CME T-34 Syring Pump Service manual
NIKI V4
Infusion Pump
SERVICE MANUAL
0473
Manufacturer:
C.M.E. LTD
Tel. 49-(7129) 92550
Staufenburgstr. 23 Lichtenstein
P.o.b. 1248 Lichtenstein 72805 Germany
E-mail: c-m-e@internet-zahav.net
EDITION JULY 2004
Fax 49-(7129) 925520
Ref.: 100-092
NIKI V4 Operator’s Manual 2
Table of Contents
1. INTRODUCTION
NIKI V4 Features. 4
About This Manual. 5
Safety Precautions. 6-7
Limited warranty 8
Service Information 9
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. 16-17
3. OPERATING THE INFUSION PUMP
Operation Instructions 18
Basic Operation 19-23
Priming Function 24
Preventing Maintenance 25-26
Cleaning and maintenance 27
Alarms 28-29
Automatic Calibrations 30-31
Manual Calibration 31
Changing Default "Pressure" limit 32
Hospital Service Procedure 33-34
Failure Identification 35
4. Testing And Troubleshooting
4.1.Startup Test 36
4.2.Operational Checkout 37
4.3.Test Performing 38-41
4.4.Testing Procedures 42-49
4.5.Corrective Actions – Disassemble and Calibration 50-53
4.6.Maintenance Flowchart 54
NIKI V4 Operator’s Manual 3
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.
6
Multi Programs:
6
MACRO
Macro program Infusion Rate : 1 to 999 ml/hr.
Volume : 1 to 9999 ml.
MICRO
Micro program to be used in Neonatal and Pediatric
wards. Infusion Rate: 0.1 to 99.9 ml/hr.
Volume : 0.1 to 2500 ml.
Highly accurate fluid delivery.
6
Rechargeable internal battery.
6
Integrated Mounting Clamp for securing the pump to an IV pole.
6
A.B.S. Anti-Bolus System
6
Silent operation.
6
Ultra Sonic air detection- air bubbles greater than 50 micro liters.
6
NIKI V4 Operator’s Manual 4
About This Manual:
The information in this manual is presented as follows:
1. Introduction -
Functional description and specifications.
Instructions for unpacking and setting up the pump before operation.
Terms and conditions used in manual :
)
*
,
NIKI V4 features and capabilities.
2. NIKI V4 Volumetric Infusion Pump Overview -
3. Setting Up the NIKI V4 Infusion Pump -
4. Operating the NIKI V4 Infusion Pump -
Procedures for operating.
NOTE
CAUTION
Operating procedure or condition that is essential to highlight.
A precaution that, if not followed, could result in extensive damage
to the equipment.
WARNING
A precaution that, if not followed, can result in personal injury or loss
of life.
NIKI V4 Operator’s Manual 5
Safety Precautions
WARNING
,
To avoid possible personal injury or loss of life, observe the following:
Note : Read and understand the entire Operation Manual before using the pump
since important precautions follow throughout the text.
Disconnect the pump from main, prior to opening the casing.
•
Voltage present on internal components may cause severe shock or death on
contact.
Only trained service personnel should open pump cover.
Before servicing pump, remove rings, watches, and other jewelry that may
•
cause a shock / burn hazard.
To prevent fire hazard, replace blown fuses only with fuses of same type and
•
rating. (see fuse values on the rear Pcb close to the fuses housing) .
The Equipment is not suitable for use in the presence of flammable
•
anesthetic mixture with air or with oxygen or nitrous oxide.
• Watch your fingers / nails when opening the pump’s door.
To avoid possible injury to patient, observe the following:
Make sure pump is attached securely to IV pole.
•
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 6
Safety Precautions
The pump Power cord should be connected to a grounded AC outlet Furnishing.
, WARNING
Any adjustments, maintenance or repair of the uncovered pump
under voltage, should be avoided. If necessary, these repairs should
be carried out be skilled technicians who are aware of the hazards
involved.
The should be operated within a temperature range of 15ºC (59ºF) to
45ºC (113ºF).
