i.Series and Horizon Series Platelet Agitator various models Operation Manual Rev P

Document History Revision

Date

CO

Supersession

Revision Description

28 JUN 2013* 8414

Supersedes A, B, C, D, E, F, G, Revised layout for ease of navigation and locating information. H, I, J, K, L

N

23 DEC 2013* 8965

► ► N supersedes M ► ►

O

31 JAN 2014*

O supersedes N Changed voltage for remote alarm contacts.

P

22 MAY 2014* 9497

M

9113

P supersedes O

Added 100 V information. Added caution note for remote alarm interface. Revised clearance statement. Revised section I for consistency with existing manuals.

► Added information to environmental/application specifications from technical audit. ► Revised specifications for remote alarm contacts.

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

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i

Contents Section I: General Information... 4 1 About this Manual... 4 1.1 1.2 1.3

Intended Audience... 4 Model References... 4 Copyright and Trademark... 4

2 Safety... 4 2.1 2.2 2.3

Safety Definitions... 4 Product Labels... 5 Avoiding Injury... 5

3 General Recommendations... 6 3.1 3.2 3.3

Intended Use... 6 General Use... 6 Initial Loading... 6

4 Specifications... 6 5 Compliance... 7 5.1 5.2

Regulatory Compliance... 7 WEEE Compliance... 7

6 Installation... 8 6.1

Location Requirements... 8 6.1.1 Placement... 8

7 Maintenance Schedule... 9

Section II: i.Series™ Models... 10 8 Operation... 10 8.1 8.2 8.3

8.4

Initial Start Up... 10 Configure the Platelet Agitator for Use in an i.Series Incubator (Optional)... 10 Motion Alarm... 10 8.3.1 Enable and Disable Motion Alarm... 10 8.3.2 Set Alarm Delay... 11 8.3.3 Set Alarm Volume... 11 Enable or Disable Motion... 12 8.4.1 Stand-Alone Platelet Agitators... 12 8.4.2 Platelet Agitators Installed in i.Series Platelet Incubators... 12

9 Load the Agitator... 13 10 Components... 14 10.1 10.2 10.3 10.4 10.5

Front... 14 Left Side... 15 Right Side... 16 Rear... 17 Bottom... 18

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Section III: Horizon Series™ Models... 19 11 Operation... 19 11.1 Initial Start Up... 19 11.2 Enable and Disable Motion... 19 11.2.1 Stand-Alone Platelet Agitators... 19 11.2.2 Platelet Agitators Installed in Horizon Series Platelet Incubators... 19

12 Load the Agitator... 20 13 Components... 21 13.1 13.2 13.3 13.4

Front... 21 Left Side... 21 Rear... 22 Bottom... 22

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General Information

Section I: General Information 1

About this Manual

1.1

Intended Audience This manual is intended for use by end users of the platelet agitator and authorized service technicians.

1.2

Model References Generic references are used throughout this manual to group models that contain similar features. For example, “PF48 models” refers to all models of that size (PF48i, PF48h). This manual covers all platelet agitators, which may be identified singly, by their size, or by their respective “Series.”

1.3

Copyright and Trademark Helmer®, i.Series®, Horizon Series™, and Rel.i™ are registered trademarks or trademarks of Helmer, Inc. in the United States of America. Copyright © 2014 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.

2

Safety The operator or technician performing maintenance or service on Helmer Scientific products must (a) inspect the product for abnormal wear and damage, (b) choose a repair procedure which will not endanger his/her safety, the safety of others, the product, or the safe operation of the product, and (c) fully inspect and test the product to ensure the maintenance or service has been performed properly.

2.1

Safety Definitions The following general safety alerts appear with all safety statements within this manual. Read and abide by the safety statement that accompanies the safety alert symbol.

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WARNING

The safety statement that follows this safety alert symbol indicates a hazardous situation which, if not avoided, could result in serious injury.

CAUTION

The safety statement that follows this safety alert symbol indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

NOTICE

The safety statement that follows this safety alert symbol indicates a situation which, if not avoided, could result in damage to the product or stored inventory.

4

General Information

2.2

Product Labels The following general safety and information alerts appear on the product to identify potential hazards to the operator or service technician.

