FMS ZipThaw 202 User manual

Fremon Scientific, Inc. 5726 La Jolla Blvd., Suite 304, La Jolla, CA 92037USA Doc No:. 447000-UM-01-01
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Copyright © FreMon Scientific, Inc.
Revision 09
Revision date Jan, 2022
Fremon Scientific, Inc.
5726 La Jolla Blvd., Suite # 304
La Jolla, CA 92037
USA
Approved By
Signature
Date
Farideh Bischoff PhD, Chief Executive Officer
Moni Shavit, Chief Technical Officer
William Davey, VP Product Management &
Design
01/12/2022
1/14/2022
1/14/2022

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TABLE OF CONTENTS
1 TABLE OF CONTENTS 3
2 TABLE OF FIGURES 5
3 INTRODUCTION 6
3.1 Indications for Use...........................................................................................................................................6
3.2 IMPORTANT.........................................................................................................................................................6
3.3 Terms & Abbreviations.....................................................................................................................................7
4 DEVICE DESCRIPTION 8
4.1 ZipThawTM System Modules……………………………………………………………………...........………………………..…………….…8
4.1.1 Thawing Chamber Module TCM)…………………………………………………………….……….................………....8
4.1.2 System Management Processor (SMP)………..……………….…………………………………….…..………….......…8
4.1.3 Chamber Module Controller (CMC)…………….……………..…………………………................……….……...……8
4.1.4 ZipSleeveTM………………….…………………………………….……….…………………………………….…………..……….....8
4.1.5 Power Supply……………………………………………………………………….………………………….…..........…………....8
4.2 ZIPTHAW202TM FRONT VIEW ................................................................................................................................9
4.3 ZipThaw202TM Rear View..................................................................................................................................9
4.4 ZipSleeveTM.....................................................................................................................................................10
4.5 How does it work?..........................................................................................................................................10
4.6 Default Temperature Setting..........................................................................................................................10
4.7 Labeling and Symbols.....................................................................................................................................11
4.7.1 Rear Panel........................................................................................................................................11
4.7.2 Symbols used in this User Manual...................................................................................................11
4.8 Compliance with FCC, 47 C.F.R. Part 18.........................................................................................................12
5 CONTRAINDICATIONS 12
6 SAFETY ADVICE 12
7 OPERATION 13
7.1 Device placement and power connection ………………………………………………………………………………..……………....13
7.2 Doors Status ....................................................................................................................................................13
7.3 Power Up.........................................................................................................................................................13
7.3.1 Power Up Failure.............................................................................................................................14
7.3.2 BIT failure ........................................................................................................................................14
7.3.3 System reset recovery.....................................................................................................................15
7.3.4 Successful Power Up........................................................................................................................15
7.4 Main Screen Description ................................................................................................................................16
7.5 Settings...........................................................................................................................................................16
7.5.1 Keys Descriptions..............................................................................................................................17
7.5.2 Selecting langUAGE............................................................................................................................18

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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
7.6 Configuring Warming Cushion Replacement Frequency………..…………………………………………………………………..21
7.7Getting Started...............................................................................................................................................22
7.8Insert 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
7.9STARTING A THAWING CYCLE .........................................................................................................................24
7.9.1 Loading Frozen Plasma Bag Into a ZipSleeve...................................................................................24
7.9.2 Loading the ZipSleeve Into the Chamber..........................................................................................25
7.9.3 Selecting “MELT” or “THAW” Option...............................................................................................27
7.9.4 Starting……………………………………………………………………………………………………………………………..…………27
7.9.5 Intentional Thawing Stop…………………………………………………………………..………………………..……………...27
7.9.6 Running Thawing Using the Second Chamber B…………………………………………………………………………..28
7.10 End of Thawing Cycle……………………………………………………………………………………………………….……………..………29
7.11 Timeout Thawing Cycle…………………………..…………………………………………………………………………………………..….29
8 EXPORTING DATA 31
8.1 Exporting Data Structure.................................................................................................................................31
9 POWERING DOWN 31
9.1 Standby Mode.................................................................................................................................................31
9.2 Turn-off Mode.................................................................................................................................................32
10 USERS MESSAGES 33
11 CLEANING 38
11.1 Cleaning Frequency.......................................................................................................................................38
11.2 External Cleaning and Disinfecting…………………………………………………………..…………………………………………..…..38
11.3 Display Cleaning............................................................................................................................................38
11.4 Emptying the Spill Tray.................................................................................................................................38
12 WARRANTY 38
13 CUSTOMER SERVICE 38
14 SPECIFICATIONS 39
15 PROTECTION AGAINST HARMFUL INTERFERENCE 40
15.1 EMC Safety....................................................................................................................................................................40

