QuickThaw Plasma Thawing System Models DH2,DH4,DH8 Rev P Operation Manual Oct 2021

Document History Revision

Date

CO

Supersession

Revision Description Revised layout for ease of navigation and locating information.

L

08 MAY 2013*

8409

Supersedes A, B, C, D, E, F, G, H, I, J, K

M

16 MAY 2014*

9492

M supersedes L

Removed 0086 mark from manual.

N

9 OCT 2019

15059

N supersedes M

Reformatted for consistency with other Helmer manuals. Removed PM table as it is duplicated in the Service Manual. Added EMC content to Product Specifications and Compliance sections.

O

27 OCT 2020

15707

O supersedes N

Updated programmed settings for Thaw Cycle.

P

4 OCT 2021

16380

P supersedes O

Updated Safety Compliance section

* Date submitted for Change Order review. Actual release date may vary.

Document Updates The document is furnished for information use only, is subject to change without notice and should not be construed s a commitment by Helmer Scientific. Helmer Scientific assumes no responsibility or liability for any errors or inaccuracies that may appear in the informational content contained in this material. For the purpose of clarity, Helmer Scientific considers only the most recent revision of this document to be valid.

Notices and Disclaimers Confidential / Proprietary Notices Use of any portion(s) of this document to copy, translate, disassemble or decompile, or create or attempt to create by reverse engineering or otherwise replicate the information from Helmer Scientific products is expressly prohibited.

Copyright and Trademark Helmer® is a registered trademark of Helmer, Inc. in the United States of America. Copyright © 2021 Helmer, Inc. All other trademarks and registered trademarks are the property of their respective owners. Helmer, Inc., doing business as (DBA) Helmer Scientific and Helmer.

Disclaimer This manual is intended as a guide to provide the operator with necessary instructions on the proper use and maintenance of certain Helmer Scientific products. Any failure to follow the instructions as described could result in impaired product function, injury to the operator or others, or void applicable product warranties. Helmer Scientific accepts no responsibility for liability resulting from improper use or maintenance of its products. The screenshots and component images appearing in this guide are provided for illustrative purposes only, and may vary slightly from the actual software screens and/or product components.

Helmer Scientific 14400 Bergen Boulevard Noblesville, IN 46060 USA www.helmerinc.com Part No. 360094-1/P

Helmer Scientific Plasma Thawing System

Operation Manual

Contents 1

2

3

4

5

6

About this Manual... 3 1.1

Intended Audience... 3

1.2

Model References... 3

1.3

Intended Use... 3

1.4

Safety Precautions and Symbols... 3

1.5

Avoiding Injury... 3

1.6

General Recommendations... 4

Installation... 5 2.1

Location Requirements... 5

2.2

Placement... 5

2.3

Install External Thermometer (Optional)... 5

General Operation... 6 3.1

Initial Start Up... 6

3.2

Fill the Chamber... 6

3.3

Drain the Chamber... 7

3.4

Determine the Correct Thaw Time... 7

3.5

Load Bags... 8

3.6

Thaw Cycle Functions... 9

3.7

Unload Bags... 10

3.8

Enable or Disable Agitation Motion... 11

3.9

Mute an Audible Alarm... 11

Temperature Monitor Setpoints... 12 4.1

Change the Chamber Temperature Setpoint... 12

4.2

View or Change Temperature Alarm Setpoints... 12

Components... 14 5.1

Front and Sides... 14

5.2

Control Panel... 15

5.3

Chamber... 15

5.4

Thawer Basket... 16

5.5

Rear... 16

Product Specifications... 17 6.1

7

Operating Standards... 17

References and Compliance... 18 7.1

Safety Compliance... 18

7.2

Environmental Compliance... 18

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1

About this Manual

1.1

Intended Audience

Operation Manual

This manual is intended for use by end users of the plasma thawing system and authorized service technicians.

