Summary of Contents for FMS ZipThaw 202
- Page 1 ° ™ ZipThaw 20 2 System User Manual CLEARED Fremon Scientific, Inc. 5726 La Jolla Blvd., Suite 304, La Jolla, CA 92037USA Doc No:. 447000-UM-01-01 Page 1 of 49...
- Page 2 ZIPThaw™ 202 System User Manual Copyright © FreMon Scientific, Inc. Revision 09 Revision date Jan, 2022 Fremon Scientific, Inc. 5726 La Jolla Blvd., Suite # 304 La Jolla, CA 92037 Approved By Signature Date Farideh Bischoff PhD, Chief Executive Officer 1/14/2022 1/14/2022 Moni Shavit, Chief Technical Officer...
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Page 3: Table Of Contents
ZIPThaw™ 202 System User Manual TABLE OF CONTENTS 1 TABLE OF CONTENTS 2 TABLE OF FIGURES 5 3 INTRODUCTION Indications for Use............................6 .................................6 MPORTANT 3.3 Terms & Abbreviations.............................7 4 DEVICE DESCRIPTION 8 4.1 ZipThaw System Modules……………………………………………………………………...………………………..…………….…8 4.1.1 Thawing Chamber Module TCM)…………………………………………………………….………....………..8 4.1.2 System Management Processor (SMP)………..……………….…………………………………….…..…………..…8 4.1.3... - Page 4 ZIPThaw™ 202 System User Manual 7.5.3 Selecting Temperature Unit......................18 7.5.4 Entering Site Name………………………………………………………………………………………………………………….…..18 7.5.5 Setting the Date & Time………………………………………………………………………………………………………….…..19 7.5.6 Enabling Audio..........................19 7.5.7 Adding New User…………………………………………………………………………………………………………………………19 7.5.8 Editing User............................20 Configuring Warming Cushion Replacement Frequency………..…………………………………………………………………..21 Getting Started...............................22 Insert Thawing Data............................22 7.8.1 BarCode Data Entry..........................22 7.8.2 Manual Data Entry..........................23 7.8.3 By-passing All Data Entry for Faster Throughput………………………………………………………………….……….23 7.9 STARTING A THAWING CYCLE .........................
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Page 5: Table Of Figures
ZIPThaw™ 202 System User Manual 2 TABLE OF FIGURES FIGURE 1. ZIPThaw 202 front view ...................... 9 FIGURE 2. ZIPThaw 202 rear view ......................9 FIGURE 3. ZipSleeve View ........................10 FIGURE 4. ZIPThaw 202 Label ......................11 FIGURE 5. COMPLIANCE WITH 47 C.F.R. -
Page 6: Introduction
These instructions are intended for use by medical professionals in hospitals. INDICATIONS FOR USE The FMS ZipThaw™ 202 is a thawing device intended for the following applications: • thawing of Fresh Frozen Plasma (FFP) • thawing of Plasma Frozen within 24 Hours after Phlebotomy (PF24) WARNING The device cannot be used to warm previously thawed Cryoprecipitate AHF, Platelets or Granulocytes. -
Page 7: Terms & Abbreviations
ZIPThaw™ 202 System User Manual TERMS & ABBREVIATIONS Temp Temperature Direct current Control Rate Thawing Watt Graphical User Interface Volt Electronic Information Systems Ampere Min. Minute(s) Human Machine Interface Front End Controller Chamber Where the product bag is processed Alternating Current System on a Module computer Chamber Module Controller Thawing Chamber Module... -
Page 8: Device Description
ZIPThaw™ 202 System User Manual 4 DEVICE DESCRIPTION The ZipThaw 202 System platform has an advanced modular architecture that allows for configuration flexibility. ZIPTHAW SYSTEM MODULES The ZipThaw is built with universal-basic modules: 4.1.1 THAWING CHAMBER MODULE (TCM) This is a universal module that utilizes a closed warming chamber, agitation mechanism and temperature monitoring. -
Page 9: Zip Thaw 202 Tm Front View
ZIPThaw™ 202 System User Manual ZIPTHAW 202 FRONT VIEW FIGURE 1. ZIPThaw 202 front view ZIPTHAW 202 REAR VIEW ™ ZipThaw 20 2 System User Manual FIGURE 2. ZIPThaw 202 rear view Fremon Scientific, Inc. 5726 La Jolla Blvd., Suite 304, La Jolla, CA 92037USA... -
