P900 enternal syringe pump instruction booklet rev 1

important safety precautions users The pump should only be operated by healthcare professionals and carers who have been trained in functions and indications of the pump. The pump is suitable for the delivery of enteral feeds and breast milk in hospitals but may also be used domestically under the supervision of a healthcare professional.

connections It is important to check the pump syringe and any extention lines are correctly fitted to an enteral feeding device only, normally a nasogastric tube, before the pump is operated. It is also important to check all connections between syringes, sets and tubes are secure. The correct gastric position of the feeding tube should also be confirmed before every feed delivery.

syringes The only syringes which will operate in this pump are marked “MEDICINA” or “SUPERLOCK” and are supplied by Medicina Ltd or its authorised distributors. All other syringes are not recognised by sensors on the pump and will not function. It is also important to check the automatic visual syringe size light on the pump and confirm that this matches the size of the syringe used. All syringes may be used up to their maximum volume except the PE60 60 ml syringe which has a maximum volume of 50mls only. All syringes are single use only . Syringes and sets should not be connected to the patient until the pump is ready, as an incorrectly fitted syringe has the potential to deliver uncontrolled siphoned feed to the patient. Syringes, pumps and sets are all latex free and DEHP free.

operation The pump should only be operated under the following environmental conditions 5°C – 40°C and an atmospheric pressure of 86-106 kPA and a relative humidity of 20%-90%. The pump should also be stored in a dry place and care should be taken not to drop or vibrate the pump.

electrical The pump should only be operated using a standard AC power supply 100240V @ 50-60Hz using the authorised power cord. The power cord should be protected from bending and any heat source. It should be discarded if it becomes damaged in any way. The pump should be unplugged when not in use. The pump should only be operated using the battery for transfers and only until the low battery alarm sounds. The battery should then be recharged.

maintenance The pump body should be cleaned in line with hospital policies or with a damp cloth or an alcohol type wipe (75% alcohol*) No other chemicals should be used to clean the pump. The pump should not be repaired or opened by anyone other than authorised Medicina staff. This will void the warranty. All defective pumps should be returned to Medicina Ltd or to an authorised service centre or distributor. *Alchol wipes should not be used on the display screen.

general description The P900 enteral syringe pump has been designed to deliver small volumes of enteral feeds, accurately and safely, using enteral syringes. The pump is indicated for the delivery of enteral nutritional support in small volumes to neonates and paediatric patients. The pump is part of a complete range of equipment which has been carefully put together to maximise patient safety. The non-IV compatible syringes, feeding tubes and accessories provide a comprehensive feeding system.

An important feature of the pump is that only “MEDICINA” syringes will operate in the pump. All other syringes are incompatible. Many current syringe pumps can accommodate both enteral and intravenous syringes. This poses a serious risk of hazard to the patients because Intravenous syringes can be accidentally filled with enteral feeds and connected to central lines. These misconnections are not possible with the use of this pump because the lines and syringes which it uses cannot be connected to central lines. This offers a unique additional safety feature for enterally fed patients.

The P900 enteral syringe pump has several other useful safety features. Several sensors monitor the delivery, providing comprehensive visual and auditory alarms. Although the pump is simple to use, the electronics are as sophisticated as more expensive intravenous syringe pumps. Users will find the P900 pump easy to use and it will safely and accurately provide the nutritional support needed by their patients.

P900 Quick Guide

total volume

120 mls

Syringe

Status

20 mls

stop

Rate

20

mls/hr

volume infused

40 mls

dose limit

time left

70 mls

1.20 hrs

SELECT

CLEAR

SILENCE

ENTER

POWER

START

STOP STOP

P900 Basic Controls

Syringe size

Power on/off (3 seconds)

POWER

FAST

Dose Limit

Total volume delivered 24hrs

Volume current feed

total volume

volume infused

SLOW

120 mls Syringe

20 mls Status

Rate

20

mls/hr

40 mls dose limit

70 mls

Enter

Select dose limit rate

ENTER

SELECT

SILENCE

SILENCE

time left

stop

1.20 hrs

START

STOP STOP

CLEAR

m medicina

Indicator lights Fast Mains Connections Light

(1ml increments)

Start Pump

Slow (0.1ml increments)

Stop Pump

Silence alarms

Rate Battery level and charge Stop or Run status

Time left this feed

Clear dose limit rate

m

Operation Securing the pump

Smart Setup The language can be selected in the first welcome screen. Once selected the language screen does not appear. To change language enter SMART SETUP and press and hold SILENCE, this brings up the language screen and a new language can be selected. Then press CLEAR to return to SMART SETUP SCREEN.

