blood safety · 2015. 9. 3. · blood traceability i in healthcare establishment at the blood...

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Ensuring a safe and secure supply of blood and blood products, as well as the appropriate and rational use, are important public health responsibilities of every nation and government.

“Blood Safety” comprises different activities from collection to transfusion.

BLOOD SAFETYGlobal Safe Blood Management

www.bmedicalsystems.com

Your global partner to save lives.

B Medical Systems I Blood Safety

02 | 03 BLOOD SAFETY Your global partner to save lives.

BLOOD SAFETY For a reliable cold chain within the scope of safety of blood transfusions.

Depending on the product

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SUMMARY

Blood TraceabilityRFID technology for a complete traceability and identification of RBCCs

Blood Cold Chain A selected range of products for an uninterrupted and precisely temperature controlled blood cold chain

Accessories & SoftwareFor optimum control and protection of your preparations

Pages

26 – 27

04 – 17

18 – 25

0499

EN ISO 13485

CERTIFIED

II 3 G Ex nA II T6

REINRAUMKLASSIFIZIERUNGCLASSIFICATION DES SALLES BLANCHES

CLEAN ROOM CLASSIFICATION

ADR RID (2008/68/EC)

IMDG (2002/84/EC)

ICAO-TI / IATA-DGR

ÖNORM K 2030

B Medical SystemsYour global partner to save lives.B Medical Systems S.à r.l. is a pioneer in the medical industry. The company was founded in 1979 when the World Health Organization approached Electrolux in Vianden, Luxembourg, to provide a solution to their problems in safely storing and transporting vaccines around the world. Subsequently, the Electrolux refrigeration division became the Dometic Group.

In March 2015 Navis Capital Partners and the management team acquired the medical division from the Dometic Group under the new name B Medical Systems S.à r.l.. The name change reflects the deep conviction of the team and share-holders, to continuously deploy dedicated solutions in its customers in the healthcare field.

B Medical Systems S.à r.l. specializes in research, develop-ment and the manufacture of professional refrigerators, freezers, storage and solutions for safe transport and manage-ment of blood and vaccines. With our worldwide network of distributors, our own Research and Development capability and flexible manufacturing facilities, we will continually strive for excellence in product development, manufacturing and customer service across all of our product lines.

We are committed to exploring new technologies, increasing the variety of our products and seeking new fields of busi-ness. B Medical Systems S.à r.l. is a flexible, innovative and customer-oriented company, which has always been recog-nized for the excellence and performance of its products. We have always based our reputation on one rule: “never com-promising on standards” to deliver the best performance these programs deserve, for humanity.

Over the past few years, we have been supported extensively and passionately by our regional consultants and country partners who dedicate themselves to our cause and have gained credibility in their own right with the regional agen-cies and country authorities.

Blood Traceability> RFID technology for a complete traceability and identification of RBCCs

Blood Cold Chain> A selected range of products for an uninterrupted and precisely temperature controlled blood cold chain

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04 | 05 BLOOD SAFETY

Blood Traceability I Global Haemovigilance at a glance


RFID SOLUTION> for perfect

Blood Traceability from donor to receiver

Interactions within the Biolog solution

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DONORIIIIIIIIIIIIIIIIIIIIIIIII IIIII IIIIIII IIIIIIIIIIIIIIIIIIIIIIIIIIIIIII

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BEDSIDECROSSMATCH

TRANSFUSION

QUARANTINE

PROCESSING

DONATION

TRANSFER

ASSIGMENT

STORAGE

STORAGE

RECEPTIONSHIPPING

DISTRIBUTIONTRANSPORT

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“ It is the blood transfusion services responsibility to ensure that the quality and the safety of the blood is maintained. One of the most impor-tant aspects is the traceability of the donated blood through all process that is involved until the blood is transfused to the patient. To ensure that there is this traceability, there must be a comprehensive system. “

“ The Biolog solution by B Medical Systems is an extremely important innovation, which consists in being supplied and searching for blood, before its date of expiry. This, for us, is the best solution. It’s the solution which is the most economical and allows us to have the maximum of security. “

“ Blood safety implies the full con-trol of the Blood Cold Chain from the blood transfusion centres to the recipient, by means of insulated transport boxes to our blood banks in our hospital services. “

“ If I work with RFID tags, I do save a lot of time. The employees have their hands free; they only have to drive the Blood Bag pass the scan-ner. I also have the possibility to record on the tag if the Blood Bag has been stored in this refrigerator as well as the laps of time. An other advantage, precisely for the project of the B Medical Systems Company is that I exactly know, where and in which refrigerator my erythrocyte concentrate is stored. “

Dr Yasmin AyodDirector and consultant hematologist of the National Blood Centre of Kuala Lumpur, Malaysia

Dr Claude LedouxGeneral director of Polyclinique du Parc Cholet, France

Dr Konaté SeydouDirector of the National Blood Transfusion Centre of Abidjan, Ivory Coast

Dr Ralf KnelsDirector of the production department of the German Red Cross in Cottbus, Germany

In order to meet management and traceability needs for the transfusion pro-cess, B Medical Systems, a Cold Chain specialist active in the medical sector, distributes the Biolog system.

Thanks to the electronic label associated with each Blood Bag, the system can remotely optimize stock status, traceability and Blood Bag status in real time.

Preparation

During the identification process in the preparation stage, a RFID chip which is incorporated into the product label is fixed onto the Blood Bag. The Blood donation number and product code are automatically recorded in the chip’s memory. After qualification, the bag is available for distribution.

