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koko spirometer manualRedefining Accuracy — Diagnostic Confidence KoKo PFT software blends very sophisticated features with a logical and friendly user interface. Populated with numerous predicted equation sets and a choice of three interpretive algorithms, users can be confident in their diagnostic decisions based upon spirometry results. Guided patient coaching with intelligent automatic target value adjustments for increased test performance in patients as young as 3 years old. Customizable Report Format. For content, predicted values, graphics format and size, automated interpretation and challenge protocols.Beyond Expectations. KoKo PFT Spirometer has long proven to be the spirometer of choice for accuracy and precision in clinical and academic research. KoKo’s performance and ease of use has made it the global standard for diagnostic spirometry testing in hospitals and physician offices worldwide.Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates. Operations Manual. Part Number G Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under the copyright laws. Caution: Federal law restricts this device to sale by or on the order of a physician. KoKo is a registered trademark of nspire Health, Inc. KoKo Moe is a trademark of nspire Health, Inc.The software described in this document is furnished under a license agreement. The software may be used or copied only in accordance with the terms of that agreement. It is against the law to copy the software on any medium except as specifically allowed in the license agreement. No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording, for any purpose without the express written permission of nspire Health, Inc. Printed and Bound in the United States of America. Copyright nspire Health, Inc.
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This symbol indicates that the user must read and understand all instructions and warnings prior to use. This symbol indicates this Class IIA equipment complies with the Medical Devices Directive of the European Union. This symbol indicates that the associated jack is for a Universal Serial Bus connection. Altitude Table 10 Troubleshooting Scenarios Table 11 Glossary Table 12 Messages ix 10 1 Quick Start This section provides a sequence of tasks to perform to get you started using your Legend as quickly as possible. If you need additional instructions, refer to the associated section of the manual. You have purchased a quality instrument that will give you many years of excellent service.The KoKo Legend spirometer is a desktop portable device capable of performing both pre- and post-bronchodilator forced and slow expiratory maneuvers and calculating the standard spirometric indices. Please take the time to: Inspect the contents of this package for completeness. Read the Essential Prescribing Information, especially the Precautions. Complete the enclosed warranty card. This manual is applicable to firmware version 2.5 and higher. To check your firmware version, refer to section Using the Manual This manual will provide detailed instructions on the use of the KoKo Legend spirometer and an overview of related topics. The user is encouraged to supplement this manual with additional reading in published literature. Appendix F - References of this manual provides a reference for some additional reading material. The user instructions in the following chapters assume the user is adequately familiar with the intended use and application of a spirometer Documentation Conventions The following format conventions are used in this document to identify special information: Warning statements identify conditions or practices that could result in personal injury. Caution statements identify conditions or practices that could result in damage to equipment or loss of data. Variable names are enclosed in angle brackets and presented in italicized text (e.g.: ). Notes: The screen illustrations and the displayed data in this document are for example purposes only. They may differ from the screens on your PC. Construction: High-impact Polycarbonate Dimensions: 23.5 x 25.4 x 7.0 cm; 9.25 x 10.0 x 2.75 inches Weight: 1.6 kg; 3.6 lbs C; 0 80 relative humidity non-condensing at temperatures to 31 C Use only supplied Class II Power adapter; Ordinary equipment (not protected against harmful ingress of moisture); Not suitable for use with flammable anesthetics; Suitable for continuous use. The flow sensor assembly is held by the patient, but it does not in any way interact with or influence the patient when used as specified. CAUTION: Always use the AC adapter that accompanied the system. CAUTION: Do not attempt to wash or immerse the KoKo Legend or accessories in water or cleaning fluid, as there are electronic components inside that will be permanently