Page 10: Zipsleeve Tm
ZIPThaw™ 202 System User Manual ZIPSLEEVE FIGURE 3. ZipSleeve View HOW DOES IT WORK? The plasma frozen bag is placed inside a ZipSleeve , a smart overwrap, bag and inserted into the Thawing Chamber Module (TCM). ™ ZipThaw 20 2 System During the thawing process, the plasma bag is thawed by the Chamber’s heating cushions. -
Page 11: Labeling And Symbols
ZIPThaw™ 202 System User Manual LABELING AND SYMBOLS 4.7.1 REAR PANEL FIGURE 4. ZIPThaw 202 Label 4.7.2 SYMBOLS USED IN THIS USER MANUAL: Symbol Description CE MARK ATTENTION, CONSULT ACCOMPANYING DOCUMENTS. WASTE OF ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE) COMPLIANCE SYMBOL ™... -
Page 12: Compliance With Fcc, 47 C.f.r. Part 18
ZIPThaw™ 202 System User Manual Symbol Description FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED PROFESSIONAL HIGH TEMPERATURE WARNING UL MARK COMPLIANCE WITH FCC, 47 C.F.R. PART 18 FIGURE 5. COMPLIANCE WITH 47 C.F.R. PART 18 5 CONTRAINDICATIONS ™... -
Page 13: Operation
ZIPThaw™ 202 System User Manual • To ensure complete isolation of the device from the power main source, the cord’s mains plug must be removed from the power mains socket. • With the exception of changing the Heating Cushions, do not attempt to repair the device by yourself. Repairs and modifications may only be carried out by Fremon Scientific or authorized customer personnel. -
Page 14: Power Up Failure
Switch off the Main power on the back of the device and unplug the Power Cord for 5 minutes. Restart device. If problem persists contact your FMS distributor, or contact us at info@fremonscientific.com and check our web site https://fremonscientific.com... -
Page 15: System Reset Recovery
ZIPThaw™ 202 System User Manual The following error message will appear: FIGURE 9. CHAMBER ERROR POP-UP SCREEN Pressing “OK” will make the error message disappear and the following screen will be displayed where the faulty Chamber will be disabled and will have a grayed-out graphic appearance. FIGURE 10. -
Page 16: Main Screen Description
ZIPThaw™ 202 System User Manual FIGURE 11. HOME SCREEN MAIN SCREEN DESCRIPTION ™ ZipThaw 20 2 System FIGURE 12. Home Screen User Manual Work Area A+B - the user main area FreMon logo+ site name interaction. Export Data. Main Action Buttons. Settings. -
Page 17: Keys Descriptions
ZIPThaw™ 202 System User Manual To enter the Technical Screens, press the “Settings” icon and enter the number “2” as the pass code. These screens will be helpful to troubleshoot and to configure the warming cushion replacement settings (see section 7.6 below). FIGURE 13. -
Page 18: Selecting Language
ZIPThaw™ 202 System User Manual 7.5.2 SELECTING LANGUAGE Upon touching the displayed flag button a drop down menu opens with images of additional flags allowing the user to choose the language represented by the flag. Figure 15. Selecting a Language Upon touching the chosen flag the drop-down menu will close, the language will change, and the chosen flag will be displayed. -
Page 19: Setting The Date & Time
ZIPThaw™ 202 System User Manual Figure 17. Entering Site Name Note: This field is limited to 25 characters. 7.5.5 SETTING THE DATE & TIME To set the date, touch the Date field. A dropdown menu will open. Select the desired date format (i.e., DD/MM/YY or MM/DD/YY), and then, use the displayed keyboard to type the current date. -
Page 20: Editing User
ZIPThaw™ 202 System User Manual FIGURE 20. Adding New User Screen When pressing the ID/barcode icons the built-in barcode reader is enabled (i.e., you will see the barcode reader’s red beam light up) and the user can either scan the ID or type it using the displayed keyboard. To confirm new user press - the new name and ID will be added to the list. -
Page 21: Configuring Warming Cushion Replacement Frequency
