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A7 TouchCare Insulin Management System User Guide 2018, Medtrum Technologies Inc. All rights reserved. Humalog is a trademark of Eli Lilly and Company. NovoLog is a trademark of Novo Nordisk A/S. Apidra is a trademark of Sanofi S.A. 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 Medtrum 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 Contents 1 Introduction............................................................................................................. 1 1.1 Before you begin.......................................................................................... 1 1.2 Indications.................................................................................................... 2 1.3 Contraindications......................................................................................... 2 1.4 User Safety....................................................................................................3 1.4.1 Warnings and Precautions................................................................ 3 1.4.2 Consumables.....................................................................................6 1.4.3 Radio Frequency (RF) Communication............................................. 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 USB charging cable............................................................................20 3 How to Use the PDM............................................................................................. 21 3.1 Basics of the PDM.......................................................................................21 3.1.1 Turn on/off the PDM.......................................................................21 3.1.2 Charge the PDM..............................................................................22 3.1.3 Power Mode....................................................................................23 3.1.4 Scroll Bar......................................................................................... 24 3.1.5 Beep/Vibrate...................................................................................24 3.2 Setting up the PDM.................................................................................... 24 3.2.1 Select a Language............................................................................24 3.2.2 Select country/region..................................................................... 25 3.2.3 Time and Date.................................................................................25 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 Manufacturers 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 Transmitter Specifications..........................................................................41 8.4 Glucose Sensor Specifications....................................................................42 8.5 CGM System Accuracy................................................................................43 1 Introduction 1.1 Before you begin Check with your healthcare provider regarding your individual training needs. Do NOT attempt to use the A7 TouchCare System before you have been properly trained. As part of your training, your healthcare provider will work with you to establish diabetes management guidelines and settings that best fit your needs. Your healthcare provider can provide you with the initial settings of your insulin Pump and CGM system. After adequate training and practice, you will find it easy to enter and change the systems settings. 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. Your Pump is not intended to deliver any other substance. The A7 TouchCare Continuous Glucose Monitoring System incorporates a Glucose Sensor and a Transmitter. The Glucose Sensor measures the glucose level of interstitial fluid. The Transmitter wirelessly transmits your real-time Sensor glucose information to your Personal Diabetes Manager (PDM).
(CGM) Not all devices or accessories are available in all countries where the A7 TouchCare System is approved. To order supplies, contact your local representatives. 1.2 Indications The A7 TouchCare System is indicated for use in people (ages 2 and older) with diabetes. The system is intended for single patient use and should be used under the guidance of a healthcare provider. The Patch Pump is indicated for the continuous subcutaneous delivery of insulin, at set and variable rates, for the 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 unwilling or unable to:
Maintain contact with their healthcare provider. Test their blood glucose levels as recommended by their healthcare provider. Maintain sufficient diabetes self-care skills. Recognize and respond to alerts and alarms. (Sufficient vision and/or hearing are required.) 1.4 User Safety 1.4.1 Warnings and Precautions General Make sure that you have read and are familiar with the User Guide before using the A7 TouchCare System. Failure to follow the instructions may result in pain or injury and may also affect the systems performance. If you do not understand something or have questions, ask your healthcare provider, call customer support, or contact your local Medtrum distributor. The A7 TouchCare System has many different settings and features. It is best to talk with your healthcare provider to determine which settings and features are right for you. Some 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 allergic to acrylic adhesives. Do NOT use anything other than the accessories specified in this User Guide, which could permanently damage your system and voids its warranty. Do NOT allow young children to hold the Reservoir Patch, Pump Base, Transmitter or Sensor without adult supervision. The Reservoir Patch, Pump Base, Transmitter and Sensor contain small parts and could pose a choking hazard. Do NOT operate your A7 TouchCare System in the presence of flammable anesthetics or explosive gases. The A7 TouchCare System includes active medical devices. When you dispose of any device in the A7 TouchCare System, follow the local waste disposal regulations. We recommend that you have someone around you (family, friends, etc.) who understands diabetes and the A7 TouchCare System, so that in case of an emergency, they can help you. Make sure they are familiar with any information given by your healthcare provider. Patch Pump In case the A7 TouchCare System is unable to properly deliver insulin you must be prepared to give yourself an injection of insulin. Knowing how to do this will help to avoid the risk of diabetic ketoacidosis (DKA) or very high blood glucose (BG). your healthcare provider Contact changes starting/stopping your exercise program or significant weight because this can affect the way that your body uses insulin. lifestyle about such as loss/gain Do NOT stop using your Pump if you are ill unless instructed to do so by your healthcare provider. Even when you are ill, your body still needs insulin. If failure or damage of your Pump Base is found during usage, please contact customer support or your local Medtrum distributor for replacement. CGM System Do NOT ignore symptoms of high or low glucose. If you believe your Sensor glucose readings are inconsistent with how you feel, manually measure your blood glucose with a blood glucose meter. If the problem continues, discard the old Sensor and insert a new one. The Sensor may create special needs regarding your medical conditions or medications. Please discuss these conditions and medications with your healthcare provider before using the Sensor. If failure or damage of your Transmitter is found during usage, please contact customer support or your local Medtrum distributor for replacement. If you suspect your Sensor is broken during usage, do NOT attempt to remove it yourself. Contact your healthcare provider for assistance in removing the Sensor. Personal Diabetes Manager (PDM) Check your PDM occasionally to make sure that it emits audible beeps that are easily detectable and that the vibrate