, WARNING
Do not operate pump near equipment that emits high energy radio
frequencies, such as electro-surgical cauterizing equipment and
cellular telephones. False alarm signals may occur.
) NOTE: Read and understand the entire Operation Manual before using
pump since important precautions follow throughout the text.
*
NIKI V4 Operator’s Manual 7
CAUTION
To avoid possible damage to the equipment, observe the
following:
Do not immerse pump in liquids.
•
Clean solution spills immediately from the pump. Use a damp cloth
•
or sponge. A cleaning disinfectant may be used. Wipe thoroughly
with a dry cloth.
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.
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.
CME’s or its designated representative’s obligation under this Limited Warranty shall be
limited, at CME’s or its designated representative’s option, to repairing or replacing
pumps which upon examination, are found to be defective in material or workmanship.
The repair or replacement of any product under this Limited Warranty shall not extend
the term of the Warranty beyond the original term set forth above.
All repairs under this Limited Warranty should be undertaken only by qualified, trained
service personnel. In the event that a pump is found to be defective during the
warranty period, the purchaser shall notify CME or its designated representative
within thirty (30) days after such defect is discovered.
The defective pump should be sent immediately to CME or its designated
representative for inspection, repair or replacement. Shipping costs are the
purchaser’s responsibility.
Material returned to CME or its designated representative should be properly
packaged using CME shipping cartons and inserts. Inadequate packaging may result
in severe pump damage.
This Limited Warranty shall not apply to defects or damage caused, wholly or in part,
by negligence, spilt fluids, dropping of the pump, misuse, abuse, improper installation
or alteration by anyone other than qualified, trained personnel; or to damage resulting
from inadequate packaging in shipping the pump to CME or its designated
representative.
If, after inspection, CME or its designated representative is unable to identify a
problem, CME or its designated representative reserves the right to invoice purchaser
for such inspection.
This Limited Warranty is the sole and entire warranty pertaining to CME’s products
and is in lieu of and excludes all other warranties of any nature whatsoever, whether
stated, or implied or arising by operation of law, trade, usage or course of dealing,
including but not limited to, warranties of merchantability and warranties of fitness for
a particular purpose. Purchaser expressly agrees that the remedies granted to it
under this limited warranty are purchaser’s sole and exclusive remedies with respect
to any claim of purchaser arising under this Limited Warranty.
Managing Director
NIKI V4 Operator’s Manual 8
Service Information
While under warranty, Service agreement, (optional) or lease agreement, the instrument
must not be opened by unauthorized personnel.
Contact your local distributor.
Shipping costs for all units returned for service or warranty shall be paid by the
customer, The unit must be packed in its original container or in another container that
will provide adequate protection during shipment. To assure prompt return, the
customer service department must be notified before shipping any unit for repair. When
calling product service, pls. be prepared to provide code number and serial number of
the unit. 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 9
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.
Total Time Setting 99:59 hours
Accuracy: ± 5%.
KVO rate: 0.1 to 5 ml/hr.
Air Sensor: Ultrasonic
Maximum Pressure: 0.7 bar or 10 psi Adjustable ( high, normal, low )
Power Supply: 100-240 V, 50/60 Hz. 10w 0.3A max.
Battery: Nickel-Cadmium 7.2V, 0.9Ah.
Battery Operation at 125 ml/hr: 16 hours
Battery Charging:
Alarms: Bad System
Dimensions: 138 x 138 x 72mm.
Symbol Attention (Consult accompanying documents)
Classification
IPX4
CLASS 1
Housing: ABS (with fire retarded)
Automatic when connected to an AC power source
(12 hours)
Low & End Battery
Push Run
Air
Fill Set
Bad set
High Pressure (HI PRES) (down occlusion)
Door Open
End of Program (FIN)
Loc
5.4’’ x 5.4’’ x 2.8’’ (l x w x h).
