Informationen und Anregungen von GYNEMED anlässlich AGRBM 2013

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1 GYNEMEDIA Informationen und Anregungen von GYNEMED anlässlich AGRBM 2013

2 Neu: Saturn 5 Active Laser für ultraschnelle und ultrasichere Biopsien Der Saturn 5 Active Laser unterstützt Embryologen jetzt noch effektiver und sicherer bei der täglichen Laborarbeit. Das erfolgreiche Saturn Active-Konzept wurde durch neue Bedienmöglichkeiten und Funktionen erheblich erweitert. sehr schnelles und akkurates Arbeiten an den Eizellen und Embryonen mit dichter Pulsfolge. zeige einer vordefinierten Sicherheitszone verhindern unbeabsichtigten Schaden an den umgebenden Zellen. GYNEMED Die Sicherheit des Embryos stand bei der Weiterentwicklung konsequent im Vordergrund. Durch die Verwendung eines sehr kurzen 400 mw-laserpulses wird erreicht, dass so wenig Energie wie möglich zum Eröffnen der Zona verwendet werden muss. Saturn 5 Active Laser Biopsie Modus Ein neuer Biopsy-Modus ermöglicht schnelle und sichere Biopsien an Blastozysten. Schneidelinien können per Maus auf dem Steuermonitor voreingestellt und dann automatisch abgefahren werden. Eine neue Multi-pulse-Funktion erlaubt Die gesamte Steuersoftware des Saturn Lasers ist überarbeitet und noch bedienerfreundlicher gestaltet worden ( RI-Viewer ). Die Maus- oder optionale Fußsteuerung ermöglicht intuitive Ein-Klick- Kontrolle aller Arbeitsschritte. Über die Festlegung der gewünschten Lochgröße auf dem Monitor wird automatisch die minimal benötigte Lichtpulsdauer angesteuert. Der Pilotlaser und die An- Ergänzt wird die Software durch einen Simulationsoder Demonstrationsmodus, der besonders für Schulungszwecke hilfreich ist. Der frei steuerbare Saturn 5 Active Laser ist jetzt so optimiert worden, dass in kürzerer Zeit - bei erhöhter Sicherheit - auch neue Anforderungen wie Trophektoderm-Biopsien erfolgreich bearbeitet werden können.

3 Saturn 5 Active The new Saturn 5 Active directional laser has been designed specifically for easier, safer and quicker laser drilling in IVF. The unique moveable laser means that technical procedures are more accessible than ever before. Its revolutionary new Biopsy Mode means that the operator can easily select a line, whether straight or curved, and adjust the frequency and size of holes before allowing the system to ablate exactly along the chosen path. Biopsy Mode New Biopsy Mode allows accurate laser drilling along a drawn line Safest Power Lowest laser pulse energy for minimal energy near critical cells. Exclusion Zone feature ensures cell safety Precise Sub-micron accuracy and unique computer controlled laser with guaranteed laser alignment Rapid Faster than ever directional laser increases functionality and decreases procedure times Easy to Use Intuitive RI Viewer software package with streamlined interface. Programmable foot pedal controls software and laser functions including the new biopsy and multi-pulse modes Versatile Compatible with all popular brands of micromanipulators and inverted microscopes The new Saturn 5 Active directional laser system uses cutting edge fibre-optic, laser and robotic technology delivering the best in speed, safety, accuracy and smooth operation. By employing a higher laser power, Saturn 5 Active applies less energy to achieve a specified hole size in comparison to lower power laser systems. (See graph.) The Saturn 5 Active also has a new faster motor helping to cut down on procedure times. The Saturn 5 Active laser system has a red pilot beam that confirms the shape and focus of the beam, as well as guaranteeing the exact position of the ablation laser. Energy applied to achieve the same specified hole size The Saturn 5 Active laser is a Class 1 laser product as defined by international laser safety standards. It is CE-marked and FDA cleared 1.

