BLOOD PRODUCT STORAGE.

Transcription

1 BLOOD PRODUCT STORAGE

2 Welcome to the Labcold Blood Product Storage brochure incorporating our new range of platelet incubators and agitators. Here at Labcold, we pride ourselves on developing close relationships with our customers in order to meet the extremely focussed needs of the Blood Transfusion community. Due to this partnership and our understanding of blood storage regulations, Labcold has proactively developed blood banks, plasma freezers, platelet incubators and agitators which meet and often exceed current regulatory standards. All Labcold products are manufactured in compliance with ISO specifications. As you would expect, all our blood storage products are CE marked and certified as medical devices, thus giving you the confidence that Labcold products will support you through problem-free regulatory inspections. Labcold is the only UK manufacturer of such equipment, so are in a unique position to be reactive to your requirements in this rapidly changing specialism. That s why we not only provide you with a dedicated account manager, but also have our own team of fully trained service technicians capable of providing you with ISO quality, fully traceable calibration, commissioning, maintenance and servicing. Labcold has become the market leader through innovation, listening to our customers and responding to their needs in order to provide technically superior equipment and support. I would like to thank you for taking the time to look through this brochure and look forward to working with you in the future. Andrew Gillespie Managing Director Labcold Labcold, The Loddon Centre, Wade Road, Basingstoke, RG24 8FL United Kingdom

3 CONTENTS Features Large Capacity Blood Banks Compact Blood Banks Plasma Freezers Platelet Agitators and Incubators Temperature Monitoring Temperature Mapping Commissioning Maintenance Specification Matrix Labcold, The Loddon Centre, Wade Road, Basingstoke, RG24 8FL United Kingdom

4 Key Features Medical Device Certification All Labcold blood banks, plasma freezers, platelet incubators and agitators are medical devices in accordance with Directive 93/42/EEC and are manufactured in accordance with ISO good practice. This certification ensures that blood products are kept in optimum conditions making it easy for users to demonstrate compliance with CPA and MHRA guidelines when subject to regulatory inspections. Digital Door Locks Labcold blood banks and platelet incubators are fitted with an electronic digital door lock for total security. These digital door locks are designed to interface easily with blood tracking and audit systems, enhancing traceable operating procedures. Core Temperature Simulator Labcold blood storage equipment feature core/load simulator temperature recording. The reading from this probe is displayed in real time on the touch screen, so you can be certain that the contents are at the correct temperature. Since air temperature will vary with door openings and loading activity, it is vital to be certain that the blood stored is not adversely affected. Evidence of core temperature is also logged on an independent chart recorder. Alarm System All Labcold Blood product storage equipment features accurate alarm systems to protect the contents. All models in this range feature two temperature alarms; one for air and the other to monitor the load/core fluctuations. In addition there is also a door open alarm and a vital mains failure alarm. All the alarm systems have been designed to link easily to remote alarm systems. 4

5 Designed and Built in the UK Labcold only manufacture medical and scientific refrigeration. We are corporate members of BBTS and our Blood storage products are all certified medical devices in accordance with Directive 93/42/EEC We also manufacture a wide range of industry leading medical fridges and freezers suitable for the storage of pharmaceuticals, reagents and biological material. Commissioning As the manufacturer of the equipment, Labcold knows exactly what is required. We have an expert team of service technicians who can commission your equipment as part of your IQ/OQ procedures. The commissioning process also includes a comprehensive training session to ensure everyone who uses the equipment can do so correctly and safely. Manufacturer Maintenance Labcold knows that proof of annual maintenance and calibration is required by the MHRA. For safe function, calibration and longevity of specialist equipment and alarms, it is cost effective to use technicians who really understand both the equipment and the demands of blood bank professionals. This is why Labcold are unique in that we not only design and manufacture the products, but also have engineers trained in house, who can maintain and service it to manufacturers, and therefore MHRA standards. New Green Technology Labcold is committed to environmental responsibility and works hard to source materials that are ozone friendly with low Global Warming Properties. For example, many of the Labcold units are insulated with Envirofoam a material made from vegetable oil, harmless to the ozone layer and with low GWP. All Labcold refrigerants are CFC and HCFC free for the same reason and to improve energy consumption only LED lights are used. Labcold endeavours, where ever possible to use only UK sourced components in order to support local industry and reduce carbon emissions. 5

