Light-Protected Hard-Shell Infusion Pump

A light-protected elastomeric infusion pump with a hard shell is a single-use pump that runs without electricity, for continuous infusion of light-sensitive cytotoxic drugs. The reservoir sits in a light-blocking rigid bottle, and the line and the accessories are protected from light too, so no separate sleeve is fitted. The drug flows through a flow restrictor tube at a constant rate.

Manufacturer: Tuoren MedicalClass IIa3 SUT codes10 models

This page is intended for healthcare professionals.

For patients and families: home chemo pump guide

Light-Protected Hard-Shell Infusion Pump

At a glance

Fill volume
100/275 ml
by model
Flow rate
1.5/2/4/5 ml/h
by model
Filter
1.2/5.0 µm
by model
Line drawing of the pump: the elastic reservoir inside the rigid bottle, then along the tubing the filling port with check valve and its protective cap, the clamp, the flow restrictor, the medicine filter and the connector with its protector cap. rigid bottle elastic reservoir filling port with check valve protective cap medicine filter connector tubing clamp flow restrictor connector protector cap Line drawing of the pump: the elastic reservoir inside the rigid bottle, then along the tubing the filling port with check valve and its protective cap, the clamp, the flow restrictor, the medicine filter and the connector with its protector cap. rigid bottle elastic reservoir protective cap filling port with check valve clamp tubing flow restrictor medicine filter connector connector protector cap
Part names as in the manufacturer's instructions for use.
Flow accuracy
Within plus minus 10 per cent of the nominal rate
Medicine filter
A 1.2 or 5.0 micrometre filter at the line outlet; the L12 and L50 suffix of the catalogue number says which
On the line
Total length at least 110 cm, with a check-valve filling port, a clamp and a patient-end cap
Filling and priming
Filled with 10 ml of diluent first and primed; priming takes about half a minute and stays within three minutes. Infusion is started 0 to 8 hours after filling
Delivered and residual volume
At least 90 per cent of the nominal volume is delivered; at most 3 ml stays behind, tubing included

A single-use elastomeric infusion pump with a rigid body whose reservoir, line and accessories are all protected from light: 100 and 275 ml, fixed rates of 1.5 to 5 ml/h.

In which cases?

  • An infusion that continues at home with a light-sensitive cytotoxic drug.
  • Infusions where the line and the accessories have to be covered as well, with no separate sleeve to fit.
  • A long infusion that runs in daylit chairs and corridors.
  • Regimens whose duration is set by the bottle volume and the flow rate: about twenty five hours at 100 ml and 4 ml/h, about seven and a half days at 275 ml and 1.5 ml/h.

What makes it different?

  • The light protection is part of the pump the reservoir, the line and the accessories are covered together.
  • The type is designed to hold the change in the properties of drugs used in cancer treatment to a minimum.
  • Ten items on the rigid body 100 and 275 ml, at four rates from 1.5 to 5 ml/h.

What changes the flow rate?

FactorWhat the instructions for use say
TemperatureThe stated rate was measured at room temperature (23 ± 2 °C) with water for injection, and temperature can change it. A refrigerated pump is brought to room temperature before use; a large-volume pump can take up to 12 hours.
HeightWith the pump body above the flow restrictor, pressure and rate go up; below it, both go down. The hanging height relative to the patient can also change the rate.
Drug and diluentThe nominal rate holds with 5 per cent dextrose or 0.9 per cent sodium chloride as the diluent. The drug's composition and concentration, the fluid's viscosity and the injection pressure can change it.
Fill volumeFilling below or above the nominal volume generally makes the rate inaccurate; overfilling can also break the reservoir.
Time from filling to startInfusion is preferably started 0 to 8 hours after filling; a filled pump kept longer than 8 hours can take longer to deliver.
First hoursIn the first 1 to 2 hours of infusion the rate can be faster than stated.

Source: the manufacturer's instructions for use.

Give this to your patient

A patient going home with the pump can scan this code with a phone to open our home chemo pump guide. At discharge you can also print the A5 patient card and fill it in together.

melekirmak.com/en/knowledge-centre/home-chemo-pump-guide.html

Models

Fill volume (ml)Flow rate (ml/h)Filter (µm)SUT codeModel
100 ml bottle
10021.2OR1810NUCBI10020L12
10025.0OR1810NUCBI10020L50
10041.2OR1810NUCBI10040L12
10045.0OR1810NUCBI10040L50
275 ml bottle
2751.51.2OR1830NUCBI27515L12
2751.55.0OR1830NUCBI27515L50
27521.2OR1820NUCBI27520L12
27525.0OR1820NUCBI27520L50
27551.2OR1810NUCBI27550L12
27555.0OR1810NUCBI27550L50

A catalogue number writes the type, the volume, the flow rate and the filter pore together: NUCBI10040L12 is the light-protected rigid body at 100 ml, 4 ml/h and a 1.2 micrometre filter. Ten items are supplied.