Distribution

When an order is received from a Healthcare Establishment, the distribu-tion operator selects the bags and encodes each bag’s RFID chip. The Blood donation number and product code registered on the chip are read automati-cally and this enables the central information system to be interrogated and receive feedback and records specific data to each Blood Bag :

ABO Rh group Establishment

Phenotype Expiry date

Sex Date of birth

Recipient ID number

Deadline of return to Blood establishment

The operator may view the status of the order at any time and print the dis-patch schedule when the order is closed.

Shipment / Transport A module designed to ensure temperature traceability during the various stages of transport was specifically developed for this application. Its very low inertia, its accuracy to 1/10th of a degree and its radiofrequency data transfer mode makes this module the ideal system for transfusion needs.

The B Medical Systems transport container associated with a temperature module allows to guarantee the perfect control of the Blood Cold Chain and its traceability.

Global Safe Blood Management

Subject to change without prior notice. Some of the accessories shown in the pictures are optional.

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Blood Traceability I In Healthcare Establishment At the Blood Establishment

06 | 07 BLOOD SAFETY Your global partner to save lives.

Remote reassignment of a Blood Bag

A reassignment request is systematically subject to onscreen remote validation by the Blood Establishment, depending on needs, the operator has the option of remotely reassigning a valid unused Blood Bag to a new patient.

While making a request on the Blood Establishment cen-tral system and the issuing of a reassignment schedule, the operator can retrieve all data of the initial receiver and the new receiver.

The interface with the central information system per-mits an automatically remote update of the data on the RFID chip of the Blood Bag in question. In addition to the data on the initial and new receiver, transport and stor-age temperatures will of course also be recorded on the bags tag.

Stock management : Stock status

At both, the Blood Establishment and the Healthcare Establishment, operators have access to identically organized stock status. At the Blood Establishment, the system supports viewing all deposits through various searches and sorting criteria, such as the status of the concerned bags and the data description specific to each bag: group, rhesus, expiry date, aso…

The operator has the option of accessing all dated movements in the Blood Bags history as well as all related information. From this screen, the operator has access to all information needed to easily locate the Blood Bag in the fridge and view the full set of data spe-cific to that bag.

At any time, the system can remotely provide informa-tion in real time on the transport conditions and storage temperatures of each available bag. It does ensure the perfect integrity of the Cold Chain during the various flows.

Stock management : Blood Bag searchThe system also offers the operator of the Blood Establish-ment the possibility of conducting a search for one or several bags by multi criteria sorting :

By identifying the name or date of birth of the receiver for personally allocated bags

By rhesus group and phenotype

By donation number for unassigned bags

The operator can therefore easily locate by Healthcare Establishment the bag he’s looking for.

Stock management : HistorySimilarly, the system provides access to a history of the various operations performed at the Blood Establishment or in the Healthcare Establishment during a given period for the entire life of the Blood Bag.

Stock management : Threshold managementWith the objective of facilitating the restocking of allo-cated bags, the system offers the ability to trigger order alerts through a range of configurable threshold criteria.

Reception and checking at the Healthcare Establishment In reception, the operator validates the transport con-ditions by retrieving the temperature curves of the sealed container which is automatically memorized. After accepting the transport conditions, the operator opens the container. Before storing the Blood Bag inside the intelligent fridge, the operator checks it and automatical-ly receives the full data contained on the chip, including in particular, data concerning the receiver when prescrip-tion is for personal attribution :

ABO Rh group Establishment

Phenotype Expiry date

Sex Date of birth

Recipient ID number

Deadline of return to Blood establishment

During this unit data processing reception, the tempera-ture curve of the transport container is memorized in each bags history. At the end of reception, the operator can print the reception schedule. The operator also has the option to print all prior schedules.

Stock management is ensured by the intelligent fridge equipped with the latest technological developments in radiofrequency data transfer and management. RFID readers enable the fridge to communicate in real time with the Blood Banks, the Healthcare Establishment and the blood establishment information systems via a secured web connection.

Each drawer is divided into 15 cells (for model BR 750 G), each equipped with a fixed RFID reader, provid-ing individualized and continuous management of each Blood Bag. The software allows displaying each drawer individually and obtaining high precise information on the content of each one. The cell occupied by a new bag is indicated on the screen by a green diode. Related bag and patient information appear simultaneously. Operators can naturally find out their stock status as well as the status of each Blood Bag at any time.

The system is equipped with fridge temperature manage-ment and tracking software. It monitors storage tem-perature in real time and creates temperature history for each Blood Bag.

Departure from stock for transfusionFor a vital emergency prescription or a prescription for a personal attribution, the operator searches for the corres ponding prescribed Blood Bag on the screen and intuitive search by selecting patient information quickly

and simply displays the prescribed Blood Bags location in the fridge.

Using the column heading function, the operator can sort the bags by expiry date or return deadline in order to select those with the closest dates.

As soon as the operator removes the bag from the fridge, its storage temperature and prior temperature curves are memorized in the bags log. The operator then places it on the reader / encoder in order to confirm that it matches the prescription and checks the patient’s blood type and immuneo-hematological data.

Departure from stock for return to Blood EstablishmentBags may be removed from the stock for return to the Blood Establishment for several reasons, including :

Return of valid unused bags to stock

Reentry in stock

Return of invalid bags for destruction

On basis of specific sorting criteria :

Green diode : indicates a valid bag

Beige diode : indicates the return deadline of the bag

Yellow diode : indicates an invalid diode

Orange diode : indicates an expired diode

The operator has the option of selecting bags by major categories according to their stock status. The software allows you to search for Blood Bags which are approach-ing their return deadline and periodically receiving alert-ing e-mails.