6 Large Capacity Blood Bank Refrigerators Key Features: Labcold blood banks are the brand of choice for NHS and private hospitals throughout the UK. Designed and manufactured to ensure the safe and secure storage of blood in accordance with current legislation, all models are certified Medical Devices. Uniquely Labcold has a dedicated team of trained area representatives who are able to advise and work with you prior to your purchase, carry out site surveys and offer support throughout the life of the product. Each product is purpose built to order at our Basingstoke factory and undergoes stringent testing before delivery. Labcold s experienced team of in-house engineers are available to provide a comprehensive commissioning service with user training and on-site calibration. An optional temperature mapping service is available on request. Designed and manufactured in the UK All models are certified medical devices in compliance with Directive 93/42/EEC Dual independent refrigeration systems* Touch screen control and temperature display Load alarm Air alarm Open door alarm Mains failure alarm Remote alarm contacts Electronic key pad door lock 7 day chart recorder Battery back up for alarm system Stainless steel interior Choice of drawers or shelves Choice of solid or glass doors* Inner doors Interior LED lights Lockable castors Access Port Environmentally friendly construction *Not available on the RDBB1160MD or RSBB1140MD 6

7 RSBG2540MD RSBG2270MD RDBB2640MD RSBB1140MD RSBB2270MD RDBG2640MD Did you know Labcold blood banks over 250 litres have two independent refrigeration systems? RDBB2320MD 7

8 Compact Blood Bank Refrigerators Key Features: Labcold compact blood banks are designed for small capacity requirements such as operating theatres, maternity units and community hospitals. Built to the same high specification as Labcold large capacity blood banks, these models offer a choice of two sizes. The smaller RSBG1030MD is suitable for a bench top location whilst the others are free standing. All larger models are available with a choice of glass or solid doors, drawers or shelves. For the transfer of blood between hospital departments Labcold has developed low cost, reusable, insulated transport boxes. These boxes, made from strong easy to clean plastic, come in a pack of ten for self assembly and convenient storage. 8 Labcold Insulated Transport Box Product code: RTBB0006 Designed and manufactured in the UK All models are certified medical devices in compliance with Directive 93/42/EEC Bench top or free standing models Touch screen control and temperature display Load alarm Air Alarm Open door alarm Mains failure alarm Remote alarm contacts Electronic key pad door lock 7 day chart recorder Battery back up for alarm display Stainless steel interior Choice of shelves or drawers Choice of glass or solid doors Inner doors or drawer fronts Interior light Access Port

9 RSBG1030MD RSBT1056MD Labcold Blood Baskets Labcold produce a range of baskets to be used in conjunction with Labcold shelf-model blood banks. Our baskets have been designed to fit all models and ensure good air circulation around the product whilst keeping product organised with labels visible. Part Number: BABB holds 5 bags BABB holds 7 bags BABB holds 8 bags BABB holds 10 bags RDBG1068MD 9

10 Plasma Freezers Key Features: Labcold plasma freezers have been designed specifically for the safe storage of fresh frozen plasma. All plasma freezers are manufactured to the same high standards as our blood banks at our Basingstoke head quarters. Our freezers are designed to operate at a temperature that maintains plasma in optimum condition and to minimise bag cracking on thawing. Labcold plasma freezers are fully tested before they leave the factory, so you can be confident that your freezer will be delivered ready to give you years of reliable service. A commissioning service is offered that includes comprehensive training and on-site calibration to aid your validation process. 10 Designed and manufactured in the UK All models are certified medical devices in compliance with Directive 93/42/EEC Conforms to BS4376:Part 2:1996 Bench top or free standing models Touch screen control and temperature display Load alarm Air alarm Door open alarm Mains failure alarm Remote alarm contacts Battery back up for alarm display 7 day chart recorder Lockable Optimum temperature for faster thawing

