SCAN” button on the rear of the analyzer by a sharp object like a needle. Then, retry to read the barcodes. It may not be able to read the barcodes at a dark place. In this case, please enhance the brightness of the light in around. If the same problem occurs, turn off and on the power switch of the analyzer. If one of following situations applies: The screen does not respond. The screen is frozen. Abnormal screen appears. 1. Turn off the power switch of the analyzer. 2. Wait 10 seconds. 3. Turn on the power switch of the analyzer. 8-1 i-Smart 300 Blood Gas Analyzer 8. Troubleshooting Troubleshooting, continued Battery If one of following situations applies: The analyzer was turned off immediately upon disconnection from the outlet. The analyzer was turned off during brief power outages. The battery does not recharge. 1. If not already done, turn off the power switch of the analyzer. 2. Check for loose power connections between the analyzer and the outlet. Tighten any loose power connections. 3. Turn on the power switch of the analyzer. 4. The analyzer will turn on and the battery will begin to recharge. 5. If the analyzer does not turn on, turn off the power switch of the analyzer. 6. Recharge the battery for 10 minutes. 7. Turn on the power switch of the analyzer again. 8. While the analyzer is turned, if the battery level stays low and does not increase at all over the time, call a service engineer for help. 9. Until the battery is replaced, the analyzer will operate normally as long as the power is supplied from the outlet. If the “Battery is low” appears, 1. Check for loose power connections between the analyzer and the outlet. 2. Tighten any loose power connections. Operator’s Manual 8-2 8. Troubleshooting Troubleshooting, continued Calibration If the sensor state appears as slope error in red background, 1. Run Cal 2. 2. If needed, repeat additional Cal 2 a few times more. Cartridge Data Copy If the analyzer fails to detect a USB memory, 1. Remove the USB memory from the USB port. 2. Insert the USB memory into a different USB port. 3. If it still doesn’t work, try a different USB memory. If “Cartridge data copy has failed” message appears during data copy, 1. Close the message and try again from the beginning. 2. Select desired cartridge data and press Copy. Cartridge Installation If the analyzer does not change to the warming-up screen after the cartridge is inserted into the analyzer, 1. Check that the cartridge is an i-Smart 300 cartridge. 2. Check that the cartridge is not past its expiration date. 3. Check that the cartridge has not been previously used. 4. Open and close the cartridge door. 8-3 i-Smart 300 Blood Gas Analyzer 8. Troubleshooting Troubleshooting, continued Power While the analyzer is connected to the outlet, the power cord icon does not appear: 1. Check for loose power connections between the analyzer and the outlet. 2. Tighten any loose power connections. If one of following situations applies: The analyzer has turned off. The analyzer does not turn on. 1. If not already done, turn off the power switch of the analyzer. 2. Check for loose power connections between the analyzer and the outlet. Tighten any loose power connections. 3. Turn on the power switch of the analyzer. 4. If the analyzer does not turn on, turn off the power switch of the analyzer. 5. Recharge the battery for 10 minutes. 6. Turn on the power switch of the analyzer again. Printer If one of following situations applies: The printer does not print. The printer does not feed the paper. 1. Check for loose power connections between the analyzer and the outlet. If the analyzer is on battery power, the printout is only available in more than 50% battery levels. 2. Open the printer cover. 3. Replace a roll of print paper if the paper has run out. 4. Lift up the printer head and check for paper jam. If jammed, remove the jam. Then, press the RESET switch on the left side of the printer and close the printer head. Operator’s Manual 8-4 8. Troubleshooting Troubleshooting, continued Sample Analysis If one of following situations applies: The “Insufficient sample error” appears on the result screen. The “Out of range” appears on the results screen. A result is suspicious. 