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.