2. Select a temp basal type, temp rate or percent and duration, then s Tap Next to review the temporary basal rates set. Ve rit a Note: If Percent is selected, you can set the temp basal rate, not exceeding the Max Basal Rate, between 0 and 200% with an increment of 1%. If Rate (U/H) is selected, you can set the temp basal between 0 and the Max Basal Rate with an increment of 0.05 U/H. ur ea Make sure that the temp basal is correct in this Temp Basal Review, then Slide to activate. B 3.
Main Menu➔Basal➔Cancel Temp Basal Slide to stop temp basal delivery, or tap to continue delivering. s 2. B ur ea u Ve rit a Note: If you suspend insulin delivery while a temp basal rate is active, the temp basal rate will be canceled. 5.6 Preset Temp Basal With the preset temp basal feature, you can program temp basal rates for recurring short-term situations. You can set up to seven preset temp basal rates: Heavy Ex, Medium Ex, Light Ex, Sick, Temp 1, and Temp 2 and Temp 3. 5.6.
Main Menu➔Settings➔Insulin Pump➔Basal Setup➔Preset Temp Setup Select a preset temp basal you want to edit. Choose the temp basal type (rate or percent). 3. Set the duration and rate/percentage of the preset temp basal. Tap Save to save settings. Ve rit a s 2. 5.6.2 Activate a Preset Temp Basal B ur ea u You must set up a preset temp basal before you can activate it. 1. Go to the Preset Temp Basal screen. Main Menu➔Basal➔Preset Temp Basal 2.
3. 4. Confirm your preset temp basal settings. Slide to activate. 5.7 Reminder 5.7.1 Bolus Reminder s When you fail to deliver a Bolus at between time point A and time point B, you will receive a Reminder at time point B. 1. Time Point A 2. Time Point B rit a 1 u Ve 2 B ur ea You can add, delete, or review Reminders when the Bolus Reminder option is turned on. Go to the Bolus Reminder screen.
rit a s Note: (1) The end time should be at least 30 min later than the start time. You can program up to four bolus Reminders. (2) The Reminders will be saved automatically. B ur ea u Ve Delete Reminder Slide from right to left on one segment, tap Delete to delete this segment. 5.7.2 BG Reminder After you deliver a bolus, you may want to check your BG. The BG Reminder is an optional feature that reminds you to check your BG after a bolus. Go to the BG Reminder Setup screen.
s If you have BG Reminder turned on, the BG REMINDER DURATION screen appears when you set Bolus. rit a It allows you to set the time before you are reminded to check your blood glucose after a bolus. Ve The time ranges from 00:30 to 05:00 with an increment of 30 minutes. The default time is 00:30. B ur ea u You can also turn off the BG reminder after each bolus. You can accept or modify the time before you are reminded. 5.8 Pump History 5.8.
delivery history) and alert history (pump alerts and alarms). Go to the Pump History screen. rit a s Main Menu➔History➔Pump History 5.8.1.1 Delivery History ur ea u Ve You can select one day to review its delivery graph. It displays the summary of basal, bolus and total delivery for one day. 1. Tap the date to switch between records of different dates 2. Tap the info icon to review legend meanings. B 3.
Significance Basal Basal Rate infusion curve Temp Basal Rate infusion curve Normal Bolus delivery icon s Abbreviation rit a Legend Temp Basal Ve Normal Bolus ur ea u Extended Bolus Auto Suspend B Manual Suspend Stop New Patch Extended Bolus delivery icon This tag appears when any of the following alarms occurs: AUTO OFF, PREDICTIVE LOW SUSPEND, LOW SUSPEND, EXCEEDS MAX TDD, EXCEEDS MAX 1HR DELIVERY ALARM.
(3) Bolus history ur ea u Ve rit a The start time of this bolus; Status of bolus: completed, canceled, delivering; Bolus type; Amount of bolus delivered |Amount of bolus programmed.
Combo: Combo Bolus by Manual Bolus Calc-N: Normal Bolus by Bolus Calculator Calc-E: Extended Bolus by Bolus Calculator Calc-C: Combo Bolus by Bolus Calculator Tap record line to view more detailed information. See Chapter “Advanced Pump Features” for more information. (4) Daily Totals ur ea u Ve rit a s This screen displays most detailed Daily Totals information. N represents Normal Bolus. E represents Extended Bolus. C represents Combo Bolus. FoodBolus 7.