The beige diode is used to isolate them on the screen and launch the automatic exit procedure for return and stor-age to the Blood Establishment. After cancellation of the personal registered data, at any time, the operator can conduct an onscreen search for bags which’s expiry date and/or return deadline is imminent.

The Blood Bags physical return is confirmed by a blood Establishment operator, after an onscreen inspection of the history, listing of all events recorded since its preparation and especially its conformity with regulation transport and storage temperatures. These temperature curves are naturally memorized in the Blood Bags history and are accessible at any time on screen by entering the donation number or the patient’s name.

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Blood Traceability I Advantages Intelligent Blood Refrigerators / Transport Boxes


To secure the patients circuit during its hospitalization, B Medical Systems is presenting the patient bracelet. The bracelet allows realizing a triangular cross matching between the patient, the Blood Bag and the sample.

Within this chain, the identification of the patient is essential. The bracelet needs to be encoded and fixed at the admission of the patient or encoded by the hemato-logical laboratory (group / Rh) before being given to the healthcare department.

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fig. BR 490 G Biolog

fig. MT 8 B

Each blood bag is equipped with a RFID chip that registers all relevant transfusion data.

Each drawer has RFID detectors for every cell in order that all blood bags are indivi-dually identified and supervised.

Intelligent blood refrigerators for a consistent tracing of blood bags

B Medical Systems has adapted four of its blood refrigerators for the Biolog solution. RFID detectors for each drawer level observe the presence or movement of the blood bags in the different cells of the drawers.

Biolog temperature loggerThe Biolog temperature logger records the temperature of the RBCC’s continuously (Integrated to the MT Boxes).

The temperature logger is read before and after transportation to have always most actual data.

Before every transportation the battery of the logger is automatically verified.

Blood boxes for a safe traceability of blood bags during transport

B Medical Systems Transport Boxes are an essential link within the Biolog solution. The temperature logger always ensures perfect temperature-controlled conditions during transport. The quality of the transported blood bags is not left to chance.

The patient bracelet integrated at the solution

The advantages of the system

Absolute identification and traceability of RBCC’s Optimal management and exhaustive tracking

of all transport and storage temperatures Computerized management

of the transfusion chain Elimination of all retranscription errors Real-time visibility of RBCC’s supplies Optimization of advice on transfusions Optimization of safe delivery of RBCC’s Remote querying of relocated stocks Disappearance of RBCC’s seals Elimination of losses of RBCC’s prescribed

but not transfused Secured and facilitated return to

Blood Establishment Secure remote reassignment from

Blood Establishment Reduction of the number of barcode labels Streamlining of distribution and cost reduction

The encoded information needs to be at least : The patient’s name Date of birth Identification number of the patient Blood group / rhesus

But, some other information can naturally be included :

Previous allergies Regular doctor Color codes

The electronic bracelet allows : Full traceability all over the patient’s stay at the

Healthcare Establishment A total safety of encoding, reading and

interpretation An automatic update of the medical files A real-time consultation (on screen) of the patient’s medical file at his bed

US Patent N° 6 285 285 N° 7 209 045

EU Patent N° 1 072 030 N° 1 492 583

Japan Patent N° 4 130 178

Identification of the Blood Bags

Identification of the samples

Identification of the patient

Patented system


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Blood Traceability I Intelligent Blood Refrigerators I BR Biolog Technical Data


Drawer - 15 cellseach equipped with a

fixed RFID reader(for model BR 750 G)

The Safety Standards developed by B Medical Systems define certain significant technical features of a product. These ensure the safe storage of the preparations as well as the trend-setting safety of the user.

The B Medical Systems Gold Safety Standard efficiently complements the safety requirements of the B Medical Systems Silver Safety Standard and therefore exceeds even the official standards. Gold models are denominat-ed with a “G”.

BR biologModel BR 250 G BR 410 G BR 490 G BR 750 G

PERFORMANCEGross / Net volume (l) 246 / 167 408 / 319 489 / 395 746 / 620

Storage capacity : blood bags 32 80 104 210

Energy consumption (KWh/24h) 1.50 1.70 1.90 2.00

Heat emission 31 kcal/h 43 kcal/h 48 kcal/h 58 kcal/h

Compressor running time 18% 21% 23% 24%

Noise level at 1m height & 1m distance 49 dB(A) 51 dB(A) 51 dB(A) 51 dB(A)

Hold Over Time (from +4°C to +10°C) 192 min 204 min 210 min 168 min

DIMENSIONS / WEIGHTSExternal dimensions H x W x D (mm) 1305 x 850 x 785 1735 x 850 x 785 1950 x 850 x 785 1990 x 910 x 985

Inner dimensions H x W x D (mm) 655 x 680 x 552 1085 x 680 x 552 1300 x 680 x 552 1352 x 730 x 760

Net weight with standard equipment (kg) 176 256 296 397

TECHNICAL DETAILS

Material outer casing & door Galvanized sheet steel (STO2Z-AZ150)

Galvanized sheet steel (STO2Z-AZ150)



Material inner body Stainless steel (V2A - 1.4301) Stainless steel (V2A - 1.4301) Stainless steel (V2A - 1.4301) Stainless steel (V2A - 1.4301)

Casing insulation (PU foam) 85 - 95 mm 85 - 95 mm 85 - 95 mm 90 mm

Door insulation (PU foam, with triple insulating glazing) 100 mm 100 mm 100 mm 85 mm