1.2

Model References

Generic references are used throughout this manual to group models that contain similar features. For example, “DH models” refers to all models of that type (DH2, DH4, DH8). This manual covers all plasma thawing systems, which may be identified singly, by their size, or by their “series” (DH).

1.3

Intended Use

Helmer plasma thawing systems are intended for thawing frozen blood products and other medical, biological, and scientific products.

1.4

Safety Precautions and Symbols Symbols found in this document The following symbols are used in this manual to emphasize certain details for the user: Task Indicates procedures which need to be followed. Note Provides useful information regarding a procedure or operating technique when using Helmer Scientific products. NOTICE Advises the user against initiating an action or creating a situation which could result in damage to equipment; personal injury is unlikely.

Symbols found on the units Caution: Risk of damage to equipment or danger to operator

Refer to documentation

Caution: Pinch point

1.5

Avoiding Injury

Review safety instructions before installing, using, or maintaining the equipment. ♦ Before moving unit, ensure chamber water has been removed. ♦ Never physically restrict any moving component. ♦ Avoid removing electrical service panels and access panels unless so instructed. ♦ Use supplied power cords only. REQUIRED: Decontaminate parts prior to sending for service or repair. Contact Helmer or your distributor for decontamination instructions and a Return Authorization Number.

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1.6

Operation Manual

General Recommendations

General Use Allow plasma thawer to come to room temperature before switching power on. During initial startup, low temperature alarm may sound while plasma thawer reaches operating temperature. Initial Loading Allow chamber temperature to stabilize at the setpoint before thawing frozen product.

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2

Installation

2.1

Location Requirements

Operation Manual

Note Helmer recommends placing the drain or waste container on the same side as the drain port. ♦ Has a sturdy, level surface ♦ Has a grounded outlet meeting national electric code (NEC) and local electrical requirements ♦ Is clear of direct sunlight, high temperature sources, and heating and air conditioning vents ♦ Minimum 8” (203 mm) above ♦ Access to a water supply ♦ Adjacent to a sanitary drain or waste water container ♦ Meets limits specified for ambient temperature and relative humidity

2.2

Placement NOTICE Ensure chamber has been drained before moving.

Unplug unit from AC power before moving.

2.3

Install External Thermometer (Optional)

Install the external thermometer according to the manufacturer’s documentation. Refer to the Digital Thermometer Manual for more information on the Helmer DT1 digital thermometer.

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3

General Operation

3.1

Initial Start Up

Operation Manual

1. Plug the power cord into a grounded outlet that meets the electrical requirements on the product specification label. 2. Press the AC ON/OFF button to power the plasma thawer ON. Notes • The AC ON/OFF switch also controls the fan on 100V DH8. • High temperature alarm activates quickly when chamber is empty.

3.2

Fill the Chamber

Two fill lines are marked on the rear wall of the chamber. The lines indicate the maximum water level for the following applications: ♦ Upper line: maximum level for thawing random bags ♦ Lower line: maximum level for thawing apheresis bags

Chamber fill lines. Notes • Determine the type of water to be used (tap or distilled), according to your organization’s requirements. • Use of a bacterial growth inhibitor, such as Helmer CleanBath, is recommended. • Do not use deionized water as it may be corrosive to the chamber and baskets.

Add water to the chamber: 1. Ensure the chamber and drain are free of debris or contaminants. 2. Ensure the drain tube is not connected. 3. Fill the chamber to the appropriate level. 4. Add bacterial growth inhibitor (optional).

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3.3

Operation Manual

Drain the Chamber

• Disconnect the plasma thawer from AC power before draining the chamber. • Do not move the plasma thawer when the chamber is filled or if the plasma thawer is connected to AC power. The plasma thawer has a drain port to drain water from the chamber. The drain valve is integrated into the drain fitting on the side of the plasma thawer. The drain valve remains closed until the drain tube is connected to the valve. When the drain tube is connected, the chamber begins to drain immediately. The drain coupling must be installed on the drain tube before the drain tube can be connected to the drain valve. The 90º elbow may be installed in the drain tube to facilitate convenient routing of the drain tube.

