Micropump MP Daily Directions for Use

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Contents____________________________ Getting Started ...5 Introduction ...5 Installation...6 Installing/Replacing the Batteries ...6 Preparing an Infusion ...7 Operating the pump...8 Turn the Pump ON /OFF ...8 Prime function...8 Edit Rate and infuse ...9 Bolus function ...9 Fitting pump into holster and wearing ...12 Alarms and Troubleshooting...13 Alarms...13 Warnings...14 Rate range limitation...16 Unusual Rate warning. ...16 Rate titration ...17 Silent End Of Infusion...17 Display Backlight ...17 Bolus Configuration ...17 Occlusion pressure level ...18 Configuration MP Daily ...19 Specifications...22 Symbol Definition...22 Regulatory Compliance ...23 Batteries Type ...24 Event Log...24 Trumpet Curves...25 Precautions & Maintenance...26 Routine Maintenance Procedures ...26 Operating Precautions...28 Disposal ...31 Spare Parts...31 ML056DFU180608GB

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Warranty ...32

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Getting Started Introduction Micropump™ MPDaily is a technologically advanced, easy to use infusion pump designed for precision, safety and durability for many years to come. Please read the following instructions carefully before using this device. The MP Daily offers many quality features that make it highly suitable for today’s hospital and home care treatments.

Thanks to its high contrast LCD display and membrane keyboard Micropump™ MP Daily allows you to set the rate in millimetres per 24 hours and efficiently manage the infusion events.

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Getting Started Installation Check that the pump is complete and undamaged. Items supplied with this Micrel Medical Devices MICROPUMP MP Daily are as follows: Directions for Use Plastic Bag Set of 6 AAA size Batteries Short Directions for Use

Shoulder holster for 10 ml syringes Shoulder holster for 20 ml syringes Fastening belts

Should the instrument fail to perform correctly, place it in its original protective packaging and contact a qualified service engineer for investigation.

Installing/Replacing the Batteries Micropump™ MPDaily uses six Alkaline batteries 1.5V type LR03, AAA size. Slide the battery compartment lid towards the rear of the casing. Insert the batteries within the compartment, observing the correct polarity as shown by the illustration within the battery compartment. Slide the lid back in place.

Important: Do not remove the batteries while the pump is switched ON as this may damage the pump. Check that the polarity of the batteries is correctly oriented. The pump cannot be damaged if the batteries are incorrectly oriented. Remove the batteries if the pump is to be stored for more than six months.

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Getting Started Preparing an Infusion Prepare the medication for treatment. Draw-up the syringe with the medication according to the instructions of your doctor. Connect the infusion set to the syringe and prime it . Important: Always use Luer Lock Syringes for safe infusion set attachment. Press the plunger driver button, to pull it back up to the end of the lead screw. Remove the syringe that might already be in place, before trying to disengage the drive mechanism. The mechanical system prevents the release of the drive mechanism when it is under pressure. This is to prevent wear on the lead screw and to

Press the center of the clip and pullout the syringe retainer to open it.

Insert one of the syringe flanges in the appropriate slot. Insert the syringe plunger between button and metallic ‘M' shaped anti-siphon. Move the plunger driver as close as you can to the syringe plunger head by depressing the button down. Secure the syringe with the syringe retainer. Important: Do not use two parts syringes (syringes without black seal) as they might leak during long infusions. ML056DFU180608GB

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Operating the pump Turn the Pump ON /OFF Turn the pump ON by pressing & keys simultaneously for 3 seconds. At any time the pump can be turned OFF using the same procedure. While keeping keys down, you can test the display and watch the numbers, low battery & bell symbols. After switching ON, the pump is on hold. The last rate used flashes and a warning beep is emitted every minute.

Prime function When enabled, this function allows the user to precisely finish the priming of the infusion set. It could be useful to use it to speed up the starting time for the infusion as it reduces the mechanical backlash that may appear during syringe installation. The Prime function is only available after power on, before initiating the infusion,. and simultaneously.The pump displays To prime, press priming as long as the keys are held down. Prime stops when both keys are released.

pr and starts

To disable the access to this facility, please, refer to the Configuration chapter.

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Operating the pump Edit Rate and infuse Set the Rate using the up chevrons.

/ down

Pressing once, the Rate changes by 1 mm/24HR. Start the infusion, or confirm the changed Rate, by pressing ENTER

for 1 second,

until the pump displays Go and starts the infusion. During infusion, up / down bars flash alternatively. The Rate is memorized and not lost by turning pump OFF, or even after changing batteries. Rate can be set from 1 to 99mm/24hr. Rate range can be restricted using the min - max hard limits, or even can be limited to one single flow rate, as described in the configuration chapter.

