Medtrum A7 TouchCare Скачать руководство пользователя страница 35 | Manualshive

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6 Manufacturer’s Declaration

The A7 TouchCare® System (consisting of the MD-FM-008 PDM, MD-JN-012
Pump Base, MD-JN-011 Reservoir Patch, MD-TY-012 Transmitter and
MD-JY-006/JY-016 Glucose Sensor) is intended for use in the electromagnetic
environment specified below. The customer or the user of A7 TouchCare®
System should make sure that it is used in such an environment.

6.1 Electromagnetic Emissions

Emissions Test

Compliance

RF emissions

EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007, CISPR
11:2009+A1:2010and IEC 60601-1-2:2014

Group 1

RF emissions

EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007, CISPR
11:2009+A1:2010and IEC 60601-1-2:2014

Class B

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Содержание A7 TouchCare

Страница 1: ...A7 TouchCare Insulin Management System User Guide ...

Страница 2: ...m Technologies Inc 7F Building 8 No 200 Niudun Road Shanghai 201203 China Tel 86 21 50274781 Fax 86 21 50274779 www medtrum com Medtrum Ltd Citibase Watford 42 44 Clarendon Road Watford WD17 1JJ United Kingdom Tel 44 1923312391 0197 This product complies with Directive 93 42 EEC MDD and Directive 2014 53 EU RED REF MD SY 011C Version 1 0 Publication date 4 Sep 2018 UG882111GB 348300 ...

Страница 3: ...unication 7 1 4 4 Emergency Kit 8 1 4 5 Water 9 1 4 6 Storage 9 1 4 7 FCC Caution 10 1 4 8 IC Caution 11 1 5 Warranty Information 12 Warranty 12 Personal Diabetes Manager PDM 12 Warranty 13 Pump Base 13 Warranty 14 Transmitter 14 2 Your A7 TouchCare System 17 2 1 Personal Diabetes Manager PDM 17 Personal Diabetes Manager PDM MD FM 008 18 2 2 Patch Pump 18 2 3 Glucose Sensing System Optional 19 ...

Страница 4: ...5 3 2 4 Bolus Calculator 26 4 Safety System and Alarms 28 4 1 Safety System 28 4 2 Safety Checks 28 5 Troubleshooting 30 6 Manufacturer s Declaration 31 6 1 Electromagnetic Emissions 31 6 2 Electromagnetic Immunity 32 7 Appendix I Symbols and Icons 34 7 1 Product Label Symbols 34 7 2 PDM Icons 36 8 Appendix II Technical Information 37 8 1 Patch Pump Specifications 37 8 2 PDM Specifications 40 8 3 ...

Страница 5: ...ttings The A7 TouchCare Pump is designed to use U 100 insulin The following insulin analogs have been tested and found to be safe for use with the A7 TouchCare Pump Humalog NovoLog and Apidra Before using different insulin with this Pump check the insulin label to make sure it can be used with your Pump Use of any insulin with lesser or greater concentration can result in serious injury or death Y...

Страница 6: ... management of diabetes mellitus in persons requiring insulin The CGM System is indicated for continuous monitoring of interstitial fluid glucose levels and detecting possible low and high glucose episodes Interpretation of the CGM System results should be based on the glucose trends and several sequential readings 1 3 Contraindications The A7 TouchCare System is not recommended for people who are...

Страница 7: ... features require great knowledge of insulin pumping and advanced self care skills Do NOT use the A7 TouchCare System until you have specific information for your treatment plan and have had specific training on each feature from your healthcare provider or local Medtrum distributor No modification of this system is allowed Do NOT use the A7 TouchCare System if you have delicate skin or if you are...

Страница 8: ... how to do this will help to avoid the risk of diabetic ketoacidosis DKA or very high blood glucose BG Contact your healthcare provider about lifestyle changes such as starting stopping your exercise program or significant weight loss gain because this can affect the way that your body uses insulin Do NOT stop using your Pump if you are ill unless instructed to do so by your healthcare provider Ev...

Страница 9: ...eturn your PDM for service a replacement PDM will be sent Do NOT use the replacement PDM until it has been programmed to fit your specific needs If you drop your PDM or if it has been hit against something hard inspect it to be sure it is still Check whether the display screen and the touch screen are working properly whether the PDM can be charged normally Call customer support or your local Medt...

