Platelet Agitator Operation Manual2
Platelet Agitator Operation Manual2
Countertop
PF15-Pro, PF48-Pro,
PF96-Pro
360390/A
Document History
Revision Date CO Supersession Revision Description
A 23 APR 2019* 14560 N/A Initial Release
* 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 as 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.
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. 360390/ Rev A
Helmer Scientific i.Series® - Platelet Agitator Operation Manual
Contents
1 About this Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.1 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2 Model Reference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3 Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.4 Safety Precautions and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.5 Avoiding Injury. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.6 General Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1 Location Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2 Power and Communication Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.3 Mounting Brackets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.4 Placement, Leveling and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.5 Storage Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.6 Load the Agitator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3 Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.1 Initial Start Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.2 Motion Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.3 Motion Alarm Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.4 Enable or Disable Motion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.1 Operating Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5 Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.1 Safety Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.2 Environmental Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.3 Electromagnetic Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6 Maintenance Schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Appendix A: Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
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Helmer Scientific i.Series® - Platelet Agitator Operation Manual
Helmer platelet agitators are intended to provide the continuous gentle agitation conditions required for the storage of platelet products.
The devices are intended to be operated by personnel who have procedures in place for meeting FDA, AABB, EU or any other
applicable regulations for the processing and storage of platelet products.
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.
CAUTION Advises the user against initiating an action or creating a situation which could result in damage to
equipment or impair the quality of the products or cause minor injury.
WARNING Advises the user against initiating an action or creating a situation which could result in damage to
equipment and serious personal injury to a patient or the user.
Authorized representative in the European Community
EC REP
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Caution: Hot surface Product falls under the scope of the WEEE
(Waste Electrical and Electronic Equipment)
directive.
CAUTION
Decontaminate parts prior to sending for service or repair. Contact Helmer Scientific or your distributor for decontamination
instructions and a Return Authorization Number.
General Use
Allow platelet agitator to come to room temperature before switching power on.
During initial startup, motion alarm may sound if the motion is disabled.
During initial startup for stand alone operation, device selection of “X” is required for motion to occur.
Initial Loading
After platelet agitator reaches room temperature, begin storing product.
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2 Installation
2.1 Location Requirements
Stand Alone Installed in Incubator
♦♦ To ensure continuous operation of linearly shifting loads, the ♦♦ To ensure continuous operation of linearly shifting loads, the
location surface must be level and adequately accommodate location surface must be level and adequately accommodate
the full weight of the agitator when loaded with product. the full weight of the incubator with installed agitator when
♦♦ Has a grounded outlet meeting the electrical requirements loaded with product.
listed on the product specification label.
♦♦ Is clear of direct sunlight, high temperature sources, and Note
heating and air conditioning vents. • Only Helmer Pro series platelet agitator may be used
♦♦ Minimum 0.5” (13 mm) behind. with Pro series platelet incubator.
♦♦ Minimum 0.75” (20 mm) on left and right sides. • When placing an agitator in the PC900-Pro or
♦♦ Meets limits specified for ambient temperature (15˚C to 35˚C) PC1200-Pro, ensure agitator placement allows the
and relative humidity. roll-top door to open
Note
Add 1.5” (38 mm) to the width to accommodate the
trolley frame when agitation motion is enabled with
standard throw (default).
Note
• Use only the DC power cord supplied with the incubator when configuring the agitator within the incubator.
• Use only the optional Helmer AC/DC power supply for stand-alone configuration.
Notes
• Only Helmer Pro Series Platelet Agitator models may
be used with Pro Series Platelet Incubator models.
• Ensure AC power and backup battery power are
turned OFF prior to connecting an agitator.
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CAUTION
• To prevent damage, do not use the storage frame, trolley or trolley drawer to lift agitator.
• The communication switch is fragile, do not use excessive force when changing the setting.
NOTICE
• When lifting platelet agitator, lift using the ends of the base.
• If the base is not accessible, lift using the ends of the storage frame.