5.8.1.2 Alert History rit a s Go to the pump Alert History screen. Main Menu➔History➔Pump History➔Alert History Tap the date to switch between records of different dates. Tap each Alert/Alarm to view alert detail information. Tap to return to the previous menu. u Ve See Section “Alert Icons” in Chapter “How to us the PDM” for more information about how to address alarms and alerts and the meanings of different alarm/alert icons. ur ea 5.8.2 Pump Summary History 5.8.2.
Daily Insulin: Total daily dose of insulin delivered per day. Daily Basal: Average daily dose and percentage of insulin delivered as Basal. Daily Bolus: Average daily dose and percentage of insulin delivered as Bolus. Daily Carbs: Average daily amount of carbs. 5.8.2.2 Summary History: Bolus History This screen displays the Bolus summary history.
Your Patch Pump is waterproof to a depth of 2.5 meters (8 feet) for up to 60 minutes (IPX8). It means the maximum pressure the device can tolerate equals the pressure in 2.5m deep in STILL water instead of flowing water. It is OK to take a shower or go swimming with the devices on, but if you go diving, the water pressure may be too high for the devices. I didn’t see an alert message, but it appeared in History.
If the PDM is away from the Patch Pump, how will the basal rate be delivered? The selected basal pattern is stored in the pump base, which means that even if the PDM is away, the basal pattern will continue as planned. Can I fill the patch with insulin when the patch is on body? NO. NEVER DO THAT. Insulin can go directly into your body, which is very dangerous.
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6 How to use CGM system (Optional) 6.1 Glucose Alerts Set your Low and High glucose alerts before using the sensor. See Section “Glucose Alerts” in Chapter “How to use (P)LGS” for more information. 6.2 Change Sensor rit a s Your Sensor gives glucose readings for up to fourteen days. When a Sensor expires or fails, your Sensor session ends automatically, and PDM displays no more glucose readings. You must remove the Sensor and disconnect the Transmitter. 6.2.
6.2.2 Remove the Current Sensor and Disconnect the Transmitter Gently peel the adhesive pad off your skin in one continuous movement to remove the Sensor and Transmitter. 2. Pinch the ribbed release tabs on the sides of the Sensor support mount, and gently pull the Transmitter away from the Sensor support mount. 3. Discard the Sensor support mount and reuse the Transmitter. ur ea u Ve rit a s 1. B Note: Do Not discard your Transmitter. It is reusable and rechargeable.
The battery must be fully charged the first time you use the Transmitter, which may take up to 2 hours. It is recommended to recharge the Transmitter after each Sensor session. If a Transmitter is stored for two months, you must fully charge the Transmitter battery to ensure it works properly. The indicator light will flash when the Transmitter is being charged, and go off when the Transmitter is fully charged. Note: We recommend that your Transmitter is only charged by an intended and qualified operator.
s rit a Ve B ur ea u 2. You can either enter SN manually or search for the SN if it is the first time you enter the SN. 3. You can only enter SN manually if you want to update the SN.
Enter SN manually B ur ea u Ve rit a s Tap --------- or the existing Transmitter SN, you will see the following screen. Then enter the SN to your PDM and press Done. Search for the SN If you select Search, make sure that your Transmitter is connected to a new Sensor and move the PDM closer to your CGM before searching. See Section “Insert a New Sensor” for more information. If you tap Search in Sensor, you will see the following message when you search for the SN.
ur ea u Ve rit a s If your PDM finds one Transmitter, the Transmitter SN appears on the screen. Confirm it once it matches the SN printed on your Transmitter. If it is correct, tap OK. B If your PDM finds multiple Transmitters, tap OK to go back to Sensor Menu, then select “---------” to enter the SN manually.
rit a s If your PDM does not find a Transmitter, make sure that your Transmitter is connected to a new Sensor, move the PDM closer to your CGM, and enter the SN manually. 6.2.5.1 Select an Insertion Site Ve 6.2.5 Insert a New Sensor ur ea u When choosing the location for the Sensor, consider the following: That you can comfortably reach the Sensor. That you apply the Sensor to a flat area of skin with adequate subcutaneous fat.