Frequently asked questions

Which drugs need a light-protected pump?

The drug's own instructions for use and its label say whether it must be protected from light, and the hospital pharmacy keeps the list. For such drugs this pump protects the reservoir, the line and the accessories together.

What is the difference between the hard-shell and the soft-shell light-protected pump?

The light protection is the same on both and covers the reservoir, the line and the accessories together. On the hard-shell type the reservoir sits in a light-blocking rigid bottle. On the soft-shell type the outer body takes less room in storage and in transport, and the infused volume is followed on the body of the pump.

Is a separate light-protective sleeve needed on this pump?

No sleeve is fitted on this pump, because the reservoir, the line and the accessories are protected together. A light-protective sleeve covers a bag, a syringe or a line.

What does the price of the light-protected infusion pump depend on?

The price depends on the model, volume and quantity. The volume (100 and 275 ml), the flow rate and the filter pore make up the catalogue number. Use the Request an export quote button in the Export and Bulk Orders section of this page for a fast quote.

What does the light protection cover?

The reservoir, the tubing and the accessories are protected together, so no separate sleeve is fitted for the infusion.

What sizes does the light-protected hard-shell pump come in, in volume and flow rate?

Bottles of 100 ml and 275 ml, at 1.5, 2, 4 and 5 ml/h, one fixed rate per item. The models table gives the volume, the rate and the filter pore of every catalogue number.

Can the patient shower with the pump?

The instructions for use do not cover showering; they say only that cleaning agents such as soapy water or alcohol must not touch the filter, which can then leak. Our patient guide tells the patient to shower only if the nurse allows it, to keep the pump in a plastic bag outside the shower and never to put the pump or the line in water.

What does the team do if the pump leaks?

If the pump body or one of its parts breaks or leaks, the instructions say to stop the infusion by clamping the tubing, inform the responsible caregiver and replace the pump if necessary. Our patient guide tells the patient to close the clamp, put on gloves, use the spill kit the hospital gave them and call the hospital straight away. The spilled drug is cleaned up under your unit's own spill procedure.

What if the pump finishes early or late?

The mean rate stays within plus minus 10 per cent of the nominal rate and can be faster than stated in the first 1 to 2 hours. Temperature, the height of the pump body against the flow restrictor, the drug's composition, concentration and viscosity, a fill other than the nominal volume and a filled pump kept longer than 8 hours before the start can all change the time. At the end at most 3 ml stays behind, tubing included. Our patient guide tells the patient to call the hospital if the pump finishes much earlier than they were told, or is still full well after the expected time.

Can the pump be refilled or used again?

No. The pump is for single use: it is not used again and not re-sterilised. The instructions warn that reuse or re-sterilisation can make the flow unpredictable and cause infection in the patient. After use it is discarded under local regulations.

How is the pump stored before use?

In a cool, dry and well-ventilated place, protected from moisture and direct sunlight. It is not frozen, because freezing can damage the tubing and the plastic parts. Shelf life is 5 years. A refrigerated pump is brought to room temperature before use; a large-volume pump can take up to 12 hours, and dew inside the case meanwhile does not affect its use.

Who supplies light-protected elastomeric pumps in Türkiye (Turkey), and can I order in bulk or for export?

Melekırmak, an Istanbul-based medical device distributor founded in 2006, supplies light-protected elastomeric pumps to hospitals across Türkiye and answers international enquiries. Bulk and institutional orders are quoted case by case. For an export order, state the volume (100 or 275 ml), the flow rate and the quantity, together with the destination country, and use the Request an export quote button in the Export and Bulk Orders section of this page. Availability, documentation and lead times in your country are confirmed in the reply.

Technical data

Manufacturer
Tuoren Medical
Class
IIa
SUT codes
OR1810OR1830OR1820
Sterility and shelf life
Sterilised with ethylene oxide, single use, shelf life 60 months
Bottle
A light-blocking rigid bottle holding the elastomeric reservoir, with a protective cap
Light protection
The reservoir, the tubing and the accessories are protected together
Flow control
A micro flow restrictor tube; no rate dial and no bolus button
Material
Silicone, medical PVC and ABS; latex free and DEHP free

Export and Bulk Orders

Based in Istanbul, Türkiye, we supply hospitals nationwide and answer international enquiries. Ask us about availability, documentation and lead times in your country.

Request an export quote

Distributing Light-Protected Hard-Shell Infusion Pump in Türkiye

Registration, the first cases and nationwide supply are handled by one team.