feature is working properly. If you return 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 Medtrum distributor if you identify or suspect your PDM has been damaged. Your PDM is designed to be charged by matching charger. Use of anything other than a charger that does not match could permanently damage your PDM and voids its warranty. Operating Temperature Range Your A7 TouchCare System is designed to operate between 5C (41F) and 40C (104F). Do NOT expose the system to temperatures outside that range. Do NOT expose the system to direct sunlight for a long period of time. Cleaning Do NOT use household cleaners, chemicals, solvents, bleach, scouring pads or sharp instruments to clean your PDM, Pump Base, or Transmitter. Never put your PDM, Pump Base or Transmitter in the dishwasher or use very hot water to clean it. Do NOT use a hair dryer, microwave oven, or conventional oven to dry your PDM, Pump Base, or Transmitter. Use a soft towel. Do NOT clean any part of the system while it is in use. X-rays, MRIs and CT Scans The A7 TouchCare System may be affected by strong radiation or magnetic fields. If you are going to have an X-ray, MRI, CT scan or other type of exposure to radiation, remove your 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 PatchThe Pump Base (MD-JN-012) is only used with the 200-unit Medtrum Reservoir Patch (MD-JN-011). Change your Reservoir Patch every 2-3 days or as directed by your healthcare provider. Glucose SensorThe Transmitter (MD-TY-012) is used with the Medtrum Glucose Sensor (MD-JY-006/JY-016). Change your JY-006 Glucose Sensor every seven days or change your JY-016 Glucose Sensor every fourteen days. Warning: For your protection the Pump Base and Transmitter have undergone extensive testing to confirm appropriate operation when used with consumables manufactured or distributed by Medtrum. We recommend using Medtrum Reservoir Patches and Glucose Sensors as we cannot guarantee appropriate operation if the system is used with consumables offered by third-parties and therefore we are not responsible for any injury or malfunctioning of the system that may occur in association with such use. 1.4.3 Radio Frequency (RF) Communication energy, and may Note: The A7 TouchCare System can generate, use, and radiate radio frequency radio communications. There are no guarantees that interference will 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:
interference harmful cause to 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 that transmit in the same frequency band used by the A7 TouchCare System may prevent communication between the PDM and your Patch Pump or Transmitter. This interference, however, does not cause any incorrect data to be sent and does not cause any harm to your device. RF communication between your Patch Pump and PDM works up to a distance of 4 meters (13 feet). RF communication between your Transmitter and PDM works up to a distance of 10 meters (33 feet). 1.4.4 Emergency Kit Keep an emergency kit with you at all times to make sure you have necessary supplies. Inform a family member, co-worker, and/or friend where this emergency kit is kept. This kit should include 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 numbers 1.4.5 Water Both your Patch Pump and Sensor (including the installed Transmitter) are waterproof to a depth of 2.5 meters (8 feet) for up to 60 minutes (IPX8). After exposure to water, rinse the devices with clean water and dry them with a towel. Warning: Do NOT expose your Patch Pump or Sensor (including the installed Transmitter) to water at depths greater than 2.5 meters (8 feet) or for more than 60 minutes. Check often to make sure the devices are securely attached and in place. Warning: The PDM is not waterproof. Do NOT spill fluids on it or drop it 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 -10C (14F) and 55C (131F), and at humidity levels between 20% and 90% relative humidity. Do NOT store the Pump Base and Reservoir Patch in direct sunlight, extreme temperatures, or in very humid areas. Store the Sensor at temperatures between 2C (36F) and 30C (86F), and at humidity levels between 20% and 90% relative humidity for the length of the Sensors shelf life. For temperatures greater than 30C (86F), the Sensor will require cooled storage at temperatures no lower than 2C (36F). You may store the Sensor in the refrigerator if it is within this temperature range. The Sensor should not be stored in the freezer. Wait for the Sensor to warm to room temperature before usage to prevent condensation. Storing the Sensor improperly may cause the Sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. Store the Transmitter at temperatures between -10C (14F) and 55C (131F), and at humidity levels between 20% and 90% relative humidity. Keep the USB charging cable and the Transmitter separate when in storage. Store the Personal Diabetes Manager (PDM) at temperatures between -10C
(14F) and 55C (131F), and at humidity levels between 20% and 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 approved by the party responsible for compliance could void the user's authority to operate the equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio if not installed and used in accordance with the frequency energy and, interference to radio communications. instructions, may cause harmful However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between 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 device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions:
(1) This device may not cause interference, and (2) This device must accept any interference, including interference that may cause undesired operation of the device. 1.5 Warranty Information Warranty Personal Diabetes Manager (PDM) Medtrum Technologies Inc. (Medtrum) warrants its PDM against defects in materials and workmanship for the period of 4 years from the original date of shipment of the PDM to the original end use purchaser (the Warranty Period). During the Warranty Period, Medtrum will, at its discretion, either repair or replace
(with a new or recertified PDM, at Medtrums discretion) any defective PDM, subject to the conditions and exclusions stated herein. This Warranty applies only to new 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 Medtrums 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 PDM by any person or entity other than Medtrum;
If a charger without matching is used with the PDM 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 PDM covered by this warranty to or by a user other than the original end use purchaser shall cause this warranty to immediately terminate. This warranty only applies to the PDM 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 ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE PRODUCT. ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, ARE EXCLUDED, 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, either repair or replace (with a new or recertified Pump Base, at Medtrums discretion) any defective Pump Base, subject to the conditions and exclusions stated herein. This Warranty applies only to new devices and, in the event the Pump Base is repaired or replaced, the warranty period shall not be extended The warranty is valid only if the Pump Base is used in accordance with Medtrums instructions and will not apply:
If damage results from changes or modifications made to the Pump Base by the user or third persons after the date of manufacture;
If damage results from service or repairs performed to any part of the Pump Base by any person or entity other than Medtrum;
If a non-Medtrum Reservoir Patch is used with the Pump Base;
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 Pump Base covered by this warranty to or by a user other than the 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 ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE PRODUCT. ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, ARE EXCLUDED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Warranty Transmitter Medtrum Technologies Inc.
