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Related Manuals for CME NIKI V4
Summary of Contents for CME NIKI V4
- Page 1 NIKI V4 Infusion Pump SERVICE MANUAL 0473 Manufacturer: C.M.E. LTD Fax 49-(7129) 925520 Tel. 49-(7129) 92550 Staufenburgstr. 23 Lichtenstein P.o.b. 1248 Lichtenstein 72805 Germany E-mail: c-m-e@internet-zahav.net Ref.: 100-092 EDITION JULY 2004...
- Page 2 NIKI V4 Operator’s Manual...
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Page 3: Table Of Contents
Table of Contents 1. INTRODUCTION NIKI V4 Features. About This Manual. Safety Precautions. Limited warranty Service Information 2. NIKI V4 Volumetric Infusion Pump Overview Specifications. 10-11 Front Panel – Control and Indicators 12-13 Front Panel - with Open Door. 14-15 Rear Panel. -
Page 4: Introduction
1.Introduction This Manual Provides direction for setup and operation of the NIKI V4 Volumetric Infusion Pump. NIKI V4 Features Small, light and compact pump. Multi Programs: MACRO Macro program Infusion Rate : 1 to 999 ml/hr. Volume : 1 to 9999 ml. -
Page 5: About This Manual
NIKI V4 features and capabilities. 2. NIKI V4 Volumetric Infusion Pump Overview - Functional description and specifications. 3. Setting Up the NIKI V4 Infusion Pump - Instructions for unpacking and setting up the pump before operation. 4. Operating the NIKI V4 Infusion Pump - Procedures for operating. -
Page 6: Safety Precautions
If the pump was dropped, send the pump back to be inspected by qualified service personnel. • Before operation, verify that administration set tubing is not kinked or occluded. NOTE: The maximum volume that may be infused under SINGLE FAULT CONDITION is 0.1 ml. NIKI V4 Operator’s Manual... -
Page 7: Safety Precautions
Do not clean pump with chemicals such as Xylene, Toluene, Acetone, or similar solvents. These chemicals cause damage to plastic components and paint. • Do not use pens or any other sharp object to press keys. Torn or punctured membranes expose keys to damage. NIKI V4 Operator’s Manual... -
Page 8: Limited Warranty
Limited warranty on distribution sold products The NIKI V4 infusion pump has been carefully manufactured from the highest quality components. Caesarea Medical Electronics Ltd. Warrants that the pump will be free of defects in material and workmanship for twelve (12) months from the date of purchase by the original purchaser. -
Page 9: Service Information
A service request number will be issued should accompany all communications A brief written description of the malfunction should be attached to the instrument when it is returned for service. NIKI V4 Operator’s Manual... -
Page 10: Niki V4 Volumetric Infusion Pump Overview
2. NIKI V4 Volumetric Infusion Pump Overview Specifications Pumping Mechanism: Linear peristaltic movement Flow Rate: Micro - 0.1 to 99.9ml/hr in 0.1ml increments Macro - 1 to 999ml/hr in 1ml increments Total Infusible Volume: Micro - 0.1 to 2,500ml. Macro - 1 to 9,999ml. - Page 11 10 years. Electrical Safety Comply with Ph60601-1 (medical equipment) and IEC60601-2-24 (Infusion pumps and controllers) with UL 2601- 1 and CAN/CSA C22.2 No 601.1 and MDD 93/42 EEC. Weight 1100 gr. 2.5 pounds NIKI V4 Operator’s Manual...
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Page 12: Front Panel - Control And Indicators
Front Panel – Control and Indicators NIKI V4 Operator’s Manual... - Page 13 • Charging Indicator Lights when pump operates on AC power and battery is being charged. • Opens and closes the pump door. Door Latch • Door Label NIKI V4 VOLUMETRIC INFUSION PUMP NIKI V4 Operator’s Manual...
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Page 14: Front Panel - With Open Door
Front Panel – with Door Open NIKI V4 Operator’s Manual... - Page 15 Air sensor Ultrasonic air detector, mounted on the front housing. Tubing Guide Guide the Administration set Air sensor Mounted on the door. Door springs Located between the door and press plate. NIKI V4 Operator’s Manual...
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Page 16: Rear Panel
Rear Panel NIKI V4 Operator’s Manual... - Page 17 Attachment for AC power cord 220-240v 50/60 Hz CF protection Pump safety classification Serial number sticker Display’s the serial number of the pump CE marking Admission to market the NIKI V4 pump in Europe Pump mounting screw Same as 3 NIKI V4 Operator’s Manual...