damaged. CAUTION: This device complies with the minimum electromagnetic compatibility requirements of the Medical Device Directive (MDD). However, electromagnetic interference may still be encountered. If the device is behaving erratically due to electromagnetic interference, contact our service department (refer to page iii for contact information) Maintaining Device Effectiveness The recommended operating conditions for the KoKo Legend spirometer are 10 to 40 C, 0 to 80 humidity non-condensing at temperatures to 31 C, decreasing linearly to 50 relative humidity at 40 C. The recommended transport and storage conditions are -20 C to 50 C; 0 to 95 noncondensing humidity; to 10,000 feet or mm Hg. The KoKo Legend spirometer housing may be wiped clean with a soft cloth dampened with soapy water. Refer to the section 7, Maintenance, for complete cleaning instructions.http://www.bouwdata.net/evenement/color-laserjet-cp1518ni-service-manual Your KoKo Legend Spirometer has been assembled with care and tested thoroughly to provide you with a quality instrument for many years of use. We ask that you provide the extra effort and care required to familiarize yourself with all of its features to assure proper and effective use. 5 15 3 Getting Started This section describes the components of your KoKo Legend spirometer. We strongly recommend that you read it before using your KoKo Legend - even if you are already familiar with spirometers. 3.1 Unpacking When you receive your KoKo Legend, unpack it carefully, and compare the parts you have received with the items listed below: Figure 1 KoKo Legend Parts Figure KoKo Legend 1 AC Adapter with AC Power Cord 6 Flow Sensor Assembly 2 KoKo Legend Desk Top Spirometer 7 Nose Clip 3 Printer Paper 8 Disposable Filter 4 KoKo Legend Operator s Guide 9 Optional Software Configurator 5 Handset Cable 10 USB Cable Once you have checked and confirmed that your KoKo Legend is complete, read through the following pages to learn all about your spirometer s capabilities. 3.2 Assembling Be sure to observe the safety precautions listed in section 2.2.4, Warnings and Precautions, of this manual Connecting the Flow Sensor Assembly The flow sensor assembly is connected to the desktop spirometer with the handset cable. 6 16 Figure 2 Handset Cable The small jack located on the right side of the KoKo Legend device is used to connect the flow sensor assembly. To connect the flow sensor assembly, follow these steps: 1. Align the connector on the handset cable with the port opening labeled: 2. Push the connector into the port until it is seated. 3. Plug the other end into the matching port on the bottom of the flow sensor assembly Connecting the AC Adapter Caution: Do not operate the KoKo Legend using any other power supply than the one provided with the system. The Legend is powered by an external AC adapter, which also functions as a charger for the internal NiMH rechargeable battery. Figure 3 External Power Supply Notes: Only authorized service personnel should replace the battery. Charge the battery for approximately four hours prior to initial use if using under battery power. It is acceptable to use the device immediately if it is plugged into AC power. 7 17 2 1 3 Figure 4 Parallel Printer Compatible KoKo Legend Rear View Figure KoKo Legend 1 Power port 2 USB port (optionally used to connect to a PC) 3 External printer port (parallel printer) Figure 5 USB Printer Compatible KoKo Legend Rear View Figure KoKo Legend 1 Power port 2 USB port (optionally used to connect to a PC) 3 Reset button 4 External printer port (USB printer) 1. Plug the round end of the power adapter cable into the matching round DC power input jack on the back panel of the KoKo Legend. The jack is labeled: 2. Plug the AC adapter into an AC electrical outlet Connecting to an External Printer (Optional) There are two Legend models, one has a parallel printer port and the other has a USB printer port. Refer to Figure 4 and Figure 5. The KoKo Legend has been designed to interface with HP printers supporting PCL 3 or later. 8 18 Note: Since many printers support this character set, the Legend device has not been validated with every model. It has been validated with the HP Connect the cable to the printer. 2. Connect the other end of the printer cable to the back panel of the Legend device. a. If you have a parallel printer compatible Legend device, plug the parallel printer cable into the parallel printer port on the back panel of the KoKo Legend device. The port is labeled: b. If you have a USB printer compatible Legend device, plug the USB printer cable into the USB printer port on the back panel of the KoKo Legend device. The port is labeled: 3. Connect the printer to a power supply. 