Front Back Front Back rit a s If you choose an insertion site on your abdomen (buttock for children), apply the Sensor horizontally. If you choose an insertion site on your upper arm, apply the Sensor vertically. 6.2.5.2 Prepare the Insertion Site Wash your hands thoroughly with soap and water and wait for them dry up. 2. Wipe the selected insertion area with rubbing alcohol and wait for the area to dry up. This may help prevent infection. Do NOT insert the Sensor until the cleaned area is dry.
surface. You may contaminate the insertion site and suffer an infection if you have unclean hands while inserting the Sensor. 6.2.5.4 Remove the Protective Liner from the Sensor Support Mount Ve rit a s Bend the two-piece protective liner slightly on the edge so you can see the seam between the two pieces. Hold the inserter part of the Sensor, and try not to touch the adhesive surface. Remove the liners from the Sensor support mount one after another. 6.2.5.
6.2.5.7 Insert the Sensor Ve rit a s Hold the inserter as shown below and press the two buttons at the same time. You might feel a slight pinch as the Sensor is placed just under your skin. 6.2.5.
6.2.5.9 Check the Sensor Support Mount Confirm that the Sensor support mount remains tightly adhered to your skin by sliding your finger along the edges of the adhesive pad and examine for any gaps in adhesion. Warning: If bleeding occurs at the insertion site, do not attach the Transmitter to the Sensor. Apply steady pressure using a sterile gauze or clean cloth for up to 3 minutes. If bleeding stops, attach the Transmitter to the Sensor.
successful connection, three times after properly connected and another six times after successful system check. Note: Make sure that you hear a click when you snap the Transmitter in place. If it is not fully snapped in, electrical connection and waterproof can be compromised, which can lead to inaccurate Sensor glucose readings. B ur ea u Ve rit a s Tape the Sensor Support Mount (Optional) The Sensor support mount should stay on your skin using its own adhesive.
s Note: The Connect Sensor option is only available when no Sensor is currently connected to the PDM. B ur ea u Ve rit a 2. Make sure that your Transmitter is connected to a Sensor and that your Transmitter SN is found or entered, and then continue by tapping Next. 3. If the sensor is calibration-free, enter the sensor code on the sensor label which is unique for each sensor. Once the sensor code is entered successfully, the calibrations aren’t required.
Note: B ur ea u Ve rit a s If you want to remove a Sensor before its expiration, disconnect it from your PDM first before you connect a new Sensor. When you connect a new Sensor directly, a “SENSOR RECONNECTED” message will appear on your PDM. 6.3 Calibrate Your Sensor Each time the PDM prompts you with the message “METER BG NOW” or “SENSOR CAL REMINDER”, you must enter a BG measurement to calibrate your Sensor. Go to the Sensor Calibration screen.
rit a s Note: If your sensor is not a calibration-free sensor, or you skip the sensor code input step, you must calibrate your sensor at least twice (once every 12 hours) on the first day and then once every 24 hours since the second day. If you have entered sensor code successfully, the system won’t require calibration. But you can calibrate the sensor if you want.
s Note: Please enter the exact blood glucose value of a carefully performed fingerstick displayed on your blood glucose meter within five minutes. Tap Done to confirm your fingerstick, then tap Yes button to start calibration. 3. When finished, the following screen appears. B ur ea u Ve rit a 2.
s 6.3.2 Set Calibration Repeat rit a Go to the Cal Repeat screen. B ur ea u Ve Main Menu➔Settings➔CGM System➔Cal Repeat After you receive and clear a “METER BG NOW” alert, PDM will repeat the alert until you enter a new blood glucose measurement. You can turn Cal Repeat on/off. If Cal Repeat is on, you can set the repeat time of “METER BG NOW” alert from 5 min to 1h with an increment of 5 min. 6.3.
Main Menu➔Settings➔Reminders ➔Cal Reminder You can turn Cal Reminder on/off. s 2. Go to the CGM System screen. Ve 6.4 CGM System settings rit a Note: If Cal Reminder is on, you can set the time between 5 min and 6 h with an increment of 5 min. B ur ea u Main Menu➔Settings➔CGM System 6.4.1 CGM Feature on/off The CGM feature must be turned on to receive Sensor data. 1. Select CGM System in the Settings menu.
You can turn on or off the CGM feature. 3. After you turn on the CGM System, the Transmitter SN menu appears. B ur ea u Ve rit a s 2. 6.4.2 Set the Transmitter SN Tap Settings on the Main Menu to enter the Settings screen. Tap CGM System to enter the CGM settings screen. Turn the CGM System feature on. Tap Transmitter SN to add this Transmitter to your PDM. You can use your PDM to search for your Transmitter (only for the first time), or you can enter the SN printed on your Transmitter manually.