2.3

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Caution: Risk of damage to equipment or danger to operator

Caution: Unlock all casters

Caution: Hot surface

Earth / ground terminal

Caution: Shock/electrical hazard

Protective earth / ground terminal

Avoiding Injury ► Review safety instructions before installing, using, or maintaining the equipment. ► Before moving unit, remove contents from the drawers. ► Do not open multiple drawers at the same time. ► Before moving unit, disconnect the AC power cord and secure the cord. ► When moving unit, use assistance from a second person. ► Never physically restrict any moving component. ► Avoid removing electrical service panels and access panels unless so instructed. ► Keep hands away from pinch points when agitation motion is enabled. ► Avoid sharp edges when working inside the electrical compartment. ► Ensure biological materials are stored at recommended temperatures determined by standards, literature, or good laboratory practices. ► Proceed with caution when adding and removing samples from the platelet agitator. ► Use supplied power cord only. ► Using the equipment in a manner not specified by Helmer Scientific may impair the protection provided by the equipment. ► Decontaminate parts prior to sending for service or repair. Contact Helmer Scientific or your distributor for decontamination instructions and a Return Authorization Number. ► Ensure biological materials are stored safely, in accordance with all applicable organizational, regulatory, and legal requirements. ► The platelet agitator is not considered to be a storage cabinet for flammable or hazardous materials.

5

General Information

3

General Recommendations

3.1

Intended Use 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.

3.2

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.

3.3

Initial Loading After platelet agitator reaches room temperature, begin storing product.

4

Specifications PF15

PF48

PF96

PF396i

Height

12.50” (318 mm)

15.25” (387 mm)

15.25” (387 mm)

62” (1575 mm)

Width

13.00” (330 mm)

17.50” (445 mm)

33.00” (838 mm)

37” (940 mm)

Depth

9.25” (235 mm)

14.50” (368 mm)

14.50” (368 mm)

27” (686 mm)

Weight

26.5 lbs (12 kg)

51.0 lbs (23 kg)

82.0 lbs (37 kg)

250.0 lbs (114 kg)

Physical (1, 2)

Electrical Input Voltage and Frequency Voltage Tolerance Fuses (3) Power Consumption (4) Power Source (5) Agitation Speed (cycles / minute) Remote Alarm Capacity

115 V, 60 Hz 230 V, 50 Hz 230 V, 60 Hz

100 V, 50/60 Hz / 115 V, 60 Hz 230 V, 50 Hz / 230 V, 60 Hz ±10% 0.5 A (100 V, 115 V, quantity 1) 0.3 A (230 V, quantity 2)

6.3 A (115 V, quantity 1) 5.0 A (230 V, quantity 2)

0.4 A (100 V, 115 V) 0.25 A (230 V)

3.0 A (115 V) 2.0 A (230 V)

Varies (refer to product specification label) 72 (100 V / 115 V) 60 (230 V, 50 Hz) 72 (230 V, 60 Hz)

60 (115 V) 60 (230 V, 50 Hz) 72 (230 V, 60 Hz)

i.Series: 0.5 A at 30 V (RMS); 1.0 A at 24 V (DC) Horizon Series: 0.25 A at 30 V (RMS); 0.25 A at 60 V (DC)

Control and Monitoring Alarms

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Motion

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General Information

PF15

PF48

PF96

PF396i

Environmental

Application

► ► ► ►

Indoor use only Altitude (maximum): 2000 m Ambient temperature range: 5 °C to 35 °C Relative humidity (maximum for ambient temperature): 80% for temperatures up to 31 °C, decreasing linearly to 50% at 40 °C ► Overvoltage category: II ► Pollution degree: 2 ► Mains supply voltage: ±10% of nominal voltage

(1) Add 0.5” (13 mm) to the width for PF15i, PF48i, and PF96i platelet agitators to accommodate the alarm buzzer. (2) Add 1.5” (38 mm) to the width for PF15i, PF48i, and PF96i platelet agitators to accommodate the storage frame when agitation motion is enabled. (3) Fuses are 5 mm x 20 mm, time lag (Type T). (4) Power consumption is measured in full-load Amperes. (5) Product specification label is located on the bottom of the platelet agitator (PF15) or the rear of the platelet agitator (PF48, PF96, PF396i). CAUTION

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► 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 60 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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General Information

5

Compliance

5.1

Regulatory Compliance This device complies with the requirements of directive 93/42/EEC concerning Medical Devices, as amended by 2007/47/EC. Sound level is less than 70 dB(A).

EC

REP

Emergo Europe Molenstraat 15 2513 BH The Hague, Netherlands

NOTE 5.2

PF396i platelet agitator is not CE compliant.

WEEE Compliance The WEEE (waste electrical and electronic equipment) symbol (right) indicates compliance with European Union Directive WEEE 2002/96/EC and applicable provisions. The directive sets requirements for the labeling and disposal of certain products in affected countries. 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.