4. Turn on the printer Opening and Closing the Internal Printer Cover To open the internal printer cover, perform the following: 1. Press the printer cover release button. The cover releases from the unit. Release Button Figure 6 Printer Cover Release Button 2. Remove the cover from the unit and set aside. 3. Perform the desired maintenance. 4. Replace the cover by positioning it on to the unit. Make sure the end of the paper supply passes through the slot in the cover. Slide the two tags on the cover into the slots on the unit. 5. Press the door down on the domed area until it engages Loading the Printer Paper To load the paper roll for the internal printer, perform the following: 1. Open the printer cover (refer to section ). 2. Remove the old paper roll. 9 19 3. Insert a new roll of paper in the well with the feed of the paper originating from underneath the paper roll and feeding towards the front of the unit. 4. Pull the paper through the serrated slot opening in the printer cover, attempting to keep it centered. Figure 7 Paper Feed 5. Replace the printer cover. Filters are designed for single use and should be replaced for each patient and before calibration. It is a friction fit and is pressed onto the flow sensor as shown below: 1 2 Figure 8 Filter Attached to the Flow Sensor Figure Legend 1 Disposable Filter 2 Flow Sensor 10 20 3.2.5 Battery Mode The KoKo Legend has an internal battery supply. It can operate without external power for up to two hours under continuous use. Note: When the unit is operated without external power, the of the screen.The unit will turn off after 10 minutes. To turn the unit back on, press the Power button (labeled: ) Low Battery Condition The battery voltage is monitored continuously and when the battery voltage is determined to be low, the unit starts to beep and the battery indicator ( ) starts flashing. When this condition exists, connect the unit to the external power supply Recharging the Battery To recharge the battery, connect the KoKo Legend to the external power supply. The very first time the KoKo Legend is turned on, a screen is displayed showing the flags of nations that reflect the languages supported in the device. 2. Select the appropriate flag based upon the language choice. This will automatically activate that language and open the Setup screen to adjust any other settings. Ordinarily, the Setup screen can be accessed during the start-up period by pressing the Setup button in the lower right corner. After the startup screen is displayed for a few seconds, the screen appears, containing any current data from the last patient tested. Figure 9 Main Testing Screen 4.2 Calibrating the Spirometer Please refer to section 7.1.2, Calibration, for instructions in calibrating your KoKo Legend spirometer. It is important to calibrate each day you plan on performing spirometry tests with the device. Time format: Select either 12 hr or 24 hr (relates to your entry in the Time field above). Pressure units: Select either kpa or mmhg. Ethnic group: This function allows the entry of new ethnic groups for the patient data entry field called ETHNICITY. It also allows the entry of a specific ethnic correction value 14 24 to be associated with any chosen ethnic group. Available languages include: English, Spanish, French, Portuguese, German, Italian, Dutch, Danish, Norwegian, Swedish, and Finnish. This should be selected if a calibration cannot be successfully completed, or when technical support advises you to select it. There are testing options for the and the SVC test. These options should be verified for each test series. Note: Since the SVC options are a subset of the options, this document uses the screens to illustrate the options. Time: If selected, tests must be longer than six seconds in length to be considered acceptable as long as no other error conditions exist. If not selected, tests less than six seconds are considered acceptable as long as no other error conditions exist. Caution: When testing children or healthy adults, typically their test length will be less than six seconds. If this Quality Check is selected, most efforts on these subjects will fail. If you are testing subjects that meet these criteria, do not select this option. Protocol: Tidal Phase: If selected, at least one tidal breath is required at the start of a test. If not selected, the test will be conducted without requiring the patient to perform tidal breathing prior to maximal exhalation. The raw data graph is displayed. Patient position: Select the appropriate checkbox based on the patient s position during testing. Physn: Enables you to enter a comment (applies to this test series only) documenting the Physician s name (or initials). Tech: Enables you to enter a comment (applies to this test series only) documenting the Technician s name (or initials). Test series comment: Allows entry of a free form entry comment about this specific test. This entry is limited to 35 characters. The