6.4.3 Graph Range rit a s You can set the time range of sensor graph in horizontal screen as 3, 6, 12, 24 hours. The default range is 12 hours. Ve 6.4.4 Cal Repeat ur ea 6.4.5 Alert Silence u See Section “Calibrate Your Sensor” in this chapter for more information. Go to the Alert Silence screen. B Main Menu➔Settings➔CGM System➔Alert Silence Warning: Muting the alarms is not recommended when you are unable to interact with your PDM (for instance, when you are asleep).
Interacting with your PDM includes activities such as pressing the power button and checking the screen. With the Alert Silence feature you can keep glucose alerts silent for a specified time of 30 minutes to 24 hours. There are five Alert Silence options: u Ve rit a s Off— This means all glucose alerts are turned on: the PDM will beep or vibrate if any Sensor alert occurs.
For MD1026, the expiration date is fixed as 14 days. In both settings, “SENSOR EXP IN 6 HOURS” alert, “SENSOR EXP IN 2 HOURS” alert, “SENSOR EXP IN 30 MIN” and “SENSOR EXPIRED” alert will respectively appear. 6.5 Sensor History 6.5.1 Sensor History Your PDM stores detailed Sensor history to help you keep track of your glucose readings and Sensor conditions. s Go to the Sensor History screen. B ur ea u Ve rit a Main Menu➔History➔Sensor History 6.5.1.1 Data History 1.
2. Select a Sensor session and you will see the last day’s Sensor history data. B ur ea u Ve rit a s The Y-axis of the Sensor graph is featured by four values: 5, 10, 15, 20 mmol/L (90, 180, 270, 360 mg/dL). The X-axis of the Sensor graph presents a period of 24 hours. The Sensor graph can be switched to a landscape screen display. Long tap the Sensor graph for 1 second and the display will turn horizontal. Note: ⚫ Tap the Sensor graph and move the cursor to spot the glucose values.
Glucose value or special status will always be shown in the area below, between the left and right arrow button. Special status includes: calibration error (ERR), no readings (???), warm-up phase (Warm-up), Sensor glucose is above 22.2 mmol/L or 400mg/dL (HIGH) and Sensor glucose is below 2.2 mmol/L or 40mg/dL (LOW). ⚫ After the warm-up phase, the values before the first calibration are marked as “BG“. ⚫ When the Sensor calibration expires, the reading values will be underlined.
6.5.1.3 Alert History B ur ea u Ve rit a s Select Alert History in the Sensor History screen. The Alert History screen shows you all of the Sensor alerts that have recently occurred. Select an alert record to view the details. Tap to return to the previous menu. See Section “Alert Icons” and Chapter “Safety System and Alarms/Alerts” for more information about how to address the alarms and alerts. 6.5.2 Summary History: Sensor History This screen displays the SG readings summary history.
u Ve rit a s Average SG: Average SG readings of the selected days. Time in target range: The percentage of the duration in which SG reading is in the target range (3.9 - 10.0 mmol/L or 70 - 180 mg/dL). Time above range: The percentage of the duration in which SG reading is above the target range (10.0 mmol/L or 180 mg/dL). Time below range: The percentage of the duration in which SG reading is below the target range (3.9 mmol/L or 70 mg/dL). ur ea 6.
I didn’t see an alert message, but it appeared in History. If one of the following alerts happened, the PDM would beep/vibrate and display a message first, and if you missed that alert, later when you checked the PDM, the condition that triggered the alert had changed (for example, your glucose level returned to the target range), then you wouldn't see any message on the screen, you would only find it in History. Ve rit a s 1. LOW GLUCOSE 2. HIGH GLUCOSE 3. LOW PREDICTED 4. HIGH PREDICTED 5.
Some Sensor readings missing on the Sensor Trend Screen If the PDM is too far away from the Transmitter, or the Bluetooth communication between the Transmitter and the PDM is temporarily interrupted, some Sensor readings might be missing in the Sensor Trend Graph screen. Solution: Move the PDM close to the Transmitter, and wait for a while. The data will be recovered automatically. What to do when a “Lost Sensor” alert happens B ur ea u Ve rit a s Move the PDM closer.