Страница 10: ...our Patch Pump and Glucose Sensing System and put them outside the treatment area with your PDM Change the Reservoir Patch and Sensor after the test or procedure is completed The A7 TouchCare System is designed to tolerate common electromagnetic and electrostatic fields including airport security systems and mobile phones 1 4 2 Consumables Reservoir Patch The Pump Base MD JN 012 is only used with ...

Страница 11: ...not occur in a installation If the A7 TouchCare System does cause harmful interference to radio or television reception you are encouraged to try to correct the interference by one of the following measures Move or relocate the A7 TouchCare System Increase the distance between the A7 TouchCare System and the other device that is emitting receiving interference Common consumer electronic devices th...

Страница 12: ...nclude but is not limited to Fast acting glucose tablets or gel BG monitoring supplies Urine ketone testing supplies Insulin syringe Rapid acting U 100 insulin Extra Medtrum 2 0 mL Reservoir Patches Extra AAA alkaline batteries Instructions from your healthcare provider about how much insulin to inject if pump delivery is interrupted Alcohol wipes Glucagon emergency kit Emergency contact phone num...

Страница 13: ...into fluids Warning The Patch Pump may not be able to deliver normally in water The Transmitter may not be able to send data normally in water Note Hot water may decrease Sensor life 1 4 6 Storage Store the Pump Base and Reservoir Patch at temperatures between 10 C 14 F and 55 C 131 F and at humidity levels between 20 and 90 relative humidity Do NOT store the Pump Base and Reservoir Patch in direc...

Страница 14: ... 90 relative humidity 1 4 7 FCC Caution Labelling requirements This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Information to user Any Changes or modifications not expressly approve...

Страница 15: ...n the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help RF warning for Portable device The device has been evaluated to meet general RF exposure requirement The device can be used in portable exposure condition without restriction 1 4 8 IC Caution This dev...

Страница 16: ... devices and in the event the PDM is repaired or replaced the warranty period shall not be extended The warranty is valid only if the PDM is used in accordance with Medtrum s instructions and will not apply If damage results from changes or modifications made to the PDM by the user or third persons after the date of manufacture If damage results from service or repairs performed to any part of the...

Страница 17: ...UDED INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Warranty Pump Base Medtrum Technologies Inc Medtrum warrants its Pump Base against defects in materials and workmanship for the period of 1 year from the original date of shipment of the Pump Base to the original end use purchaser the Warranty Period During the Warranty Period Medtrum will at its discretion eithe...

Страница 18: ...e original end use purchaser shall cause this warranty to immediately terminate This warranty only applies to the Pump Base and does not apply to other products or accessories THE REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE FOR ANY WARRANT CLAIMS NEITHER MEDTRUM NOR ITS SUPPLIERS OR DISTRIBUTORS SHALL BE LIABLE FOR ANY INCIDENTAL CONSEQUENTIAL OR SPECIAL DAMAGE OF A...

Страница 19: ... Glucose Sensor is used with the Transmitter If damage results from a Force Majeure or other event beyond the control of Medtrum or If damage results from negligence or improper use including but not limited to improper storage or physical abuse such as dropping or otherwise This warranty shall be personal to the original end use purchaser Any sale rental or other transfer or use of the Transmitte...

Страница 20: ...EXCLUDED INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ...

Страница 21: ...nd so on When RF communication is lost or interrupted because of adverse conditions or overlong distance you will not be able to use your PDM to control or monitor your Patch Pump or Continuous Glucose Monitoring System Yet the Patch Pump is able to continue delivering basal insulin based on your programmed settings perform safety checks and automatically stop delivery in case of serious condition...

Страница 22: ...reusable Pump Base and a disposable Reservoir Patch The reusable Pump Base holds the electronics and stores all your Pump settings The disposable 200 Unit Reservoir Patch incorporates a precise dispensing screw a plunger a driver a needle a buzzer and a battery to power your Pump The delivery system and enclosure of the Reservoir Patch are applied parts of the Pump 1 Power Key 2 Home Key Softw Key...