Select a suitable position for the operation of the pump before inserting the power cable. The pump should be used in a horizontal position either on a table or on a drip stand. A pole clamp is provided with the pump. The black plate is screwed into the underside of the pump with the silver clamp facing the rear of the pump. The second screw is used to secure the whole assembly to the drip stand.

In the second screen, SMART SETUP, all the parameters can be entered. The syringe size is automatically detected and the max dose for that size of syringe is also automatically detected. The Medicina syringe is also verified at this stage. The volume, time and rate are interdependent. The user inputs any two to WER get the third parameter. The dose limit is also user defined within the limits for that syringe size. Each parameter is selected in turn and changed by use of the arrow buttons.

Caution Never mount the pump so high on the drip stand that it becomes unbalanced or unstable.

Power

When correct press ENTER to move to the operation screen. All parameters are now locked until the feed is stopped and then SELECT to re-enter Smart Setup.

When the pump is secured the power cable should be plugged into the mains supply. The cable can be fixed to the pump using the fixation device supplied.

Syringe installation

Press the power button for 3 seconds and the AC Power status light should come on. The battery level status light also shows the level of charge in the battery.

Caution Only “MEDICINA” or “SUPERLOCK” single use syringes may be used in this pump.

The pump will then self test all the circuits and all lights will flash once before the pump is ready to use. An instructions screen illustrates the necessary user checks and then the user presses START to display the main operating screen. The pump is turned off by pressing the power key for 3 seconds.

POWER

POWER

3sec

3sec

A suitable syringe for the volume to be delivered is selected and connected to an extention set. All connections should be checked. Both are then primed aseptically by using the syringe. To insert the syringe into the pump the syringe clamp is raised and rotated. The syringe barrel flanges are inserted into the grooves on the syringe bed and the plunger flanges are inserted into the syringe drive mechanism. The Medicina logo should be uppermost. The drive mechanism should be adjusted so it is tight on the syringe plunger. Fitting adjustments can be made by pressing the mechanism release button on the side. When the syringe is correctly fitted the syringe clamp can be rotated back into position. It is important to check that the automatic syringe size indicator light matches the syringe size. The pump will then check that a correct Medicina syringe is fitted. If an incorrect syringe is fitted then an alarm “Incorrect syringe” will be seen on the screen. Caution the 60ml syringe PE60 has a maximum volume of 50mls and cannot be fitted into the pump with a higher volume than 50mls.

smart setup volume infused Rate dose max 40 120 mls mls 20 mls 10mls Syringe dose limit total volume syringe

volume

20 mls 10 mls Status stop

FAST

20

time

70 mls 1.00 hrs mls/hr rate time left 10mls/hr 1.20 hrs

SLOW

total volume syringe

smart setup volume infused Rate dos max 40 10mm dose lim

120 mls 20 mls Syringe volume

20 mls 10 mls Status stop START

20

time

70 m 1.00 h mls/hr rate time left 10mls/hr 1.20 h STOP STOP

Alarms Clear Volume Infused and Total volume

The following auditory and visual alarms and indicators are displayed by the pump. All can be silenced by pressing the silence button or the stop button. The volume has three settings selected by pressing the select button.

The “volume infused” shows the total volume given for just that feed and the “total volume” shows the volume delivered in 24hrs. At the beginning of a new day the total volume and the volume infused should be cleared, in the stop status, by pressing the clear button. The volume infused is cleared by a short press and the total volume by holding the clear button for a few seconds.

! low battery!

low battery

STOP - CLEAR - VOLUME INFUSED

When the battery is about to become exhausted the low battery alarm will sound. Delivery should stop and the battery should be recharged at the mains. The battery life at average rate of delivery is approximately 4 hours. The battery is fully recharged in approximately 12 hours. The battery indicator light also illustrates the state of charge with all four bars indicating a fully charged battery.

HOLD ‘CLEAR’ - TOTAL VOLUME

AC power When this light is on the pump is connect to the mains power supply. !