Bolus function When enabled from configuration, this function allows during the course of the infusion, to deliver a dose that has been previously preset in tenth of mm. The bolus dose is delivered at maximum rate. To start immediately the bolus, press and hold the enter key

and make a

simple push to the Up key

.

The pump displays the bolus dose in mm eg: D 0.5

Release the Enter key when you hear the starting beep. The pump will ML056DFU180608GB

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Operating the Pump start delivering programmed bolus dose. Changing the bolus dose within limits. If the bolus range has been set to allow various bolus settings , the last bolus dose is recorded until the pump if turned OFF. To change the bolus dose within the preset limits, Press and hold the enter key

, then make a simple push to the Up key

and immediately release

. the Enter key The bolus dose in mm eg: D 0.5 is displayed. Use the up/down chevron to set the new bolus value. Press the Enter key

to initiate the bolus injection.

it is possible to stop the injection of a bolus at any time by pressing the enter key,

or switching Off the pump.

Bolus Lockout Time Bolus lockout time in minutes disables repeating bolus demands. Lockout time zero means repeated bolus enabled without limitation. After delivering a Bolus, a lockout time in minutes as programmed at configuration, starts to count. Attempt to get Bolus within this lockout time, will display No and Bolus will not be delivered.

NO

The Bolus function is only available after initiating the infusion. To disable the access to this facility, please, refer to the Configuration chapter. Warning: Bolus function needs full understanding and training of the user. Please make sure that the end user fully understands this functionality.

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Operating the pump Dose over Time setting An easy procedure to calculate the Rate when the prescription is to be delivered within 24hours, is to measure the length in millimetres of the volume contained in the syringe and program the Rate 1 of the pump with this length.

Eg : 10mg to be delivered in 24 hours. 10mg are diluted in 13.5cc in a BC 20cc syringe L=48mm: RATE =48mm/24HRs

1

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Operating the Pump Fitting pump into holster and wearing The shoulder holster protects syringe security to the pump and also the patient from any moving parts. The belt passes through slits on its’ back. It can be worn on the shoulder or the waist .

The holster fits onto the pump as shown in the picture, leaving one flange of the syringe’s barrel passing through the top of the holster. Clamp the bottom clips and secure the pump in the holster. 12 / 33

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Alarms and Troubleshooting The Micropump™ MPDaily has two alert modes; alarms and warnings.

Alarms On alarm, the infusion stops, the symbol is displayed concurrently to the alarm identification message. The instrument will sound intermittently, except for the End of infusion alarm when the Silent End of infusion mode is enabled. Turn the pump OFF to cancel the alarm. In the unlikely event that instrument indicates an internal error, note the error code, withdraw the instrument from service and have the instrument inspected by a qualified service engineer. Action to be taken

Display During Alarm

OCClusion or end of plunger travel. Pressing any key will silence the alarm for one hour, Remove the syringe or disconnect the extension set to release the pressure, remove the obstruction and resume the infusion by pressing the ENTER

key.

Depleted battery. Turn the pump OFF and replace the batteries One Hour on Hold Alarm. Turn pump ON again End of Infusion. The infusion is finished. Remove the syringe, turn OFF the pump. The End message is displayed when an occlusion is detected after about 24 hours of infusion or a full infusion stroke.

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Alarms and Troubleshooting Display During Alarm

Action to be taken Coded message displayed, an internal error has been detected. An alarm may originate from Electromagnetic Interference or extreme vibration. Turn pump OFF then ON again. If the alarm persists, withdraw the unit from service, note the error code and have the unit checked by a qualified engineer E10, E11 Alarms: Key buttons pressed for long. Turn pump OFF, then ON again. This is a safety feature, to prevent unintentional Rate change.

Important: The occlusion detection activates the alarm with a delay time, which depends on the syringe type, catheter and infusion rate used.

Warnings During warnings the infusion continues. Warnings have audible and sometimes visual signals. On warning, the pump sounds intermittently and doesn’t need to be turned OFF. Condition

Display

Low battery signal; Change the battery when the infusion is finished. The first time this warning is triggered, the remaining battery life is about 24hours. To silence the alarm press any key.

Buzzer One beep every minute

Pump reject rate change that is not cofirmed Old Rate appears. Four beeps within 5 seconds by pressing Enter

.

At Standby, flashing display, warning that pump is not infusing.

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One Beep every minute.