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7 How to use (P)LGS (Optional) 7.1 (P)LGS settings The Glucose Alerts and Low Glucose Suspend/Predictive Low Glucose Suspend (Low Suspend/ Pre Low Suspend) functions are included under the EasyLoop Menu. The (Pre) Low Suspend function is available when CGM and Insulin Pump systems are both online. The glucose limits for alerts of Low Suspend and Pre Low Suspend are the same. ur ea u Ve rit a s Tap EasyLoop on the Home Menu Screen to enter the EasyLoop screen. B 7.1.
2. Tap ur ea u Ve rit a s 1. You can turn on or off the Glucose Alerts. to save the settings. B 7.1.1.1 High/Low Limits You need to set the high and low Glucose Limits recommended by your healthcare provider after you turn the glucose alerts On. Your recommended glucose limits may vary throughout the day, you can set up to eight pairs for different time periods. Go to the Glucose Limits screen.
1. Add segments s The starting time of the first segment is fixed to be 00:00 or 12:00A. rit a Add time segments by choosing from 00:30-23:30 or 12:30A-11:30P, with an increment of 00:30. Ve You will be reminded if the time segment to be set already exists. When the time segments are successfully set, they will be listed chronologically. ur ea u If you only set one segment, the glucose limits of this segment will be applied for 24 hours.
rage is 2.8-5.0mmol/L (50-90 mg/dL), the High Limit range is 5.522.2mmol/L (100-400 mg/dL), both with an increment of 0.1mmol/L (1mg/dL). The High Limit value is always larger than the Low Limit value. ⚫ In the first segment, the default Low Limit is 4.4mmol/L, the default High Limit is 13.3mmol/L. 2. Delete Segments to save the settings. ur ea 3. Tap u Ve rit a s Slide from right to left on one segment, tap Delete to delete this segment. 7.1.1.
ur ea u Ve rit a s 2. Tap the blue plus/ minus sign to set the predictive alert time. You will be reminded of a predicted high or low glucose value some time (the predictive alert time) in advance. B Note: You can set the time between 5 min and 30 min with an increment of 5 min. 3. Tap to save the settings. 7.1.1.
ur ea u Ve rit a s Go to the Rise screen. 1. You can tap to turn on/off the Rise Alerts. B 2. You can choose a relative mild or an acute rising rate. See Section “Sensor Status” for more information.
3. You can also set the rate between 0.065 mmol/L/min and 0.275 mmol/L/min (1.1 mg/dL/min and 5.0 mg/dL/min) with an increment of 0.005 mmol/L/min (0.1 mg/dL/min). to save the settings. Go to the Fall screen. u 4. Tap Ve rit a s Tap the blue plus/minus sign to set the rise alert. You will be reminded when your SG is rising rapidly. B ur ea 1. You can tap to turn on/off the Fall Alerts. 2. You can choose a relative mild or an acute falling rate. See Section “Sensor Status” for more information.
rit a s You also can set the custom rate between 0.065 mmol/L/min and 0.275 mmol/L/min (1.1 mg/dL/min and 5.0 mg/dL/min) with an increment of 0.005 mmol/L/min (0.1 mg/dL/min). B ur ea u Ve Tap the blue rate value to set the fall alert time. You will be reminded when your SG is falling rapidly. 3. Tap to save the settings. 7.1.1.4 Repeat You can set the amount of time between alerts after the first alert.
Note: You can turn on or off alert. rit a s Note: You can set the Repeat time between 5 min and 3h with an increment of 5 min. Go to the Low Suspend screen. Ve 7.1.2 (Pre) Low Suspend B ur ea u Main menu➔EasyLoop➔(Pre) Low Suspend Note: If you turn the Low Suspend on, the Predictive Low Suspend feature will appear. 7.1.2.1 Low Suspend The Low Glucose Suspend feature is only available when both a Patch Pump and a Glucose Sensor are in use. The factory setting for this feature is off.
when your Sensor glucose is at or below the low suspend limit, and resume basal insulin when the risk of low glucose no longer exits. This feature can be used as a safe guard against excessive insulin delivery. You may choose to program this feature based on the lowest acceptable Sensor glucose. Discuss what settings are best for you with your healthcare provider. Note: The low suspend limit between 2.8 mmol/L and 5.0 mmol/L (50 mg/dL and 80 mg/dL) based on the Glucose Low Limit settings.
ur ea u Ve rit a s If the Low Suspend alarm is not cleared during suspension and insulin is resumed within 2 hours, the following Reminder will appear. B If the Low Suspend alarm is not cleared during suspension and insulin is automatically resumed after 2 hours, the siren will continue, and the following emergency message will appear.
ur ea u Ve rit a s If the Low Suspend alarm is cleared during suspension, a Reminder will appear when insulin is automatically resumed. B For information on when the Low Suspend feature is unavailable, refer to “Predictive Low Suspend”. 7.1.2.2 Predictive Low Suspend The Predictive Low Glucose Suspend feature is available only when the Low Suspend feature is turned on and available. The factory setting for the Predictive Low Suspend feature is turned off.
