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CME NIKI T34 - User Manual

CME NIKI T34
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NIKI T34
SYRINGE PUMP
Instruction Manual
Ref.: 100-090SS Edition June 2008
0473

Questions and Answers

Summary

A - Introduction

What is the T34 Syringe Pump?

Defines the T34 Syringe Pump as a small, lightweight, ambulatory device for delivering fluids.

Indications for Use

Details the T34 Syringe Driver's purpose for various infusion medications and routes.

Contraindications

Pump Lockout Protection Features

B - General Warnings

General Safety Warnings

Provides critical safety information and precautions for operating the T34 syringe pump.

C - Precautions

Handling and Usage Precautions

Details important precautions for safe and effective use of the pump, including fluid exposure and cleaning.

D - Feature Recognition

Pump Features and Controls

Identifies and describes the main buttons, display, and LED indicators on the T34 syringe pump.

E - Symbols on pump, consumables & accessories

Device and Safety Symbols

Explains common symbols found on the pump, accessories, and in the manual for safe operation.

F - Installation and Inspection

Unpacking and Initial Inspection

Guides users through the process of unpacking the pump and checking for damage or missing items.

G - Administration Sets

Administration Set Usage and Warnings

Discusses compatibility, inspection, and proper connection of administration sets.

H - Batteries

Battery Recommendations and Testing

Covers suitable battery types, installation procedure, and how to check battery status.

I - Access Codes & Keypad Lock

Security and Keypad Locking Features

Explains access codes for security and how to use the keypad lock feature to prevent tampering.

J - Infusion set up & programming

Syringe Selection and Priming

Details how to select the correct syringe and prime the infusion set for accurate delivery.

Pre-Loading and Syringe Placement

Guides users through loading the syringe into the pump and confirming its placement.

Syringe Detection & Confirmation

Explains how the pump detects and confirms the syringe size and brand.

Purge Option

Describes the process of purging air from the infusion set before starting.

Programming Paths

Outlines the two different programming paths based on whether Program Lock is ON or OFF.

Setting the Infusion Rate

Details how to set the infusion rate in milliliters per hour (ml/hr).

Set Program Lock

Instructions on entering the program code to enable the program lock.

Start Infusion

Guides the user to confirm programmed parameters and start the infusion.

Confirming Infusion Parameters

Pressing YES/START to confirm pre-set or programmed infusion parameters.

Starting the Infusion

Prompts to check the set and clamp before commencing infusion.

Pump Operation Display

Explains what is displayed on the LCD screen during pump operation.

K - Using Accessories with T34 Syringe Pump

Lockbox and Carry Pouch Usage

Provides instructions on using the lockbox and carry pouch to protect the pump and syringe.

L - Recommended Checks during infusion

Routine Infusion Monitoring Checks

Describes essential checks for the LCD, LED, and physical condition during infusion.

Using the INFO Key for Status

Explains how to use the INFO key to check VTBI, VI, and Battery Level.

Event Log

Accessing and Interpreting the Event Log

Guides on how to view and understand the pump's event log data.

M - Advanced Functions of the T34

KVO (Keep Vein Open) Operation

Explains how the pump can maintain vein patency with a low KVO rate after infusion.

Infusion Rate Titration

Details how to adjust the infusion rate within set limits during operation.

N - Change Set Up

Accessing and Modifying Setup Parameters

Explains how to access the Change Set Up menu using an unlock code and modify parameters.

O - Alarm Conditions

Understanding and Responding to Alarms

Details common alarm conditions, their likely causes, and the recommended actions.

P - Troubleshooting

Common Pump Faults and Solutions

Lists common pump faults, their potential causes, and recommended troubleshooting steps.

Q - Specifications

Technical Specifications Summary

Provides a comprehensive list of the T34 syringe pump's technical specifications.

Electrical Safety and Standards

Details compliance with electrical safety standards and certifications.

Environmental Operating Conditions

Specifies the recommended temperature, humidity, and air pressure for operation.

R - Patient Training - Using the T34

Healthcare Provider Responsibilities

Defines the duties of the healthcare provider in patient training and support.

Training Content for Patients and Caregivers

Lists the key topics to be covered when training patients and their assistants.

S - Service, Calibration and Maintenance

Service and Unscheduled Repairs

Outlines who can perform service and repairs, and warranty voidance.

Annual Maintenance and Cleaning

Details recommended annual maintenance, monthly cleaning, and between-patient procedures.

Storage Guidelines

Provides instructions for storing the pump for extended periods.

T - LIMITED WARRANTY

Warranty Coverage and Limitations

Explains the 12-month warranty period, obligations, and exclusions.

U - APPENDIX

Default Syringe Brands Configuration

Lists the syringe brands pre-configured for use with the T34 pump.

Manufacturer and Contact Information

Provides the manufacturer's name, address, and contact details.

Overview

The NIKI T34 Syringe Pump is a small, lightweight, robust, and battery-powered ambulatory syringe pump designed for the precise delivery of medications or fluids from 2ml to 50ml syringes. It supports continuous or intermittent infusions at controlled rates, making it suitable for hospital, alternate site, and homecare settings for both adults and pediatric patients. The pump's actuator drives the syringe plunger forward at a controlled rate, adjustable from 0.1 to 1000 ml/h. Increments are 0.1 ml/h up to 100 ml/h and 1 ml/h up to 1000 ml/h.

Function Description:

The NIKI T34 is intended for the infusion of medications or fluids requiring precisely controlled rates through various clinically acceptable routes, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site. It is used for maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents, and general fluid therapy.

The pump features a 3-point syringe detection system that identifies commonly used syringe brands (or programmed ones), minimizing programming errors and ensuring accurate calculations. This system also triggers an alarm if the syringe is removed or partially displaced during infusion.