(Medtrum) warrants its Transmitter against defects in materials and workmanship for the period of 1 year from the original date of shipment of the Transmitter to the original end use purchaser (the Warranty Period). During the Warranty Period, Medtrum will, at its discretion, either repair or replace (with a new or recertified Transmitter at Medtrums discretion) any defective Transmitter, subject to the conditions and exclusions stated herein. This Warranty applies only to new devices and, in the event the Transmitter is repaired or replaced, the warranty period shall not be extended. The warranty is valid only if the Transmitter is used in accordance with Medtrums instructions and will not apply:
If damage results from changes or modifications made to the Transmitter by the user or third persons after the date of manufacture;
If damage results from service or repairs performed to any part of the Transmitter by any person or entity other than Medtrum;
If a non-Medtrum 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 Transmitter covered by this warranty to or by a user other than the original end use purchaser shall cause this warranty to immediately terminate. This warranty only applies to the Transmitter 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 ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE PRODUCT. ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, ARE EXCLUDED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. 2 Your A7 TouchCare System 2.1 Personal Diabetes Manager (PDM) The Personal Diabetes Manager (PDM) monitors and controls your Patch Pump and Continuous Glucose Monitoring System via wireless RF communication. It stores your pump and Sensor data of the last 90 days. Keep the PDM with you at all times so that, when needed, you are able to deliver a bolus, change the basal rate, check your glucose level and 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 conditions. The Transmitter can continue to record Sensor glucose readings. The PDM is designed to detect and notify you about a disconnection. As soon as the problem is solved, RF communication will be resumed. 1. Power Key 2. Home Key (Softw Key) 3. Charging Port 4. Sound Hole 5. Charging Indicator Personal Diabetes Manager (PDM) (MD-FM-008) 2.2 Patch Pump The Patch Pump is a small, portable, self-adhesive device worn directly on your body to deliver precise, personalized doses of insulin into your body through a needle. The Patch Pump consists of a 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. Reservoir Patch
(MD-JN-011)(Consumable) Pump Base
(MD-JN-012) 2.3 Glucose Sensing System (Optional) The Glucose Sensing System is an optional part of the A7 TouchCare System which consists of 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 Transmitters USB charging cable is also included in the package. Glucose Sensor
(MD-JY-006 or JY-016)
(Consumable) Transmitter
(MD-TY-012) USB charging cable 3 How to Use the PDM 3.1 Basics of the PDM 3.1.1 Turn on/off the PDM 1) Turn-on When you long-press the power key, then a green light will flash, the screen will light 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. Or you long-press the power key for about 6 seconds, a yellow light will go on for about 2 seconds, indicating that the shutdown is completed. 3.1.2 Charge the PDM It is recommended to fully charge the PDM the first time it is used. As a safety measure, the PDM will give you " PDM BATTERY LOW " or " PDM CHARGE NOW" alert when you keep the PDM working at a low power level. If you receive a PDM BATTERY LOW alert, respond to the alert and continue. Though the PDM will still function normally, the battery life could be decreased. 60601-1 The PDM requires an AC adapter with an output of DC 5.0V that complies with IEC 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. 60950 such and IEC as 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 the PDM is mistaken, the setup information stored in the PDM will not be lost. It takes at least 1 hour to fully charge. Usually, the handheld is fully charged, available for handhelds for 1 weeks. Blue light flashes when PDM is charging, and the green light is always on indicates full charge. Dont change the battery of the PDM at any time. Only person including patient with adequate training is permitted to operate the PDM. 3.1.3 Power Mode The PDM has two power modes:
1. Sleep Mode The PDM enters the Sleep Mode after screen backlight timeout and the screen shuts down. You can turn the PDM into Lock Screen of Awake Mode by short-pressing the Power Key. a. The activated basal, temporary basal and all bolus functions will not be changed. b. c. The screen will be locked after screen backlight timeout. 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 Alert and Alarms regarding the Pump and CGM will immediately wake the screen to enter Lock Screen. The Alerts and Alarms shall be manually cleared after sliding to unlock. 3.1.4 Scroll Bar If there is excessive text length for the screen, a scroll bar appears 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. 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. Setting the correct time and date in your PDM is necessary for accurate basal insulin delivery and enables you to keep a correct record of your insulin 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;
If you choose Skip, the Bolus Calculation function will stay turned-off. 4 Safety System and Alarms 4.1 Safety System Your A7 TouchCare System automatically performs a series of safety checks. The PDM sounds an alert or alarm and displays an on-screen message to let you know of an abnormal condition. If you have more than one notification, you need to clear the first notification to see the next one. All of your alarm settings and alarm history are stored in the PDM if the battery is removed and will be restored once a new battery is installed. However, only 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 notification, the PDM battery power drops fast as the notifications repeat and progress. This will result in reduced battery life and the CHARGE PDM NOW Alarm screen will appear sooner than expected. 4.2 Safety Checks A single fault condition will cause the pump to suspend insulin delivery. Maximum infusion with a single fault condition is 0.05U. 5 Troubleshooting This chapter contains 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. 6 Manufacturers 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 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 Class B 6.2 Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electrostatic discharge