Main Menu➔EasyLoop➔(Pre) Low Suspend rit a s Note: You can set the Time before Low between 5 min and 40 min with an increment of 5 min. The factory default is 30 min. Ve Triggering Conditions for Predictive Low Suspend (from 30 min to 2 h after suspension) Both of the following two conditions must be met to start Predictive Low Suspend. ◼ u The Sensor glucose value is at or within 3.9 mmol/L (70 mg/dL) above the low suspend limit. The Sensor glucose value is predicted to fall at or within 0.
◼ The Sensor glucose value is predicted to be at least 1.7 mmol/L(30 mg/dL) higher than the low suspend limit in half an hour. Reminder of Resumption Ve rit a s Whether a Predictive Low Suspend alert is cleared or not, the same Reminder will appear when insulin is automatically resumed.
Ve rit a s This screen displays the (Pre) Low Suspend summary history. # of LGS: Average daily number of Suspend due to LGS. # of PLGS: Average daily number of Suspend due to PLGS. Time in suspend: Average daily duration suspended due to LGS or PLGS. 7.3 Troubleshooting Low Suspend issues u I didn’t see an alert message, but it appeared in History.
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8 Safety System and Alarms/Alerts 8.1 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.
s When Alarm “PATCH EXPIRED” occurs, the Lock Screen and Alarm screen display the following screen. Alarm on the unlocked screen rit a Alarm on the Lock Screen Ve If it is a high priority alarm, the PDM will display an alarm message with instructions and icon (a red triangle with three exclamation marks) in Alarm screen. ur ea u If it is a medium priority alarm, the PDM will display an alarm message with instructions and icon (a red triangle with two exclamation marks) in Alarm screen.
Patch Pump Alarms of different priorities in different audio modes: Audio Mode high priority alarm medium priority alarm PDM emits ten beeps every ten seconds. PDM emits ten beeps every twenty seconds.
Alarm sound wave: Icon Sound wave Significance PDM emits ten beeps/vibrations each time. PDM emits Three beeps/vibrations each time. Patch Pump emits Three beeps/vibrations each time. rit a s Patch Pump emits Three beeps/vibrations each time. 8.3.1 PDM Alarms Priority Reason PDM ERROR Remove device. Call customer support. u PDM Message ur ea Ve If a PDM alarm is not cleared within 10 minutes, your PDM will make a siren sound until the alarm is cleared. B A PDM error is detected.
8.3.2 Pump Alarms When a Pump alarm occurs: Indicator light: The indicator light on the pump flashes red once per second until the alarm is cleared. Note: If a Pump alarm is not cleared within 10 minutes, both your PDM and Patch Pump will make a siren sound until the alarm is cleared. The following table lists high priority alarm messages. Priority Reason Pump occlusion is detected. PATCH ERROR Delivery stopped. Change Patch now. A Reservoir Patch error is detected.
Priority Reason The current Reservoir Patch has reached the end of its 3-day operating life. Actions to Take PATCH BATT DEPLETED Delivery stopped. Change Patch now. The Reservoir Patch battery is depleted. Tap to clear it. Change Patch. Check blood glucose. EXCEEDS MAX TDD Exceeds max TDD. Delivery stopped. You have attempted to deliver more insulin than expected based on your Daily Max setting. EXCEEDS MAX 1HR DELIVERY Exceeds 1 hour max. Delivery stopped.
If the following alarm is not cleared within 10 minutes, only your PDM will make a siren sound until the alarm is cleared. PDM Message Priority Actions to Take Low Suspend or Predictive Low Suspend failed because the PDM had lost communication with the Patch Pump. Tap to clear it. Move PDM close to Pump. rit a s PUMP OUT OF RANGE Low Suspend failed. Move PDM close to Pump. Pre Suspend failed. Move PDM close to Pump. Reason 8.
