NIKI T34 & T34L In-Service Guide

 Origins in New Zealand in 1983  New Zealand’s largest private medical supplier

 Sydney HQ since 1999  Main Principals:

 CME

-Caesarea Medical Pumps  CODAN – Anaesthetic & I.V. Products  BAXA – Pharmacy ,TPN Consumables  AIRTRAQ – Disposable Optical Laryngoscope



Established in 1993



Incorporated in Israel & Germany



Privately owned company



Main focus on small ambulatory technology



Advanced therapies in Chronotherapy (Sinusoidal Chemotherapy)



Enteral & MRI Pumps



Device type: Syringe driver with motor driven linear actuator, pulsed motion



Flow rate/Bolus: 0.5 to 100 ml/hr (0.1ml increments), 100 to 1000 ml/hr (1ml increments)



Clinician assisted bolus option and full PCA model available.

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Duration: 1min to 5 days in 1 min increments

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Actuator stroke: 60mm

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Syringe sizes: 2ml to 50ml, BD, Monoject, Braun, Terumo, CODAN, custom option

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Lockbox: Weight 185gm, will accommodate up to 30ml BD syringe.

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System accuracy: +/- 2%, approx +/- 5% with syringe and set

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Occlusion pressure: 100 to 1000mmHg

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Battery: Duracell Alkaline 9V or Lithium rechargeable, Approx 7 full deliveries

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Indicators: 3 line LCD display 122 x 32 pixel

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Alarms: Both audible and visual:

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◦Downstream Occlusion ◦Near end Infusion (15min from end)

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◦End Infusion ◦Syringe empty

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◦Low Battery, 15min ◦End Battery

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◦Load Syringe ◦Pump Unattended

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◦Syringe dislodged ◦Technical fault

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Event history: Downloadable 500 events via Infrared

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Dimensions: 169mm x 53mm x 23mm

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Weight: 262gm with battery

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Housing: ABS fire retardant

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Classification: Type CF Equipment

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Electrical Safety: Complies with EN 60601-1 Electrical safety, IEC 60601-2-24 Infusion Pumps, IEC

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60601-1-4 Programmable Device, IEC 601.1 EMC, UL 2601-1 and CAN/CSA

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C22.2 No 601.1.

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Standards: Manufactured in accordance with ISO 13485. CE marked in accordance with

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device directive 93/42/EEC

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Operating Conditions: Temperature +15ºC to +45ºC (593ºF to 113ºF)

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Humidity 20% to 90% non condensing

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Air Pressure 70kPa to 110kPa

 Pump setup dependant on clinical

setting

 Emergency /Retrieval – “Open” protocol, any drug, max rate possible, KVO on, titratable rate  NETS / NICU / Anaesthesia – “Open” protocol with limits on max rate, Lower occlusion pressure.  Immunology / Thalassemia – High viscosity drugs, subcut, increased Occlusion pressure  Palliative / Home Care – “Closed” protocol. Program locked, no titration, KVO off, Set duration

Palliative Care

Emergency / Retrieval

NICU

Program Lock

ON

OFF

OFF

Maximum Rate

5ml/hr

600ml/hr

~50ml/hr

Titration

OFF

ON

OFF

Default duration

24 hrs

0

30-60 min

Occlusion Alarm

540-800mmHg

~400mmHg

~300mmHg

OFF

ON

OFF

KVO

 No user calculations 

- reducing programming errors

 No mandatory consumables 

- uses and detects any brand or size syringe

 Large screen display

READ ME !!

 Program LOCK- No change to duration or

rate (by Accident)  SAFETY!!!

 Audible AND Visual Alarms

Actuator

•Actuator (dont move by hand) •Instructions on Front Panel •ON/OFF (half to one second) •LED – Green when running, Red when stopped •FF/BACK – Move actuator for syringe insertion or Prime line •YES/NO (Start / Stop) – Select menu options, confirm data •UP/DOWN – Change numbers, scroll in menus •INFO – Infusion data, Battery check, Change setup, Keypad LOCK

Battery 9V Duracell, can be replaced without opening lockbox 2-5 days infusion per battery

Terminals for Communications station

       

Ensure Clamp is DOWN Turn ON Pump, notice actuator will move to same position of LAST syringe. Place syringe on top of Clamp Align barrel flange with groove in pump Press either  or to align the Actuator with the end of plunger Lift Clamp, rotate 90 deg Place syringe on pump Close clamp

Align Groove

C



3 Point Syringe ldentification

A- Barrel clamp arm detects size/width of barrel and secures B- Syringe ear/collar sensor small metal switch-detects secure loading of syringe collar C- Plunger sensor detects secure loading of syringe plunger. Ensure plunger is between fingers Pump can be setup, programmed for any brand and size of syringe ie Terumo OR BD or…

A

B

Lift clamp and rotate

1ml Length is Distance from 0 to 3ml divided by 3 = 17mm 51mm

12.3mm

Hard Height is distance from top plunger to top barrel flange

 Program Lock ON  Max Rate set at 5ml/hr  Occlusion Pressure set at 540 mmHg

 Duration set at 24 hrs

1.

TURN ON

2.

Watch Actuator – Moves to same

MOST Important

position as last syringe ! 3.

Software Version displayed

4.

Check Pump settings Occlusion, Max

rate, Program Lock ON, Battery % 5.

Load syringe !!

6.

Check Syringe Brand and Size

7.

Check volume, Duration, rate

8.

Start Infusion ?

MOST Important

Fig 1

On day one and other days when a new IV line is used the line will need to be primed. 1. BEFORE Starting Infusion 2. Press FF button once. 3. Check patient is NOT connected 4. Press YES to confirm you want to prime – see Fig 2 5. Watching fluid in the line hold down  FF button until prime is completed. 6. Maximum prime is 2.0ml (Setting 0 – 2ml) NOTE: Only ONE prime is allowed each time the NIKI is turned on. To re-prime, pump must be turned off and on again.

Fig 2

Before Prime

1. What does YES Mean ? 2. What does NO mean ? 1. Yes Means “Use the LAST infusion rate” 2. No means “Reset volume to infuse over 24 hours” Default Duration

 VOLUME will reduce by prime volume  DURATION will reduce based on volume  RATE will remain the same

NOTE: Only ONE prime is allowed each time the NIKI is turned on. To re-prime, pump must be turned off and on again.

After Prime

Once infusion is started:  Time Remaining is displayed  Infusion Rate is displayed in ml/hr  Syringe brand display alternates with



“<<<<pump delivering”

KEYPAD Lock OFF The pump can be stopped and turned off  KEYPAD Lock ON The pump can be stopped but NOT turned off. 



To turn KEYPAD Lock ON or OFF hold down the button until bar has crossed the screen.

i INFO

Press

i INFO

key to display infusion data :

VTBI (Volume to be Infused)  VI (Volume Infused…. so Far)  Battery Level eg74% 



Data should match that of syringe

Audible and Visual alarms for the detection of:  Pump Paused Too Long – Take Action  Check syringe sensors ….  Occlusion Alarm –Default pressure (540

mmHg)  Near end infusion (15min)  Finished Infusion  Battery Low ~15min  Syringe dislodged