6

Installation

6.1

Location Requirements ► Has a sturdy, level surface. ► Has a grounded outlet meeting the electrical requirements listed on the product specification label. ► Is clear of direct sunlight, high temperature sources, and heating and air conditioning vents. ► Minimum 0.5” (13 mm) in front and behind. ► Minimum 1” (25 mm) on left and right sides (when installed in a corresponding Helmer platelet incubator). ► Minimum 2” (50 mm) on left and right sides (when installed in a stand-alone configuration). ► Meets limits specified for ambient temperature and relative humidity. NOTE

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A power cord is supplied to configure the platelet agitator for stand-alone use.

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General Information

6.1.1

Placement WARNING 1 2 3

To prevent tipping, ensure the casters are unlocked (PF396i).

Ensure all casters are unlocked (PF396i). Place platelet agitator on study surface or roll platelet agitator into place and lock casters (PF396i). Ensure platelet agitator is level.

NOTICE

Countertop models: ► 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. PF396i: ► When moving the platelet agitator, push using the sides of the base, not the front or back.

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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.

Task Test the motion alarm. Clean the fan (except PF396i).

Frequency Quarterly

Annually

(i.Series) 

Clean the vents in the base (PF396i).

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As Needed



Check the backup battery for the motion alarm system after an extended power failure and change it if necessary, or change the battery if it has been in service for one year.

(i.Series)

Check moving parts for wear. Clean and lubricate moving parts.



Replace moving parts if worn.



Clean the exterior of the platelet agitator.



NOTE

Clean the fan on a quarterly basis.

NOTE

► 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. ► i.Series: If battery has been in service for one year, replace battery.

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i.Series® Models

Section II: i.Series® Models 8

Operation

8.1

Initial Start Up 1 Switch the agitation ON/OFF switch OFF. 2 Plug the power cord into a grounded outlet that meets the electrical requirements on the product specification label. 3 Connect the backup battery for the motion alarm. 4 Switch AC ON/OFF switch ON.

8.2

Configure the Platelet Agitator for Use in an i.Series Incubator (Optional) Helmer i.Series platelet agitators may be installed in a stand-alone configuration, or in a Helmer i.Series platelet incubator. When installed in a Helmer platelet incubator, motion information is transmitted from the platelet agitator to the platelet incubator through a data cable. NOTE

8.3

Refer to the platelet agitator service manual for information regarding the installation of a platelet agitator in a platelet incubator.

Motion Alarm When platelet agitator motion stops the motion alarm is activated. The alarm condition is communicated as follows: ► Red alarm LED illuminates. ► Audible alarm buzzer sounds. ► 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 i.Series countertop platelet incubator (if platelet agitator is installed in an i.Series platelet incubator).

8.3.1

Enable and Disable Motion Alarm

Motion alarm switch (circled). ► Switch the motion alarm ON/OFF switch ON. ► Switch the motion alarm ON/OFF switch OFF. NOTICE

If motion stops while the motion alarm is switched off, communication of the alarm (visual, audible, and signals to external devices) is suppressed.

Stand-Alone Platelet Agitators ► Enable the motion alarm when using the platelet agitator. ► Disable the motion alarm when not using the platelet agitator. Lack of motion triggers the alarm. Platelet Agitators Installed in i.Series Platelet Incubators ► Disable the motion alarm when installing the platelet agitator in a Helmer i.Series platelet incubator. 360092-1/P

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i.Series® Models

NOTE

8.3.2

► 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. ► If the motion alarm is not disabled on the platelet agitator, the motion alarms on both devices will sound.

Set 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.

Alarm delay control (circled). The default motion alarm delay is set at the halfway point (approximately 4 to 5 minutes). To change the motion alarm delay, use a small flat-head screwdriver. ► Rotate the control to the left (counterclockwise) to shorten the motion alarm delay. ► Rotate the control to the right (clockwise) to extend the motion alarm delay. NOTE

8.3.3

► Do not set the alarm delay to 0 minutes. ► Default alarm delay is set at the halfway point (approximately 4 to 5 minutes). ► Maximum alarm delay is 8 minutes.

Set Alarm Volume

Alarm volume control (circled). ► The motion alarm has three settings (low, medium, high). ► Default setting is medium (switch is in the middle position). ► Slide the motion alarm switch to the appropriate position for the desired volume level.