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Page 18: Operating The Infusion Pump
WARNING: The pump is calibrated to a specific set. Do not use any other set. A certified technician would be able to help you calibrate your set to the NIKI V4 pump. Call your local representative for assistance. c. Prepare the IV solution container and prime the IV set being used according to the instruction provided with the IV set. -
Page 19: Basic Operation
On the left side of the display, the word RATE will change to TIME. TIME The pump will automatically calculate the Total Volume. Press SELECT key again, to set the VTBI (optional) The pump will automatically calculate the Total Infusion Time. NIKI V4 Operator’s Manual... - Page 20 The pump’s memory retains all parameters even if it was turned off. “TIME REMAIN” Display - During Operation 1. Pressing the SELECT key during operation causes the displayed “RATE” to change for 5 seconds to “Time Remains hr: min” NIKI V4 Operator’s Manual...
- Page 21 NOTE: Use the Select key to display current data : Rate, Time left, VTBI, Infused volume. 3. Set the desired infusion rate using the arrow keys. Pressing continuously will increase the speed and steps of changes. 4. Press the RUN/HOLD key to renew operation. NIKI V4 Operator’s Manual...
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Page 22: Battery Operation
The “Locking” Option The NIKI V4 has a unique option, which enables the user to lock out the setting keys, so that entered parameters, or set programs cannot be changed once they are set, especially during operation. This option is important in such cases as in pediatric ward, where there is a danger that the child user will play with the pump and unknowingly change the program. - Page 23 Leaving the battery in a discharged state for a long period of time may damage the battery. Whenever possible, operate the pump on AC power. This preserves battery power supply for when it is needed. Replace the battery once every 4 years. NIKI V4 Operator’s Manual...
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Page 24: Priming Function
4. Once the priming is completed, the display will change from FILL to the last rate setting. RATE- VOL.- 5. Press the RUN/HOLD key to start operation. NOTE: The pump will prime 5 ml instead of 16 ml in case the set is partially Primed. NIKI V4 Operator’s Manual... -
Page 25: Preventing Maintenance
Press run/hold key to resume operation. Check that there are no obstruct Remove obstruction upstream or downstream tubing. and/or open roller clamp. Check the administration set for Replace administration correct type or code. set if required. NIKI V4 Operator’s Manual... - Page 26 Safety (CF) Check ground resistance measured on the pump’s door if it is greater than 0.1 Ohm check tightness of grounding screws. It should be 100 microamps or less using UL2601 specified test methods (CF classification) NIKI V4 Operator’s Manual...
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Page 27: Cleaning And Maintenance
Periodic maintenance (every 12 months) should be initiated to assure the proper function of the pump. Dropped or damaged pumps should not be cleaned / used and should be rechecked by an authorized service technician. NIKI V4 Operator’s Manual... -
Page 28: Alarms
V O L . - operation, or was accidentally R A T E - opened V O L . - The pump is Set infusion RATE- parameters and priming the press administration V OL.- RUN/HOLD to set. restart infusion. NIKI V4 Operator’s Manual... - Page 29 RATE- VOL.- The pump Using non- Use the set the calibrated pump was RATE- wrong set calibrated to. detected an VOL.- unsuitable set. RATE- VOL.- Pump is in Press simultaneously lock-mode. RATE- the two arrows. VOL.- NIKI V4 Operator’s Manual...
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Page 30: Automatic Calibrations
Automatic Calibrations The NIKI V4 Volumetric Infusion Pump has many functions which allow the biomedical department to specify the device to every department. The access to the functions are not disclosed to the user manual, and are limited to the biomedical engineers as they were trained to use and to decide which modes are suitable for each hospital department. -
Page 31: Manual Calibration
Pump will display a number – change according to the differences in volume (if volume was more than VTBI, set to lower number and if the volume was lower set to higher number). Repeat steps 2-4 until VI will be 30 ml. ±5%. NIKI V4 Operator’s Manual... -
Page 32: Changing Default "Pressure" Limit
Press the RUN/HOLD key, in order to store the parameter in the pump’s memory. NOTE The pump has an antibolus system, which prevent a bolus delivery to the patient, once a downstream occlusion is released. NIKI V4 Operator’s Manual... -
Page 33: Hospital Service Procedure
Introduction This section contains a table describing preventing maintenance which should be performed on the NIKI V4 Volumetric infusion pump. The maintenance procedures outline in this section may be performed in the hospital, by the biomedical department. An abnormal condition accurse which is not correctable by performing the following procedures, remove the device from service and troubleshoot it in accordance with section 4.4. - Page 34 The selected program will remain in the pump’s memory until changed NOTE again. List of programs The NIKI V4 volumetric infusion pump features 2 different programs. Following are the specifications for each program: MACRO program. Rate: 1 to 999ml/hr Total volume to be infused: 1 to 9999ml.