Страница 23: ...f a disposable Glucose Sensor and a reusable Transmitter The Glucose Sensor is inserted under the skin to measure your glucose level in interstitial fluid The Sensor is the applied part of the Glucose Sensing System The Transmitter records Sensor data and sends data to a display device via wireless RF communication The Transmitter s USB charging cable is also included in the package ...

Страница 24: ... Glucose Sensor MD JY 006 or JY 016 Consumable Transmitter MD TY 012 USB charging cable ...

Страница 25: ...ght up the PDM is successfully turned on When you short press the power key a yellow light will go on for about 8 seconds but the PDM is not turned on 1 Turn off When you long press the power key for about 2 seconds the shutdown screen appears Then you can slide to power off a yellow light will last for about 6 seconds indicating that the shutdown is completed ...

Страница 26: ...01 1 and IEC 60950 such as UES06WNCPU 050 100SPA input 100 240V 50 60Hz 0 2A output 5 0V DC 1 0A The adapter is designed as a part of the ME system Note Do not use other types of chargers Otherwise the PDM may not work normally You must charge the PDM when the battery is low to keep using the PDM If the battery is exhausted the PDM will shut down automatically Even if the PDM is exhausted or if th...

Страница 27: ...reen backlight timeout c Press Power key and the screen lights up the PDM displays the Lock Screen When PDM is displaying a certain screen before it turns to Lock Screen PDM will show the previous screen after the screen is unlocked 2 Awake Mode The PDM is in the Awake Mode when the screen backlight stays on a You can turn Sleep Mode to Awake Mode by pressing Power key b In the Sleep Mode all Aler...

Страница 28: ...on the right side of the screen You can view any additional text by scrolling up and down 3 1 5 Beep Vibrate The PDM beeps and or vibrates to notify you of a condition For more information about Beep Vibrate 3 2 Setting up the PDM 3 2 1 Select a Language Select your language then tap Next ...

Страница 29: ...You can change language 3 2 2 Select country region Select your country region then tap Next 3 2 3 Time and Date When starting PDM for the first time you need to set the time and date ...

Страница 30: ...delivery and Sensor readings You can select a 12 hour or 24 hour clock format 3 2 4 Bolus Calculator After you finish the settings for date and time you can choose whether you shall use the Bolus Calculator Tap Yes to enter Bolus Calc Setup Tap No to go directly to Lock Screen If you choose Setup the Bolus Calculator function will be forced to turn on ...

Страница 31: ...If you choose Skip the Bolus Calculation function will stay turned off ...

Страница 32: ...y the remaining alarm alert conditions will be recorded after the new battery is installed Note Do NOT set alarm time point limit value etc beyond the thresholds or in a way that makes the alarm system useless Talk with your healthcare provider to see which settings are best for you Note Your PDM consumes battery power when notifying you of alerts alarms and reminders If you do not acknowledge a n...

Страница 33: ...Maximum infusion with a single fault condition is 0 05U ...

Страница 34: ...ontains procedures and information to help you understand and address conditions that might occur with A7 TouchCare System It will give a simple analysis and some detailed answers please look for it in the corresponding sections it on ...

Страница 35: ...ctromagnetic environment specified below The customer or the user of A7 TouchCare System should make sure that it is used in such an environment 6 1 Electromagnetic Emissions Emissions Test Compliance RF emissions EN 60601 1 2 2007 AC 2010 IEC 60601 1 2 2007 CISPR 11 2009 A1 2010and IEC 60601 1 2 2014 Group 1 RF emissions EN 60601 1 2 2007 AC 2010 IEC 60601 1 2 2007 CISPR 11 2009 A1 2010and IEC 60...

Страница 36: ... 0 kV 15 0 kV air 56 RH RF electromagnetic field immunity test IEC 61000 4 3 10 V m 10 V m Power frequency magnetic fields IEC 61000 4 8 30 A m 30 A m Warning 1 Medtrum MD SY 011C system is not designed to be used in an environment with high voltage high intensity magnetic field where the intensity of EM DISTURBANCES is high 2 Portable RF Communications equipment should be used no closer than 30 c...