The PDM displays an alert message with instructions and icon triangle with exclamation mark) in Alert screen. (an empty CGM Alerts and PDM Alerts in different audio modes: Audio Mode Alert PDM emits two beeps every three minutes. Vibrate PDM emits one-pulse vibration every three minutes. Audio and Vibrate Audio off /Vibrate off PDM emits two beeps and one-pulse vibration every three minutes.
The sound wave of every alert beep: Icon Sound wave Significance Your PDM emits two beeps every time. 8.4.1 PDM Alerts The following table lists alert messages for PDM. PDM Message PDM BATTERY LOW Low PDM battery. Charge battery soon. Priority Reason Actions to Take Tap to clear it. Charge PDM battery soon. Ve rit a s The PDM battery is low. 8.4.
PDM Message PATCH EXP ADVISORY Patch expiration in [] hours. PATCH EXP IN 1 HOUR Patch expiration in 1h. Change Patch soon. Priority Reason The Reservoir Patch will expire within the set time limit. The Reservoir Patch will expire in less than 1 hour. Actions to Take Tap to clear it. Change Patch soon. Tap to clear it. Change Patch soon. ur ea u Ve rit a s The Patch battery is running low. No PATCH BATTERY bolus can be Tap to clear it. LOW delivered. Basal Change Reservoir No bolus allowed.
When “BELOW 3.1 mmol/L(BELOW 56 mg/dL)” occurs, your PDM emits threepulse vibration every three minutes. If not cleared within 9 minutes, your PDM will make a siren sound until the alert is cleared. When “TRANSMITTER ERROR”, “CHARGE TRANSMITTER”, “SENSOR EXPIRED”, or “SENSOR FAILURE” occurs, your PDM emits three-pulse vibration every three minutes. The following table lists alert messages for CGM. PDM Message Priority Actions to Take The Transmitter battery is close to running out of power.
Priority METER BG NOW Enter a new meter BG for calibration or tap OK to clear the alert. SENSOR CAL ERROR Enter a meter BG after 15 minutes. Reason A meter BG is needed immediately to calibrate the Sensor. The Sensor hasn't been calibrated properly. HIGH GLUCOSE Glucose level above High Limit. The last Sensor glucose reading is at or above the High Glucose Limit. Tap to clear it. Enter new meter BG for calibration or tap OK to clear the alert. Tap to clear it. Enter meter BG after 15 minutes.
PDM Message Priority Reason Actions to Take RAPID FALL Sensor glucose is falling rapidly. The Sensor glucose is falling at a rate that is faster than the set Fall limit. Tap to clear it. Monitor trend and glucose level. Follow instructions from your healthcare provider. Tap to clear it. Monitor trend and glucose level. Follow instructions from your healthcare provider. s RAPID RISE Sensor glucose is rising rapidly. The Sensor glucose is rising at a rate that is faster than the set Rise limit.
PDM Message Priority LOST SENSOR Move PDM close to Transmitter. Reason Actions to Take The PDM has not received a signal from the Transmitter for 10 minutes. Tap to clear it. Move PDM close to Transmitter. If Alert Silence is turned on, the PDM gives no beep or vibration when an alert occurs. The ALERT SILENCE message will be displayed on your PDM screen instead, and you can check the alert in Sensor alert history. See Chapter “How to use CGM system” for more information.
”will appear in the top right corner of ur ea u Ve rit a s If the Audio is off, the audio off icon” this screen. B 8.5 Reminding messages Reminding messages are automatically displayed to remind you of a condition, function or event. Reminding messages include the notifications you get after setting reminders and the low-priority reminding notifications. A Message requires you to press buttons to clear it and/or to take action if necessary.
Message in Lock Screen Message after unlock in Alert screen LOW BG Alarm Clock. u Check all settings. ur ea HIGH BG PDM Message Treat high BG. Monitor BG. B Condition CHECK SETTINGS ALARM CLOCK Ve 8.5.1 PDM reminding messages rit a s Audio/vibration: Your PDM emits two beep and/or one vibration every three minutes, three times in total. Treat low BG. Monitor BG. Reason An error might have occurred to your settings. An alarm clock is set at this time.