Set temperature (preset - not changeable, l by DIN 58371) +4°C +4°C +4°C +4°C

Temperature cold alarm limit (preset – not changeable, l by DIN 58371) +2°C +2°C +2°C +2°C

Temperature warm alarm limit (preset – not changeable, l by DIN 58371) +6°C +6°C +6°C +6°C

Control sensor PT1000 2-WIRE 1/3DIN CL.B PT1000 2-WIRE 1/3DIN CL.B PT1000 2-WIRE 1/3DIN CL.B PT1000 2-WIRE 1/3DIN CL.B

Precision (from –80°C to +180°C) ± 0,2°C ± 0,2°C ± 0,2°C ± 0,2°C

Display sensor PT1000 2-WIRE 1/3DIN CL.B PT1000 2-WIRE 1/3DIN CL.B PT1000 2-WIRE 1/3DIN CL.B PT1000 2-WIRE 1/3DIN CL.B

Precision (from –80°C to +180°C) in reference body with reference fluid 100 ml DOW corning 200-5CST (Silicon Oil) ± 0,2°C ± 0,2°C ± 0,2°C ± 0,2°C

Voltage 220-240 V - 50/60 Hz (10 A) 220-240 V - 50/60 Hz (10 A) 220-240 V - 50/60 Hz (10 A) 220-240 V - 50/60 Hz (10 A)

Power 215 W 240 W 265 W 280 W

Accu data / function time of the control panel when power failure 12V -7 AH / 48 h 12V -7 AH / 48 h 12V -7 AH / 48 h 12V -7 AH / 48 h

Climate class (ambient temperature range) SN / T (+10°C to +43°C) SN / T (+10°C to +43°C) SN / T (+10°C to +43°C) SN / T (+10°C to +43°C)

Relative humidity ≤ 75% ≤ 75% ≤ 75% ≤ 75%

Defrosting technique Natural Natural Natural Natural

Refrigerant type R134a R134a R134a R134a

CERTIFICATIONSafety class I I I I

European Medical Device directive 93/42/EEC 93/42/EEC 93/42/EEC 93/42/EEC

GMP - clean room classification A / ISO 5 A / ISO 5 A / ISO 5 A / ISO 5

EQUIPMENTStainless steel drawers (V2A - 1.4301) 4 10 13 14

Blood bag capacity per drawer 8 8 8 15

For each blood bag 1 RFID reader 1 RFID reader 1 RFID reader 1 RFID reader

1 PC + software, to watch the RFID readers

LAN output with 3m cable for network connection

standard

The BR range comprises 4 Blood Refrigerators that are built in compliance with the requirements of :

DIN 58371 (Germany, “ Blutkonserven-Kühlgeräte “ / Blood Refrigerators)

ÖNORM K 2030 (Austria, “ Blutkonserven-Kühlschränke “ / Blood Refrigerators)

European Medical Device Directive 93/42/EEC

In conformity with :

AS 3864 (Australia, “ Medical refrigeration equipment – for the storage of blood & blood products “)

BS 4376-1:1991 (UK, “Electrally operated blood storage refrigerators. Specifications for closed reach-in types “)

European Directive : “ Guide to preparation, use and qua-lity assurance of blood components “

Water cooling, external (ex factory) (optional, for BR model range)

S G G

Subject to change without prior notice. Some of the accessories shown in the pictures are optional. The approximate figures are based on the number of bags that are really to be stored and on the different bag manufacturers’

specifications available on the market, on the actual bag sizes as well as on the individual user’s practice of loading.

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Blood Traceability I Passive Transport Boxes I MT Technical Data


MT passive

MT 4 BPassive

Gross volume (l) 8

Storage capacity (blood bags)

4 at 450 ml

6 at 270 ml

MT 8 BPassive

Gross volume (l) 20


8 at 450 ml

14 at 270 ml

MT 12 EPassive

Gross volume (l) 24


15 at 450 ml

25 at 270 ml

MT 25 EPassive

Gross volume (l) 44


26 at 450 ml

40 at 270 ml

Modèle MT 4 B MT 8 B MT 12 E MT 25 E

PERFORMANCECooling Passive Passive Passive Passive

Gross volume (l) 8 20 24 44

Storage capacity (blood bags) 4 at 450 ml 8 at 450 ml 15 at 450 ml 26 at 450 ml

6 at 270 ml 14 at 270 ml 25 at 270 ml 40 at 270 ml

Cold Life at : +32°C Up to 46 h Up to 57.02 h Up to 96.14 h Up to 109.08 h

+43°C Up to 32.5 h Up to 16.39 h Up to 56.5 h Up to 74 h

(without lid opening +2°C to +10°C)with 6 bags (270 ml) and 3 (0.3 l) + 2 (0.6 l) icepacks

with 14 bags (270 ml) and 4 icepacks (0.6 l)



DIMENSIONS / WEIGHTSOuter dimensions H x W x D (mm) 299 x 362 x 283 437 x 588 x 288 499 x 550 x 475 499 x 710 x 550

Inner dimensions H x W x D (mm) 186 x 260 x 156 245 x 460 x 180 270 x 340 x 260 264 x 496 x 334

Dimensions of interior container H x W x D (mm) 135 x 245 x 90 167 x 345 x 132 192 x 310 x 237 192 x 390 x 237

Net weight - empty (kg) 3.1 7 11.7 17

Gross weight - fully stocked (kg) 7.6 14.2 25 40

TECHNICAL DETAILSOuter / Interior material Polyethylene Polyethylene Polyethylene Polyethylene