Страница 37: ...be avoided to use this equipment adjacent to or stacked with other medical equipment because it could result in improper operation If such use is necessary this equipment and the other medical equipment should be observed to verify that they are operating normally ...

Страница 38: ...ymbol Meaning LOT Lot number Do NOT use if package is damaged REF Reference number STERILE EO Sterilized using ethylene oxide Manufacturer STERILE R Sterilized using radiation Use by yyyy mm dd Follow instructions for use Caution See Instructions for use Radio communication ...

Страница 39: ...NOT reuse SN Device serial number 0197 CE mark by notified body Type BF equipment Protection from electrical shock Waste Electrical and Electronic Equipment Authorized representative in the European Community IP22 Protection Against Insertion of Large Objections and Dripping Water IEC 60529 ...

Страница 40: ...7 2 PDM Icons Icon Meaning Icon Meaning High priority alarm Medium priority alarm Alert Audio off Audio temporary off 00 00 am Time Pump RF signal Battery Charging Charged ...

Страница 41: ...Relative Humidity Range 20 90 RH Operating Atmospheric Pressure 700 1060 hPa Storage Temperature Range 10 C 55 C Storage Relative Humidity Range 20 90 RH Storage Atmospheric Pressure 700 1060 hPa Classification Internally powered Type BF applied parts Continuous operation Battery Powered by two button batteries 1 5 V Wireless Communication Distance 4 m Waterproof Rating IPX8 2 5 m 60 min Limited W...

Страница 42: ...05 or 0 1 U Bolus Delivery Rate 0 05 U 2 s Maximum Infusion Pressure and Occlusion Pressure Threshold 15 psi Maximum Time to Occlusion Alarm Basal Delivery 0 1 U h 30 h Basal Delivery 1 U h 3 h Bolus Delivery 3 U at 1 5 U min 120 s Bolus Volume after Occlusion Release 3 U Delivery Accuracy Basal 5 at rates 0 1 10 U h Bolus 5 for all set values 0 05 25 U Accuracy Test Results test cycle 29 H delive...

Страница 43: ...Note The Patch Pump may not be able to achieve the above measurement accuracy under certain circumstances such as vigorous exercise or abnormal operating conditions ...

Страница 44: ... Humidity Range 20 90 RH Storage Atmospheric Pressure 700 1060 hPa Classification Internally powered Continuous operation Battery Built in 3 8 V polymer lithium ion battery Power 5 0VDC 1 0A Battery Life Approximately 1 weeks for fully charged Data Storage Automatically stores the previous 90 days data Wireless Communication Distance 10 m with the Transmitter 4 m with the insulin pump Alarm Type V...

Страница 45: ...90 RH Operating Atmospheric Pressure 700 1060 hPa Storage Temperature Range 10 C 55 C Storage Relative Humidity Range 20 90 RH Storage Atmospheric Pressure 700 1060 hPa Battery Built in 3 7 V polymer lithium ion battery Waterproof Rating IPX8 2 5 m 60 min Classification Type BF equipment Continuous operation Data Storage Automatically stores the previous 14 days data Wireless Communication Distanc...

Страница 46: ...ssure 700 1060 hPa Glucose Range 2 2 22 2 mmol L 40 400 mg dL Sterilization Method By radiation Sensor Life Up to 7 days Model JY 016 Storage Temperature Range 2 C 30 C Storage Relative Humidity Range 20 90 RH Storage Atmospheric Pressure 700 1060 hPa Glucose Range 2 2 22 2mmol L 40 400mg dL SterilizationMethod By radiation Sensor Life Up to 14 days ...

Страница 47: ...fe The accuracy is based on the percentage of CGM glucose readings that are within 20 30 or 40 of YSI values at glucose values at or above 100 mg dL 5 6 mmol L or within 20 mg dL 1 1 mmol l 30 mg dL 1 7 mmol L or 40 mg dL 2 2 mmol L of YSI values at glucose values below 100 mg dL 5 6 mmol L Table Percentage of CGM Glucose Readings within 20 20 mg dL 30 30 mg dL or 40 40 mg dL of the YSI Calibratin...

Страница 48: ...UG882111GB 348300 Version 2 8 ...

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