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2 TABLE OF FIGURES
FIGURE 1. ZIPThawTM 202 front view ......................................................................................................9
FIGURE 2. ZIPThawTM 202 rear view........................................................................................................9
FIGURE 3. ZipSleeveTM View..................................................................................................................10
FIGURE 4. ZIPThawTM 202 Label ............................................................................................................11
FIGURE 5. COMPLIANCE WITH 47 C.F.R. PART 18..................................................................................12
FIGURE 6. Door Open with Pop-up Screen ............................................................................................13
FIGURE 7. ZIPThawTM 202 power-up Screen..........................................................................................14
FIGURE 8. System Error Pop-up Screen .................................................................................................14
FIGURE 9. Chamber Error Pop-up Screen ..............................................................................................15
FIGURE 10. Home Screen with Chamber Error........................................................................................15
FIGURE 11. Home Screen........................................................................................................................16
FIGURE 12. Home Screen........................................................................................................................16
FIGURE 13. Login to the Settings Screen .................................................................................................17
FIGURE 14. Settings Screen.....................................................................................................................17
FIGURE 15. Selecting a Language............................................................................................................18
FIGURE 16. Temperature Units...............................................................................................................18
FIGURE 17. Enter a Site Name………………………………………………………………………………………………………………19
FIGURE 18. Setting Date and Time..........................................................................................................19
FIGURE 19. Enabling Audio .....................................................................................................................19
FIGURE 20. Adding a New User Screen ...................................................................................................20
FIGURE 21. Adding a New User...............................................................................................................20
FIGURE 22. Warming Cushion Replacement Screen................................................................................21
FIGURE 23. Cushion Replacement Reminder Screen...............................................................................21
FIGURE 24. Select Chamber from Home Screen......................................................................................22
FIGURE 25. Barcode, Insert Data Screen .................................................................................................22
FIGURE 26. Manual Entry Data Screen....................................................................................................23
FIGURE 27. Mandatory Fields Data Entry Error and Bipassing Data Entry……………………………………………..23
FIGURE 28. Home Screen After Data Entry (Chamber A)……………………………………………………………………….24
FIGURE 29. ZipSleeve Orientation...........................................................................................................25
FIGURE 30. Device Door Open………………………………………………………………………………………………………………25
FIGURE 31. Replace ZipSleeve Due to Number of Uses Screen................................................................26
FIGURE 32. Home Screen with Chamber A Loaded - Start Options; "Melt" (to Ice Free) or "Thaw" ........26
FIGURE 33. Chamber A Thawing Screen..................................................................................................27
FIGURE 34. Thawing Cycle Intentionl Stop..............................................................................................28
FIGURE 35. Thawing Cycle Chamber A Running & Chamber B Ready Screen ..........................................28
FIGURE 36. Thawing Cycle Chamber A Complete & Chamber B Loaded and Running……………………………29
FIGURE 37. Time Out Screen…..……………………………………………………………………………………………………………30
FIGURE 38. Export Data Screen…..……………………………………………………………………………………………………….30
FIGURE 39. Downloading Data Screen……..………………………………………………………………………………………….30
FIGURE 40. Device Shutdown Prompt First Screen………..…………………………………………………………………….31
FIGURE 41. Device Power Down Prompt Screen..………………………………………………………………………………..32