Type CF Equipment
(Degree of protection against electrical shock)
Protected against splashing water
(Degree of protection against liquid ingress)
NIKI V4 Operator’s Manual 10
Electrical Safety Comply with IEC 601-1(medical equipment) and
IEC60601-2-24 (Infusion pumps and controllers)
Memory Retention All calibration and set information will be retained in
the pump memory for a minimum of 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 11
Front Panel – Control and Indicators
NIKI V4 Operator’s Manual 12
No. Function Description
1.
2.
3
4.
5.
6.
• Displays selected infusion rate, total time,
• Whenever the pump is operated on battery,
• The cursors indicate that the set program is
• Sets a PIGY program
• Automatically primes the administration set
• Unprimed set- priming volume 16 ml.
• Partially primed set- priming volume 5 ml.
• Guide the administration set.
• Increases / Decreases the infusion RATE,
TIME limit, and VTBI.
• Continue to press the arrow key to increase
volume to
be infused, and volume infused.
the
display will blink on and off.
running.
- Single Pigy program
- Auto Pigy program
the setting steps and speed.
Pigy key
Prime key
Tubing Guide
Arrow keys
Display
7.
8.
9.
10.
• Starts or stops pump operation and delivery.
· Hold may be used to silence an alarm
condition and pause priming.
• Lights when pump operates on AC power
and battery is being charged.
• Opens and closes the pump door.
• NIKI V4
VOLUMETRIC INFUSION PUMP
NIKI V4 Operator’s Manual 13
RUN / HOLD Key
Charging Indicator
Door Latch
Door Label
Front Panel – with Door Open
1
2
12
13
14
15
16
17
18
19
21
3
4
5
6
7
8
920
10
11
NIKI V4 Operator’s Manual 14
No. Description
Function
1. Display LED display
2. MACRO The pump is operating in the Macro program.
3. SELECT key Used to scroll between rate, time, volume to be infused,
and total volume infused.
4.
5.
6.
7.
8.
RUN / HOLD key Start/hold the program
Arrow key Setting the desired values for rate, time and vtbi.
Pumping block mounting
screw
Latch holder
Pressure sensor
Connect the pumping block to the front housing.
Holds the door closed when latch is positioned.
Horizontally.
y Detects downstream tubing restriction and occlusion.
y The alarm level can be adjusted to suit the needs
of the hospital department.
9.
10. Pump door Covers the press plate.
11. Recessed latch
12. RATE The rate message indicates that the figure shown on the
13. VTBI The volume to be infused.
Press plate Connected to the door by 3 springs.
Push to open door.
display is the current rate.
14. VI (Volume Infused) The accumulated infused volume, from the time the
CLEAR key was last pressed.
15. ON/OFF key Switches the pump on and off.
16. Charge indicator Lights when pump is connected to main.
17. PRIME key Pressing the prime key, at the data setting stage, after
door open or air alarm, will remove air from administration
set.
18. Air sensor Ultrasonic air detector, mounted on the front housing.
19. Tubing Guide Guide the Administration set
20. Air sensor Mounted on the door.
21. Door springs Located between the door and press plate.
NIKI V4 Operator’s Manual 15
Rear Panel
1
2
3
8
9 5
4
6
7
10
11
12
13
NIKI V4 Operator’s Manual 16
Description Function
1. Pump handle
Pump carrying handle
2. Pole clamp handle
Fixing the pump to an IV pole
3. Pump mounting screw
Used to assemble/disassemble the housing
4. Pole clamp
Mounts the pump on the IV pole
5. Pole clamp screw
Turn clockwise to secure the pump to the IV pole
6. Buzzer
Sounds an acoustic alarm
7, Pole screw adapter
A plastic tip to assure connection to the IV pole
8. Pump mounting screw
Same as 3
9. Electrical cord connector Attachment for AC power cord 220-240v 50/60 Hz
10. CF protection
11.
Serial number sticker Display’s the serial number of the pump
12.
CE marking Admission to market the NIKI V4 pump in Europe
13. Pump mounting screw
Pump safety classification
Same as 3
NIKI V4 Operator’s Manual 17
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