Left: Drain port with coupling valve and drain tube connected (release button identified with arrow). Middle: Drain tube with coupling valve installed. Right: 90° elbow fitting. Drain water from the chamber: 1. Press the AC ON/OFF button to power the plasma thawer OFF. 2. Disconnect the power cord from AC power. 3. Place the open end of the drain tube into a waste container or sanitary drain. 4. On the opposite end of the drain tube, push the coupling valve into the drain port. The coupling valve will click when it is properly seated. Water immediately begins to drain from the chamber. 5. After the water has drained from the chamber, release the drain tube by pressing down on the release button on the coupling valve and pulling the coupling valve out of the drain port.

3.4

Determine the Correct Thaw Time

Thaw time varies by bag type and how the bags were manipulated when frozen (flat or folded). The table below indicates median thaw times for bags previously stored at -30 °C. Plasma Bag (Size and Type)

Manner Frozen

Median Thaw Time (Minutes)

10 mL to 15 mL cryoprecipitate

Folded

5

250 mL standard

Flat

10

250 mL thick plastic

Flat

16

250 mL standard

Folded

17

300 mL standard

Flat

14

500 mL (jumbo) apheresis

Flat

18

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3.5

Operation Manual

Load Bags

• Do not manually lift the baskets out of the chamber. Manually lifting baskets will damage the system. Press the LIFT OUT button to raise the baskets. • Press the LIFT OUT button only if the baskets are installed. The basket must be installed for the lift out system to operate correctly. ♦ DH2 basket holds 2 standard bags. ♦ DH4 uses 2 of the same basket used in the DH2, for a total capacity of 4 compartments. ♦ DH8 basket holds 8 standard bags. Note On the DH8, the divider between compartments on each side can be removed to hold jumbo or wide bags. When thawing a plasma bag (of any type or size), a plasma overwrap bag must be used. The plasma bag is placed inside the overwrap bag, and the overwrap bag is attached to the basket. Overwrap bags provide the following benefits: ♦ Secure the plasma bag to the basket ♦ Protect the plasma bag from water-borne contaminants ♦ If the plasma bag breaks, the contents will not contaminate the water bath Note Use only 1 overwrap bag, of the appropriate size, per plasma bag. The following recommendations will aid in thawing plasma bags: ♦ Use security snaps on smaller bags that tend to float ♦ Load plasma bags together that require the same thaw time ♦ When loading 2 bags on same side of the basket in DH8 models, place thicker bag in the front-most compartment Load the bag(s): 1. Insert plasma bag into appropriate size overwrap bag. LIFT OUT button. 2. On control panel, press the LIFT OUT button to raise and open basket. 3. DH8 models: Remove the basket divider if a jumbo or wide bag is loaded by squeezing sides of the divider together and pull divider away from basket.

Removing divider from DH8 basket. 4. Place overwrapped plasma bag in basket. Hook the slot at the top of the overwrap bag over the tab on the basket. For large overwraps, ensure both slots are hooked over the tabs. 5. Insert a security snap through top set of holes on the basket compartment. Push the snap toward the basket until it snaps against the overwrap bag.

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Operation Manual

Bag in standard-sized overwrap bag with security snap.

3.6

Thaw Cycle Functions

Keep fingers and clothing away from basket(s) while in motion. Note • If a temperature alarm is active, a thaw cycle cannot be initiated until the alarm condition is cleared. • A lift-out malfunction alarm for one basket will not prevent the other basket from performing a thaw cycle (DH4 and DH8 models). • Allow the water temperature to stabilize at the setpoint between thaw cycles. Button

Button Name

Function

CYCLE TIME

► ► ►

CYCLE START

Start a thaw cycle

LIFT OUT

► ► ►

Set thaw cycle time (in minutes) Extend thaw cycle time Select the hold (“HO”) setting

Pause a thaw cycle in process (press to raise the basket) Resume a paused thaw cycle (press to lower the basket) Stop a thaw cycle