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3 INTRODUCTION
This document contains the Instructions for Use (IFU) and technical description of the ZIPThaw™202 system based
on system requirements that have been derived from several sources, including customer voice, marketing
requirements and previous system generations.
These instructions are intended for use by medical professionals in hospitals.
3.1 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.
This device is not intended for the thawing of, but not limited to, Red Blood Cells, Hematopietic Progenitor Cells or
Umbilical Cord Blood, except for Research Use Only.
3.2 IMPORTANT
These instructions use the following pictograms, symbols and words to highlight warnings and special advice:
WARNING
A warning alerts the user to the possibility of a danger to persons associated
with misuse of the device
CAUTION
A caution alerts the user to the possibility of a problem with the device which
could pose danger to property, the device or basic device functions
These instructions are intended for use by medical professionals.
You must follow the instructions and safety information contained in this user manual at all times when using the
device. This will prevent risks to patients and users as well as prevent damage to equipment.
FreMon Scientific can accept no liability for damage caused as result of failure to follow these instructions.
WARNING
These instructions for use must be retained throughout the life of the product and handed to any subsequent user.
WARNING
Medical Electrical devices are subject to safety measures regarding electromagnetic compatibility (EMC). The device
must be installed and operated in accordance with the EMC advice contained in these instructions.

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3.3 TERMS & ABBREVIATIONS
Temp
Temperature
DC
Direct current
CRT
Control Rate Thawing
W
Watt
GUI
Graphical User Interface
V
Volt
EIS
Electronic Information Systems
Amp
Ampere
Min.
Minute(s)
HMI
Human Machine Interface
FEC
Front End Controller
Chamber
Where the product bag is processed
AC
Alternating Current
SOM
System on a Module computer
CMC
Chamber Module Controller
TCM
Thawing Chamber Module
SMP
System Management Processor
BIT
Built-in-Test: a diagnostics program
that checks system functions.

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4 DEVICE DESCRIPTION
The ZipThawTM 202 System platform has an advanced modular architecture that allows for configuration flexibility.
4.1 ZIPTHAWTM SYSTEM MODULES
The ZipThawTM 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. It mechanically and wirelessly connects to ZipSleeveTM .
The TCM contains two heating cushions, each filled with 300ml water-based liquid, that are sealed. Each cushion is
affixed to heating element and being controlled by a temperature sensor and Chamber Module Controller (CMC).
In addition, each heating element has its own heating sensor for overheating protection.
Overall overheating protection is accomplished by utilizing an independent temperature sensor that shuts down
power in case of cushion overheating.
4.1.2 SYSTEM MANAGEMENT PROCESSOR (SMP)
System Management Processor unit (SMP) that can control up to 4 CMCs. The SMP is a high-level CPUs that controls
and monitors system function, drives a touch-screen GUI module, and external memory media.
4.1.3 CHAMBER MODULE CONTROLLER (CMC)
Chamber Module Controller: a universal chamber control module. It controls one Chamber unit (i.e. sensors,
agitation, limit switches and heating) and communicates with the SMP for data/status synchronization.
4.1.4 ZIPSLEEVETM
A protective sleeve that has embedded wireless temperature sensor that measures the thawed product bag
substance temperature and will signal the CMC to stop heating once the sensor temperature reading reaches the
“Target Temperature” of 31 °C (87.8 °F) for the THAW option or 15 °C (59.0 °F) for the “MELT” to ice-free state
option.
4.1.5 POWER SUPPLY
Universal, medical grade AC/DC power supply that fitsinternational power system and supplies the necessary power
to drive up 2 pockets modules.

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4.2 ZIPTHAW 202TM FRONT VIEW
FIGURE
1.
ZIPThawTM 202 front view
4.3 ZIPTHAW 202TM REAR VIEW
FIGURE 2. ZIPThawTM 202 rear view