ZIPThaw™ 202 System User Manual CONFIGURING WARMING CUSHION REPLACEMENT FREQUENCY Figure 22. Warming Cushion Replacement Screen This screen configures warming cushion replacement maintenance reminder schedule. This is user configurable based upon anticipated ZipThaw202 usage level. It is the preference of the manufacturer that the cushions be proactively replaced at least 1x per year. -
Page 22: Getting Started
ZIPThaw™ 202 System User Manual GETTING STARTED From the home screen select a Chamber, A or B, by touching the screen area, as shown below. FIGURE 24. Select Chamber from Home Screen Selecting a Chamber will open the “Insert Data Screen”. 7.8 INSERT THAWING DATA Data can be entered: ►... -
Page 23: Manual Data Entry
ZIPThaw™ 202 System User Manual 7.8.2 MANUAL DATA ENTRY To enter data manually, Touch the relevant field: The following screen will appear: FIGURE 26. Manual Data Entry Screen ► Touching the fields opens keyboard. Pressing “OK” inserts data, closes the keyboard and moves to the next field. ►... -
Page 24: Starting A Thawing Cycle
ZIPThaw™ 202 System User Manual If no data entry errors occur, or if you elected to continue without entering data, and if the “OK” button was pressed, the system will default to the home screen as shown below: FIGURE 28. Home Screen after Data Entry (Chamber A) Procede to loading frozen plasma unit into the ZipSleeve. -
Page 25: Loading The Zipsleeve Into The Chamber
ZIPThaw™ 202 System User Manual FIGURE 29. ZipSleeve Orientation. 7.9.2 LOADING THE ZIPSLEEVE INTO THE CHAMBER 1. Open the Chamber door and place the loaded ZipSleeve inside the Chamber. 2. Align the 3 slots at the top of the ZipSleeve with the 3 hangers inside the Chamber. Note: Please note that the ZipSleeve can be loaded only in the orientation indicated by the slots in the hard plastic strip at the top of the ZipSleeve... - Page 26 ZIPThaw™ 202 System User Manual 3. Close the Chamber door. Upon Chamber door closing, the ZipThaw system will verify that a valid ZipSleeve is placed inside the device (i.e. number of uses is less than or equal to 8) before the “START” key is enabled. If the ZipSleeve was used 8 times the system will display the following screen: ZipSleeve Reached Max.
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Page 27: Selecting "Melt" Or "Thaw" Option
ZIPThaw™ 202 System User Manual 7.9.3 SELECTING “MELT” OR “THAW” OPTIONS Select either the abbreviated “Melt” cycle which stops the process for an Ice Free liquid or “slushy consistency” product at a product temperature of no more than 15˚C, or select “Thaw” with a stopping point of 31˚C for a totally thawed product at a transfusable temperature between 30 and 37˚C. -
Page 28: Running Thawing Using The Second Chamber B
ZIPThaw™ 202 System User Manual FIGURE 34. Thawing Cycle Intentional Stop Prompt To confirm thawing cycle stop press “OK” or to continue the thawing cycle press “Cancel”. 7.9.6 RUNNING THAWING USING THE SECOND CHAMBER B The ZipThaw system enables thawing in both Chambers simultaneously but independent of each other. Simply tap on the Chamber B icon, the screen will be updated: ™... -
Page 29: End Of Thawing Cycle
ZIPThaw™ 202 System User Manual 7.10 END OF THAWING CYCLE Upon thawing cycle completion of Chamber A, the following screen will be displayed: ˚ FIGURE 36. Thawing Cycle Chamber A Complete & Chamber B Loaded and Running Open the Chamber door and remove the ZipSleeve from the Chamber and than take out the thawed plasma bag. - Page 30 ZIPThaw™ 202 System User Manual Press “OK” and open the chamber door and remove the ZipSleeve from the chamber and than take out the thawed plasma bag. Always be sure to immediately close the Chamber door! 8 EXPORTING DATA At the end of a thawing session or before starting a thawing session, logged data can be exported onto USB media. Press the “Export Data”...