4 RI Viewer software is included with Saturn 5 Active and Saturn 5. It offers a modern, clean user interface featuring: One click mouse or foot pedal image capture and video recording Measurements tools Laser simulator for training and demonstration purposes An Exclusion Zone based on published medical research 2, which indicates how close to critical cells the laser can be fired Biopsy Mode allows ablation along a drawn curved line Senior Embryologist, Nicole Schlanger uses the Saturn Active laser system for Blastocyst Biopsy procedures We use the Saturn Active laser system routinely for blastocyst biopsy, explains Nicole. To biopsy a blastocyst, the laser must be used multiple times throughout the procedure to separate the trophectoderm cells, and therefore it is important that the laser moves, rather than the blastocyst. With Saturn Active, we are able to keep the blastocyst and biopsy/holding pipettes in the one place and use the computer to move the laser to the desired point on the blastocyst. This is the major difference between the Saturn Active and other laser systems. Applications 3 For Blastocyst/Trophectoderm Biopsy, the Saturn 5 Active is unparalleled in its ease of use. The directional laser allows the user to make multiple ablations across the trophectoderm cells without needing to move the blastocyst. This gives the user superb accuracy, safety and incredible speed. Blastocyst Biopsy Directional Laser Target Biopsy Mode For Blastomere Biopsy, Polar Body Biopsy and Blastocyst Collapsing (for vitrification), the Saturn 5 Active directional laser allows the embryo to stay in the desired position and focus so that ablations can be made wherever required without additional manipulation. Our unique Biopsy Mode also allows safe Multi-Pulse drilling along a predetermined line. For Assisted Hatching, the directional laser means that accurate ablations can be made without the need to hold the embryo, making it very quick and accurate, with no additional consumable costs. With Saturn 5 Active, these procedures are almost effortless and can be performed quickly and accurately. These procedures require difficult embryo manipulation when performed using fixed lasers. This has clear advantages to the welfare of the embryo. 1 In the USA, FDA cleared for clinical use for Laser Assisted Hatching (LAH) only 2 Chatzimeletiou, K., Picton, H.M. & Handyside, A.H., Use of a non-contact, infrared laser for zona drilling of mouse embryos: assessment of immediate effects on blastomere viability. Reproductive biomedicine online, 2(3), p.178. Available at: 3 The applicability of procedures is dependent on the regulations of the country into which the device is sold

5 System Overview Pilot Laser 40x Objective nm spot targeting solid state diode laser red guarantees the position of the invisible ablation laser Custom designed objective for optimum laser transmission, crystal clear imaging and minimal laser pulse times. Tested and proven not to exhibit astigmatism with Saturn 5 Active Ablation Laser 1480nm / 400mW solid state diode laser. Pulse length range ms / µs Class 1 laser product Tested and proven not to exhibit thermal lensing Laser unit dimensions (WxDxH) CRi Oosight Compatibility Compatible microscope brands PC System Requirements Operation Software Mains Input 220mm x 180mm x 34mm Compatible with CRi Oosight and SpindleView systems Zeiss, Nikon, Olympus and Leica all popular models supported Operating systems: Windows 7, Windows Vista, Windows XP RI Viewer imaging software included with digital laser targeting VAC, 50-60Hz Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall, TR11 4AT, UK Tel: +44 (0) Fax: +44 (0) sales@research-instruments.com visit: MKTG-BR /11/2012. All information correct at time of print. Specifications are subject to change without notice or obligation on the part of the manufacturer.