Material of interior container Polystyrene Polystyrene Stainless Steel Stainless Steel

Insulation material and thickness PU foam / 23-27 mm PU foam / 50-60 mm PU foam / 90-105 mm PU foam / 90-105 mm

ACCESSORIESBiolog temperature logger 1 1 1 1

Cooling element at 0.3 l 3 - - -

Cooling element at 0.6 l 2 4 14 24

Polystyrene interior container 1 1 (with lid) - -

Stainless steel interior container - - 1 (with lid) 1 (with lid)

Document compartment (front) 2 1 - -

Document compartment (back) 1 - - -

Carrying strap (adjustable) 1 1 - -

Securing plastic frame for interior container - - - 1

40 cooling elements at 0.3 l each - - -

24 cooling elements at 0.6 l each

Temperature Data Loggers LogTag / Testo

Eutectic cooling system (tests available upon request)

1 polystyrene interior container (with lid) - -

optional / - not available



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Blood Traceability I Biolog Components


Biolog Hardware

Did you know?

The Biolog logger can be read without opening the box from the outside, allowing thus to refuse a sealed box when the cold chain has not been res-pected.

This fanless type PC, has been specially adapted for the Biolog users. It is equipped on the top with a RFID reader which allows to immediately read out the information that are stored on the RFID tag. Beside the software application, this device is also used for checking the entry and departure of stock.

Biolog Bioposte / RFID WorkstationThe function of the Biolog logger is to record the Blood Bag’s temperature during transport. It offers a continu-ous surveillance from storage, during transport until the bag is stored again in an intelligent fridge. The tempera-ture curves are then continuous and give a global picture of the entire life of the Blood Bag.

The Biolog solution by B Medical Systems is the first global traceability system covering all life cycles of the Blood Bag

Biolog temperature logger : records the temperature of the RBCC’s continuously (Integrated to the MT Boxes)

The barcode reader is used at different stages of the pro-cess like, at the reception of an order, the check of the temperature logger, aso…

The portable scanner that we offer gives you optimal reading abilities at a reasonable price. It allows a quick and reliable reading and increases productivity and effi-ciency whilst reducing the total cost of ownership.

Robust and durable construction :

The barcode reader is designed for intensive and continu-ous daily use. It has been tested to withstand repeated drops on to concrete from 1.5 m.

Biolog Barcode Reader : quick, reliable and optimal reading

Physical characteristicsDimensions H x W x D (mm) 152 x 63 x 84

Weight 146 g

Power sources External power source or USB

Color Twilight black

RS 232 connector interfacesUSB compatible Synapse and non decoded

Temperature sensor consist-ing of a recorder and a receipt

module which registers the tem-peratures during transport and

forwards data to the server.

Dual technology printer which allows both printing of the

secondary tag and encoding of its electronic RFID chip.

Barcode reader to identify labels from blood bag + trans-

port box

“Intelligent” RFID blood bank refrigerator which allows

precise knowledge of date of receipt, issue date, last return

date status of each bag, storage conditions (temperature, …)

Server located at the blood bank institution to connect all

parts + sites within the transfu-sion chain

Transport container for blood transportation with unique

identifier (barcode)

Workstation connected to the blood bank refrigerator, consist-ing of an RFID reading position and a temperature controller

Electronic RFID tags which allow writing and reading of data (product code, donor

identification no., ABO Rh (D) grouping, extended phenotype,

expiry date, ….)


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Blood Traceability I Biolog Components


Processor, operating system and memoryProcessor Type Intel® Xeon® quad core processorProcessor speed 2 GHzNumber of processors 1 processorAvailable processor core QuadrupleInternal cache memory 12 MB (2 x 6 MB) of 2 level cache memoryChipset Intel® 5000ZBus system 1,333 MHz front-side busStandard memory 2 GB (2 x 1 GB)Memory type DIMM PC2-5300 (DDR2-667) memory with complete buffering with a frequency of 667 MHzMemory slots 8 slots

Internal drivesInternal hard disc 2 x SAS 146 GB 2.5 inch hot-plug hard discsHard disc speed 10,000 rpmHard disc controller Smart Array E200i/128 MB BBWC (RAID 0/1/1+0/5) controller Expansion slots 6 expansion slots (3 PCI Express, 3 PCI-X)Floppy disc drive None delivered as standardBays for internal drives Bays for 8 hard disks 2.5 inch SAS/SATA (SFF) hot-pluggableOptical discs DVD-ROMInternal mass storage SFF SAS 1.168 TB

System characteristicsChassis type 5U tower

Network interface Integrated NC373i Multifunction Gigabit network card with TCP/IP offload engine including compatibility with the accelerated iSCSI via an optional licence management kit

E-S external portsParallel - Parallel port available as an option ; Serial - 1 (second serial port available as an option) ; peripheral pointer device (mouse) - 1 ; graphics card - 1 ; keyboard - 1 ; RJ-45 ports - 2 (1 dedicated to the iLO 2) ; USB 2.0 ports - 6 (2 at the front, 2 at the back, 2 internal)

Type of power supply 800 W hot-pluggable power supply compliant with CE marking (power 1,000 Watts) ; optional second power module for redundant operation

Power supply required Input voltage : 100 to 120 V AC, 200 to 240 V AC ; 50/60 Hz

Compatible operating systemsMicrosoft® Windows® Server 2003/R2 (Standard, Web and Enterprise versions) ; Microsoft® Windows® Small Business Server 2003 ; Microsoft® Windows® Small Business Server 2003, R2 ; Microsoft® Windows® Server 2008 ; Novell NetWare 6.5/Open Enterprise Server ; Red Hat Enterprise Linux ; SUSE Linux Enterprise Server ; SCO OpenServer 5.0.7/6.0 ; SCO UnixWare 7.1.3/7.1.4