(ESD) 2.0 kV, 4.0 kV, 6.0kV, 8.0 kV contact discharge IEC 61000-4-2 2.0 kV, 4.0 kV, 8.0 kV, 15.0 kV air discharge electromagnetic RF field immunity test 10 V/m IEC 61000-4-3 Power magnetic fields frequency 30 A/m IEC 61000-4-8 2.0 kV, 4.0 kV, 6.0 kV, 8.0 kV contact(56% RH) 2.0 kV, 4.0 kV, 8.0 kV, 15.0 kV air (56% RH) 10 V/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 cm (12 inches) to any part of the Medtrum products. Otherwise, degradation of the performance of this equipment could result. 3. It should 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. 7 Appendix I: Symbols and Icons 7.1 Product Label Symbols Symbol Meaning Symbol Meaning LOT Lot number Do NOT use if package is damaged REF Reference number STERILE EO Sterilized using ethylene oxide Manufacturer STERILE R Use by:
(yyyy-mm-dd) Caution: See Instructions for use Sterilized using radiation Follow instructions for use Radio communication Symbol Meaning Symbol Meaning Storage temperature IPX8 Waterproof to 2.5 m for 1 hour Do NOT reuse SN Device serial number Type BF equipment
(Protection from electrical shock) Authorized representative in the European Community 0197 CE mark by notified body Waste Electrical and Electronic Equipment Protection Against Insertion of Large Objections and Dripping Water IEC 60529 IP22 7.2 PDM Icons Icon Meaning Icon Meaning High priority alarm Medium priority alarm Alert Audio off Audio temporary off Pump RF signal Charging 00:00 am Time Battery Charged 8 Appendix II: Technical Information 8.1 Patch Pump Specifications Model:
Pump Base: MD-JN-012 Reservoir Patch: MD-JN-011 Size: 56.5mm x 33.3mm x 13.3 mm Weight: 21.5 g (without insulin) Operating Temperature Range: +5 C ~ +40 C Operating Relative Humidity Range: 20%~90%RH Operating Atmospheric Pressure: 700~1060 hPa Storage Temperature Range: -10C ~ +55C 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 Warranty of Pump Base: 1 year Shelf Life of Reservoir Patch: 2 years Sterilization Method of Reservoir Patch: By EO gas Reservoir Volume: 200 U (2 mL) (1 U=10 L) Insulin Type Used: U-100 Basal Rate Range: 0.00~ 10 U/h (increment: 0.05 U/h) Bolus Range: 0.05 ~ 25 U (increment: 0.05 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, delivery rate: 1.0 U/H, average error:
0.40%):
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. 8.2 PDM Specifications Model: MD-FM-008 Size: 76.2 x 48.4 x 9.375mm Weight: 42.4 g Screen: 2.4 in Operating Temperature Range: +5C ~ +40C Operating Relative Humidity Range: 20%~ 90%RH Operating Atmospheric Pressure: 700~1060 hPa Storage Temperature Range: -10C ~ +55C Storage Relative 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: Visual, audible and vibratory Volume: 52.3 dB(A) measured from 1 m distance Limited Warranty: 4 years Dust-proof and Waterproof Rating: IP22 8.3 Transmitter Specifications Model: MD-TY-012 Size: 36.1 mm x 19.4 mm x 12 mm Weight: 4.8 g Operating Temperature Range: +5C ~+40C Operating Relative Humidity Range: 20%~90%RH Operating Atmospheric Pressure: 700~1060 hPa Storage Temperature Range: -10C~+55C 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 Distance: 10 m Limited Warranty: 1 year 8.4 Glucose Sensor Specifications Model: MD-JY-006 Storage Temperature Range: +2C ~+30C Storage Relative Humidity Range: 20%~90%RH Storage Atmospheric Pressure: 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: +2C~+30C 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 8.5 CGM System Accuracy A multi-center, randomized clinic study is designed to determine the Sensor accuracy in adults with Type 1 or Type 2 diabetes. In-clinic testing consisted of frequent venous blood sample testing (by Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer, YSI) on a random day in the 7-day Sensor life. 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; Calibrating every 12 hours, Abdomen insertion site. Number of Matched Pairs CGM-YSI 20%/20 mg/dL 30%/30 mg/dL 40%/40 mg/dL 1678 91%
97%
99%
UG882111GB 348300 Version: 2.8
| 1 2 3 | Internal photos | Internal Photos | 716.44 KiB | July 24 2019 |
Photographs OF THE EUT Test Report Q190701S003-FCC-E Page No. 1 of 4 Test Report Q190701S003-FCC-E Page No. 2 of 4 Chip antenna location Test Report Q190701S003-FCC-E Page No. 3 of 4 Test Report Q190701S003-FCC-E Page No. 4 of 4
| 1 2 3 | External Photos | External Photos | 1.35 MiB | July 24 2019 |
Photographs OF THE EUT EUT External Photo Test Report Q190701S003-FCC-E Page No. 1 of 5 Test Report Q190701S003-FCC-E Page No. 2 of 5 Test Report Q190701S003-FCC-E Page No. 3 of 5 Test Report Q190701S003-FCC-E Page No. 4 of 5 Test Report Q190701S003-FCC-E Page No. 5 of 5
| 1 2 3 | Label and location | ID Label/Location Info | 738.73 KiB | July 24 2019 |
VER. SYMBOL 0.90 1.10 1.11 DESCRIPTION NEW DATE 2015.07.03 2017.01.14 2018.06.25 DEG. DIV. 0-5 5-10 A 0.02 0.05 B 0.05 0.1 C 0.1 0.15 10-50 0.1 0.15 0.2 50-100 100-
0.15 0.2 0.25 0.15%
0.2%
0.25%
ANGLE D 0-30 0.1 31-60 61-90 0.3 0.5 56.50 0 0
. 8 TouchCare SN XXXXXXXXX FCC ID: 2AARU-JN012 REF MD-JN-012 IPX8 0 0
. 1 1 REVISION VIEW DIRECTION Unit Scale MM 1:1 APPROVAL M D Y Material CHECK DESCRIPTION Medtrum FINISH LASER DESIGN LZZ M D Y 03 03 16 M D Y DATE DESIGN CHECK APPROVAL VER. Q'TY DRAW 01.11 1 LZZ M D Y 03 03 16 MODEL 760012 PART NAME JN012 FILE NO 760012LANEU0111 COPY& USE FOR ANY PURPOSE NEED WRITTEN PERMISSION FROM SHANGHAI MEDTRUM ALL DIMENSIONS IN mm; DON'T SCALE THIS DRAWING
| 1 2 3 | Authorization Letter | Cover Letter(s) | 64.02 KiB | July 24 2019 |
Tel: 408-526-1188 Fax: 408-526-1088 Email: sales.eaw@us.bureauveritas.com 775 Montague Expressway Milpitas, CA 95035 Project and Product Certification Representative Authorization Letter Reason for Amendment (current / obsolete) Initial Release (obsolete) Revised wording (obsolete) Updated company template (obsolete) Updated letter information (obsolete) Added FCC ID field (obsolete) Updated company name & logo (current) Revision History From 1.0 1.0 2.0 3.0 4.0 5.0 To 1.0 2.0 3.0 4.0 5.0 6.0 Approved Date Nov-14-2006 Sept25-2007 Jan-31-2012 May-23-2014 Sep-16-2014 Jun-27-2018 SCS-F18: Project and Product Certification Representative Authorization Letter Page 1 of 2 Rev 6.0 MEDTRUM TECHNOLOGIES Inc.