1. Place platelet agitator on sturdy surface. 1. Using a small flathead screwdriver, turn the
2. Ensure platelet agitator is level. communication switch to the 1 position. Ensure the
arrow (shown in red for visibility in the picture above)
3. Using a small flathead screwdriver, turn the
is pointing to the 1.
communication switch to the X position. Ensure the
arrow (shown in red for visibility in the picture above) 2. Place platelet agitator inside platelet incubator.
is pointing to the X. 3. Ensure platelet agitator is level.
CAUTION
To avoid injury, ensure both left and right side drawer stop panels are fully installed prior to operating the agitator.
Thumb Screws
Remove and Replace Drawers
1. Remove the thumb screws securing the drawer stop panels to the left and right sides of
the agitator. (Note the orientation of each panel)
2. Carefully pull each panel from the agitator and set panels and thumb screws aside.
3. Slide the drawer(s) out and remove.
4. Reinstall drawer in desired location by aligning the outer edges of the drawer with the slots in
the drawer guides and push inward.
5. Reinstall the drawer stop panels in the same orientation as removed, and secure with thumb
screws ensuring they are finger tight.
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Install Label Holders (optional)
1. Insert the tabs on the label holder into the slots on the drawer.
2. Pivot the holder around the drawer handle and align the hole on the label holder with the corresponding hole on the drawer.
3. Push thumb screw through the hole in the label holder and through the hole in the drawer to secure.
Table 1
Capacity
Model
WBD/Random Bags SDP/Apheresis Bags
PF15-Pro 15 (2 per drawer; 3 per shelf) 7 (1 per drawer/shelf)
PF48-Pro 48 (6 per drawer/shelf) 16 (2 per drawer/shelf)
PF96-Pro 96 (12 per drawer/shelf) 32 (4 per drawer/shelf)
CAUTION
When opening drawer, grasp handle (not label holder). Open one drawer at a time.
Open the drawer to be loaded and lay the platelet bags flat. The top of the storage frame may also be used for bag storage. Avoid
stacking bags. Maintain enough space around each bag for air circulation. For thicker bags, remove drawers. Place the bag tubing
under or around the bag.
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3 Operation
3.1 Initial Start Up
Notes
• Helmer recommends the motion alarm ON/OFF switch
remain in the ON position.
• Motion information is transmitted through the data
cable to the platelet incubator, even when the motion
alarm is disabled.
• The platelet incubator interprets the motion
information and generates its own motion alarm,
based on its own alarm delay period.
• Once the agitator has been connected to the
incubator, communication will be interrupted, and the
incubator will alarm, if the power switch is turned OFF.
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When platelet agitator motion stops the motion alarm is activated. The alarm condition is communicated as follows:
♦♦ Red alarm LED on motion alarm switch flashes.
♦♦ Audible alarm buzzer sounds when in stand-alone mode, the motion alarm switch is turned on, adjustable alarm delay time has been
exceeded, and volume has been turned up.
♦♦ Through a dry (no voltage) connection to an external monitoring device (if connected).
♦♦ Through a 9 V connection to an external monitoring device (if connected).
♦♦ Through a data cable to the Pro Series Platelet incubator (if Pro Series platelet agitator is installed in a Pro Series platelet incubator).
NOTICE
If motion stops while the motion alarm is switched OFF, communication of the alarm (visual, audible, and signals to external
devices) is suppressed.
Alarm Delay
The duration of time between when agitation stops and when the alarm sounds is the alarm delay. The alarm delay is set using the
alarm delay control.
Notes
• The minimum alarm delay that can be set is approximately 10 seconds.
• Maximum alarm delay is approximately 10 minutes.
• The default motion alarm delay is set at the halfway point (approximately 4 to 5 minutes).
Alarm Volume
The motion alarm volume has a variable setting.
Note
• Rotating the volume control fully counter-clockwise will silence the audible alarm. If the motion alarm switch is turned ON,
the LED will blink providing a visual alarm when the agitator is in an alarm condition.
• Alarm volume is applicable only when the agitator alarm switch is in the ON position and the platelet agitator is in
stand-alone mode, or when communication is lost when configured in a platelet incubator.