Dimensions H x W x D (mm) 467 x 218 x 596Weight (kg) 30.4

Technical characteristicsHF RFID reader/encoderImproved system of alert messagesElement Energy Equalizer technology at several levels for superior-quality printingPrinting modes: thermal transfer or direct thermal32-bit RISC 133 MHz processorPrinter wizard for Microsoft® Windows® 3.X and Windows® 95/98/NT/2000Bi-fold door with clear panel for the supports

Power supplyStandard supply with correction of the power factor 100-240 V AC, 50/60Hz

Communication interfacesHigh-speed bidirectional parallel interface IEEE 1284RS 232 CUSB 2.0 portRS 422/485 multipoint functionality (optional adapter)

Intelligent labelsMaximum length of the labels and the liner : 991 mm (with standard memory)Width of the labels and the liner : 20 mm to 114 mmMaximum external diameter of the roll : 203 mmDiameter of the core : 76 mmMedia thickness : 0.076 mm to 0.305 mmMedia types : Continuous or cut

RibbonExternal diameter : 81.3 mm

The installation of the visualization and management programs of the Biolog solution by B Medical Systems are performed on the Proliant server. This server is the link between the intelligent Blood Banks equipped with RFID readers and the stock management and distribution program.

The server has been chosen on basis of its well defined functionalities which are reliability, development poten-tial and performance. On basis of these criteria, it is one of the most flexible towers in the world.

The server has the essential characteristics of availabil-ity: thanks to its optional redundant power supply, fans, memory and disc, the server will continue to operate even if there’s a problem with the system’s power supply, temperature, memory or disc.

The server combines the most up-to-date quad core pro-cessor technologies with high-performance memory and E-S technologies as standard.

Robust and reliable, the RFID printer is designed for the toughest applications:

During the preparation stage of the Blood Bag, a RFID chip integrated to the label is applied to the bag. The printer allows labeling the Blood Bags with a RFID chip which contains all related information of the Blood Bag (donation number, product code, aso…).

The frequency used to encode the RFID chips is 13,56 MHz.

High-performance and high-yield printing of intelligent labels:

The printer offers a printing width of 104 mm, resolution of 203 dpi and a wide range of connections to choose from.

Biolog Proliant Server : reliable, development potential and performance

Biolog RFID chip and barcode printer


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Blood Cold Chain I Blood Transport Boxes I MT BR I Blood Bank Refrigerators I +4°C


BR range for legally safe storage of blood bags and erythrocyte concentrates

B Medical Systems’s Blood Refrigerators are perfect to store unscreened and screened blood at the legally required temperature of +4 °C (DIN 58371 & European Medical Device Directive 93/42/EEC). An autonomous control sensor and the innovative B Medical Systems Electronic assure additionally the uniformity and control of temperature and with it the quality of the stored blood.

S G G

BR 750 G GGSet temperature +4°C

Gross volume (l) 746


450 at 450 ml

550 at 350 ml

External dimensions H x W x D (mm)

1990 x 910 x 985

Energy consumption (Kwh/24h)

2.00 1.20




300 at 450 ml

400 at 350 ml


1950 x 850 x 785


1.90 1.10




240 at 450 ml

320 at 350 ml


1735 x 850 x 785


1.70 1.00




120 at 450 ml

160 at 350 ml


1305 x 850 x 785


1.50 0.95

BR 110 GGSet temperature +4°C



54 at 450 ml

72 at 350 ml


820 x 560 x 580


0.75BR

MT 4 B PassiveGross volume (l) 8

Storage cap.(blood bags)

4 at 450 ml

6 at 270 ml

Ext. dimensionsH x W x D (mm)

299 x 362 x 283

Cold life (+32°C) up to 46h

Cold life (+43°C) up to 32.5h

MT 42 P ActiveActive (Peltier)

Set temperature +4°C

Gross volume (l) 43


30 at 450 ml

50 at 270 ml


500 x 840 x 550

Cold life (+32°C) 10h

MT 8 B PassiveGross volume (l) 20


8 at 450 ml

14 at 270 ml


437 x 588 x 288



MT 100 ActiveActive (Compressor)

Set temperature +4°C or +22°C

Gross volume (l) 90


48 at 450 ml


1000 x 520 x 800


MT 12 E PassiveGross volume (l) 24


15 at 450 ml

25 at 270 ml


499 x 550 x 475



MT 25 E PassiveGross volume (l) 44


26 at 450 ml

40 at 270 ml


499 x 710 x 550



MT range for safe blood transport

B Medical Systems offers sturdy passive and active transport systems working with the Peltier system or with a compressor. These systems are perfect for the transport of unscreened thrombocyte concentrates and screened blood between donation and transfusion sites. MT models are conform with the European agreement on the international transport of hazardous goods by Road (ADR), by Rail (RID), by sea (IMDG) and with the International agreement for air transport (ICAO-TI / IATA-DGR).

For all passive transport boxes eutectic cooling systems are available as an option (–32°C, +4°C, +22°C and +37°C).

With its „Blood Cold Chain“ family B Medical Systems offers a comprehensive mix of its products to ensure a safe blood cold chain. Beginning with the blood collection at peripheral centres, over transport to sites of testing and processing, plasma freezing to the point of final storage of screened blood and plasma, B Medical Systems provides reliable active and passive products out of its different ranges to suit all requirements in every step of the blood transfusion process.