(2019/7/9) To: BVCPS, INC. 775 Montague Expressway, Milpitas, CA 95035 USA Dear Sir/Madam, Re: Project and Product Certification Representative Authorization Letter We, MEDTRUM TECHNOLOGIES Inc. hereby authorize Bureau Veritas Consumer Product Services, Inc. to act as a Certification Body for certifying for the following project(s):
FCC ID: 2AARU-JN012 Product Description: Pump Base Model: MD-JN-012 We affirm that between Bureau Veritas Consumer Product Services, Inc. and ____ MEDTRUM TECHNOLOGIES Inc ___, any difference in understanding, including test plan, measurement methods, applicable standards and relevant procedures and processes have been resolved prior to commencement of testing activities. Sincerely, Clients signature:
Clients name / title: Sherry He Contact information / address : 7F, Buiding 8, 200 Niudun Rd Shanghai SCS-F18: Project and Product Certification Representative Authorization Letter Page 2 of 2 Rev 6.0
| 1 2 3 | EMC Test Report | Test Report | 673.53 KiB | July 24 2019 |
EMC TEST REPORT Report No.: Q190701S003-FCC-E Supersede Report No: N/A Applicant Medtrum Technologies Inc. Product Name Pump Base Model No. MD-JN-012 Serial No. N/A Test Standard FCC Part 15 Subpart B Class B, ANSI C63.4: 2014 Test Date July 02 to July 03, 2019 Issue Date July 04, 2019 Test Result Pass Fail Equipment complied with the specification Equipment did not comply with the specification Evans He Test Engineer David Huang Checked By This test report may be reproduced in full only Test result presented in this test report is applicable to the tested sample only Issued by:
SIEMIC (SHENZHEN-CHINA) LABORATORIES Zone A, Floor 1, Building 2 Wan Ye Long Technology Park South Side of Zhoushi Road, Baoan District, Shenzhen, Guangdong China 518108 Phone: +86 0755 2601 4629801 Email: China@siemic.com.cn Test Report Q190701S003-FCC-E Page No. 2 of 19 Laboratories Introduction SIEMIC, headquartered in the heart of Silicon Valley, with superior facilities in US and Asia, is one of the leading independent testing and certification facilities providing customers with one-stop shop services for Compliance Testing and Global Certifications. In addition to testing and certification, SIEMIC provides initial design reviews and compliance management throughout a project. Our extensive experience with China, Asia Pacific, North America, European, and International compliance requirements, assures the fastest, most cost effective way to attain regulatory compliance for the global markets. Accreditations for Conformity Assessment Country/Region Scope USA Canada Taiwan Hong Kong Australia Korea Japan Singapore Europe EMC, RF/Wireless, SAR, Telecom EMC, RF/Wireless, SAR, Telecom EMC, RF, Telecom, SAR, Safety RF/Wireless, SAR, Telecom EMC, RF, Telecom, SAR, Safety EMI, EMS, RF, SAR, Telecom, Safety EMI, RF/Wireless, SAR, Telecom EMC, RF, SAR, Telecom EMC, RF, SAR, Telecom, Safety Test Report Q190701S003-FCC-E Page No. 3 of 19 This page has been left blank intentionally. CONTENTS Test Report Q190701S003-FCC-E Page No. 4 of 19 1. REPORT REVISION HISTORY............................................................................................................................. 5 2. CUSTOMER INFORMATION ................................................................................................................................ 5 3. TEST SITE INFORMATION ................................................................................................................................... 5 4. EQUIPMENT UNDER TEST (EUT) INFORMATION ......................................................................................... 6 5. TEST SUMMARY .................................................................................................................................................... 7 6. MEASUREMENTS, EXAMINATION AND DERIVED RESULTS ..................................................................... 8 6.1 AC POWER LINE CONDUCTED EMISSIONS ..................................................................................................... 8 6.2 RADIATED EMISSIONS ......................................................................................................................................... 10 ANNEX A. TEST INSTRUMENT ................................................................................................................................. 15 ANNEX B. TEST SETUP AND SUPPORTING EQUIPMENT ................................................................................ 16 ANNEX C. USER MANUAL / BLOCK DIAGRAM / SCHEMATICS / PARTLIST/ DECLARATION OF SIMILARITY ..................................................................................................................................................................... 19 1. Report Revision History Test Report Q190701S003-FCC-E Page No. 5 of 19 Report No. Report Version Description Q190701S003-FCC-E NONE Original Issue Date July 04, 2019 2. Customer information Applicant Name Medtrum Technologies Inc. Applicant Add 7F Building 8, No.200 Niudun Road, Shanghai 201203, China Manufacturer Medtrum Technologies Inc. Manufacturer Add Building 3 and 6F~7F, Building 8, No. 200, Niudun Road, Shanghai 201203, China 3. Test site information Lab performing tests SIEMIC (Shenzhen-China) LABORATORIES Zone A, Floor 1, Building 2 Wan Ye Long Technology Park Lab Address South Side of Zhoushi Road, Baoan District, Shenzhen, Guangdong China FCC Test Site No. 518108 535293 IC Test Site No. 4842E-1 Test Software of Radiated Emission Test Software of Conducted Emission EZ-EMC(ver.Icp-03A1) EZ-EMC(ver.Icp-03A1) Test Report Q190701S003-FCC-E Page No. 6 of 19 4. Equipment under Test (EUT) Information Description of EUT:
Pump Base Main Model:
Serial Model:
Antenna Gain:
MD-JN-012 N/A 1.6dBi Antenna Type:
Chip antenna Input Power:
DC 3V(1.5V*2*L1154F) From Battery Equipment Category JAB Type of Modulation:
GFSK RF Operating Frequency (ies):
2402-2480 MHz Number of Channels:
Port:
Trade Name :
FCC ID:
40CH Please refer to the users manual Medtrum 2AARU-JN012 Date EUT received:
July 01, 2019 Test Date(s):
July 02 to July 03, 2019 Test Report Q190701S003-FCC-E Page No. 7 of 19 5. Test Summary The product was tested in accordance with the following specifications. All testing has been performed according to below product classification:
FCC Rules Description of Test 15.107; ANSI C63.4: 2014 AC Power Line Conducted Emissions 15.109; ANSI C63.4: 2014 Radiated Emissions Result N/A Compliance Measurement Uncertainty Parameter Uncertainty AC Power Line Conducted Emissions
(150kHz~30MHz) Radiated Emission(30MHz~1GHz) Radiated Emission(1GHz~6GHz) 2.70dB 3.74dB 4.66dB Test Report Q190701S003-FCC-E Page No. 8 of 19 6. Measurements, Examination And Derived Results 6.1 AC Power Line Conducted Emissions Temperature Relative Humidity Atmospheric Pressure Test date :
Tested By :
Requirement(s):
--
--
--
--
--
Spec Item Requirement Applicable For Low-power radio-frequency devices that is designed to be connected to the public utility (AC) power line, the radio frequency voltage that is conducted back onto the AC power line on any frequency or frequencies, within the band 150 kHz to 30 MHz, shall not exceed the limits in the following table, as measured using a 50
[mu] H/50 ohms line impedance stabilization network (LISN). The lower limit applies at the boundary between the frequencies ranges. Frequency ranges Limit (dBV)
(MHz) QP 0.15 ~ 0.5 66 56 0.5 ~ 5 5 ~ 30 56 60 Average 56 46 46 50 47CFR15. 107 a) Test Setup 1. The EUT and supporting equipment were set up in accordance with the requirements of Procedure the standard on top of a 1.5m x 1m x 0.8m high, non-metallic table. 2. The power supply for the EUT was fed through a 50 /50mH EUT LISN, connected to filtered mains. Test Report Q190701S003-FCC-E Page No. 9 of 19 3. The RF OUT of the EUT LISN was connected to the EMI test receiver via a low-loss coaxial cable. 4. All other supporting equipment were powered separately from another main supply. 5. The EUT was switched on and allowed to warm up to its normal operating condition. 6. A scan was made on the NEUTRAL line (for AC mains) or Earth line (for DC power) over the required frequency range using an EMI test receiver. 7. High peaks, relative to the limit line, The EMI test receiver was then tuned to the selected frequencies and the necessary measurements made with a receiver bandwidth setting of 10 kHz. 8. Step 7 was then repeated for the LIVE line (for AC mains) or DC line (for DC power). Remark The EUT was powered by battery . Result Pass Fail N/A Test Data Yes N/A Test Plot Yes (See below) N/A 6.2 Radiated Emissions Temperature Relative Humidity Atmospheric Pressure Test date :
Tested By :
Requirement(s):
Test Report Q190701S003-FCC-E Page No. 10 of 19 26 oC 59%
1015mbar July 03, 2019 Evans He Spec Item Requirement Applicable Except higher limit as specified elsewhere in other section, the emissions from the low-power radio-frequency devices shall not exceed the field strength levels specified in the following table and the level of any unwanted emissions shall not exceed the level of the fundamental emission. The tighter limit applies at the band a) edges Frequency range (MHz) Field Strength (V/m) 47CFR15. 109(d) 30 88 88 216 216 - 960 Above 960 100 150 200 500 Test Setup 1. 2. The EUT was switched on and allowed to warm up to its normal operating condition. The test was carried out at the selected frequency points obtained from the EUT Procedure characterization. Maximization of the emissions, was carried out by rotating the EUT, changing the antenna polarization, and adjusting the antenna height in the following manner:
a. Vertical or horizontal polarization (whichever gave the higher emission level Test Report Q190701S003-FCC-E Page No. 11 of 19 over a full rotation of the EUT) was chosen. b. The EUT was then rotated to the direction that gave the maximum emission. c. Finally, the antenna height was adjusted to the height that gave the maximum emission. 3. The resolution bandwidth and video bandwidth of test receiver/spectrum analyzer is 120 kHz for Quasiy Peak detection at frequency below 1GHz. 4. The resolution bandwidth of test receiver/spectrum analyzer is 1MHz and video bandwidth is 3MHz with Peak detection for Peak measurement at frequency above 1GHz. The resolution bandwidth of test receiver/spectrum analyzer is 1MHz and the video bandwidth with Peak detection for Average Measurement as below at frequency above 1GHz. 1 kHz (Duty cycle < 98%) 10 Hz (Duty cycle > 98%) 5. Steps 2 and 3 were repeated for the next frequency point, until all selected frequency points were measured. Remark Result Pass Fail Test Data Yes N/A Test Plot Yes (See below) N/A Below 1GHz Test Report Q190701S003-FCC-E Page No. 12 of 19 Test Data Horizontal Polarity Plot @3m No. P/L Frequency Reading Ant_F PA_G Cab_L Result Limit Margin Height Degree