Start a Thaw Cycle When the thaw cycle is started, the lift out system closes the basket and lowers it into chamber. If agitation motion is enabled, the basket begins to agitate after the basket reaches the bottom of its travel. The remaining cycle time (in minutes) is displayed on the cycle time indicator (located on the control panel). Programmed time settings of 0, 3, 5, 8, 10, 12, 14, 16, 18, 20, 25, 35, 45 and 55 minutes, as well as a hold (“HO”) setting, are preprogrammed in to the timing system. ♦ Pressing the TIME SET button advances through each pre-programmed time setting. ♦ To indefinitely extend a thawing cycle that is already in progress, press the TIME SET button until the display reads “HO”. ♦ Press the TIME SET button again and the cycle will finish its initial programmed time.

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Operation Manual

Start a Cycle: Note The cycle time, cycle start, and lift out for each basket is controlled individually on DH4 and DH8 models. 1. Confirm the chamber has been filled to the appropriate level. 2. Confirm the water temperature stabilized at temperature setpoint. 3. Enable or disable agitation motion, depending on your organization’s specific needs. 4. Load overwrapped bags into basket(s), with security snap(s) as needed. 5. For each basket, press the CYCLE TIME button to select the desired time. 6. Press the CYCLE START button to lower basket and start the thaw cycle. Stop, Pause, or Resume a Thaw Cycle Notes • When a thaw cycle is stopped or paused, the basket lifts out of the chamber before the thaw cycle is completed. • The hold (“HO”) setting may be selected while the thaw cycle is paused (LIFT OUT button pressed). 1. Press the LIFT OUT button to raise the basket and temporarily pause the thaw cycle. The remaining time is displayed on the cycle time indicator. 2. Press the LIFT OUT button again to resume the thaw cycle. The basket is lowered into the chamber and the agitation motion resumes. Complete a Thaw Cycle When a thaw cycle reaches the end of its programmed time setting, the basket stops agitating, lifts out, and opens. An audible alert sounds to indicate the thaw cycle has completed, and the cycle time indicator resets to the previously selected time setting.

3.7

Unload Bags

• Do not manually lift the baskets out of the chamber. Manually lifting baskets will damage the system. Press the LIFT OUT button to raise the baskets. • Press the LIFT OUT button only if the baskets are installed. The basket must be installed for the lift out system to operate correctly.

Unload the bag(s): 1. On control panel, press the LIFT OUT button to raise and open basket. 2. Remove the security snap from the basket. 3. Unhook the slot at the top of the overwrap bag from the tab on the basket. 4. Remove the overwrap bag from the basket. 5. Remove the plasma bag from the overwrap bag. Discard the overwrap bag.

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LIFT OUT button.

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3.8

Operation Manual

Enable or Disable Agitation Motion

Default is enabled. Agitation reduces thaw time. It is controlled with the switch located at the rear of thawer. For DH4 and DH8, top and bottom switches control right and left basket agitation, respectively.

Agitation switches.

3.9

Mute an Audible Alarm

Audible alarms can be muted. The temperature controller will still continue to flash an alarm message if the alarm has been muted. To mute an audible alarm, press the MUTE button.

Mute button. Pressing the MUTE button silences alarms for both baskets (DH8 models). If a second audible alarm activates while the first audible alarm is muted, the second alarm will be muted as well. When an alarm is muted, the duration is indefinite. Muting is cleared under the following conditions: ♦ The condition that triggered the alarm is resolved ♦ AC power to the plasma thawer is switched off Alarm Reference If an alarm condition is met, an alarm activates. The following table indicates if an alarm is audible (A) or visual (V). Messages for visual alarms, if applicable, appear in the table as well. Alarm

Alarm Type

High Temperature

A, V (“-AL-” on temperature controller, “E1” on all cycle time indicators)

Low Temperature*

A, V (“-AL-” on temperature controller)

Lift Out System Malfunction

A, V (“E2” on affected cycle time indicator)

* Low temperature alarm is available but not used.