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Page 31: Exporting Data Structure
ZIPThaw™ 202 System User Manual When finished exit the screen by pressing “EXIT”. The device exports a copy of all records stored on the device (2000 records possible). The user is not able to sort the records stored on the device. The ZIPThaw keeps the most recent 2000 thawing session records. -
Page 32: Turn-Off Mode
ZIPThaw™ 202 System User Manual FIGURE 41: Device power down Prompt Screen ► Press “CANCEL” to cancel and return to the previous screen. ► Press “YES” to confirm standby mode. The system will enter a standby mode. Pressing the standby mode button will wake the system and a power up process will be initiated as described above (see Section 7.3). -
Page 33: Users Messages
OR when pressing “OK”. 1. Switch off the Main “System Error, power on the back of Error Messages: Error A System Error Pop- FMS Technical the device. found during system Up message. Support 2. Unplug the Power BIT Testing. Operational Halt. - Page 34 ZIPThaw™ 202 System User Manual “Data is System Prompt: Pressing “OK” will close Incorrect or When entering wrong A System Pop-Up the popup. Missing, Please barcodes OR not filling message. Follow IFU. Recheck Data” the mandatory fields. “Place Plasma System Prompt: Bag in Chamber A System Prompt Operational...
- Page 35 ZIPThaw™ 202 System User Manual 1. A System Pop- Up a message. “Chamber A 2. The system 1. Pressing “OK” will Error Message: Failure, disables close the popup Indicating that upon Technical Chamber A, message. thawing cycle Support after 3 test 2.
- Page 36 ZIPThaw™ 202 System User Manual 1. A System Pop-Up 1. Pressing “OK” will Error Message: “Chamber B a message. close the popup Indicating that Door Opened, 2. The system message. Chamber Door B was Thawing Cycle terminates 2. Chamber B GUI will left open for more Stopped!”...
- Page 37 ZIPThaw™ 202 System User Manual “Scan/Enter Your System Prompt: when ID, then Insert entering the Export None. USB and Export” Data screen. Error Message: 1. Pressing “OK” will "Incorrect ID, A System Pop-Up a Indicating that an close the popup. Re-Enter ID"...
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Page 38: Cleaning
ZIPThaw™ 202 System User Manual 11 CLEANING 11.1 CLEANING FREQUENCY Cleaning should be done Daily and As-needed, if there is visible soiling of the surfaces or if the Spill Tray is seen to have any fluid in them. 11.2 EXTERNAL SURFACE CLEANING AND DISINFECTING The ZipSleeve should contain any plasma bag leak, if the frozen unit was cracked during storage and leaked during the thawing process. -
Page 39: Specifications
14 SPECIFICATIONS Thawing Technology: Electrical power, disposable pocket Typical Thawed Bag Capacity: Single or Dual Bags Cushions Heating Temperature: Idel (Standby): 36.5°C±0.5°C Thawing: 36.5°C±0.5°C ZipSleeve Sensors Cutoff Temperature: 31.0°C±0.5°C (THAW) ≤15.0°C±0.5°C (MELT) Average Thawing Time (Minutes), 100ml - ≤ 10 single or dual Bag 250ml - ≤... -
Page 40: Protection Against Harmful Interference
ZIPThaw™ 202 System User Manual 15 PROTECTION AGAINST HARMFUL INTERFERENCE 15.1 EMC SAFETY ➢ The device has been tested and found to comply with the limits for the medical devices to the IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical clinical installation. - Page 41 ZIPThaw™ 202 System User Manual IEC 61000-3-3 Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the ZIPThaw 202 or shielding the location.
- Page 42 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m. Recommended separation distances between portable and mobile RF communications equipment and the ZipThaw 202 Fremon Scientific, Inc. 5726 La Jolla Blvd., Suite 304, La Jolla, CA 92037USA...
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Page 43: Fremon Scientific, Inc. 5726 La Jolla Blvd., Suite 304, La Jolla, Ca 92037Usa
ZIPThaw™ 202 System User Manual The ZIPThaw 202 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ZIPThaw 202 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ZIPThaw 202 as recommended below, according to the maximum output power of the communications equipment.
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