Start Delivery Caution It is important to check the pump syringe and any extention line are correctly fitted to an enteral feeding device only, normally a nasogastric tube, before the pump is operated. It is also important to check all connections between syringes, sets and tubes are secure. The correct gastric position of the feeding tube should also be confirmed before every feed delivery.

over!

! occlusion!

! dislocated!

incorrect

! syringe!

!

STOP STOP

Summary SECURE PUMP POWER ON PRIME SYRINGE CHECK CONNECTIONS INSTALL SYRINGE SET DOSE LIMIT AND RATE IN SMART SETUP PRESS ENTER CLEAR TOTAL VOLUME AND OR VOLUME INFUSED IF NEEDED CONFIRM NASOGASTRIC TUBE POSITION START DELIVERY ALARM OVER THEN STOP

This alarm sounds and the light comes on at the end of a delivery. This means that the delivery is complete. The same alarm and light will also sound and light up when a preset maximum volume is reached. Delivered volumes should be noted and new feeds initiated or the pump should be switched off until the next feed.

occlusion This alarm sounds and lights up if the line becomes occluded. The occlusion should be identified and removed then the feed can recommence. The occlusion pressures are fixed for the average range of enteral feeds.

START

The delivery is started by pressing the start button and stopped by pressing the stop button. The run status light indicates correct operation. The rate is locked during delivery. To stop delivery it is necessary to press the “stop” button for about 5 seconds. At the end of the feed the pump will alarm “over”, press stop and note volume infused in that episode of feeding and/or the total volume over 24hrs.

over

near!

dislocated This alarm sounds if the syringe has become dislocated during an infusion. The volume of the alarms has three settings Low Medium and High. This volume can be adjusted by pressing and holding the silence button. The level is indicated by the alarm volume light.

incorrect syringe This alarm sounds if the syringe is a non-Medicina syringe. This prevents accidental misconnections. If the alarm continues then remove clamp and refit.

near This alarm sounds when the delivery is almost over and 2 minutes are left.

you ! Do want to start

prompt: “Do you want to start”

! Internal error please

Internal error please restart pump

Prompt sounds when the infusion is not started 5 minutes after it is setup.

restart pump

This alarm sound when there is a problem with the camera. The pump should be turned off and rebooted.

pump body

Pump body blocked

! blocked! ! ERR1

! ERR2

The pump is stuck and the manufacturer should be contacted

ERR1 This alarm indicates a hardware malfunction. If restart is unsuccessful, please contact manufacturer.

ERR2 This alarm indicates a hardware malfunction. If a restart is unsuccessful, please contact manufacturer.

Disposable Syringes & sets The following single use syringes and sets may be used with the Syringe pump P900

Medicina Syringes

Pumps & Accessories Pump

Super Lock Syringes

The P900 pump includes a clamp to fit to a drip stand, an instruction booklet and a mains lead.

(Larger connector)

1ml

1ml

Ref: PE01

Ref: MD01

medicines only

ref: P900

medicines only

2.5ml

2.5ml

Ref: PE25

Ref: MD25

5ml

medicines only

Pump

medicines only

Ref: PE05

5ml

Ref: MD05 10ml

Ref: PE10 10ml

Ref: MD10

20ml

Ref: PE20 20ml

Ref: MD20

30ml

Ref: PE30

UK Power Lead

ref: PL01

30ml

Accessories

Ref: MD30 60ml

Replacement power cords and instruction booklets are also available.

Ref: PE60 60ml

Ref: MD60

Caution the 60ml syringe PE60 and MD60 have a maximum volume of 50mls and cannot be fitted into the pump with a higher volume than 50mls.

EEC Power Lead

ref: PL02

Enteral Extension Sets 75cm long

Ref: EP075 150cm long

150cm long

Ref: EP150

150cm long

Ref: MF150Y

Ref: MF150

USA Power Lead

ref: PL03 Y-Site 75cm long

Ref: EP075Y 150cm long Y-Site 150cm long

Ref: EP150Y

75cm long

Ref: MF075

Ref: MM150Y

Instruction Booklet

ref: P5INS

Medicina Prototype Enteral Syringe Pump Specification P900

Maintenance Caution The pump body should be cleaned in line with hospital policies or with a damp cloth or an alcohol type wipe (75% alcohol*) No other chemicals should be used to clean the pump. The pump should not be repaired or opened by anyone other than authorised Medicina Staff. This will void the warranty. All defective pumps should be returned to Medicina Ltd or to an authorised service centre or distributor. *ALCOHOL WIPES SHOULD NOT BE USED IN THE DISPLAY SCREEN.