following screen is displayed: Note: The Best effort and Retain efforts fields are not displayed until after some patient testing is performed. When this option is selected, the horizontal (time) scale adjusts accordingly to accommodate the longest time maneuver. The goal of this incentive graphic is to blow out all the candles, indicating 100 of the predicted value. The degree of success is shown by the position of the sailboat on the screen. The goal of this incentive graphic is to blow the sailboat off the screen. When the sailboat is off the screen, 100 of the predicted values have been meet. Best effort: Automatic: Allows the KoKo Legend software to use standard ATS and ERS criteria for the automatic choice of best test in the test series. Up to eight different efforts can be retained in memory and long-term storage on the compact Flash RAM card. A major source of variability is the patient. To minimize patient inconsistency it is important to develop a standardized approach used with each patient. Teaching the patient how to perform a spirometry test properly is critical for achieving meaningful results. Spirometry is a patient effort dependent test, so proper coaching of the subject is very important. The coach should fully explain the test to the patient. First explain that the purpose of the test is to measure the function and health of his or her lungs. Remind the patient that the test is painless. Simulate the correct maneuver using a spare filter reserved for that purpose. The instructions should be as follows: 20 30 1. We re going to be doing a test to check your lung function. We will be repeating this test a few times to get what we need. 2. First I am going to have you breathe normally using the mouthpiece. (Show the patient the mouthpiece.) 3. At one point I will have you take a quick DEEP breath in and then BLAST it out hard and fast. 4. When I tell you to take a DEEP breath I want you to take as much air into your lungs as you can. 5. When I tell you to BLAST it out I want you to blow out as hard and fast as you can, and keep blowing until you cannot get any more air out. 6. Once you are sure that you are completely empty, take another great big breath in. Then you can take the mouthpiece out and breathe normally. Actually blow through a spare filter yourself, using body language to emphasize the importance of a maximal inhalation, maximal force and prolonged effort. Immediately after your demonstration, ask the patient if he or she noticed how you squeezed the last little bit of air out of your lungs. It is advisable to have the patient stand while performing spirometry, however, keep a chair immediately behind the patient in case they feel lightheaded. Loosen any restrictive clothing such as a tight belt, tie, vest, bra, girdle, or corset. It is recommended to remove loose dentures that can become dislodged during the test. Nose clips are not necessary for forced expiratory maneuvers since the nasopharynx reflexively closes during the maneuver Pre-Test Checklist Position: patient is standing unless otherwise indicated for health or disability reasons. Clothing: ideally patient should be dressed comfortably to allow good chest, and diaphragmatic excursion. Loosen the patient s belt or tie (or other clothing and accessories) if necessary. Remove dentures or other possible obstructions to the mouthpiece. Thoroughly explain the procedure to the patient. Demonstrate the procedure to the patient, remembering to be very thorough. Have the patient demonstrate the procedure for you. Complete all patient data fields. 21 31 Figure 19 Entering a New Patient 2. Pressing on any alphanumeric field in the Patient information screen displays the Keypad screen. Figure 20 Keypad 3. Complete the required fields: Last Name, First Name, ID, DOB (Date of Birth), Sex, Height, and Ethnicity. 4. If you choose to, you can set the selected Ethnic group and Predicted set as defaults by selecting the Set as default checkbox next to each selection. The following screen is displayed. 22 32 Figure 21 Select Patient Screen To search for a patient, you can specify the first letter of the last name or the first number of the patient ID. 1. To search for a patient, perform one of the following: a. To search for a patient by last name, select the checkbox next to Last name starts with and then use the up and down arrows to specify the first letter. Note: To search for all patients, select all (all) from the list. b. To search for a patient by ID, select the checkbox next to ID starts with and then use the up and down arrows to specify the first number. 