(MHz)
(dBuV/m)
(dB/m)
(dB)
(dB)
(dBuV/m)
(dBuV/
m)
(dB)
(cm)
() 1 H 31.6202 23.09 19.06 22.27 0.14 20.02 40.00
-19.98 100 113 2 H 122.8340 23.05 11.44 22.37 0.99 13.11 43.50
-30.39 200 195 3 H 207.8501 23.32 11.47 22.37 1.56 13.98 43.50
-29.52 100 30 4 H 460.7271 28.50 17.66 21.89 2.04 26.31 46.00
-19.69 100 122 5 H 790.6188 27.35 22.11 21.17 2.54 30.83 46.00
-15.17 100 157 6 H 955.4381 29.38 23.70 20.77 2.71 35.02 46.00
-10.98 100 2 Below 1GHz Test Report Q190701S003-FCC-E Page No. 13 of 19 Test Data Vertical Polarity Plot @3m No. P/L Frequency Reading Ant_F PA_G Cab_L Result Limit Margin Height Degree
(MHz)
(dBuV/m)
(dB/m)
(dB)
(dB)
(dBuV/m)
(dBuV/
m)
(dB)
(cm)
() 1 V 30.9619 23.77 19.48 22.27 0.13 21.11 40.00
-18.89 100 348 2 V 87.4177 23.31 7.44 22.35 0.61 9.01 40.00
-30.99 100 346 3 V 261.9753 22.80 12.47 22.29 1.64 14.62 46.00
-31.38 100 77 4 V 494.1984 23.53 18.63 21.82 2.12 22.46 46.00
-23.54 200 264 5 V 790.6188 27.22 22.11 21.17 2.54 30.70 46.00
-15.30 100 229 6 V 955.4381 32.36 23.70 20.77 2.71 38.00 46.00
-8.00 100 142 Above 1GHz Test Report Q190701S003-FCC-E Page No. 14 of 19 Frequency Read_level Height Polarity Factors Level Limit Margin Detector
(MHz)
(dBV/m) Azimuth 1947.5 56.12 1947.5 46.29 3924 57.11 3924 48.11 1613.4 58.18 1613.4 39.35 3424 62.95 3424 49.65 62 62 218 195 235 168 305 305
(cm) 100 100 100 100 100 100 100 100
(H/V)
(dB)
(dBV/m)
(dBV/m)
(dB)
(PK/AV) V V V V H H H H
-19.38 41.43
-19.38 26.91
-15.96 46.98
-14.18 33.93
-18.52 39.66
-13.68 25.67
-16.75 46.2
-16.75 32.9 74 54 74 54 74 54 74 54
-32.57
-27.09
-27.02
-20.07
-34.34
-28.33
-27.8
-21.1 PK AV PK AV PK AV PK AV Note1: The highest frequency of the EUT is 2480 MHz, so the testing has been conformed to 5*2480MHz=12,400MHz. Note2: The frequency that above 3GHz is mainly from the environment noise. Note3: The AV measurement performed, more than 20dB below limit so AV test data was not presented. Test Report Q190701S003-FCC-E Page No. 15 of 19 Annex A. TEST INSTRUMENT Instrument Model Serial #
Cal Date Cal Due Radiated Emissions EMI test receiver ESL6 1300.5001K06-
100262-eQ 01/04/2019 01/03/2020 Active Antenna AL-130 121031 02/07/2019 02/06/2020 3m Semi-anechoic Chamber 9m*6m*6m N/A 10/17/2019 10/16/2020 Signal Amplifier 8447E 443008 01/24/2019 01/23/2020 MXA signal analyzer N9020A MY49100060 01/04/2019 01/03/2020 Horn Antenna Horn Antenna AMPLIFIER AMPLIFIER HAH-118 HAH-118 EM01G26G 71259 71283 60613 01/25/2019 01/24/2020 02/01/2019 01/31/2020 01/24/2019 01/23/2020 Emc012645 980077 01/04/2019 01/03/2020 Bilog Antenna (30MHz~6GHz) JB6 A110712 02/07/2019 02/06/2020 Test Report Q190701S003-FCC-E Page No. 16 of 19 Annex B. TEST SETUP AND SUPPORTING EQUIPMENT Annex B.ii. TEST SET UP BLOCK Block Configuration Diagram for Radiated Emissions EUT Test Table 80cm above ground plane d=3meter Receiving Antenna Test Report Q190701S003-FCC-E Page No. 17 of 19 Block Configuration Diagram for Radiated Emissions Above 1GHz. EUT Test Table 150cm above ground plane d=3meter Receiving Antenna Test Report Q190701S003-FCC-E Page No. 18 of 19 Annex C. iI. SUPPORTING EQUIPMENT DESCRIPTION The following is a description of supporting equipment and details of cables used with the EUT. Supporting Equipment:
Manufacturer Equipment Description Model Serial No
-
-
-
-
Supporting Cable:
Cable type Shield Type Ferrite Core Length Serial No
-
-
-
-
-
Test Report Q190701S003-FCC-E Page No. 19 of 19 Annex C. User Manual / Block Diagram / Schematics / Partlist/
DECLARATION OF SIMILARITY N/A
| 1 2 3 | EMC Test set-up Photo | Test Setup Photos | 259.64 KiB | July 24 2019 |
Photograph: Test Setup Photo EMC:
Test Report Q190701S003-FCC-E Page No. 1 of 1 Radiated Emissions Test Setup Below 1GHz Radiated Emissions Test Setup Above 1GHz BLE:
Radiated Spurious Emissions Test Setup Below 1GHz Radiated Spurious Emissions Test Setup Above 1GHz
| 1 2 3 | LTC Letter | Cover Letter(s) | 100.65 KiB | July 24 2019 |
775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: sales.eaw@us.bureauveritas.com Confidentiality Request Letter Reason for Amendment (current / obsolete) Initial Release (obsolete) Adding CFR 2.459 (obsolete) Updated company template & Added text box
(obsolete) Added IC confidentiality letter form (obsolete) Corrections to STC form. Added reference to KDB
(obsolete) Updated company logo (current) Revision History From 1.0 1.0 2.0 3.0 4.0 5.0 To 1.0 2.0 3.0 4.0 5.0 6.0 Approved Date Nov-14-2006 August 11 - 2008 Jan-31-2012 March-26-2015 Nov-19-2015 Jun-26-2019 SCS-F19: Confidentiality Request Letter Page 1 of 2 Rev 6.0 MEDTRUM TECHNOLOGIES Inc.