11 Did you know that Labcold can take care of all your service and maintenance needs? Why not ask for a quotation when you place your order? RVPF0234MD RVPF1434MD RVPF0734MD 11

12 Platelet Incubators and Agitators Key Features: Labcold platelet incubators have been designed and developed to operate in conjunction with Labcold agitators to ensure that platelets are stored under optimum conditions. Available in a range of sizes from compact bench top model to large capacity free standing, you can be sure there is an incubator to cover all your storage requirements. AGIT1006MD Labcold platelet agitators can accept either a 6-tray or 8-tray rack, and have been engineered to agitate at the correct speed as defined by the World Health Organisation. When used in conjunction with a Labcold incubator the agitator stops when the door is opened and resumes movement when the door is closed. An integral motion sensor and alarm will alert the user to any agitator failure.* *Not currently available on the RLPI0090MD. Designed and manufactured in the UK All models are certified medical devices in compliance with Directive 93/42/EEC Bench top or free standing models Touch screen control and temperature display Load alarm Air alarm Door open alarm Mains failure alarm Motion sensor alarm on larger models Remote alarm contacts Electronic key pad door lock 7 day chart recorder Battery back up for alarm display Internal light Access Port 12

13 Did you know that all Labcold Platelet Incubators and Agitators are certified Medical Devices? RLPI0090MD RLPI0130MD RACK1008 plus AGIT1006MD RLPI0550MD 13

14 Temperature Monitoring To supplement the in-built systems fitted to Labcold products we also offer a selection of temperature monitoring devices. These can be as simple as a portable logger for transport boxes up to sophisticated centralised multi-function systems. With increasing vigilance requirements from regulatory authorities it is essential to be able to prove storage temperatures at every step in the cold chain. Monitoring systems can provide a central alarm console and validated temperature records that are independent of the equipment s own recording device and are presented in a user friendly format that is easy to store and refer to. All Labcold blood storage equipment is fitted with remote contacts that activate in conjunction with the in-built alarm. This can provide a link to the hospital s own systems or external devices such as a telephone dial-out unit or remote alarm panel, both of which are available as accessories from Labcold. Key Features: Centralised Multi Channel Monitoring from 4 to 96 points Single Channel Portable Devices Data storage and analysis software (CFR21/11 compliant on some models) Temperature range from -220ºC to +100ºC Battery back up for continuous monitoring during power failures Compatible with most temperature controlled laboratory equipment On-site programming and commissioning service Optional telephone dial-out and remote alarms Monitor Max Part no. RMAS296CP Portable data logger Part no. RMBL1510 Repeat alarm module RLMR0016 Dial-Out unit RLMC

15 Temperature Mapping Key Features: To complete the validation picture Labcold offers a comprehensive temperature mapping capability, and report service. Labcold temperature mapping solutions are easy to use so please contact your area representative for more details on Three or seven day mapping service Report available as soft or hard copy Customised mapping available User friendly service The FuTure is coming The new generation of Labcold blood banks will incorporate temperature monitoring and mapping solutions in the control panel. They will feature: Paperless24/7monitoring Integral24/7mapping Comprehensivegraphic display of data on fridge Remoteaccessfromany webenableddevice 15

16 Commissioning and Calibration Key Features: To ensure your equipment performs at its best when you receive it, all Labcold products are fully tested before despatch. For example prior to despatch our blood banks undergo a comprehensive 31-point series of tests and checks to ensure they are performing correctly, and are then run for a minimum of 72 hours. However well equipment is tested during manufacture, transport and storage conditions combined with operation in a different environment make it essential to retest and validate before putting into use. Labcold offers an extensive manufacturers commissioning service to aid with user IQ/OQ procedures. As the manufacturer Labcold is best placed, and the professional choice, to provide this service using their own experienced in-house service technicians. When you order a commissioning your Labcold technician will: Check all packaging is removed Check the condition of the cabinet Fit pen, battery and chart paper to recorder (if necessary) Check operation of the digital lock Check operation of the internal light Test alarm panel function Test high alarm both air and load Test low alarm both air and load Test door open alarm Check dual cycling of refrigeration system (where necessary) Demonstrate the safe operation of keypad and change code Demonstrate how to change between refrigeration systems (where necessary) Demonstrate how to fit new chart paper and pen (where necessary) Demonstrate how to use the touch screen display and explain functionality Ensure the equipment is functioning correctly and key functions are MHRA compliant Train your team on how to use the equipment as required Check calibration of temperature monitoring systems and issue a hard copy certificate 16

17 Maintenance and Service Key Features: Our engineering team are in the unique position of knowing Labcold products better than anyone else. All our engineers are employed by us and spend every working day maintaining Labcold equipment. The field engineering team are backed up by office-based technical advisors and service administrators, who can provide you with support, spare parts and information on both new and older Labcold products. Labcold blood storage equipment is a certified Medical Device and therefore should be installed and maintained in accordance with manufacturer s instructions (DB2006 Managing Medical Devices, MHRA), and where parts are fitted it is important to ensure that these are manufacturer s original items or of identical specification. Failure to adhere to these standards potentially compromises your equipment s Medical Device status. As the manufacturer of the equipment, Labcold is the professional choice to provide this service. At Labcold we know there is no such thing as a typical maintenance but please see below for some of the work that would form part of your annual preventative maintenance contract. Full mechanical inspection including doors, gaskets, fans and wiring Full electrical inspection Full testing and recording of alarm system function and remote alarm connection Full inspection of the chart recorder with a calibration and change of battery if necessary Full check of temperature sensors and simulated load bottle Full check of compressor electronics and replace where necessary Check and calibrate digital display for air and load temperatures Provide advice on best practice and update training of operators if required Issue a comprehensive maintenance certificate Issue a calibration certificate In the unlikely event of your equipment needing an engineers visit in between preventative maintenance checks we can provide this service at a significantly reduced cost 17

18 Plasma Freezer ProDUCT information TaBle Plasma Freezer ParT NUmBer rvpf0234md rvpf0734md rvpf1434md CaPaCiTy (litres) CaPaCiTy (PaCks DePeNDiNg on size) HeigHT (mm) WiDTH (mm) DePTH (mm) WeigHT (kg) operating TemPeraTUre ºC -34 +/ / /-2 interior CoNsTrUCTioN Moulded Plastic Moulded Plastic Moulded Plastic exterior CoNsTrUCTioN Painted Mild Steel Painted Mild Steel Painted Mild Steel ColoUr White and blue White and blue White and blue style Counter top Upright Upright Door style Solid Solid Solid Door HiNgiNg Right Right Right open Door alarm load TemPeraTUre alarm air TemPeraTUre alarm mains FailUre alarm DUal refrigeration system microprocessor CoNTrol CasTors x rollers adjustable FeeT lock Manual key Manual key Manual key TemPeraTUre DisPlay - air TemPeraTUre DisPlay - load BaTTery BaCk UP 7 Day CHarT recorder shelves DraWers 3 6 interior light remote alarm CoNTaCTs auto DeFrosT CerTiFieD medical DeViCe in accordance WiTH DireCTiVe 93/42/eeC.ComPlies WiTH Bs4376:ParT 2:

19 BLOOD BANKS - COMPACT PRODUCT INFORMATION TABLE BLOOD BANKS - COMPACT MODEL RSBG1030MD RSBG1056MD RSBT1056MD RDBG1068MD RDBT1068MD CAPACITY (Litres) CAPACITY (250ml BAGS) HEIGHT (mm) WIDTH (mm) DEPTH (mm) WEIGHT (Kg) OPERATING TEMPERATURE ºC +4 +/ / / / /-2 INTERIOR CONSTRUCTION Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel EXTERIOR CONSTRUCTION Painted Mild Steel Painted Mild Steel Painted Mild Steel Painted Mild Steel Painted Mild Steel COLOUR White and blue White and blue White and blue White and blue White and blue STYLE Counter top Upright Upright Upright Upright DOOR STYLE Glass Glass Solid Glass Solid DOOR HINGING Right Right Right Right Right OPEN DOOR ALARM LOAD TEMPERATURE ALARM AIR TEMPERATURE ALARM MAINS FAILURE ALARM DUAL REFRIGERATION SYSTEM MICROPROCESSOR CONTROL CASTORS 4 x rollers 4 x rollers 4 x rollers 4 x rollers ADJUSTABLE FEET LOCK Digital Keypad Digital Keypad Digital Keypad Digital Keypad Digital Keypad TEMPERATURE DISPLAY - AIR TEMPERATURE DISPLAY - LOAD BATTERY BACK UP 7 DAY CHART RECORDER SHELVES DRAWERS 2 2 INTERIOR LIGHT REMOTE ALARM CONTACTS AUTO DEFROST* BASKET ACCESSORY FOR SHELF MODELS (ORDER SEPARATELY) CERTIFIED MEDICAL DEVICE IN ACCORDANCE WITH DIRECTIVE 93/42/EEC.COMPLIES WITH BS4376:PART1:1991 * may require periodic manual defrosting Max 5 x BABB4005 Max 8 x BABB per shelf Max 8 x BABB per shelf N/A N/A 19 Telephone:

20 BLOOD BANKS - LARGE CAPACITY PRODUCT INFORMATION TABLE BLOOD BANKS - LARGE CAPACITY PART NUMBER RSBB1140MD RDBB1160MD RSBB2270MD RSBG2270MD RDBB2320MD RDBG2320MD RSBB2540MD RSBG2540MD RDBB2640MD RDBG2640MD CAPACITY (Litres) CAPACITY (250ml BAGS) HEIGHT (mm) WIDTH (mm) DEPTH (mm) WEIGHT (Kg) OPERATING TEMPERATURE ºC +4 +/ / / / / / / / / /-2 INTERIOR CONSTRUCTION Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel EXTERIOR CONSTRUCTION Painted Mild Steel Painted Mild Steel Painted Mild Steel Painted Mild Steel Painted Mild Steel Painted Mild Steel Painted Mild Steel Painted Mild Steel Painted Mild Steel Painted Mild Steel COLOUR White and Blue White and blue White and blue White and blue White and blue White and blue White and blue White and blue White and blue White and blue STYLE Upright Upright Upright Upright Upright Upright Upright Upright Upright Upright DOOR STYLE Solid Solid Solid Glass Solid Glass Solid Glass Solid Glass DOOR HINGING Right Right Right Right Right Right Double Double Double Double OPEN DOOR ALARM LOAD TEMPERATURE ALARM AIR TEMPERATURE ALARM MAINS FAILURE ALARM DUAL REFRIGERATION SYSTEM MICROPROCESSOR CONTROL CASTORS 4 Heavy duty; lockable 4 Heavy duty; lockable 4 Heavy duty; lockable 4 Heavy duty; lockable ADJUSTABLE FEET LOCK Digital Keypad Digital Keypad Digital Keypad Digital Keypad Digital Keypad Digital Keypad Digital Keypad Digital Keypad Digital Keypad Digital Keypad TEMPERATURE DISPLAY - AIR TEMPERATURE DISPLAY - LOAD BATTERY BACK UP 7 DAY CHART RECORDER SHELVES DRAWERS INTERIOR LIGHT REMOTE ALARM CONTACTS AUTO DEFROST BASKET ACCESSORY FOR SHELF MODELS (ORDER SEPARATELY) CERTIFIED MEDICAL DEVICE IN ACCORDANCE WITH DIRECTIVE 93/42/EEC. COMPLIES WITH BS4376:PART1:1991 Max 16 x BABB per shelf N/A Max 5 x BABB x BABB5610 Max 5 x BABB x BABB Heavy duty; lockable N/A 4 Heavy duty; lockable N/A 4 Heavy duty; lockable Max 10 x BABB x BABB Heavy duty; lockable Max 10 x BABB x BABB Heavy duty; lockable N/A 4 Heavy duty; lockable N/A Telephone:

21 PLATELET INCUBATORS PRODUCT INFORMATION TABLE PLATELET INCUBATORS MODEL RLPI0090MD RLPI0130MD RLPI0550MD CAPACITY (Litres) CAPACITY (EQUIPMENT) 1x Labcold Platelet Agitator 1x Labcold Platelet Agitator 2x Labcold Platelet Agitators HEIGHT (mm) WIDTH (mm) DEPTH (mm) WEIGHT (Kg) OPERATING TEMPERATURE ºC +22 +/ / /-2 INTERIOR CONSTRUCTION Stainless steel Stainless steel Stainless steel EXTERIOR CONSTRUCTION Coated Steel Coated Steel Coated Steel COLOUR White and blue White and blue White and blue STYLE Upright Upright Upright DOOR STYLE Glass Glass Glass DOOR HINGING Right Right Right OPEN DOOR ALARM LOAD TEMPERATURE ALARM AIR TEMPERATURE ALARM MAINS FAILURE ALARM MOTION ALARM DUAL REFRIGERATION SYSTEM MICROPROCESSOR CONTROL CASTORS 4 x rollers 4 Heavy duty; lockable ADJUSTABLE FEET 4 2 LOCK Digital keypad Digital keypad Digital keypad TEMPERATURE DISPLAY - AIR TEMPERATURE DISPLAY - LOAD BATTERY BACK UP 7 DAY CHART RECORDER SHELVES 2 DRAWERS REMOTE ALARM CONTACTS AUTO DEFROST INTERIOR LIGHT CERTIFIED MEDICAL DEVICE IN ACCORDANCE WITH DIRECTIVE 93/42/EEC 22

22 PLATELET AGITATORS PRODUCT INFORMATION TABLE PLATELET AGITATORS (motion sensor available when platelet agitator is purchased with incubator) MODEL AGIT1006MD RACK1006 RACK1008 CAPACITY (Litres) N/A N/A N/A CAPACITY (PACKS DEPENDING ON SIZE) N/A 6 8 HEIGHT (mm) WIDTH (mm) DEPTH (mm) WEIGHT (Kg) INTERIOR CONSTRUCTION N/A N/A N/A EXTERIOR CONSTRUCTION Painted Mild Steel Stainless steel/aluminium Stainless steel/aluminium COLOUR White N/A N/A STYLE Upright Upright Upright MICROPROCESSOR CONTROL N/A N/A N/A SHELVES Rigid steel stand to support rack 6 slide out shelves with safety stops 238mm (w) x 299(d) 8 slide out shelves with safety stops 370mm (w) x 330mm(d) STROKE PER MINUTE (RANGE) 20-80rpm N/A N/A CERTIFIED MEDICAL DEVICE IN ACCORDANCE WITH DIRECTIVE 93/42/EEC The images and specifications of the products in this brochure are correct at the time of going to press, however Labcold reserve the right to change products and specification. Please confirm full details at time of order. Some products and services may not be available outside of the UK. For full terms and conditions please visit our website at or contact us by phone on or by post at Labcold, The Loddon Centre, Basingstoke, Hants, RG24 8FL. Labcold is a limited company based in the United Kingdom. Labcold The Loddon Centre Basingstoke RG24 8FL United Kingdom 23 Telephone:

23 The Loddon Centre Tel: Wade Road Basingstoke RG24 8FL