2. Select Search. The patients meeting the search parameters are displayed. If you have more patients displayed than fit on the screen, use the UP and DOWN arrows to scroll to the desired patient test series. You can sort the list by any of the columns by pressing the button at the top of each column. See the following example. This patient would be a returning for another visit and have previously recorded test series. Refer to Appendix B - Glossary for explanation of each value measured by the KoKo Legend. The object of the test is to measure the volume and flow of air from a patient after they have taken the largest and most forceful exhalation (expiration) they are capable of. To ensure good effort, and to gain insight into the flow and volume during the inspiration, have the patient take another deep breath in after performing the maximum expiration. It is very important to perform more than one effort to ensure that the patient actually has done his or her best. The ATS standard also recommends discontinuing testing after eight efforts if the usability, acceptability, reproducibility, and quality criteria still have not been met Performing the Test 1. Enter or recall a patient. Follow the on-screen prompts to perform the maneuver. In some cases, a prompt will appear to first wait until the flow sensor has zeroed. This will be indicated by a red message box. Then start relaxed tidal breathing through the filter mouthpiece. Then, the patient should blow out as hard and fast as possible, and continue blowing until no more air can be exhaled. Then, the patient should take another deep breath back in. When finished, the effort is complete. If an effort is completed which does not meet the acceptability criteria a message will be displayed to assist in understanding what went wrong (see Table 5 for an explanation of the Messages Related to a Patient s Effort). Note: If Tidal Phase is not selected in the Options screens, the first two screens in the following example will not be displayed. 25 35 Figure 23 Test Screens 6.2 SVC Test The SVC (Slow Vital Capacity) is the maximum amount of air expired from the point of maximum inspiration without attention to speed. However, a maximal effort is still required through the endexpiration. The primary diagnostic value of the SVC test is a relative measure of the effort dependence of the value. Some patients can produce a higher vital capacity when the maximal expiration is done slowly (SVC) versus quickly and forcefully (). When this is true, there is usually an indication of air trapping in the lung. The SVC test can also help uncover a poor effort 26 36 on the test due to a misunderstanding of the test procedure. The SVC test also presents a breakdown of some of the standard classifications of lung volume (IRV, ERV, IC, TV) Objective of the SVC Test The object of the SVC test is to have the patient establish a steady tidal breathing rate for at least six breath cycles. The patient then fills his or her lungs maximally as in the test, but then lets the air out slowly instead of forcefully. The patient should still continue the expiration until no more air can be exhaled. Refer to Appendix B - Glossary for an explanation of each value measured by the KoKo Legend Performing the SVC Test 1. Explain the procedure to the patient. 2. Enter or recall a patient. The SVC Test screen is displayed. If the Effort less than 1 second, try again message is displayed, it means that the patient did not exceed 1 second of expiration for the effort. The predicted value (Pred), results for the Best Effort (Bst), and the percent of predicted (Prd) are displayed. Results from the 2nd and 3rd best efforts are also shown on this screen. The overall test grade and a countdown of acceptable and reproducible efforts are shown. The standard list of SVC parameters shown on this first screen of test results are SVC, IC, ERV, Vt, and RR. Pressing the DOWN arrow displays the results for effort number 4 through 8 Pressing the DOWN arrow again displays the quality cautions (usability, acceptability, and reproducibility codes) for efforts 2 and 3 (see Table 3, Table 4, Table 5, and Table 6). Expiratory time was too short ( 0.030L in the last second of expiration). If several efforts were performed and the peak flow variability is too high, it indicates that the effort was insufficient. If several efforts were performed and the FEV6 variability is too high, it indicates that the patient is taking inconsistent deep breaths before each effort. Initial prompt at start of expiration. 50 of goal volume has been reached. Texp OK means that the time goal of 6 seconds has been met. End of expiration detected. It is advisable to report the to the patient as a percentage of predicted. This is the number the patient should remember. Up to eight efforts will be allowed. 