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Configurable options Configurable options

Rate range limitation In order to help prevent misprogramming, it is possible to restrict the Rate range to the highest and lowest possible rate you use for a given application. This feature allows you to even trim the rate range down to one single value and turn the pump into a single Rate pump.

High and low flow rate limits High and low flow rate limits could be configured in the pump. The Up / Down chevron increment /decrement the flow rate between these two limits. For the possible Up/down limit values and configuration procedure, refer to the Configuration chapter.

Unusual Rate warning. High rate zone, Low rate zone It is possible to configure the pump to get a warning beep when programming a rate that is outside the rate range you commonly use. It doesn’t prevent you from selecting this rate . For the possible soft limit values and configuration procedure, refer to the Configuration chapter. Inside the high or low rate zones, no beep is heard Eg: 60 mm/24hr A warning beep will be heard to warn you that your setting is above or below what you have defined as your High or low rate zone.

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Configurable options Rate titration Certain applications may require rate change during the course of the infusion. It is possible to unlock the Rate titration mode to allow to change the Rate whenever you need during the course of the infusion. When Rate Titration mode is ON, use the Up/down chevron to adjust the Rate and press Enter until Go is displayed. The new rate is validated. To enable this function please, refer to the Configuration chapter. Until the rate is confirmed, the pump continues to infuse at the previous rate. If rate change is not confirmed by pressing key, within 5 seconds the display shows the actual rate and warns you by four consecutive beeps.

Silent End Of Infusion Depending of the infused drug, it is sometimes not necessary and potentially stressful to have an audible alert at the end of the infusion. The Silent End OF Infusion mode provides the capability to disable the buzzer at the End Of Infusion. at the end of When the silent EOI is enabled, the pump will show infusion and stops without a beep sound. We do not recommend to use this function if the infusion is supposed to last more the 24Hours. Always turn Off the pump after the end of infusion. To enable this function, please refer to the Configuration chapter.

Display Backlight The pump has an LCD display backlight for night view. The backlight slightly increases power consumption, so this function can be configuration enabled only when it is necessary: always on (A) or just be turned on when a key is pressed or the pump going on alarm (Y), or always Off (n).

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Configurable options The bolus function can be enabled or disabled in the configuration menu. When enabled,(b-y) the bolus function is accessible during the course of the infusion.

It is possible to preset the accessible range for this bolus dose up to the point that it can be set to a fixed value when the upper bolus limit value is set equal to the lower bolus limit value. The bolus lockout time in minutes from 00 to 99 is also preset at configuration. When t=00 then no lockout time is set, and bolus can be given just after preceding one.

Occlusion pressure level It is possible to lower the occlusion pressure alarm level. Lowering the occlusion alarm level may generate unintended occlusion alarm particularly when used with viscous drug. When occlusion alarm level is selected at a lower level than Pr3, the device inform the user after power On by displaying the selected level eg Pr1 or Pr2 before displaying the rate.

Warning: The next page explains how to access the configuration. You may wish to remove the next page to secure the access of this programming option. May you need a copy, please contact your manager.

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Configurable options Configuration MP Daily To access the configuration menu of the pump, Turn the pump ON and hold the two chevron keys down. When all segment of the display are on, maintaining the down key

key pressed, press and release the ENTER

. Then release the down key

. you entered the configuration menu,

Parameter

Numerical limits

High flow rate limit Upper Rate limit

up to 99

60

Low flow rate limit Down Rate limit

1 up to upper rate limit or 99

40

High rate zone above

1 up to upper rate Limit

55

Low Rate zone

1 up to high rate zone

45

Rate Titration enabled (yes –no)

n or Y

No

Prime function enabled (yes –no)

n or Y

Yes

Buzzer On at end of infusion (yes –no)

n or Y

No

Display Backlight

n or Y or A n or Y

No

Bolus Enable

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No

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Ward settings

Displa y

Mfg default setting

U-- is displayed Pressing Enter key, scrolls along the parameters list to give access to the value of the parameter that needs to be changed. The chevron keys change the values. The Enter key, stores the value and scrolls to the next parameter. Press simultaneously the two chevrons to turn the pump off and save the settings.

Configurable options Bolus Max Volume Increment 0.1 mm

Min up to 5.0 mm

5.0

Bolus Min Volume Increment 0.1 mm Bolus Lockout Time

0.1 to Max mm

0.1

01 to 99 min

00

Occlusion Pressure Level

1 to 3

3

Configured by: according to the prescription of: Date: Pump SN:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ to _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Remove and store this page, if you need to secure the access to this configuration program. Important: After configuration, is the last used rate was out of the limits, it will be reset down to the lowest possible rate. It is this rate that you will retrieve after power On.

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