1. Try sample analysis again with the same sample. 2. If the same error is repeated, run Cal 2. 3. Try sample analysis again. 4. Repeat Cal 2 a few times if the same problem occurs. 5. Try QC solutions for analysis. If the QC results are within the QC range, the analyzer is okay for sample analysis. 6. Check the sample collection and handling method. 8-5 i-Smart 300 Blood Gas Analyzer 8. Troubleshooting Error Code 1. If the analyzer encounters an error during operation, the following error code will appear on the screen. Error Code ESYS001 ~ ESYS999 Hardware error ESW001 ~ ESW999 Software error EDB001 ~ EDB999 2. Memo the error code. 4. Wait 10 seconds. 3. 5. Operator’s Manual Description Database error Turn off the power switch of the analyzer. Turn on the power switch of the analyzer. 8-6 8. Troubleshooting This page is intentionally left blank. 8-7 i-Smart 300 Blood Gas Analyzer 9. Specification 9. Specifications Operating Specifications ···································································· 9-1 Analyzer Specifications ····································································· 9-2 Cartridge Specifications ····································································· 9-3 Measuring Principles ········································································· 9-4 9. Specification Operating Specifications Measured Parameters Measured Parameters Parameter pH Unit pCO2 mmHg cNa+ mmol/L pO2 cK+ mmHg mmol/L Reportable Range Measuring Range Resolution 0.0 ~ 250.0 0.1 6.500 ~ 8.000 6.000 ~ 8.500 0.001 5 ~ 700 0 ~ 800 5.0 ~ 150.0 80 ~ 200 1.0 ~ 20.0 20 ~ 250 1.0 ~ 60.0 0.1 cCa2+ mmol/L 0.25 ~ 5.00 0.25 ~ 15.00 0.01 Hct 10 ~ 70 5 ~ 75 cCl- mmol/L 50 ~ 150 20 ~ 250 Sample types: whole blood Anticoagulant: heparin Sample volume: 80 μL Sample introduction method: aspiration Sample analysis time: 50 seconds Sample analysis temperature: 37.0 ± 0.2°C Measuring principle: electrochemical (potentiometry, amperometry, conductometry) Calibration : automatic or manual Environmental Conditions Operating location: indoors on a flat surface Operating temperature: 15 ~ 35°C Operating humidity: 5 ~ 85% (relative humidity) Operating altitude: under 3,000 m Power supply: 100 ~ 240 Va.c., 50/60 Hz 9-1 i-Smart 300 Blood Gas Analyzer 9. Specification Analyzer Specifications Internal PC: 1.6 GHz processor / 2 GB RAM / 8 GB flash storage Operating system: Windows® Embedded Standard 7 Display: 8 inch TFT-LCD, touch screen Printer: 2 inch thermal printer (built-in) Printer paper: thermal paper (width: 57 mm, diameter: 50 mm) Barcode scanner: visible red 630 nm LED laser (built-in) RFID reader: 13.56MHz ISO 15693 read/write (built-in) Port: USB (4 ports), Serial (RS-232), LAN (RJ45 Ethernet), VGA Power adapter: - AC-DC power supplies (IEC/EN 60950-1 approved) - Input: 100 ~ 240 V a.c., 1.5 A, 50/60 Hz - Output: + 24 V d.c., 2.7 A Input power: + 24 V d.c., 2.7 A Internal battery: 14.8 V d.c., 4.4 Ah (Lithium-ion cells: 4S2P) - Discharge time: maximum two hours Battery life: - 20% reduced capacity for charging/discharging for 300 times. - Replace when the capacity drops below 50% (discharging time is less than one hour). - The life and replacement cycle of the battery can vary depending on operating conditions. Storage temperature: -20 ~ 50°C Storage humidity: 0 ~ 90% (relative humidity) Size (HxWxD): 394 mm x 257 mm x 252 mm Weight: 5.5kg (without accessories) FCC Regulatory Domain : compiled with Part 15 of FCC Rules. Note: Operation is subject to the following two conditions; 1) this device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation. Operator’s Manual 9-2 9. Specification Cartridge Specifications Unit: 1 cartridge Uselife: maximum 2 weeks Shelf life: 6 months from manufactured date Storage temperature: 15 ~ 25°C Components: - Sensors - Sampler - Waste bag - Valve and tubing - Solution bag - Cal 1solution, approx. 500 g - Cal 2 solution, approx. 100 g - Reference solution, approx. 