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4.4 ZIPSLEEVETM :
FIGURE 3. ZipSleeveTM View
4.5 HOW DOES IT WORK?
The plasma frozen bag is placed inside a ZipSleeveTM, a smart overwrap, bag and inserted into the Thawing Chamber
Module (TCM).
During the thawing process, the plasma bag is thawed by the Chamber’s heating cushions. The heating cushions
temperature is controlled by the system to maintain a heating temperature to ensure that the product bag
temperature does not exceed 37 °C (98.6 °F).
The plasma frozen bag temperature is monitored by the ZipSleeveTM temperature sensor (RFID) and will signal the
system to stop heating once the sensor temperature reading reaches the “Target Temperature” of 31 °C (87.8 °F)
for the THAW option or no more than 15 °C (59.0 °F) for the MELT option, while the ZipThawTM system controls the
agitation mechanism to ensure homogeneous mixing and heat distribution.
4.6 DEFAULT TEMPERATURE SETTING
The final, “Target Temperatures”for both the THAW and MELT options, are fixed as a factory setting. The
ZipSleeveTM sensor monitors the temperature of the frozen plasma bag and will signal the system to stop heating
once the Target Temperature is reached.
Note: The user cannot modify the “Target Temperature” but can select between the two start options, THAW and
Melt to ice-free.

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4.7 LABELING AND SYMBOLS
4.7.1 REAR PANEL
FIGURE 4. ZIPThawTM 202 Label
4.7.2 SYMBOLS USED IN THIS USER MANUAL:
No.
Symbol
Description
1
CE MARK
2
ATTENTION, CONSULT ACCOMPANYING
DOCUMENTS.
3
WASTE OF ELECTRICAL AND ELECTRONIC
EQUIPMENT (WEEE) COMPLIANCE SYMBOL
4
MANUFACTURER
5
AUTHORIZED REPRESENTATIVE IN THE EUROPEAN
UNION
6
FUSE
7
PI LOT NUMBER
8
CATALOG NUMBER
LOT
CAT

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No.
Symbol
Description
9
FEDERAL LAW RESTRICTS THIS DEVICE TO
SALE BY OR ON THE ORDER OF A LICENSED
PROFESSIONAL
10
HIGH TEMPERATURE WARNING
11
UL MARK
4.8 COMPLIANCE WITH FCC, 47 C.F.R. PART 18
FIGURE 5. COMPLIANCE WITH 47 C.F.R. PART 18
5 CONTRAINDICATIONS
Other than those substances described in the Intended Purpose (see Section 3.1), the ZipThawTM is not intended
to thaw, heat or keep warm any blood product or other substance, including but not limited to red blood cells,
hematopoietic progenitor cells, umbilical cord blood, previously thawed Cryoprecipitate AHF, Platelets, or
Granulocytes. There are no known contraindications for thawing or heating blood products.
6 SAFETY ADVICE
WARNING
•Read the instructions contained in this user manual and any other user documentation before using the
device.
•This device is class I electrical equipment.
•Only use the device according to the instructions in this user manual.
•Do not exceed heating temperature and time limit when heating blood and blood products.
•If the device has a fault, do not use it and contact FreMon Scientific.
•Electrical installations must comply with the applicable regulations and standards.
•Only use the power cord supplied by FreMon Scientific to connect to the main power source.

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•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.
•The influence of strong magnetic fields can cause malfunctions in the ZIPThawTM. If electromagnetic
interference occurs, increase the distance between the ZIPThawTM and the device causing the
interference. The ZIPThawTM works within the limit values set in the EN 60601-1-2 standard, and can be
influenced outside these limit values.
•Portable and mobile HF communication equipment can affect the device.
•Do not use the device near:
oFlammable materials
oFlammable mixtures of anesthetic substances with air, oxygen or nitrous oxide whose flashpoint is
below 50 °C (122 °F).
7 OPERATION
7.1 DEVICE PLACEMENT AND POWER CONNECTION.
▪Ensure there is enough space for the ZipThawTM 202 to be placed on the bench or cart.
▪Leave at least 10cm (4”) between the rear side of the ZipThawTM 202 and a wall to allow easy access to
power ON/OFF main switch located as part of the IEC socket.
▪Leave clear at least 40cm (15.7”) from each side to allow loading and unloading of bags into/from the
chambers.
▪Connect the power cable to the ZipThawTM 202 IEC socket, located at the back and plug the cord into a
power outlet.
▪Always use the power cord supplied by FreMon Scientific to connect to the main power source.
7.2 DOORS STATUS
During the system-operations if any Chamber door is opened or unproperly locked, the following error message
will be displayed:
FIGURE 6. DOOR OPEN ERROR POP-UP SCREEN
Close Chamber Door and Press “OK” will clear the message.
7.3 POWER UP
Press the power switch at the back of the device to "ON" position to provide power to the system. (see Figure 2).
The system goes through self-diagnostics and setup cycles (pre-heating) that may take up to 3 minutes.

