ACCU-CHEK Solo Micropump System Instruction Manual

: June 10, 2024
: ACCU-CHEK

Table of Contents

ACCU-CHEK Solo Micropump System
AccuChek Solo Reservoir Assembly
Intended Use
Package Contents and Storage Conditions
Component Overview
Before You Get Started
Preparing and Filling the Reservoir
Instructions for use
Package Contents and Storage Conditions
Component Overview
Preparing and Filling the Reservoir
Disposal
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

ACCU-CHEK Solo Micropump System

AccuChek Solo Reservoir Assembly

The Accu-Chek Solo reservoir assembly is a part of the micropump system that is used to deliver insulin to the body. It includes a filling aid, a handle for the piston rod, and a sterile container for holding insulin.

Intended Use

The Accu-Chek Solo reservoir assembly is intended to be used with the Accu- Chek Solo pump base to deliver insulin to the body.

Package Contents and Storage Conditions

The package contains a reservoir assembly, a filling aid, a handle for the piston rod, a protective film for the battery, a reservoir needle, and a piston rod. The product should be stored in the outer packaging and away from small children and vulnerable persons.

Component Overview

A Reservoir
B Filling aid (blue)
C Handle for the piston rod (blue)
D Protective film for battery (orange)
E Reservoir needle
F Piston rod

Do not touch the needle of the filling aid or the reservoir needle. This product contains pointed and sharp-edged parts that may cause injury.

Before You Get Started

Read the instructions for use and the User’s Manual of the Accu-Chek Solo micropump system before using the product. Take note of all warnings, information, and notes required for the safe and proper use of the micropump system. The product is sterile, single-use, and can be used for up to 4 days. Replace the reservoir immediately if it has been exposed to mechanical stress. Use and store insulin in compliance with the manufacturer’s specifications, and check the Use by date of the insulin before use.

Preparing and Filling the Reservoir

The micropump system is intended for use with U100 insulin only. Follow the steps below to prepare and fill the reservoir:

Wash your hands and dry them thoroughly. Disinfect the top of the insulin vial with a sterile alcohol wipe. Allow the disinfected top of the insulin vial to dry.
Slowly and carefully pull out the battery’s protective film downwards in the direction of the arrow to activate the battery.
Hold the round part of the handle firmly and pull it downwards in the direction of the arrow to fill the reservoir with air. Fill the reservoir with the volume of air that you later want to fill with insulin.
Place the insulin vial on a flat and solid surface (for example, a tabletop) and hold it firmly. Place the filling aid onto the vial. Push the filling aid downwards until you hear a click into place. Press the handle all the way down in the direction of the arrow to fill the insulin vial with air.

Once the insulin vial is filled with air, turn it upside down and draw the required amount of insulin into the reservoir. Remove any air bubbles from the reservoir before attaching it to the micropump system. For more information on handling steps, refer to the animated video available in the diabetes manager app under Help.

Instructions for use

Accu‑Chek Solo Reservoir Assembly Intended Use

The Accu‑Chek Solo reservoir assembly (including the filling aid and the handle for the piston rod) is a part of the micropump in addition to the Accu‑Chek Solo pump base. The reservoir is a sterile container for holding the insulin that the micropump delivers to the body.

Package Contents and Storage Conditions

See outer packaging. You can find the symbol explanations in the User’s Manual of the Accu‑Chek Solo micropump system.

Component Overview

ACCU-CHEK-Solo-Micropump-System-
FIG-1

A Reservoir
B Filling aid (blue)
C Handle for the piston rod (blue)
D Protective film for battery (orange)
E Reservoir needle
F Piston rod

Do not touch the needle of the filling aid (B) or the reservoir needle (E). This product contains pointed and sharp-edged parts that may cause injury. Keep pointed and sharp-edged parts away from small children and vulnerable persons.

WARNING

Risk of suffocation
This product contains small parts that may be swallowed. Keep small parts away from small children and vulnerable persons.