Contraindications:

The NIKI T34 is not suitable for:

  • Infusion of blood and blood products.
  • Infusion of insulin.
  • Infusion of critical medications where stoppage or interruption could cause serious injury or death.
  • Ambulatory regimens for patients lacking the mental, physical, or emotional capability to self-administer therapy, or who are not under the care of a responsible individual.

Pump Lockout Protection Features:

The T34 incorporates several lockout features to prevent unintended programming and key presses:

  • The syringe is contained within a locked box, accessible only by the healthcare provider.
  • After programming, the healthcare provider can lock the program with a special code, preventing changes without re-entering the code.
  • The keypad has a locking feature to prevent unintentional power-off, available to the patient. This lock does not affect the STOP keys, allowing patients to stop infusions in emergencies.
  • Service screens and troubleshooting are protected by a technician's code, accessible only to trained personnel.

Important Technical Specifications:

  • Type: Syringe Pump with motor-driven linear actuator, pulsed motion (540 pulses per mm).
  • Flow Rate: 0.05-10 ml/h in 0.01 ml increments, 10-650 ml/h in 1 ml increments (up to 1000 ml/hr available).
  • Actuator Travel: Approximately 67 mm.
  • Syringe Sizes: 2 ml to 50 ml (most commonly used manufacturers).
  • Accuracy: ± 5% system accuracy (pump and set combined).
  • Occlusion Pressure: 100-1500 mmHg configurable (10 mmHg increments). Max actuator force 50N (5 Kgf).
  • Battery: 9V alkaline, IEC 6LR61 type (or Lithium for extended life).
  • Battery Operation: 7 full deliveries depending on infusion and setup parameters.
  • Indicators: 4 Line LCD display (122 x 32 pixels), Dual color operation LED (Green for running, Red for stop/programming/alarm).
  • Alarms: Displays messages, sounds an audible alarm, and lights the red LED for conditions like Occlusion, Syringe Empty, End Program, Near End, Low Battery, Pump Paused Too Long, Syringe Displaced, and End Battery.
  • Dimensions: 169 x 53 x 23 mm.
  • Classification: Type CF Equipment (degree of protection against electrical shock).
  • Housing: ABS (fire retardant).
  • Weight: 210 gr. without battery.
  • Electrical Safety: Complies with EN 60601-1, IEC 60601-2-24, IEC 60601-1-4, UL 60601-1, and CAN/CSA C22.2 No 601.1.
  • Standards: Manufactured in accordance with ISO 9001 and ISO 13485. CE marked (Medical Devices Directive 93/42/EEC).
  • EMC: Complies with IEC 60601-1-2 (EMC).
  • Non-Operating Conditions (Transportation and Storage): Temperature: -25°C to 55°C, Humidity: 5% to 100% R.H. (non-condensing), Air pressure: 48 kPa to 110 kPa.
  • Operating Conditions: Temperature: +15°C to +45°C, Humidity: 20% to 85% R.H. at +40°C (non-condensing), Air pressure: 70 kPa to 110 kPa.

Usage Features:

  • Display: LCD with backlight, activated by any key press.
  • Operation LED: Green for infusing, Red for stop or alarm.
  • Keys:
    • ON/OFF: Switches pump on and off.
    • NO/STOP: Returns to previous step, stops pump.
    • YES/START: Confirms choices, starts infusion.
    • Up/Down Arrows: Scrolls between options.
    • Info Key: Shows technical data and battery status. Long press locks/unlocks keypad.
    • Forward/Backward Keys: Navigates through menus.
  • Syringe Selection: Recognizes most common syringes (2ml to 50ml). Luer lock syringes are recommended. Default syringe brands can be disabled by technicians for homecare use to prevent incorrect selection.
  • Priming: Manual priming to remove air from syringe and extension set.
  • Pre-Loading & Syringe Placement: Actuator moves to the start position. Syringe graphic on screen flashes at barrel, ear/collar, and plunger to indicate sensor status.
  • Purge Option: Eliminates slack and reduces start-up time (max 0.5 ml).
  • Program Lock: Prevents alteration of default duration and infusion rate during setup.
  • KVO (Keep Vein Open) Operation: Configurable to deliver a KVO infusion at End Program to maintain IV access patency.
  • Infusion Rate Titration: Allows patient, carer, or clinician to adjust the rate within pre-set maximum and minimum limits during infusion. Requires confirmation with YES key press. A maximum rate limit can be set by technicians to prevent accidental over-infusions.

Maintenance Features:

  • Service and Unscheduled Repairs: Must be performed by the T34 distributor, approved service representative, or qualified biomedical technicians. Unauthorized modifications void warranty.
  • Annual Maintenance and Calibration: Recommended to send the pump to a service center annually.
  • Monthly Cleaning: Clean the lead screw thread and guiding rods with a small dry brush to remove debris.
  • Between Patients: Change the battery. Clean the unit with a lint-free cloth lightly dampened with warm water and a mild detergent, disinfectant, or 10% bleach solution. Always turn off the pump and remove the battery before cleaning.
  • Cleaning Precautions: Do not use chemicals like Xylene, Acetone, or similar solvents. Do not soak or immerse the pump in any liquid.
  • Storage: For extended storage, clean the pump, remove the battery, and store in a clean, dry atmosphere at room temperature, preferably in original packaging.

Patient Training:

Healthcare providers are responsible for assessing patient suitability, providing comprehensive training on pump use and care, handling alarms and minor troubleshooting, and offering contact numbers for support. Training should cover keypad functions, starting/stopping infusions, and adapting pump use for daily activities like bathing and sleeping. A patient guide is provided for this purpose.

CME NIKI T34 Specifications

General IconGeneral
BrandCME
ModelNIKI T34
CategoryWater Pump
LanguageEnglish

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