Routine Maintenance The pump should be kept clean in line with hospital policies. The battery should be fully charged before storage and then recharged at 3 monthly intervals. The power cord should be inspected for damage at least once per year. The functions of the pump can be tested using the Medicina test procedure, which can be obtained from Medicina Ltd or its authorised distributor. Test intervals will be in line with local hospital policies.

Caution If the AC light does not illuminate with the ac power on the fuse in the plug should be replaced. If it still does not illuminate the pump fuse may need replaced. The pump should be returned to Medicina Ltd or its authorised distributor.

Syringes

5,10, 20, 30, 60 ml Medicina & Medicina SUPERLOCK Enteral Syringes

Flow rate

Accuracy of flow rate (Nominal value)

0.1– 100 mls/hr (0.1 ml increment) 0.1– 100 mls/hr (0.1 ml increment) 0.1– 100 mls/hr (0.1 ml increment) 0.1– 50 mls/hr (0.1 ml increment) 0.1– 20 mls/hr (0.1 ml increment) Accuracy including syringe: within ±4% Dedicated software Medicina syringes.

Display of volume infused

0.1– 99 ml (0.1–100 ml, 0.1 ml step) 24hr volume (0-99 ml, 0.1 ml increments)

Dose limits

5 ml (10 mls) 10 ml (20 mls) 20 ml (60 mls) 30 ml (100mls) 60 ml (100mls)

Occlusion detection

Fixed occlusion pressure fixed @0.1MPa (14.5psi)

Alarms

OCCLUSION: BLOCKED OR OCCLUSION

60 ml syringe 30 ml syringe 20 ml syringe 10ml syringe 5ml syringe

OVER: DELIVERY FINISHED (END OF DOSE LIMIT) DISLOCATED: SYRINGE DISLOCATED LOW BATTERY: LOW BATTERY INCORRECT SYRINGE

Caution Pump batteries should be replaced after 5 years by returning the pump to to Medicina Ltd or its authorised distributor.

Power

AC110~220V ±10%, 50~60 Hz ±1 Hz. Lithium polymer battery: DC12 V Continuous operation time of battery: over 4 hours when battery is recharged for 12 hours.

Operation conditions Storage conditions Electricity /safety class Weight Dimensions

Ambient temperature: 5- 40°C, Relative humidity to 80% Ambient temperature: -40 to 55°C, Relative humidity: 95% Class I1 and internal power supply: Type BF, (CE0120) 2.90kg 288mm x 130mm x 122mm

warranty Medicina Ltd warrants that each new enteral syringe pump and accessories are free from defects in material and workmanship under normal use and service for a period of 12 months from the date of delivery by Medicina Ltd or its authorised distributor to the original purchaser. If any product requires repair during the warranty period the purchaser should communicate directly with Medicina Ltd or its authorised distributor. Except as provided in this warranty. Repairs or replacement will be at the expense of Medicina Ltd. Loss or damage in return shipment will be at the purchasers risk. Medicina Ltd or its authorised distributor will in no event be liable for any incidental, indirect or consequential damages in connection with the purchase or use of any Medicina or Superlock products. This warranty applies to the original purchaser only. This warranty does not apply to any subsequent owner or holder of the product.

This warranty shall not apply to, and Medicina Ltd. or its authorised distributor shall not be responsible for, any loss or damage arising when the product has been repaired or altered, affecting its stability or reliability, by any unauthorised person. Or if the product is subjected to misuse, accident or negligence , improperly maintained or used in any way other than in accordance with these written instruction. This warranty is in lieu of all other warranties, express or implied, and of all obligations or liabilities of Medicina Ltd. Medicina Ltd disclaims all other warranties, express or implied, including any warranty of merchantability or fitness for a particular purpose.

DISPLAY Syringe size Dose limit Total volume AC and battery power indication Alarm volume

Volume infused Battery Capacity Flow rate Status