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FIGURE 7. ZIPThawTM 202 power-up screen
7.3.1 POWER UP FAILURE
If the self-diagnostics and setup cycles fail, an error beep will sound for 1 second, and the touch screen will display
a system error message.
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 [e-mail] and check our web site
https://fremonscientific.com for assistance!
FIGURE 8. SYSTEM ERROR POP-UP SCREEN
7.3.2 BIT FAILURE
During the self-diagnostic tests, the system will determine whether both Chambers are functioning or one or both
of the Chambers has a fault and must be disabled. The system will disable the faulty Chamber(s) but will allow the
device to fully function if one Chamber is functioning.
Running BIT...

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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. HOME SCREEN WITH CHAMBER ERROR
7.3.3 SYSTEM RESET RECOVERY
In case that the system defaults to an unexpected “Reset” mode, upon successful BIT , the home screen will
appear and the system will recover in to pre-thawing state see 7.7, Fig 24.
Note: It is the user’s discresion to start a new thawing cycle, using these bags or discarding them.
To continue a new thawing cycle proceed to 7.3.2.
7.3.4 SUCCESSFUL POWER UP
Upon successful pre-heating cycle, the home screen will appear,. The screen will prompt: “Select Chamber” as
shown below.

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FIGURE 11. HOME SCREEN
7.4 MAIN SCREEN DESCRIPTION
FIGURE 12. Home Screen
1
FreMon logo+ site name
2
Export Data.
3
Settings.
4
Date & Time.
5
Work Area A+B - the user main area
interaction.
6
Main Action Buttons.
7
Instructions for active Chamber.
8
Number of ZipSleeveTM uses indicator.
7.5 SETTINGS
Pressing the “Settings” icon will open the settings login screen. The following screens are for the device
administrator and technical support use only.
Entering the Settings Screen requires an administrator password. The administrator will have a default password
(45253, factory default) that can be changed in the setting screen.

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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. Login to the Settings Screen
Note: If the administrator password is forgotten, the password may only be reset by a certified technician.
Upon entering the correct administrator password and pressing “OK”, the following setting screen will appear:
FIGURE 14. Settings Screen
7.5.1 KEYS DESCRIPTIONS
Pressing this key will revert back to the home screen without saving.
Pressing this key will revert back to factory settings.
Pressing this key will save settings and go to the home screen.
“ENTER”key.

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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.
Note: Default Language is English represented by the American flag icon and is currently the only language that is
actively available.
7.5.3 SELECTING TEMPERATURE UNIT
The administrator can select which temperature unit will be displayed (i.e., Celsius or Fahrenheit) by touching the
corresponding radio button.
Figure 16. Temperature Units
7.5.4 ENTERING SITE NAME
To enter the site’s name touch the the screen at the “New Site” location to highlight it and use the keyboard to type
the site’s name. The typed name will appear at the header upper left, next to the FreMon Scientific logo.

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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.
To set the time, touch the Time field. The time format is 24:00.
Use the keyboard to enter the current time.
Figure 18. Setting Date & Time
Note: If the typed information is incorrect, the field will be marked red
7.5.6 ENABLING AUDIO
To enable audio alerts turn “Sound” ON or OFF by sliding the corresponding switch.
ON
OFF
Figure 19. Enabling Audio
7.5.7 ADDING NEW USER
Touching the Users field enables typing a new user name by either typing it into the “New name” field and ID
number into the ID/Barcode field by using the display keyboard or, scanning the new user’s ID badge. A minimum
of one User ID must be entered to be used when uploading data from ZipThaw202 to a USB Thumdrive.

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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.
7.5.8 EDITING USER LIST
•Mark the “Users” (i.e. touching) the drop-down list will be displayed.
•To delete a user name from the list, press the “X”icon on the right side of the user ID.
•To add a newly added user press the “ENTER” key.
•When finished editing the whole screen, to save the data entry press “SAVE”.
•To return to the home screen press the “HOME” key.
`
FIGURE 21. Adding New User Screen