6.5 Performing Post-BD Tests After selecting the same patient or an existing patient, you are now ready to perform the Post-BD test. It is possible to test new patients while the previous patient is being administered the bronchodilator. Simply enter and test a new patient, then re-select the ID number of the patient currently waiting for the bronchodilator to take effect Object of the Test This spirometry test is also commonly called the Post-BD or Post-BD Forced Vital Capacity test (often referred to as Post-BD). Some clinicians refer to this as Bronchospasm evaluation. Refer to Appendix B - Glossary for an explanation of each value measured by the KoKo Legend. The object and procedure of this test is identical to the Pre-BD tests, except the final results are compared numerically to the pre-bd test and a percentage change is calculated. The Print Test Series screen is displayed. Lung Age is calculated using the predicted parameter from the predicted equation set currently selected for the patient. If Lung Age is less than or equal to the actual patient age, Lung Age is reported as the patient's actual age. To remove this parameter from a report, refer to section 45 7 Maintenance Minimal maintenance is required for the KoKo Legend. Daily calibration and minor cleaning is recommended. Refer to sections 7.1.2, Calibration, and 7.2, Cleaning. Additionally, replacing parts and accessories is required when needed Replacement Parts and Accessories To maintain your system, some parts and accessories may need to be replaced. Please refer to the following tables for details. It is most convenient to perform this calibration check first thing in the morning. The KoKo Legend software will warn the user if this calibration check has not been completed in the last 24 hours. The following calibration techniques are available to calibrate the flow sensor: One-Effort Calibration (refer to section ) Multiple Effort Calibration (refer to section ) A 1-liter or 3-liter syringe is required for all calibration techniques. Before performing a calibration, verify the following have been performed: Selected the desired calibration technique in the Setup screens (see Figure 13). Entered the current temperature, barometric pressures, and relative humidity in the Options screens (see Figure 18). Cautions: It is critical that the station barometric pressure be entered, not an altitude correct barometric pressure. If calibration is not successfully completed, the previous calibration factors will be used and they may not accurately represent the current conditions One-Effort Calibration Note: You will have to perform two efforts to complete the calibration if it is the first time you are calibrating the device, if the previous calibration factor has been cleared (using the Clear current option), or if the device is out of the acceptable calibration range. The calibration parameters screen is displayed. Figure 31 Calibration Parameters 2. Review the displayed temperature, barometric pressure, and relative humidity; modify if needed. Connect the flow sensor assembly to the calibration syringe using the filter as a coupler. Note: The filter needs to be attached to the flow sensor assembly to perform a calibration. a. Push the syringe handle all the way in and back out (following the flow guide displayed on the screen) and follow the prompts on the screen. Calibration is successful, when the following screen is displayed: Figure 33 Calibration Successful b. If the calibration check is not successful, the following screen is displayed and you must perform another attempt. The calibration parameters screen is displayed (see Figure 31). 2. Review the displayed temperature, barometric pressure, and relative humidity; modify if needed. The start calibration screen is displayed. Pull out the syringe handle. Note: The filter needs to be attached to the flow sensor assembly to perform a calibration. 4. Push the syringe handle all the way in and back out (following the flow guide displayed on the screen) and follow the prompts on the screen. You can perform one, two, or three calibration efforts, stopping the calibration procedure at any time to print the results Barometric Pressure Weather centers report an altitude corrected barometric pressure, which will be close to 760 mmhg no matter the altitude. For example, the station barometric pressure in Denver, Colorado, is typically 630 mmhg, but the weather news reports 760 mmhg. You need to enter the 630 mmhg value into the device. Table 9 shows an estimated barometric versus altitude. Table 9 Estimated Barometric Pressure vs. Altitude (Smithsonian 1963, Irbarne 1973) Feet The above values are estimates only. Other sources of information on cleaning are the American Association of Respiratory Care AARC 1 and ATS 2 clinical practice guidelines Cleaning the Main Unit Use a non-abrasive mild cleanser with very little moisture on a soft cloth to clean the outside of the KoKo Legend. Do not disassemble the device for any cleaning. CAUTION: Do not attempt to wash or submerge the KoKo Legend in water or cleaning fluid.