Condition ACTIVE BASAL EMPTY BASAL RESUMED PDM Message Reason The selected basal rate or temp basal rate is 0.00 U/H. Your active Basal is 0.00 U/H. The previously suspended basal rate is automatically resumed. Check BG. [ ] Basal active. 8.5.3 CGM reminding messages Reason PDM Message SENSOR CAL REMINDER Enter a new meter BG for CAL by [ ]. SENSOR CAL FAILED Sensor calibration failed. Please retry to calibrate later. A meter BG must be entered by the time shown to calibrate Sensor.
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9 Manufacturer’s Declaration 9.1 Electromagnetic Emissions Emissions Test Compliance IEC 60601 Test Level Compliance Level Ve Immunity Test rit a 9.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment The A7+ TouchCare® System is intended for use in the electromagnetic environment specified below. The customer or user of the A7+ TouchCare® System should assure that it is used in such an electromagnetic environment. Table 4 of IEC 60601-12:2014 30A/m, The network power supply should have the quality used in a typical commercial or hospital environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment The A7+ TouchCare® System is intended for use in the electromagnetic environment specified below. The customer or user of the A7+ TouchCare® System should assure that it is used in such an electromagnetic environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment The A7+ TouchCare® System is intended for use in the electromagnetic environment specified below. The customer or user of the A7+ TouchCare® System should assure that it is used in such an electromagnetic environment. Ve rit a s level in each frequency range.
B ur ea u Ve rit a s System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the A7+ TouchCare® System. B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
ur ea u Ve rit a s Recommended separation distances between portable and mobile RF communications equipment and the A7+ TouchCare® System The A7+ TouchCare® System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
4. 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. B ur ea u Ve rit a s 5. Other cables and accessories may negatively affect EMC performance.
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10 Appendix I: Symbols and Icons 10.1 Product Label Symbols Symbol Meaning Symbol Do NOT use if package is damaged Lot number REF Reference number STERILE EO Manufacturer STERILE R rit a Ve ur ea Storage temperature B IPX8 SN Do NOT reuse 0197 Sterilized using radiation Follow instructions for use Radio communication u Caution: See Instructions for use Sterilized using ethylene oxide s LOT Use by: (yyyymm-dd) Meaning Waterproof to 2.
Symbol Meaning IP22 Protection Against Insertion of Large Objections and Dripping Water IEC 60529 Symbol Meaning Icon Meaning 10.
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11 Appendix II: Technical Information 11.1 PDM Specifications B ur ea u Ve rit a s Model: FM-018 Size: 76.2 x 48.4 x 9.375mm Weight: 42.4 g Screen: 2.4 in Operating Temperature Range: +5°C ~ +40°C Operating 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, Continuous operation Battery: Built-in 3.
B ur ea u Ve rit a s 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.
B ur ea u Ve rit a s 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.
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11.3 Transmitter Specifications Ve rit a s Model: MD1026 Size: 36.1 mm x 19.4 mm x 7.2 mm Weight: 3.57 g Operating Temperature Range: +5°C ~+40°C Operating 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 Battery: Built-in 3.7 V polymer lithium ion battery Waterproof Rating: IPX8 (2.
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.
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12 Glossary Basal Pattern Basal Rate BG BG Target Blood Glucose (BG) rit a s Blood Glucose Meter/Meter/BG Meter Bolus Calculator Ve B ur ea Bolus Reminder Calc-C Calc-E Calc-N C-Ext. C-E CGM C-N C-Normal Combo A feature that calculates an estimated bolus amount based on the BG values and carbs that you enter. The amount of insulin used to cover an expected rise in glucose levels from carbohydrates, or to lower a high blood glucose value down to your target range.
Combo Bolus Part of the bolus amount delivered immediately, and the remainder delivered evenly over time period. A Sensor is inserted under the skin to check glucose levels in interstitial fluid. A Transmitter sends Sensor glucose readings to a display device. Bolus used to lower a high blood glucose value down to your target range.
Max Total Daily Dose (TDD) N Normal Bolus Note Occlusion Preset Bolus Preset Temp Basal Sensitivity Sensor Glucose (SG) Suspend B SG ur ea u Ve Sensor Session s Max Bolus Set the maximum insulin amount that can be delivered in one hour. Set the maximum bolus amount that can be delivered in one dose. Set the maximum insulin amount that can be delivered in one day. Abbreviation for Normal Bolus. See Normal Bolus. Entire bolus amount delivered immediately. A Note provides helpful information.
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s rit a Ve u ur ea B UG881116GB 348431 Version: 1.