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Page 35: Failure Identification
Failure Identification Specific errors which may occur in the operation of the NIKI V4 Volumetric Infusion Pump are represented on Section 3 pg.25-27. On the biomedical mode. The user can display the last 10 failures which are stored in the device's memory. -
Page 36: Testing And Troubleshooting
4. Testing And Troubleshooting 4.1. Startup Test Before attaching the NIKI V4 to a patient, run a startup test to verify that all indicators and alarms work properly. When an alarm is activated the following will occur: 1. An alarm message appears on the display. -
Page 37: Operational Checkout
If pump fails to perform as described or stops with a failure alarm, troubleshooting in accordance with section 6 and repair it in accordance with section 4.5. before attempting to place the device in service. NIKI V4 Operator’s Manual... -
Page 38: Test Performing
When the pump has delivered the selected volume, an audible alarm is activated while the display will show 'fin' 'open vein'. To stop an alarm, press the run/hold key. Check that the pump is infusing the KVO rate, and displays open vein. NIKI V4 Operator’s Manual... - Page 39 5. AIR alarm will activate as soon as the air bubble enter the RATE- set segment located behind the pumping door. VOL.- 7. Press the RUN/HOLD key to turn the alarm off. 8. HOLD appears on the display. RATE- VOL.- NIKI V4 Operator’s Manual...
- Page 40 Door Open Alarm Test 1. Insert primed administration set into the pump. 2. Press the RUN/HOLD key to start operation. 4. Close the door. RATE- VOL.- 5. HOLD appears on the display. NIKI V4 Operator’s Manual...
- Page 41 3. Press RUN/HOLD key to silence the alarm. RATE- 4. HOLD appears on the display. VOL.- The pressure threshold can be changed to suit the ward need, (see NOTE Changing the current default “Pressure” Limit to another on page 32). NIKI V4 Operator’s Manual...
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Page 42: Testing Procedures
(should be 250). Occlusion test Insert a NIKI V4 primed set into the pump. Occlude the set. Check on JP8 P5 frequency increase by (number x16 › 300 HZ) in case to frequency increase the sensor is either broken. - Page 43 Input 5v Switch pump on. Check using an avometer the voltage on JP8 P7. The allowed values are between 4.9 to 5.1v. 12V Input Check on JP8 P8 the 12v input. Values allowed are 11.5 to 12.5v. NIKI V4 Operator’s Manual...
- Page 44 When performing the above mentioned test set the Hi pressure alarm level high. Fill / Bad Set Load an administration set, without the NIKI Valve. The pump will alarm fill set after 30 sec, or bad set when 15 ml are completed. NIKI V4 Operator’s Manual...
- Page 45 Connect the common line C5 and C61 to ground. The pump's motor will stop. Immediately stop its function and audible alarm will occur and the display will show 'Err'. Check on the same point if frequency can be detected, if not, check U1 P29 the frequency output. NIKI V4 Operator’s Manual...
- Page 46 Leakage current should not exceed 100 microamps. Ground impedance should be measured on the pump's door. If the device fails to meet these requirements, remove it from service, troubleshoot it in accordance with section 6 and repair it in accordance with section 4.5. NIKI V4 Operator’s Manual...
- Page 47 4.4 and repair in accordance with section 4.5. Air Detection Test The NIKI V4 pump is designed to detect air bubbles passing through the set. The air bubble size detection is adjustable through the configuration option and is factory set to 50 micro liter (section 6).
- Page 48 Connect the power cord to the AC power outlet. Verify that the CHARGE indicator is on, and the display has stopped flashing. NIKI V4 Operator’s Manual...
- Page 49 Electronic load device or a fixed 5 ohm, Allen key 2.5 mm. 20W resistor with variable load Antistatic mat Antistatic work surface When receiving a pump for maintaining: Check the last 10 alarms on the biomedical mode (can be accessed using code 10). NIKI V4 Operator’s Manual...
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Page 50: Corrective Actions - Disassemble And Calibration
List of Decisions When receiving a NIKI V4 pump for service the first decision should be made either it’s a user mistake or pump malfunction. Secondly decide if the failure was caused by the pump or by the administration set. - Page 51 Replace 4 mounting screws (Fig.2) and tighten them to 9 kg-cm (8 in lbs) with a toque screwdriver. Replacement of Pump's Door 1. Remove the pump's door label (NIKI V4 – Volumetric Infusion Pump). 2. Open the security screws. 3. Open the door completely.
- Page 52 4. Replace 3 springs to their place on the door. 5. Install the new Press Plate inserting door shafts. 6. Press the Press Plate a few times from the inside of the door to ensure smooth operation. NIKI V4 Operator’s Manual...
- Page 53 1. Separate front and rear housing in accordance with Section 4.5. 2. Remove connecting screws of rear PCB S31, S32. 3. Replace the new PCB in a reverse order. 4. Perform the operation checkout procedure of Section 4.2. NIKI V4 Operator’s Manual...
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Page 54: Maintenance Flowchart
Perform operation checkout of section 4.5 Does Device perform Place device in Operational checkout service Satisfactorily Troubleshoot in accordance with section 5 Repair in accordance with section 6 Recalibrate in accordance with section 4.4 NIKI V4 Operator’s Manual...