6 Benchtop Inkubator der neuesten Generation GYNEMED Der von Gynemed vertriebene Multi-Room Tischinkubator (MIRI) von ESCO zeichnet sich durch die derzeit fortschrittlichste Technologie auf dem Markt der Benchtop-Inkubatoren aus: Kompaktes Design Das kompakte Design nimmt wenig Platz in Anspruch und der Tischkubator kann somit sogar in einer Sterilwerkbank untergebracht werden. In die Inkubationskammer können mehrere IVF-Dishes platziert werden, z.b. 4 x IVF 4-well-Dishes oder aber auch 8 x 30 mm-dishes. Online Temperaturüberwachung Im MIRI ist jede der 6 Inkubationskammern mit einem Temperatursensor (PT 1000) ausgestattet. Da jede Kammer über ein eigenes Heizsystem verfügt, können Sie jede Kammer temperaturindividuell einstellen und auch diesbezüglich kontrollieren. Mit 12 Temperaturmesspunkten setzt der MIRI-Tischinkubator eine bislang unerreichte Benchmark. Schnelle Erholungszeiten und externe Überwachung Der MIRI-Tischinkubator ist standardmäßig sowohl mit einem abweichungsresistenten IR-CO2-Sensor ausgestattet als auch mit einem PT 1000 Temperatursensor; beide sorgen für besonders schnelle Erholungszeiten. Eine im MIRI- Tischinkubator integrierte Luftstrom-Aufzeichnung kontrolliert diese, wodurch sich eine schnelle und präzise Temperatur- und Gaserholung einstellt. Nach dem Türöffnen wird die Temperatur sofort wiederhergestellt. Mit den Alleinstellungsmerkmalen beheizbarer Deckel und Luftbefeuchtung sind auch offene Zellkultivierungen möglich. Verschiedene der Gaszufuhr Optionen Mit dem MIRI-Tischinkubator können Sie bezüglich der Gase frei wählen, so dass hypoxische Anwendungen problemlos unterstützt werden. CO2, N2, O2 aber auch vorgemischtes Gas können an den MIRI- Tischinkubator Ihren Vorstellungen entsprechend angeschlossen und aufeinander eingestellt bzw. gemischt werden. Die externe Beschaffung teuren Mischgases mag somit ab sofort der Vergangenheit angehören. Online ph-überwachung Keine Sorgen mehr um den ph-wert! Optional ist ein AccessPort. Schnelle Dekontamination Dekontamination bzw. Sterilisation war noch nie so einfach. Alle Kammern sind widerstandsfähig und ermöglichen ein schnelles, einfaches und effektives Abwischen mit dem hierfür getesteten Oosafe- Tüchern. Darüber hinaus bewahren Filtersysteme (VOC-/HEPA- und UV- Lichtfilter) die Inkubationskammern kontinuierlich vor Verschmutzung.

7 Miri Multi-room CO 2 incubator for IVF EU MDD Class IIa M e dical Device VIP treatment for cultured embryos in IVF THE LATEST IN ESCO S SUITE OF PRODUCTS FOR IVF LABORATORY Building on Esco s tradition of producing quality laboratory is the ONLY multi-room incubator in the market featuring a combination of the following: Mixed gas NOT required = reduced operating costs Heating in the lid Documented UVC decontamination of recirculated gas MEA tested and documented 12 x PID regulation system, the most advanced in the world Built-in temperature validation Full parameter display visible at a distance Pressure sensors on external gas Gynemed Medizinprodukte GmbH & Co. KG Lübecker Straße Lensahn /Germany Tel.: +49 (0) Fax: +49 (0) info@gynemed.de Esco Global Offices Manama, Bahrain Beijing, China Chengdu, China Guangzhou, China Shanghai, China Bangalore, India Delhi, India Mumbai, India Banten, Indonesia Osaka, Japan Kuala Lumpur, Malaysia Melaka, Malaysia Manila, Philippines Singapore Seoul, South Korea Salisbury, UK Philadelphia, PA, USA Hanoi, Vietnam

8 Esco Multi-Room Incubator features Precise temp, CO 2 and O 2 control Optional humidification (evaporative) 6 isolated incubation compartments Heated lids to prevent evaporation HEPA/VOC filtered UV-C decontamination of air stream CO 2 and N 2 gas supply (pre-mixed gas not required) Low gas consumption Data output (RS232 software required, sold separately) Alarm relay contact 6 sampling ports ph electrode port 6 x PT1000 validation outputs Built-in pressure regulator and in-line filters All materials are embryo-safe Stackable Accessories available Universal VAC 50/60HZ power input MRI-6A10 - Esco Miri Multi-Room Incubator MRA Stacking frame for two units CONVENTIONAL INCUBATORS VS Miri Conventional Incubators MIRI Impact to other samples when incubator is accessed YES NO Ability to regulate temperature of sample while lid is opened NO YES Temp recovery 6 Min 1 Min Gas recovery 4 Min 3 Min Gas consumption HIGHER LOWER escoglobal.com LIVE SUPPORT Since 1978, Esco has emerged as a leader in the development of controlled environment, laboratory and pharmaceutical equipment solutions. Products sold in more than 100 countries include biological safety cabinets, fume hoods, ductless fume hoods, laminar flow clean benches, animal containment workstations, cytotoxic cabinets, hospital pharmacy isolators, PCR cabinets, thermal cyclers and instrumentation. With the most extensive product line in the industry, Esco has passed more tests, in more languages, for more certifications, throughout more countries than any biological safety cabinet manufacturer worldwide. Esco remains dedicated to delivering innovative solutions for the clinical, life science, research and industrial laboratory community. PT Esco Bintan Indonesia Esco Micro Pte Ltd Cert. No: Cert. No: /E Esco can accept no responsibility for possible errors in catalogues, brochures and other printed materials. Esco reserves the right to alter its products and specifications without notice. All trademarks and logotypes in this material are the property of Esco and the respective companies.

9 Temperatur-, Gas- und Luftfeuchte- Überwachungssystem für Ihre Inkubatoren, Stickstofftanks, Kühlschränke u.v.m. in Ihren Laborräumen Das von Gynemed exklusiv vertriebene Überwachungssystem besteht aus einer Basisstation und den je nach zu überwachenden Systemen darauf abgestimmten Sensoren. Die allein operierende Basisstation kann bis zu 120 drahtlose Sensoren unterschiedlicher Messtechnik verwalten. Das bedeutet für Sie, dass sich Ihre sensiblen und essentiellen Laborgeräte, wie Inkubatoren (auch Tischinkubatoren) oder Kryokannen permanent und kabelfrei überwachen lassen. Die vom Sensor erfassten Messdaten werden per Funkübertragung an die Datenstation übermittelt, dort gespeichert und grafisch dargestellt. Überbzw. unterschreiten die Messwerte eine von Ihnen selbst bestimmte Grenze, zeigt Ihnen die Basisstation einen akustischen oder optischen Alarm an. Sie können aber das System so konfigurieren, dass Sie per , SMS oder Anruf informiert werden. Auch eine Leistungsqualifizierung (zur Überprüfung der Funktionalität der Geräte) und/oder eine Requalifizierung im Rahmen Ihres Qualitätsmanagements lassen sich mit diesem System realisieren. Die Basisstation bietet folgende Funktionen: Die Basisstation kann als Stand-alone-Gerät betrieben, aber auch in Ihr lokales Netzwerk eingebunden werden (weltweiter Fernzugriff möglich) Für die Basisstation sind keine zukünftigen Softwareupdates notwendig Bis zu 120 drahtlose und kabelgebundene Sensoren können angeschlossen werden Messdaten lassen sich tabellarisch oder grafisch am LCD-Display betrachten oder in gängige Formate (HTML, csv) exportieren DATAcentre Basisstation Wireless Transmitter mit Sensor Alarmbenachrichtigung bei Über-/Unterschreiten der eigens konfigurierten Grenzwerte per SMS, Telefon (Anschluss an Wählautomaten) oder möglich USB-Anschluss zur Erweiterung des internen Speichers (2 GB) GYNEMED

