DANA Diabecare R Remote System
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- Geraldine Hill
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1 Remote System
2 Ubiquitous System Remote Control Download Internet Access 01 DANA Remote System Enables You... To keep your privacy You don t have to pull out insulin pump to get bolus since DANA Remot Control enables you to operate all functions in the pump. To get more flexible life You don t have to hurriedly look for any place to take a bolus while you re in a conference at a class or in a restaurant.
3 DANA R Remote System It s small... but big different! To download all data to your PC You can download all the data like as your Blood Glucose History, Daily Total, Bolus and Prime Histories to your PC. You can easily review your histories by a graph and print it out. 02 To access to the internet Any of your healthcare provider can adjust your basal rate or bolus through the internet if you are in a place where the internet accessible. The blood glucose level of the children or disabled patients can be managed by their helathcare professional or guardiance through this feature.
4 03 R Dana Diabecare R is equipped with wireless-connected glucose meter, which automatically sends your test results to insulin pump. Wireless communication of test results will ease diabetes management by eliminating extra button pushes and by calculating bolus dose automatically.
5 Wireless Connection to Glucose Meter Simplify Your Diabetes Management 04 Remote Control Download Internet Access
6 05 Wireless Communication > Remote Control enables you to fully control insulin pump wirelessly. It's not just a simple remote bolus button. you can command bolus injection, correct basal rates, and use all the smart features, with convenient wireless remote control. > Remote Monitor enables you to fully monitor insulin pump wirelessly. you can have full access to all the valuable information stored in the insulin pump (e.g. insulin remaining in the reservoir, alarms, bolus history etc.)
7 Easy Access Bringing Full Control within Your Hands You Can Easily Access 06
8 07 Ubiquitous System
9 Telemedicine DANA Diabecare Ubiquitous Healthcare System 08 Internet Communication Sooil offers customers secure internet access to convenient database network called DANA Diabecare Ubiquitous Healthcare System. This internet webbased system systemically organizes information from insulin pump users (blood glucose test results, bolus history, basal history, meal carbohycrate amount, and alarm history etc.) for the healthcare providers, Healthcare providers can prescribe insulin pump dose adjustments or give directions for patients, on-line, with this internet webbased system, healthcare provider and patients can enjoy the new era of telemedicine.
10 Customized Infusion Sets for DANA s Easy and Comfortable 09 Soft Release O Features The Set That Spins: Freely rotates 360 degrees! Eliminate the need to look at the site to connect or disconnect & increase site selection areas. Angle insertion: 90 degree Soft cannula: Teflon (24G) Self Adhesive tape: Body heat activated new technology tape really sticks when wet. Translucent tape matches natural skin tones and does not draw attention to site. Smooth low profile dome shape won t snag clothing. Low dexterity one handed Needle Free connector eliminates needle sticks and is comfortable for big and little fingers. Soft cannula length Total tubing length S3061 S6061 S8061 S10061 S3091 S6091 S8091 S mm 6mm 6mm 6mm 9mm 9mm 9mm 9mm 30cm 60cm 80cm 100cm 30cm 60cm 80cm 100cm Soft Release ST Features Spring clip lock mechanism: Easy to connect and reconnect. Angle insertion: degree (Straight needle) Soft cannula length Total tubing length SR102 19mm 70cm SR112 19mm 110cm Soft cannula: Teflon (24G) Self adhesive tape: Anchors the Soft Release ST to the injection site.
11 10 Easy Release Features Spring clip lock mechanism: Easy to connect and reconnect. Angle insertion: 90 degree Soft cannula: Stainless steel (27G) Self adhesive tape: Anchors the Easy Release to the injection site. Easy Release II Features Spring clip lock mechanism: Easy to connect and reconnect. Angle insertion: 90 degree Soft cannula: Stainless stell (27G) Self adhesive tape: Anchors the Easy Release II to the injection site. Soft cannula length Total tubing length SU311 SU312 SU313 SU314 7mm 9mm 7mm 9mm 110cm 110cm 70cm 70cm Soft cannula length Total tubing length SU401 SU402 SU411 SU412 7mm 9mm 7mm 9mm 70cm 70cm 110cm 110cm Superline ST Features. Angle insertion: 90 degree Soft cannula: Stainess steel (27G) Self adhesive tape: Anchors the Superline ST to the injection site. Soft cannula length Total tubing length SU203 SU201 SU mm 7mm 9mm 55cm 55cm 55cm Inserter ST
12 Since 1979~ SOOIL History
13 History of SOOIL development 1979 The first SOOIL pump is clinically tested at Seoul National University Hospital SOOIL develops the first portable insulin pump suitable for everyday use SOOIL establishes Factory Registration for the manufacturing of the SOOIL insulin pump SOOIL receives its License to Manufacture Medical Devices from the Korean Ministry of Health and Welfare SOOIL receives approval for the Diabecare R insulin pump from the Korea Food and Drug Administration (KFDA) SOOIL receives approval for Clean Lan lancets from the KFDA SOOIL obtains approval for the Diabecare MINI R insulin pump from the KFDA SOOIL establishes a collaboration with the medical colleges of Seoul National University and KonKuk University for Research and Development SOOIL receives approval for the Superline insulin infusion set from the KFDA SOOIL obtains approval for the insulin pump from the KFDA SOOIL is certified by SGS ISO9001, EN46001, ISO13485, CE0120 for worldwide sales SOOIL receives FDA clearance for the and Superline insulin infusion set SOOIL develops the Plus insulin pump SOOIL develops a disconnect insulin infusion set, Superline-Free R SOOIL develops the II insulin pump SOOIL receives FDA clearance for the DANA Diabecare R II, Soft-Release-ST soft cannula set and Superline- Easy-Release detachable Infusion set for marketing in the U.S II receives World-class Product Award from the Korean Government SOOIL opens U.S. Subsidiary in San Diego, California SOOIL obtains CE mark for the IIS and the product is launched in EU countries SOOIL develops the IISG Smart-Hybrid Insulin pump which combines the IIS technology with a glucometer US FDA clears DANA IIS insulin pump 2007 SOOIL obtains CE mark for DANA IISG insulin pump SOOIL obtains CE mark for DANA R insulin pump
14 World-Wide Acceptance 30 -Year of Longest History 13 Argentine Australia France Finland Luxemburg Norway Austria Georgia Poland Azerbaijan Germany Portugal Bahrain Greece Romania Belgium Hungary Russia Bulgaria India Saudi Arabia Canada Iran Serbia Chile Israel Slovenia China Italy Spain Colombia Japan Sweden Croatia Jordan Syria Czech Kazakhstan Turkey Denmark Latvia U.S.A Egypt Lithuania UAE
15 14
16 BR-EP-13 rev0 SOOIL Development Co., Ltd , Dogok-dong Kangnam-gu, Seoul, KOREA Tel:+82(2) Fax:+82(2)
41 T Korea, Rep. 52.3. 42 T Netherlands 51.4. 43 T Japan 51.1. 44 E Bulgaria 51.1. 45 T Argentina 50.8. 46 T Czech Republic 50.4. 47 T Greece 50.
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510(k) Summary for DANA Diabecare IS SPONSOR SOOIL Development Co, Ltd. 196-1, Dogok-dong, Kangnam-gu Seoul 135-270 Korea 2 2007 Contact Person: Soo Bong Choi Telephone: 82-2-3463-0041 Fax: 82-2-3463-7077
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