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Notes
• The agitator speed is factory set to 72 CPM (as displayed in green) and is applicable when used in stand-alone operation.
• For a setpoint of 72 CPM, rotate the arrow into the center of the green zone. This is an expanded 72 CPM setpoint area.
• For a platelet agitator in stand-alone configuration, switching the agitation ON/OFF switch ON will start the agitation motion.
• For a platelet agitator in stand-alone configuration or installed in a platelet incubator, switching the agitation ON/OFF switch
OFF will stop the agitation motion.
• For a platelet agitator installed in a platelet incubator, the communication switch must be switched to 1 or greater. If the
communication switch is set to X, the agitator will not start/stop based on the platelet incubator door position.
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4 Specifications
4.1 Operating Standards
These units are designed to operate under the following environmental conditions:
♦♦ Indoor use only
♦♦ Altitude (maximum): 2000 m
♦♦ Ambient temperature range: 15 °C to 35 °C
♦♦ Relative humidity (maximum for ambient temperature): 80% for temperatures up to 31 °C, decreasing linearly to 45% at 35 °C
♦♦ Overvoltage category: I
♦♦ Pollution degree: 2
♦♦ Sound level is less than 60 dB(A).
♦♦ Mains supply voltage: ±10% of nominal voltage
♦♦ RF Emissions: Group 1 - Class A
♦♦ EMC Environment: Basic
Note
Power draw is measured in full-load Amperes during stand-alone operation and includes power supply.
CAUTION
• The interface on the remote alarm monitoring system is intended for connection to the end user’s central alarm
system(s) that uses normally-open or normally-closed dry contacts.
• If an external power supply exceeding 30 V (RMS) or 70 V (DC) is connected to the remote alarm monitoring system’s
circuit, the remote alarm will not function properly; may be damaged; or may result in injury to the user.
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5 Compliance
5.1 Safety Compliance
This device complies with the requirements of directive 93/42/EEC concerning Medical Devices, as amended
by 2007/47/EC.
0086
This product is certified to applicable UL and CSA standards by a NRTL.
This product is IECEE CB Scheme certified and complies with national differences for safety certification beyond
IEC 61010-1-12 3rd edition.
This device complies with the 2011/65/EU Directive for the Restriction of Hazardous Substances (RoHS).
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.
This device complies with FCC Radiated and Conducted Emissions Approval to CFR47, Part 15; Class A levels
Emergo Europe
Helmer Scientific Prinsessegracht 20
14400 Bergen Blvd. EC REP 2514 AP The Hague
Noblesville, Indiana 46060 USA The Netherlands
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6 Maintenance Schedule
Maintenance tasks should be completed according to the following schedule. Refer to the service manual for more detail on the
various tasks.
Note
These are recommended minimum requirements. Regulations for your organization or physical conditions at your organization
may require maintenance items to be performed more frequently, or only by designated service personnel.
Frequency
Task
Quarterly Annually As Needed
Test the motion alarm. ü
Check the 9V NiMH backup battery for the motion alarm system after an ü
extended power failure and change it if necessary, or change the battery if it has
been in service for one year.
Check moving parts for wear. Clean moving parts. ü
Replace moving parts if worn. ü
Clean the exterior of the platelet agitator. ü
Notes
• During a power failure (when the motion alarm is enabled), the backup battery provides power to the motion alarm. If the
backup battery is not functioning, the motion alarm will not be activated.
• If the backup battery does not provide power to the alarm system during the motion alarm test, replace the battery.
• If battery has been in service for one year, replace battery.
• Use only manufacturer specified rechargeable battery for replacement (9V NiMH battery with a capacity of >175 mAh).
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Appendix A: Parts
A
B
D F
E
Front features (multiple models shown).
H
Rear features (multiple models shown).
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Right Side
B C D E F
A
Right side features (multiple models shown).
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Helmer Scientific
14400 Bergen Boulevard, Noblesville, IN 46060 USA