(2019/7/9) To:
Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD Subject: Permanent Confidentiality Request for FCC ID: 2AARU-JN012 Pursuant to sections 0.457 and 0.459 of CFR 47, we respectfully request permanent confidential treatment of the following Exhibits accompanying this application as:
- Block Diagram
- Schematics
- Operational Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Clients signature:
Clients name / title: Sherry He Contact information / address : 7F, Buiding 8, 200 Niudun Rd Shanghai SCS-F19: Confidentiality Request Letter Page 2 of 2 Rev 6.0
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2019-07-24 | PowerOutput | JAB - Part 15 Class B Digital Device | Original Equipment |
| 2 | 2402 ~ PowerOutput | DTS - Digital Transmission System | ||
| 3 | 2016-04-12 | 2402 ~ 2480 | DTS - Digital Transmission System |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 2 3 | Effective |
2019-07-24
|
||||
| 1 2 3 |
2016-04-12
|
|||||
| 1 2 3 | Applicant's complete, legal business name |
MEDTRUM TECHNOLOGIES Inc.
|
||||
| 1 2 3 | FCC Registration Number (FRN) |
0024765067
|
||||
| 1 2 3 | Physical Address |
7F, Buiding 8, 200 Niudun Rd
|
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| 1 2 3 |
Shanghai, N/A
|
|||||
| 1 2 3 |
China
|
|||||
| app s | TCB Information | |||||
| 1 2 3 | TCB Application Email Address |
t******@siemic.com
|
||||
| 1 2 3 |
h******@acbcert.com
|
|||||
| 1 2 3 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
| 1 2 3 |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
|||||
| app s | FCC ID | |||||
| 1 2 3 | Grantee Code |
2AARU
|
||||
| 1 2 3 | Equipment Product Code |
JN012
|
||||
| 1 2 3 |
JN012
|
|||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 2 3 | Name |
S****** H******
|
||||
| 1 2 3 | Telephone Number |
86-21******** Extension:
|
||||
| 1 2 3 | Fax Number |
86-21********
|
||||
| 1 2 3 |
h******@medtrum.com
|
|||||
| app s | Technical Contact | |||||
| 1 2 3 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd.
|
||||
| 1 2 3 | Name |
E****** Z********
|
||||
| 1 2 3 | Physical Address |
No. 588 West Jindu Road, Songjiang District
|
||||
| 1 2 3 |
201612
|
|||||
| 1 2 3 |
China
|
|||||
| 1 2 3 | Telephone Number |
+8621********
|
||||
| 1 2 3 |
e******@sgs.com
|
|||||
| app s | Non Technical Contact | |||||
| n/a | ||||||
| app s | Confidentiality (long or short term) | |||||
| 1 2 3 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 2 3 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
| if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
| app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
| 1 2 3 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 2 3 | Equipment Class | JAB - Part 15 Class B Digital Device | ||||
| 1 2 3 | DTS - Digital Transmission System | |||||
| 1 2 3 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Pump Base | ||||
| 1 2 3 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 2 3 | Modular Equipment Type | Does not apply | ||||
| 1 2 3 | Purpose / Application is for | Original Equipment | ||||
| 1 2 3 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
| 1 2 3 | No | |||||
| 1 2 3 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
| 1 2 3 | Grant Comments | Enter any text that you would like to appear at the bottom of the Grant of Equipment Authorization: | ||||
| 1 2 3 | Power listed is the maximum conducted output power. | |||||
| 1 2 3 | Power Output listed is conducted. End-users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. | |||||
| 1 2 3 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 2 3 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
| app s | Test Firm Name and Contact Information | |||||
| 1 2 3 | Firm Name |
SIEMIC (Shenzhen-China) Laboratories
|
||||
| 1 2 3 |
SGS-CSTC Standards Technical Services Co.,Ltd.
|
|||||
| 1 2 3 | Name |
M**** H****
|
||||
| 1 2 3 |
Z******** Z********
|
|||||
| 1 2 3 | Telephone Number |
+ (86********
|
||||
| 1 2 3 |
86(0)******** Extension:
|
|||||
| 1 2 3 | Fax Number |
86021********
|
||||
| 1 2 3 |
a******@cn.bureauveritas.com
|
|||||
| 1 2 3 |
z******@sgs.com
|
|||||
| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 15B | CC | ||||||||||||||||||||||||||||||||||||||
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 2 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0007620 | |||||||||||||||||||||||||||||||||||
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 3 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0000600 | ||||||||||||||||||||||||||||||||||||
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC