Model AGIT1006MD Instructions Ver 10 July 2015

Thank you for purchasing this Labcold product which has been made with great care and has been tested thoroughly before despatch. The following information is provided for your guidance: 1. Acceptance: Immediately upon delivery to you the product packaging and the product itself should be inspected for any signs of damage. It was perfect when it left us and should still be so when you receive it. If this is not the case, please contact the supplier from whom you ordered it within three days of delivery. 2. Warranty: This Labcold product is warranted against manufacturing defect or malfunction for a period of 12 months from the date of delivery. This warranty, valid within the United Kingdom only, covers all parts and labour required to return the product to correct working order subject to the Standard Conditions of Sale provided it has been operated and cared for in accordance with this operators manual. 3. Liability is limited to the extent of the Standard Conditions of Sale. Customers are advised that their rights to claim for damages lie with the supplier from whom the item was purchased. Labcold and its agents accept no further liability for the loss of customer’s stored samples, products or other contents, nor the direct or indirect economic or other consequences resulting from such loss. Customers are therefore advised to ensure that they establish suitable checking and monitoring protocols as appropriate to the importance and risk associated with the stored contents in order to mitigate any loss that may occur. Customers are further advised to ensure that they have a suitable contingency plan in place to safeguard their stored property in the event that the unit cannot be repaired in time to prevent loss or spoilage. 4. Customers are advised to read this manual together with the supplier’s Standard Terms and Conditions of Sale to which this product, its use, delivery and installation, repair, and warranty are subject. A copy of the Standard Terms and Conditions of sale may be obtained by contacting the supplier or viewing their catalogue or web site. WEEE: Disposal at end of life This equipment, when being disposed of in an EU Member State, is subject to the Waste Electrical and Electronic Equipment Regulations (WEEE) and must be recycled and disposed of in accordance with EU Directive 2002/96/EC as applied in local laws of that State at the time of disposal. The symbol below on the appliance or accompanying documents indicates that this Agitator should not be treated as ordinary waste but must be taken to a special collection centre for the recycling of electrical equipment. For more information regarding the treatment, recovery or recycling of this product, contact your competent local office, electrical waste disposal or supplier from whom you purchased the Agitator.

As this item is designed for medical use, before presenting for collection and disposal it will be necessary for the user to provide documentary evidence of decontamination and/or that it is entirely safe to handle and dismantle outside of a controlled environment. Goods that cannot be so certified fall outside the scope of the Directive and remain the user’s responsibility to dispose of. This Agitator is designed to operate at +22°C ± 2°C when agitating platelets 1

AGIT1006MD Platelet Agitator Instruction Manual: version 10, July 2015

Operating Instructions for Labcold Platelet Agitator Model AGIT1006MD The Agitator is designed to gently agitate platelets according to the guidelines of the UK Blood Transfusion & Tissue Transplant Services; Chapter 7.10, Platelets, Aphaeresis, Leucocyte Depleted. Racks are available to hold 6 or 8 packs and the Agitator should be placed in a suitable environment to comply with the above guidelines.  It has come to our attention that there are a variety of pack styles and sizes in use at the moment. The larger size (e.g Pooled packs) are longer than the racks were designed to accept. The Pall Medical 1.5 litre packs are not suitable for the six place rack, however, in extremis a single pack can be placed on the top tray as long as some nonslip material is placed on the tray between the pack and the bag. Some pack/bag manufacturers are no longer putting an anti slip surface on the reverse of the bags and nonslip material might be required to avoid bag movement. Non-slip material is available in packs of 6 or 8 for the two rack sizes: Part No. ANTISLIP 6 for the six shelf rack and ANTISLIP 8 for the eight shelf rack. If pack displacement is a problem then the speed of agitation may be adjusted to a slower rate. The equipment is designed to be operated only by a laboratory technician with the relevant training and experience Assembly Unpack the Agitator and remove all packing from inside and around the racking. Place the rack onto the Agitator. Ensure the moulded base is fitted evenly over the Agitator platform on all four sides. Do not plug in to the mains supply.

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Shelves should be positioned with the lip upwards

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Each shelf has 2 stops one either side of the rack

Moulded base

Agitator shelves

 Ensure that the shelf stop is positioned at right angles to the rack support. This prevents the trays being fully pulled out of the racking

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Shelf stop

Left side of racking q

q Front of racking

AGIT1006MD Platelet Agitator Instruction Manual: version 10, July 2015

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Installing the Agitator If using in a Labcold Platelet Incubator •

Open the door and place the assembled Agitator on the floor or shelf of the chamber. Do not at this stage push the Agitator fully back inside the chamber.