The enclosed product information are meant for giving a short overview. Please ask us for detailed information about each of these product ranges.

In addition to the safety of blood, B Medical Systems engages in the safety for our environment. That’s the reason why we have committed ourselves to the radical minimization of our products’ CO2 output and created a complete new range of high efficient and low noise appli-ances using natural gases as refrigerants. These new “green” models representing the new “Green Standard” by B Medical Systems are denominated with a “G”.

For an uninterrupted temperature controlled blood cold chain



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+5°C I Laboratory / Medicine / Pharmaceutical Refrigerators I ML MBF I High Performance Contact Shock Freezers I –30°C


Horizontal contact shock freezing technology for blood plasma, biological and pharmaceutical preparations

ML range for safe intermediate storage of temperature-sensitive preparations

B Medical Systems’s High Performance Contact Shock Freezers are designed for the fast freezing of blood plasma, biological and pharmaceutical preparations to a core temperature of -30°C.

MBF models are built in compliance with directives for the preparation of blood plasma.

B Medical Systems’s ML range represent laboratory refrigerators for a safe storage of tempe-rature sensitive preparations. ML models are built in conformity with DIN 58345.

Contact operating plate adjustable, separately controlled

Contact cover platefixed, separately controlled

Principle / Mode of operation

ML 155 SGSet temperature +5°C



900 x 595 x 630


0.54

ML 380 CSGSet temperature +5°C / -35°C

Gross volume (l) 233 (Refrig.) + 146 (Freezer)


2030 x 595 x 625


0.60 (Refrig.)2.10 (Freezer)




2050 x 1441 x 910


1.90

ML 355 SSet temperature +5°C



1690 x 700 x 616


1.41




2050 x 710 x 910


1.10




1830 x 595 x 625


1.15

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MBF 2114 plasma bags at 1000 ml (content 850 ml)

21 plasma bags at 350 ml (content 225 ml)

Freezing time to core temperature of -30°C

21 units (350 ml) ~ 25 min

14 units (1000 ml) ~ 55 min

External dimensions (H x W x D) 1590 x 1460 x 770 mm

Operating temperature (preset), reached within ~ 20 min (pre-cooling phase)

– 45°C (upper & lower contact plate)

MBF 4228 (2 x 14) plasma bags at 1000 ml (content 850 ml)

42 (2 x 21) plasma bags at 350 ml (content 225 ml)


42 units (350 ml) ~ 25 min

28 units (1000 ml) ~ 55 min




MBF 12 8 plasma bags at 1000 ml (content 850 ml)

12 plasma bags at 350 ml (content 225 ml)


12 units (350 ml) ~ 20 min

8 units (1000 ml) ~ 45 min





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–41°C / –35°C I Deep Freezers & Plasma Storage Freezers I FR UF I Ultra Deep Freezers I –86°C / MB I Icelined Refrigerators I +4°C


FR 110 GGSet temperature -41°C


Storage capacity (plasma bags)

54 at 450 ml

72 at 350 ml


820 x 560 x 580


4.00

FR 250 GSet temperature -41°C



120 at 450 ml

160 at 350 ml


1305 x 850 x 785


6.10




300 at 450 ml

400 at 350 ml


1950 x 850 x 785


7.80




240 at 450 ml

320 at 350 ml


1735 x 850 x 785


7.40




450 at 450 ml

550 at 350 ml


1990 x 910 x 985


7.10

FR range for safe storage of plasma and other blood products UF range for freezing down to –86 °C

MB model for safe storage at peripheral centres

B Medical Systems’s FR range consists of five freezers and represent the perfect solution for the low-temperature storage of plasma and other substances under optimum conditions. FR models are built in conformity with interna-tional norms and guidelines (e. g. DIN 58375 & European Medical Device Directive 93/42/ECC).

The Ultra Deep Freezers from B Medical Systems are perfect for long-term storage of temperature-sensitive prepara-tions. The cooling system of the UF models is optimally designed with respect to energy consumption as well as to the development of waste heat and noise.

The MB range offers a sturdy chest refrigerator, designed for urban health centers and district stores. It is provided with an icelined buffer for increased hold over times.

S G G S G GUF 455 G GG

Set temperature -82°C



1450 x 910 x 950


17.50 12.00

MB 3000 GSet temperature +4°C



910 x 1270 x 780


UF 755 G GGSet temperature -82°C



1990 x 910 x 950


19.00 13.00 UF

MB

FR



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Blood Cold Chain I Cold chain for blood products


Periphery Transport Technical Platform

Storage at Peripheral Centres

UF / FR / BR / MB

Transport of Screened Blood / Plasma to Peripheral Centres

MT

Contact ShockFreezing Plasma

MBF

Storage of ScreenedBlood / Plasma

ML

UF

FR

BR

“ Ensuring a safe, secure and ethical supply of blood and blood products and the appropriate and rational clinical use of blood are important public health responsibilities of every national government. A pre-requisite for blood safety is the existence of a nation-al blood transfusion system, based on voluntary non-remunerated donation and with every aspect gov-erned by quality management. Such systems should be nationally coordinated, financially sustainable and able to respond to any newly emerging blood safety threat ”. *

Blood Cold Chain is one key component for Blood Safety and comprises different activities involving equipment that need to offer perfect storage and transport from the beginning (collection) to the end (transfusion). Blood is collected at a body tempera-ture (~ 37°C), to keep it safe and to avoid bacterial contamination it has to be cooled and stored between +2°C and +6°C, with a set point of +4°C (for a period of around 35 days of storage).