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4

Temperature Monitor Setpoints

4.1

Change the Chamber Temperature Setpoint

Operation Manual

Note Do not change any other temperature controller parameter unless instructed in this manual or by Helmer Technical Service. The default chamber temperature setpoint is 36.5 °C. If the chamber temperature falls below the setpoint, the temperature controller activates the chamber heater until the setpoint is reached. The chamber heater and sensor are located underneath chamber. Change the setpoint: 1. Determine setpoint, if other than default. 2. The chamber temperature appears on the display. Note The displayed temperature may differ from the setpoint, especially if chamber temperature has not stabilized at the setpoint.

Temperature controller display.

*

3. Press and hold the button. The setpoint value is displayed. 4. Press the UP or DOWN buttons to change the setpoint value. The setpoint value is adjusted up or down in increments of 0.1 °C. 5. Release all buttons to exit the setpoint value adjustment. New setting is saved.

4.2

View or Change Temperature Alarm Setpoints Notes • Changing parameter values affects plasma thawer operation. Do not change values unless instructed in product documentation or by Helmer Technical Service. • By default, the Low Temperature alarm is not enabled. If the Low Temperature alarm is enabled, follow regulations for your organization to determine the appropriate temperature setting. • Ensure the Low Temperature alarm setting is no higher than 30.0 ºC.

The monitoring and control system has alarms which activate if the temperature is too high or too low (if the Low Temperature alarm is enabled). The setpoints for these alarms may be viewed and/or changed using the temperature controller.

Temperature controller display. The High Temperature alarm setpoint (AL.hi) specifies the temperature at which the High Temperature alarm should activate. If the temperature detected by the temperature control sensor is greater than or equal to this value, the alarm activates. The Low Temperature alarm setpoint (AL.Lo) specifies the temperature at which the Low Temperature alarm should activate. If the temperature detected by the temperature control sensor is less than or equal to this value, the alarm activates.

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Operation Manual

View or change parameter values: Notes • Default High Temperature alarm setpoint is 37.6 °C. • Low Temperature alarm setpoint is disabled by default (setpoint is 0.0 °C). • When setting alarm setpoints, maintain at least a 1.0 °C difference above or below the plasma thawer setpoint. • When there is no interaction for 60 seconds, the temperature controller exits program mode. 1. Enter Level 1 program mode by pressing and holding the UP and DOWN buttons simultaneously for approximately 3 seconds. The display will flash “tunE” and “oFF”. 2. Press and release the UP or DOWN buttons until the desired parameter flashes on the display. For the High Temperature setting, select the “AL.hi” parameter. For the Low Temperature setting, select the “AL.Lo” parameter. 3. Change a parameter value by pressing and holding the * button, then press the UP or DOWN buttons to change the parameter value. 4. Release all buttons to exit the parameter. New settings are saved. 5. Press and hold the UP and DOWN arrow buttons simultaneously for approximately 3 seconds to exit program mode.

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5

Components

5.1

Front and Sides

Operation Manual

G

H A

I B C

D

E

F

Front and left sides (115 V DH4 model shown). Label

Label

Description

Fan (DH8 100 V models)

F

Control panel

B

Drain port

G

Cover

C

Drain tube with coupling valve

H

Basket

D

Drain port cover

I

Plasma overwrap holder

E

Product specification label

A

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5.2

Operation Manual

Control Panel F

G

E

H

A B C D

G

A B

E

F

D

F

C

D

G

H

E

Control panel. Top: DH2 model. Bottom: DH4 and DH8 models. Label

Description

Label

Description

A

Power indicator LED

E

CYCLE START button

B

POWER button

F

Cycle time indicator

C

MUTE button

G

LIFT OUT button

D

CYCLE TIME button

H

Temperature controller

5.3

Chamber

B C A D E

Rear of thawer (230 V DH4 model shown with parts from various models). Label

Description

Label

Description

A

Chamber

D

Basket

B

Finger knob

E

External thermometer access port

C

Lift-out system

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5.4

Operation Manual

Thawer Basket C

D

E

F

A

B

DH8 basket shown with 2 plasma bags in standard overwraps. Label

Description

Label

Description

A

Basket

D

Basket divider (DH8)