100 g Size (HxWxD): 148 mm x 182 mm x 100 mm Weight: 1.4 kg 9-3 i-Smart 300 Blood Gas Analyzer 9. Specification Measuring Principles pH and Gases Electrolytes Hematocrit Potentiometry (ion selective electrode) pH, pCO2 Electrochemical Amperometry Conductometry pO2 cNa+, cK+, cCa2+, cClHct The i-Smart 300 blood gas analyzer calibrates the sensors using Cal 1 and Cal 2 solutions according to the pre-determined two-point calibration schedule during the lifetime of the cartridge. In addition, the analyzer performs one-point calibrations using Cal 1 solution between two-point calibration intervals to correct the baseline drift of the sensors. Operator’s Manual 9-4 9. Specification This page is intentionally left blank. 9-5 i-Smart 300 Blood Gas Analyzer Appendices Appendix A: Sample Collection and Handling Caution Observe the general cautions required of the hospital, laboratory, or other testing facility. All biohazardous materials should be handled and disposed of in accordance with applicable rules and regulations. The blood and/or collecting tools, and used cartridges should be treated as biohazardous materials. Wear appropriate personal protective clothing (lab coat, gloves, goggles, etc.). And Be careful not to let the blood and/or collecting tools directly touch the mouth, eyes, mucus membranes, or any area with broken skin. Wash hands after collecting the sample or using the analyzer. Sample preparation Use whole blood to a blood gas test. To draw blood samples, use containers (syringe, capillary, blood collection tube) treated with heparin. We recommend using a dry-sprayed heparin tube or a solid heparin tube. We do not recommend using a tube treated with anticoagulants such as Citrate, EDTA, Oxalate, NaF, etc., except heparin, since the blood-sampling tube containing such anticoagulants besides heparin can drop the performance of the sensors and/or can influence the analysis result. Make sure there are no small air bubbles trapped in the collected sample. Small bubbles in the sample can affect the results. Samples containing clots and/or samples in which hemolysis is present or suspected must not be used. Use whole blood samples for blood gas analysis should be analyzed as soon as possible. If immediately analysis is not possible, the sealed blood container must be placed in a bath containing ice and water. Ice-water stored samples at 1 to 4°C may give reliable results for up to 30 minutes. Operator’s Manual 10-1 Appendices Appendix B: Order Information 1. i-Smart 300 Cartridge Available Test number & Uselife REF Order unit Product Description REF Order unit QC 623 Level 2 (blood gas/electrolyte) 6201 200 Tests / 2 weeks 2. Quality Control QC 623 Level 1 (blood gas/electrolyte) QC 623 Level 3 (blood gas/electrolyte) QC 623 Multi-Level (blood gas/electrolyte), QC 900 HIGH/LOW (hematocrit) 3. Accessories of analyzer Description Power adapter Power cord Printer papers 10-2 6510 6200 1 box (30 ampuls) 6202 1 box (30 ampuls) 1 box (30 ampuls) 6203 1 box (30 ampuls, 10 ampuls each levels) 1 box (20 ampules, 10 ampuls each levels) REF Order unit 3153 6204 3152 3331 1 pack (5 rolls) i-Smart 300 Blood Gas Analyzer Appendices Appendix C: Warranty The product warranty for the analyzer and its components excluding the cartridge is one year from the product purchase date on the VAT invoice. Product quality assurance applies only if the product has been properly handled and used under normal conditions and appropriately maintained according to the operator's manual. Responsibility for the charged service (charged on the customer). Failure caused by consumer error. When the product was broken by using components or optional items that are not specified by the manufacturer. When the product was broken by external shock or fall. When the user did not read and understand the precautions, the installation, and operation methods of the instrument in the operator's manual. When the analyzer was disassembled, modified, and/or repaired by a person who is not authorized by i-SENS, Inc. When the product was broken by using incorrect power capacity. When the product was broken by the operator's lack of attention or skill. When the product was broken by natural disaster (lighting, fire, flood damage, etc.). When the consumable parts reached the end of their life spans (battery, etc.). Please call a service engineer responsible for the product if you have any questions. Operator’s Manual 10-3
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