“ Plasma components must be shock frozen below -30°C within a short period of time and stored at tem-peratures that will adequately maintain the labile coagulation factors in a functional state (for a period around 24 months when stored below -25°C and 3 months at -18°C to -25°C)”. *

We evaluate that around 7%** of the collected blood for transfusion needs can be wasted for different rea-sons (the main one is due to missing traceability). To decrease this percentage during the blood cold chain, B Medical Systems has developed a range of different products with strong safety standards. Blood units are often lost during the transport from the blood bank to the hospital and inside these buildings. Too often,

ordinary untested cold boxes which are unable to maintain the cold life on a long distance and period are responsible for significant waste.

A perfect effective blood cold chain is only available with tested and technically proven products, which respect international norms and follow WHO tested specifications.

So it is with B Medical Systems products.

Blood Collection at Peripheral Centres

Transport of Unscreened Blood / Plasma

to Technical Platform

Storage ofUnscreened

Blood

Screening, Testing,

ProcessingProduction

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* Statement from WHO / ** Figures from WHO


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Accessories (optional) B Medical Systems Software


> Interface connection of B Medical Systems appliances to an existing network.

> The DCU offers direct connection to the Ethernet, even wireless, to the serial BUS RS 485, as well as to the central building control system (4 ... 20 mA).

> Possibility of connection of actors (4 ... 20 mA out).

> Digital IN/OUT (customer-specific use of these connections is programmable).

> The integrated USB port allows stored data to be written to an external memory stick.

> Recording and storage of relevant data of the appliance.

> The DCU replaces the paper temperature recorder.

> The DCU works with all Gold electronics from 2000 on.

> All data are recorded and saved in the data base of the DMN and are available for analysis at any time.

> Possibility of connection of several additional self-sufficient temperature sensors (up to 4 PT1000 & 2 PT100).

Your essential advantages :

One integrative system for collecting all temperature relevant appliances and ambients.

Many different connection facilities allow flexible upgrades for individual projects.

DCU - Data Communication UnitHardware module that notes all operating conditions and passes them through to a central data base – via local network, on which devices are connected.

DMN & DCU in combination offer a highly flexible system that is adaptable to specific customer requirements> Complete & legally safe documentation of temperature data> Comprehensive applications and diagnostic possibilities nts.

DMN - Data Monitoring NetworkUniversal software for collection, long-term recording and visualization of temperature data.

> Complete activity list (password protected).

> Integrated event and activity history of all appliance components.

> Graphical visualisation of all temperature curves.

> Connection to existing or third-party appliances via network technology (LAN, WLAN, WAN).

> Simultaneous data monitoring and recording.

> Possibility for specific and individually configurable alarm forwardings, e. g. via email, SMS (with optional GSM module) or via DECT.

> Simple and intuitive utilization.

> Essential price advantage compared to a traditional circular chart recorder and its spare parts.

> Free of charge for all Gold & Silver ranges.

> Real-time temperature output for third-party software.

Your essential advantages :

Access to the data within your entire network via one central database.

Economy of time and money as regular changes of recorder paper, ink and battery is not necessary.

Ethernet LAN

USB

CON1: DC inletCON2: Electronic

CON3: -----CON4-6: Add. sensors

WLAN (option)

CON7: RS 232CON8: RS 485

fig. M

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B

38 mm

60 mm

LogTag temperature data logger TRID30-7R

> For continious, tamper-proof temperature recording

> With 30 days statistic display

> Temperature range -30°C to +60°C

LogTag temperature data logger TRID30-7FW

> Vaccine Refrigerator Temperature Recorder with 30 day summary display compliant to WHO PQS specification E006/TR06.3

LogTag temperature data logger TRED30-7R

> For continious, tamper-proof temperature recording

> With 30 days statistic display and connector for remote temperature control


LogTag Remote probe

> 1.5 m cable, 140 mm tipped sensor

LogTag USB interface cradle

> For reading out the data recordings via PC

Temperature Data LoggersFor perfect temperature control

Testo 174T mini data logger, 1-channel

> incl. wall bracket, battery (2 x CR 2032 lithium) and calibration protocol

> High data integrity, even with empty battery

> Large data memory

> Watertight in accordance with IP65


> Starter set including logger, interface and software also available

Testo 176 T2, 2-channel temperature logger

> with connections for highly accurate external sensor (Pt100) incl. wall holder, lock, battery and calibration protocol

> Large memory for 2 million measurement values - large, easily legible display up to 8 years battery life

> Standard battery (AA) replaceable by user

> SD card slot



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BLOOD SAFETY For a reliable cold chain within the scope of safety of blood transfusions.

COLD CHAIN Comprehensive range of storage and active / passive transport systems for the storage and distribution of vaccines and in general of all temperature-sensitive preparations under various climatic and technical conditions.

BLOOD CHAIN Storage and active / passive transport systems dedicated to the military for the supply of blood, vaccines and medicines to the front line.

BIOMEDICAL REFRIGERATION Special purpose refrigerators and deep freezers, storage and transport concepts for Laboratory, Medicine, Research, Biotechnology and Life Sciences.

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For more information :

B Medical Systems S.à r.l 17, Op der Hei

L - 9809 Hosingen, Luxembourg

Tel. : + 352 92 07 31-1

Fax : + 352 92 07 31-300

[email protected]


B Medical SystemsYour global partner to save lives.


blood safety · 2015. 9. 3. · blood traceability i in healthcare establishment at the blood...

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