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Locate the mains & sensor cables for the Agitator and connect the Agitator and the Labcold Incubator with reference to the Incubator Instruction Manual. Ensure that the sensor cable is fully inserted into the sockets at each end. Note: The mains lead (with IEC shrouded plugs at each end) will be found within the chamber of the Incubator.

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Push the Agitator back into the chamber as far as it will go without damaging the mains or sensor cable and ensuring it will not hit the Incubator interior on operation. Turn on the Agitator using the green illuminated switch on the front panel.

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The Labcold Incubator can now be plugged into the mains supply and the chamber door closed. Once the door is closed, the rack will begin to rotate.

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If the Agitator is used in a Labcold Platelet Incubator models number RLPI0130MD or RLPI0550MD then the Labcold Incubator display will show the detection of motion and the approximate rotational speed in rpm. If the Agitator malfunctions an error message will be displayed and an alarm will sound.

If the Agitator is to be used other than in a Labcold Incubator: •

The mains cable (with integral 3 pin plug) will be found packed with the Agitator;

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Plug power lead into Agitator and power socket; WARNING! If any power supply cord is damaged it MUST be replaced by the manufacturer, its service agent or similarly qualified persons in order to avoid a hazard

Loading the Agitator To load, the Agitator trays should be pulled forward individually, with packs being loaded as shown below. Tails of the packs should be tucked away to prevent catching in the rack.

Using the Agitator The Platelet Agitator is a variable speed unit which when switched on will run at one of 5 user selectable target speeds between 40 and 60 rpm. If used within a Labcold Platelet Incubator and with a door detector, the Agitator will switch off when the door is opened. When the door is closed, the rack will begin to rotate. Please allow time for the Agitator to stop rotating before touching the racking. 3

AGIT1006MD Platelet Agitator Instruction Manual: version 10, July 2015

Agitator display The Agitator has a blue LED display which indicates the speed of rotation or an error message if the Agitator encounters an issue.

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q Select button

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This light flashes with each rotation of the agitator in normal operation Digital display showing the actual speed averaged over a 10 second period

Start up The Platelet Agitator remembers key operating settings such that whenever it is powered up, it will return to its last state of operation. The Platelet Agitator will begin to turn whenever it is started, and the speed is gradually increased towards the stored target speed. This occurs over a period of around 30 seconds, during which time the display will show a rotation of one segment around its edge as can be seen below. During this start-up sequence, the select button is disabled and so the target speed cannot be viewed or altered. The first time that the Platelet Agitator starts up it will default to operating at 50 rpm.  It may take some time for your Platelet Agitator to settle at the target speed after starting up, this is perfectly normal.

After this initial start-up sequence, the Agitator requires a settling period in order to acquire an initial speed measurement, this takes approximately 10 seconds, during this time the display will alternate between illuminating two opposite corners at a time. AGIT1006MD Platelet Agitator Instruction Manual: version 10, July 2015

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Changing the rotation speed The rotation speed of the Platelet Agitator can be viewed and altered using the select button. An initial push of this button will display the current speed for a minimum of 2 seconds; during this time the central decimal point of the display will flash quickly to indicate that the displayed speed is the set speed and not the current operating speed of the Agitator. Decimal point flashes to indicate the speed shown is the set speed q

To alter the set rotation speed: Note: To complete this task when an Agitator is installed within a Labcold Incubator, you must manually hold the door switch in the closed position to allow the set rotation speed to be altered, or alternatively, the change can be completed with the Agitator on the bench and plugged directly into the mains using the three pin power cord supplied •

Whilst the Agitator is running, press the “Select” button to show the set speed;

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Press the button again to alter the rotation speed by 5 rpm. The rotation speed can be set in 5 rpm steps between 40 and 60 rpm;

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A subsequent button push that occurs when the unit is at either extreme of the possible options (40 or 60 rpm) will cause the option cycle to change direction;

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The set point will be displayed when the speed of rotation is within 2 rpm of the set point.  It may take some time for your Platelet Agitator to settle at the target speed after it is changed, this is perfectly normal.

Fault Finding If the Platelet Agitator does not run at all, i.e. the illuminated front switch and the User display are off: 1. 2.