Before You Get Started Read these instructions for use and the instructions in the User’s Manual of the Accu‑Chek Solo micropump system. Take particular note of all warnings, information, and notes required for the safe and proper use of the micropump system. This is a sterile, single-use product that has been sterilized with ethylene oxide. You can use the reservoir assembly for up to 4 days. Replace the reservoir immediately if it has been exposed to mechanical stress (for example, if it was hit or dropped). Use and store the insulin in compliance with the manufacturer’s specifications. Check the Use by date of the insulin before use.

Preparing and Filling the Reservoir

WARNING
Risk of hypoglycemia (low blood glucose level) and hyperglycemia (high blood glucose level) The micropump system is intended for use with U100 insulin. Use U100 insulin only.

To prepare the reservoir, you need a rapid-acting U100 insulin and disinfectant, such as a sterile alcohol wipe. Ensure that the reservoir and the insulin are at room temperature during filling. To replace a component of the micropump system, always use the Replace menu on the diabetes manager. To view an animated video of the handling steps, tap Help on the diabetes manager.

Wash your hands and dry them thoroughly. Disinfect the top of the insulin vial with a sterile alcohol wipe. Allow the disinfected top of the insulin vial to dry.
Slowly and carefully pull out the battery’s protective film (D) downwards in the direction of the arrow to activate the battery.
Hold the round part of the handle (C) firmly and pull it downwards in the direction of the arrow in order to fill reservoir (A) with air. Fill the reservoir with the volume of air that you later want to fill with insulin.
Place the insulin vial on a flat and solid surface (for example, a tabletop) and hold it firmly. Place the filling aid (B) onto the vial. Push the filling aid downwards until you hear it click into place. Press the handle all the way down in the direction of the arrow to fill the insulin vial with air.
Turn the reservoir assembly together with the insulin vial upside down so that the vial is above the reservoir.
Slowly pull the handle downwards in the direction of the arrow to fill the reservoir with insulin. Try to ensure that as few air bubbles as possible form in the reservoir. Fill the reservoir with at least 80 U (0.8 ml) of insulin but with no more than 200 U (2.0 ml) of insulin.
Check the reservoir from several angles to make sure that there are as few air bubbles as possible in the reservoir. To release air bubbles from the reservoir, hold the reservoir at an angle. Gently flick your finger against the reservoir several times.
Slowly push the handle upwards in the direction of arrow 1 to remove air bubbles from the reservoir. Slowly pull the handle downwards in the direction of arrow 2 until the reservoir is filled with the required amount of insulin again. An air bubble with the size of the number 0 printed on the reservoir scale corresponds to an insulin quantity of 0.4 U. Air bubbles can cause incorrect insulin delivery.
Remove the filling aid from the reservoir by pulling it off laterally in the direction of the arrow. Compress the handle on the ribbed surface 1 and then remove the handle laterally from the piston rod (F) 2.
Align the piston rod (F) of the filled reservoir such that you can insert it into the piston rod opening of the pump base. Push the filled reservoir onto the pump base until both parts are tightly connected.
When both components are connected to each other correctly and the battery is activated, the micropump issues the Start sound. If this sound is not issued, check whether the battery is activated and repeat step 10.
Make sure that there is no gap between the reservoir and the pump base. The pump base and the reservoir are only connected correctly when the Start sound is issued and when the pump base and the reservoir are seamlessly connected.

Disposal

WARNING
Risk of infection components carries a risk of infection. Dispose of the reservoir assembly, the filling aid, and the handle for the piston rod safely, in such a way that no third party can injure themselves. Dispose of used products according to local regulations. For information about correct disposal, contact your local council or authority.

Distributed in the United Kingdom by

Roche Diabetes Care Limited

Charles Avenue, Burgess Hill
West Sussex, RH15 9RY, United Kingdom
Accu‑Chek Pump Careline 1):
UK Freephone number: 0800 731 22 91
ROI Freephone number: 1 800 88 23 51
1. calls may be recorded for training purposes
Some mobile operators may charge for calls to these numbers. burgesshill.insulinpumps@roche.com. www.accu-chek.co.uk, www.accu-chek.ie.