10 DATAcentre Base Station Wireless & Wired Solutions No software required Wireless & Wired Sensors Standalone unit with LCD Web browser access In built storage Graphs & data Various alarm options Optional LAN connection The standalone monitoring alarm system which can monitor and alarm practically anything; including temperature down to liquid nitrogen levels, humidity, CO2, O2, door status as well as much more. The system comes with a base centre which can connect to up to 120 wireless sensors and up to 120 wired sensors. You can also have multiple base centres if required. On the base centre you can view real time and historical data in graphical or text format, view & acknowledge alarms as well as the ability to configure the unit providing you have logged in and have sufficient privileges to do so. The base centre can store information itself and can have an optional SD card which stores data for up to 5 years. Optionally connect the base centre to a LAN port in the building, or directly to a PC which will allow remote access to the unit with a web browser locally or from anywhere in the world! Using a web browser you can connect to the base centre to have an overview of how the system is operating with links to all other functions. It is also possible to connect a USB device to export historical data. Various file formats can be selected including HTML so that the data can be read using a web browser or in CSV format to import into a spreadsheet. Each monitored device has a set of alarm thresholds. If the threshold is exceeded and alarm can be generated via the various options Every alarm is logged internally with the time and date and the value that the sensor reached. Alarm history can be viewed at any time via the base centre or web browser. To complete the audit trail, the unit can be configured so that alarms have to be acknowledged by entering a pass code. The details of the user who acknowledge the alarm is also stored with the alarm event. Any action made by a user which requires a password is also logged. In the event that the signal from the transmitter is not strong enough to reach the base centre, repeaters modules can be used to repeat or "boost" the signal. With multiple repeaters the units create a mesh type network, which in the event that a signal path becomes unavailable will automatically re-route via another available path. In the event of a problem with the base centre, the system can simply be restored to another base centre without the need to re-configure the devices. The systems can come pre configured so even the user can plug it straight in and get going! Without the need for expensive installations! There are various levels of access from view only to complete editing and alarm management. There are various alarm options including visual & audible alarms, autodialers, alarms and connection to BMS systems. You can also connect a printer to the unit. You can also put delay period for each monitored device to prevent "false alarms". Battery life can last up to 5 years for sensors. Planer plc, 110 Windmill Road, Sunbury, TW16 7HD, UK +44(0) Specifications may change without notice Third party trademarks acknowledged 2012 Planer plc V:1.3

11 DATAcentre Base Station Monitoring & Alarm System A robust, reliable and accurate monitoring system, built to meet the challenges of today's regulated laboratory. Features Stand alone operation, or optionally connect to local area network (LAN) Receives input from up to 120 wireless or wired Sensors Repeaters available to boost wireless signal Built in visual, audible and alarms Connectable to auto-dialers for text message and phone call alarms Up to 10 years on board data storage 1 minute recording intervals Up to 8 hard wired temperature sensors can connect directly to the system alarms available via LAN General Dimensions Weight Operating Temp. 0 C to 40 C Material Supply Operating System Processor Display User Management Passwords Log Archive Data & Report MMC (Mass Storage) USB HACCP Battery Back Up Options Part Number FTEM02LCMU101/ BB FTEM02BBU101 FPLG60T 200mm (W) x 140mm (H) 55mm (D) 4mm thick High Impact UL94V0 Fire rated polystyrene 5V DC via external power brick (Supplied) Embedded High contrast 128 x 64 graphics display Service and user level passwords Alarm and event log 2GB providing 1 yrs archived data at 1m interval USB 2.0 (For reports and data backup) HTML & CSV reports produced daily to internal MMC Description Battery Backup 3.5 Hour Internal Battery Backup 15 hour External Uninterruptible power supply which powers the DATAcentre for at least 27 minutes without mains power Alarm notification Screen LED Sounder Relay IP Low powered Radio Module Frequency Power Communications Protocol Sensor Types Internal inputs Networked inputs Wireless Technical Specifications Memory Capacity Provides real-time data detailing current alarm status LED Traffic light style (OK, WARNING, ALARM) Internal sounder Single volt free relay output providing NC & NO contacts Up to 5 external addresses Alarm message directed to up to 3 IP addresses 433MHz (Europe) licence free, 6 channels 915MHz (US) licence free, 6 channels 10mW maximum Bi-directional Proprietary Up to 8 hardwired temperature and/or voltfree digital inputs Up to 20, 8 channel modules providing temperature and volt free digital inputs Up to 120 devices providing temperature, humidity, 4-20 ma, pulse count and volt-free digital inputs 16 Points 32 Points 64 Points 120 Points 2GB (std) 5.1 years 2.7 years 1.4 years 0.7 years Planer plc, 110 Windmill Road, Sunbury, TW16 7HD, UK +44(0) Specifications may change without notice Third party trademarks acknowledged 2012 Planer plc V:1.4