Check that the Agitator cable is plugged into the mains supply Check that the illuminated switch is in the on position

Should the Platelet Agitator detect that an Error has occurred (e.g. it has stopped rotating, that it is running too fast and is failing to slow down or in the event of a sensor failure) the display will flash the set target speed and either ‘Er’ or an error code alternately (depending on the software version), as shown below:

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AGIT1006MD Platelet Agitator Instruction Manual: version 10, July 2015

If this error message occurs, switch the Platelet Agitator off and wait for it to stop completely before turning it back on. This should resolve the issue, however, if the error persists please phone the Labcold Service Team on 01256 705 580 and move your platelets to a working Agitator. Cleaning and servicing Daily cleaning A daily wipe down of external surfaces with a cloth dampened with mild detergent (e.g. household washing up liquid) or a commercially available biocide wipe is all that is required. Before wiping surfaces switch the Agitator off and disconnect from the mains supply. WARNING: Always switch off the Agitator and disconnect from the mains supply before cleaning Thorough cleaning after spillage • • •

Contamination after spillage should be cleaned using an appropriate viricide. Follow the viricide manufacturer’s instructions with regard to solution strength and always remove any residual solution after cleaning. Remove the shelves by turning the shelf stops on both sides of the rack (as shown below) this will enable the shelf to completely slide out from the racking Dry all components before replacing back into the racking remembering to reposition the shelf stops on completion.

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Shelf stop in the open position allowing the shelf to be removed

Servicing Whilst the Agitator is running, any appreciable increase in, or untoward noise from it should be reported to an appropriate authorised person for further investigation. Should you require Service or advice on the use of this Agitator please call the Labcold Service Team on 01256 705 580. This Agitator requires specialist tools to repair and whilst service information is available, including wiring diagrams and parts lists, it is recommended that the equipment be returned to Labcold for repair. Maintenance and servicing of the Agitator should only be carried out by competent persons qualified for this work. WARNING: no modification of this medical quipment is allowed AGIT1006MD Platelet Agitator Instruction Manual: version 10, July 2015

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Technical Information Environmental conditions: Supply Voltage Fuse Rating Agitator Appliance Connector

Operational Temperature (with platelet bags) +22° C ± 2 °C 230V AC 50Hz Single phase 230V 2A 230V 3A

Size 5x20mm Size 6.3x25.4mm

Type T Anti Surge BS1362

EC DECLARATION OF CONFORMITY TO MEDICAL DEVICES DIRECTIVE 93/42/EEC, as amended by DIRECTIVE 2007/47/EC Equipment: Labcold Platelet Agitator Part Ref: AGIT1006MD; used in conjunction with either: RACK1006 or RACK1008 Labcold Limited (The Company) declares that: 1 It is the manufacturer of the medical device known as AGIT1006MD which has been designed to meet the requirements of the UK Blood Transfusion & Tissue Transplantation Services “Guidelines for the Blood Transfusion Services in the UK” chapter 8.10 “Platelets, Aphaeresis, Leucocyte depleted – Storage” which requires that platelets are kept under continuous gentle agitation during storage; 2. The devices listed all conform to the relevant provisions of the EC Council Directive 93/42/EEC dated 14 June 1993 as amended by Directive 2007/47/EC dated 5 September 2007; 3. The device is a class IIa product as defined in Annex IX of the Directive; 4. ‘Full quality assurance system’ as defined in Annex II (Excluding the examination of the design of the product) of the Directive is the product conformity process used in the design, development, manufacture and testing of the device; 5. A Quality Management System based on the latest edition of BS EN ISO 13485 has been developed and implemented to ensure compliance with Annex II; 6. The relevant requirements of the Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC have been implemented and are subject to both internal and external audit; 7. The Company has appointed SGS United Kingdom Ltd, (Notified Body, number 120) to verify compliance against BS EN ISO 13485 and the Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC; 8. No other application has been lodged with another Notified Body for the same devices or related quality management system; 9. No medicinal products or drugs are incorporated in any of the devices listed in this Declaration. 10. Labcold Ltd, self certifies that the devices list all conform to Article 4 and relevant Annexes of the EC Council Directive 2011/65/EU(Recast Directive on the Restriction of Hazardous Substances in electrical and Electronic Equipment). Notified Body number 0120 is not responsible for monitoring compliance with Directive 2011/65/ EU.

Appointed signatory: Andrew Gillespie Development Director, Labcold Limited Date: 4 March 2015

www.labcold.com

Cherrywood, Chineham Park, Basingstoke, RG24 8WF, United Kingdom 7

AGIT1006MD Platelet Agitator Instruction Manual: version 10, July 2015