B

Bearing

E

Overwrap bag

C

Tab

F

Security snap

5.5

Rear C

C

D A C B Rear of thawer (230 V DH4 model shown with parts from various models). Label

Label

Description

A

Agitation switch

C

Circuit breaker

B

Vent

D

Power connector

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Helmer Scientific Plasma Thawing System

6

Product Specifications

6.1

Operating Standards

Operation Manual

These units are designed to operate under the following environmental conditions: ♦ Indoor use only ♦ Altitude (maximum): 2000 m ♦ Ambient temperature range: 15 ºC to 32 ºC (59 ºF to 90 ºF) ♦ Relative humidity (maximum for ambient temperature): 80% for temperatures up to 31 ºC (88 ºF), decreasing linearly to 50% at 40 ºC (104 ºF) ♦ Pollution degree: 2 (for use in USA and Canada only) ♦ Sound level is less than 70 dB(A). ♦ EMC Environment: Basic Notes • Power consumption is measured in full-load Amperes. • Product specification label is located on the left side of the plasma thawer. Electrical Specifications DH2 Input Voltage and Frequency

DH4

Voltage Tolerance Circuit Breakers

Power Consumption

DH8

100 V, 50 Hz / 115 V, 50-60 Hz / 230 V, 50-60 Hz ±10% 5 A (100 V) 4 A (115 V) 2 A (230 V, quantity 2)

10 A (100 V) 7 A (115 V) 4 A (230 V, quantity 2)

15 A (100 V) 15 A (115 V) 6 A (230 V, quantity 2)

3.0 A (100 V) 2.5 A (115 V) 1.25 A (230 V)

8.0 A (100 V) 6.0 A (115 V) 3.0 A (230 V)

12.0 A (100 V) 10.0 A (115 V) 5.0 A (230 V)

Varies (refer to product specification label)

Power Source

Plasma Thawer Specifications

Height (Baskets Lowered)

DH2

DH4

DH8

16.25” (413 mm)

16.25” (413 mm)

16.25” (413 mm)

Height (Baskets Raised)

23.00” (584 mm)

23.00” (584 mm)

23.00” (584 mm)

Width

15.50” (368 mm)

21.75” (553 mm)

21.75” (553 mm) 22.50” (572 mm)

Depth

15.50” (394 mm)

15.50” (394 mm)

Weight

38 lbs (17 kg)

58 lbs (26 kg)

74 lbs (34 kg)

Chamber Volume

2.2 gal. (8.2 L)

4.75 gal. (18 L)

8.5 gal. (32 L)

Basket Capacity

2 units

4 units

8 units

External Port

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Standard (for external thermometer)

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Helmer Scientific Plasma Thawing System

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References and Compliance

7.1

Safety Compliance

Operation Manual

This device complies with the requirements of directive (EU) 2017/745 concerning Medical Devices.. This product is certified to applicable UL and CSA standards by a NRTL.

7.2

Environmental Compliance

This device falls under the scope of Directive 2102/19/EU Waste Electrical and Electronic Equipment (WEEE) . When disposing of this product in countries affected by this directive: ♦ Do not dispose of this product as unsorted municipal waste. ♦ Collect this product separately. ♦ Use the collection and return systems available locally. For more information on the return, recovery, or recycling of this product, contact your local distributor.

7.3

Electromagnetic Compliance

The Helmer Scientific Plasma Thawing System meets the applicable requirements of IEC61326 and EN55011 and is intended for use in the electromagnetic environment specified in 6.1 Operating Standards. The customer or the user of these devices should assure they are used in such environment.

END OF MANUAL

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Helmer Scientific

14400 Bergen Boulevard, Noblesville, IN 46060 USA Copyright © 2021 Helmer, Inc.

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