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i.Series® Models

8.4

Enable or Disable Motion

Agitation switch. 8.4.1

Stand-Alone Platelet Agitators Start Agitation: 1 Switch the agitation ON/OFF switch ON. 2 Switch the motion alarm switch ON/OFF switch ON. Stop Agitation: 1 Switch the motion alarm switch ON/OFF switch OFF. 2 Switch the agitation ON/OFF switch OFF.

8.4.2

Platelet Agitators Installed in i.Series Platelet Incubators ► The door switch on Helmer platelet incubators controls power to the installed platelet agitator(s). ► When the platelet incubator doors(s) is opened, power to the installed platelet agitator(s) is interrupted and agitation motion is paused. ► When the platelet incubator door(s) is closed, agitation motion is resumed. NOTE

Ensure the platelet agitator motion alarm switch ON/OFF is switched OFF.

Start Agitation: 1 Open the platelet incubator door(s). Agitation motion stops. 2 Load items into the platelet agitator. 3 Close the platelet incubator door(s). Agitation motion resumes. NOTE

For a platelet agitator installed in a stand-alone configuration, switching the agitation ON/OFF switch ON will start the agitation motion.

Stop Agitation: 1 Open the platelet incubator door(s). The platelet agitator motion stops. 2 Remove items from the platelet agitator. 3 Close the platelet incubator door(s). NOTE

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► Agitation motion will resume if the agitation ON/OFF switch is not switched OFF. ► For a platelet agitator installed in a stand-alone configuration, switching the agitation ON/OFF switch OFF will stop the agitation motion.

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i.Series® Models

9

Load the Agitator

PF48i agitator with platelet bags (shown in a Helmer PC900i incubator). Model

Capacity Random Bags Apheresis Bags

PF15i

15

5-10

PF48i

48

16

PF96i

96

32

PF396i

396

132

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. ► Avoid stacking bags. ► Maintain enough space around each bag for air circulation. For thicker bags, remove drawers. ► Place the tubing under or around the bag.

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i.Series® Models

10

Components

10.1

Front

A B

C

D

E

F

G

Front features (multiple models shown).

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Label

Description

A

Storage frame

B

Drawer (not included on PF15i)

C

Base

D

Agitation switch

E

Motion alarm lamp

F

Motion alarm switch

G

Alarm buzzer

14

i.Series® Models

10.2

Left Side

A

B

C

D E

F

Left side features (PF15i shown). Label

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Description

A

Power connector

B

Fuse

C

Data cable port

D

Fan

E

Alarm volume control

F

Alarm delay control

15

i.Series® Models

10.3

Right Side

A

B

C

D

E

Right side features (multiple models shown).

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Label

Description

A

Access hole

B

Alarm buzzer

C

Data cable port

D

Alarm volume control

E

Alarm delay control

16

i.Series® Models

10.4

Rear

A

B C

D E

F

G

Rear features (multiple models shown). Label

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Description

A

Product specification label

B

Power connector

C

Vent

D

Fuse

E

Data cable port

F

Alarm volume control

G

Alarm delay control

17

i.Series® Models

10.5

Bottom

A

B

Bottom features (multiple models shown). Label

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Description

A

Product specification label

B

Fan

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Horizon Series™ Models

Section III: Horizon Series™ Models 11

Operation

11.1

Initial Start Up 1 Switch the agitation ON/OFF switch OFF. 2 Plug the power cord into a grounded outlet that meets the electrical requirements on the product specification label. 3 Switch AC ON/OFF switch ON.

11.2

Enable and Disable Motion

Agitation switch. 11.2.1

Stand-Alone Platelet Agitators Start Agitation: 1 Switch the agitation ON/OFF switch ON. 2 Switch the motion alarm switch ON/OFF switch ON. Stop Agitation: 1 Switch the motion alarm switch ON/OFF switch OFF. 2 Switch the agitation ON/OFF switch OFF.

11.2.2

Platelet Agitators Installed in Horizon Series Platelet Incubators Start Agitation: 1 Open the platelet incubator door(s). 2 Switch the agitation ON/OFF switch ON. 3 Close the platelet incubator door(s). Agitation motion starts. NOTE

For a platelet agitator installed in a platelet incubator, if the agitation ON/OFF switch is switched ON, closing the platelet incubator door(s) will start the agitation.

Stop Agitation: 1 Open the platelet incubator door(s). 2 Switch the agitation ON/OFF switch OFF. 3 Close the platelet incubator door(s). Agitation motion stops. NOTE

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For a platelet agitator installed in a platelet incubator, if the agitation ON/OFF switch is switched ON, opening the platelet incubator door(s) will stop the agitation motion.

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