12 MIDIcentre Base Station Monitoring & Alarm System A robust, reliable and accurate monitoring system, built to meet the challenges of today's regulated laboratory. Features Completely Stand Alone operation Receives input from up to 19 Wireless Sensors View readings on Base Station View graphs by exporting to USB and importing into a spreadsheet Up to 10 years on-board data storage Volt Free Relay Contact USB Storage Device 5 minute recording intervals Optional on board Ethernet with HTTP server General Dimensions Weight 125mm (W) x 145mm (H) 55mm (D) TBC Operating Temp. 0 C to 40 C Material Supply Operating System Processor Display User Management Passwords Log Archive Data & Report External USB Stick USB HACCP ABS Output: 5V DC via external power brick (Supplied) Input: V AC Embedded Customer LCD with Back light, 97mm (W) x 58mm (H) Administrator and user level passwords Alarm and event log 1GB standard providing 1 years archived data at 5m interval USB 2.0 (For reports and data backup) HTML & CSV reports produced daily to external USB Alarm notification Screen Sounder Relay (Option) IP (Option) Low powered Radio Module Frequency Power Communications Protocol Sensor Types Wireless Provides real-time data detailing current alarm status Internal sounder Single volt free relay output providing NC & NO contacts Up to 5 external addresses Alarm message directed to up to 3 IP addresses 433MHz (Europe) licence free, 6 channels 10mW maximum Bi-directional Proprietary Up to 19 devices Planer plc, 110 Windmill Road, Sunbury, TW16 7HD, UK +44(0) Specifications may change without notice Third party trademarks acknowledged 2012 Planer plc V:1.2

13 DATAcentre Components Main unit & Alarm outputs Product Name/ Number DATAcentre GDFTEM02LCMU102-P Description Up to 120 sensors - wired or wireless. Built in visual, audible & alarms with delay and daytime dependent features. Connection for auto-dialers. View all graphs and logs on the unit. Set up daily reports. Access data over the Internet. Comes with UK, Europe & US style plugs The Auto-dialer can send text message or make phone call alarms up to 10 numbers. It has a feature to request acknowledgement of the alarm. Requires a direct phone line connection. Pre-record up to 4 different messages. Comes with UK style plug 2 Auto-dialer - Direct Phone Line GDFCSL-SD2 3 Auto-dialer - GSM FTEM40-GSMAUTO-P The GSM Auto-dialer can send text message or make phone call alarms up to 9 numbers. It has a feature to request acknowledgement of the alarm. Requires user to provide their own local SIM card with a mobile phone contract. Comes with UK plug 4 Repeater for Increase Signal FTEM02WS103-P Repeater to connect an unlimited number of repeaters to create a mesh network 5 Battery Back Up FPLG60-T Battery back up (30 mins powering DATAcentre & Autodialer) Planer plc, 110 Windmill Road, Sunbury, TW16 7HD, UK +44(0) Specifications may change without notice Third party trademarks acknowledged Planer plc V:1.7

14 DATAcentre Components Wireless Transmitters & Accessories Product Name/ Number 1 Thermal Printer FTEM02PRT101-P 2 Power Supply for 4-20mA sensors AP (24v 16w) 3 Wireless Sensor Mounting Bracket FTEM02WS101-P 4 Wireless Transmitter FTEM02WS108-P 5 Wireless Transmitter FTEM02WS115-P 6 Wireless Transmitter FTEM02WS111-P Description Thermal Printer to print alarms & data Power Supply. Required for some 4-20mA sensors Mounting Bracket. Required to mount transmitters onto a wall (for example FTEM02WS108-P) 4-20mA transmitter Temperature transmitter -200 C to 40 C 4 x Volt Free Contacts/NC/NO Contacts. Connect 4 door switches or up to 4 pieces of equipment with relay output to this transmitter Planer plc, 110 Windmill Road, Sunbury, TW16 7HD, UK +44(0) Specifications may change without notice Third party trademarks acknowledged 2012 Planer plc V:1.7

15 Laboratory Equipment. Gynemed Laser Systems Micromanipulation Microscopes Air Cleaning Spindle View Incubation Work-Benches Laboratory control Laboratory monitoring system IVF Witness IVF Tracker Thax Findentity May not be available in all German speaking countries!

16 IMPRESSUM Herausgeber: GYNEMED Medizinprodukte, Lensahn Telefon: 04363/ Fax: 04363/ Redaktion: Dr. Fabian Sell (V.i.S.d.P.), Lensahn, Telefon: 04363/1231 Layout: Matthias Krajny, Lübeck