ORBIT Mylife Infusion Sets Instruction Manual
- June 9, 2024
- Orbit
Table of Contents
ORBIT Mylife Infusion Sets
Product Information
The infusion set is a medical device used for delivering medication or fluids, such as insulin, through the skin and into the body. The set consists of a tubing assembly that connects the medication to the cannula base, which is inserted under the skin. The tubing may vary in length, and the cannula base may vary in size depending on the patient’s needs. The infusion set is sterilized using ethylene oxide.
Product Usage Instructions
- Consult the instructions for use prior to using the infusion set.
- Dispose of the infusion set according to your healthcare professional’s advice and government regulations for needle/sharps disposal.
- After connection of the tubing to the infusion pump, remove all air by priming the tubing assembly according to your pump manufacturer’s priming instructions.
- Rotate the tubing left and right, at least one full turn in each direction, while pulling upward on cap to ensure the tubing cap is fully engaged and the fluid path is opened.
- After proper connection of the tubing to the cannula base, prime the newly inserted cannula with medication by following the priming volumes indicated below. Failure to do so may result in missed medication.
Priming Volumes
| Tubing Assembly Length | Priming Volume (U-100 Insulin) |
|---|---|
| 45 cm (18 inch) | 11 units* (0.11 ml) |
| 60 cm (24 inch) | 14 units* (0.14 ml) |
| 75 cm (30 inch) | 17 units* (0.17 ml) |
| 105 cm (42 inch) | 25 units* (0.25 ml) |
| Cannula Size with Base | Priming Volume (U-100 Insulin) |
| --- | --- |
| 5.5 mm | 0.2* units (0.002 ml) |
| 8.5 mm | 0.2* units (0.002 ml) |
| 8 mm (27G) | 0.3* units (0.003 ml) |
Volumes are approximate.
SAFETY SYMBOLS
- Sterilized using ethylene oxide
- Single sterile barrier system. Sterilized using ethylene oxide.
- Consult instructions for use
- Non-pyrogenic
- Do not re-use
- Do not use if package is damaged
- Medical device
- Contains phthalates
- Caution
- Catalogue number
- Batch Code
- Use by date
- Date of manufacture
- Unique Device Identifier
- Manufacturer
- Keep dry
- Keep away from sunlight
- Distributor
Indications for Use
Orbit®micro Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.
Contraindications
Orbit®micro Infusion Sets are not intended for intravenous (IV) infusion or the infusion of blood or blood products
Warnings
- Follow the instructions for use of Orbit®micro Infusion Set and your infusion pump. Use the Orbit®micro Infusion Set with your infusion pump only after consultation with your physician and/or health care professional.
- Avoid infections. Do not use the Orbit®micro Infusion Set if the individual packaging is damaged, has already been opened, or if the cannula protector is missing. Do not use the Orbit®micro Infusion Sets after the expiration date on the packaging. If these instructions are not followed, there is a risk of infection. If you have any signs or symptoms of an infusion site infection, im-mediately replace your infusion set and contact your physician for treatment.
- Single use only! Do not re-use, re-insert and/or re-sterilize the cannula. Re-use and/or re-insertion may cause damage to the cannula and lead to site irritation, infection, and/or inaccurate medication delivery. Re-sterilization may affect the integrity of the Orbit®micro Infusion Set.
- Do not use Orbit®micro Infusion Set for longer than 48 hours. Longer use may lead to site irritation, infection, and/or inac-curate delivery of medication. Change your infusion site if it be-comes itchy, red, inflamed or if you have an unexplained high blood sugar reading.
- Ensure correct delivery of medication. Before insertion, check that the tubing allows free flow of medication, following the priming instructions of your infusion pump.
- This will prevent incorrect dosage caused by air in the fluid path or a clogged tubing. Use a new infusion set if priming is not successful. Never prime the infusion set tubing or attempt to free a blocked line while the tubing is connected to the inserted cannula base. You may accidentally deliver too much medication.
- Replace the Orbit®micro Infusion Set if the tape becomes loose or if the cannula becomes fully or partially dislodged from the skin. Check frequently to make sure the steel cannula remains firmly in place. It must be completely inserted at all times to receive the full amount of medication.
- For insulin therapy, 2 – 3 hours after insertion, a blood glucose test has to be performed to ensure adequate delivery of insulin. Therefore, do not change the Orbit®micro Infusion Set immedi-ately before bedtime.
- Develop a conventional insulin injection or medication replace-ment plan with your healthcare professional if any part of the infusion system fails or system supplies are depleted.
- If these instructions are not followed, there is a risk of incorrect delivery of medication. Seek immediate medical assistance if you have any health concern.
- Avoid bending or breaking the steel cannula. A broken steel cannula can remain stuck in the body or remain completely un-der the skin and may require surgical removal.
- For Healthcare Professionals: Avoid recapping or destroy-ing the used steel cannula. Recapping or destroying the used steel cannula can lead to accidental sharps injuries which can transmit serious infections. Healthcare professionals must fol-low the specific directions of local regulations for healthcare professionals using infusion sets, including directions for re-capping and disposing. Seek immediate medical assistance if you receive a sharps injury.
Caution (please note)
- Orbit®micro Infusion Sets are designed to work with continuous subcutaneous infusion pumps and pump reservoirs with stand-ard luer lock connection. Follow the instructions for use of your infusion pump and/or reservoir.
- Change the infusion site regularly in accordance with your healthcare professional’s recommendations. If this is not done, you are at risk for infusion site infection, issues with medication delivery, insulin resistance, and/or lipohypertrophy.
- Consult your healthcare professional to choose the correct cannula length. Your healthcare professional can provide re- commendations regarding the specific type of infusion set that is best matched to your needs to ensure accurate delivery of medication.
- Do not put perfumes, deodorants or insect repellent on the Orbit®micro Infusion Set as this may affect the integrity of the infusion set. Protect the product from sunlight and heat. Store Orbit®micro Infusion Sets in a dry location at room temperature and avoid high humidity.
Disposal
Dispose of the infusion sets according to your healthcare profes-sional’s
advice and government regulations for needle/sharps dis-posal.
Instruction for Use
Choose an infusion site away from the
waistline, bones, scar tissue, belly button and recent infusion sites. Wash
hands tho- roughly and clean the infusion site according to the instructions
provided by your healthcare professional. Prepare the infusion site by
removing excess hair. We recommend to wipe the site in a cir-cular outward
motion, using a 70 % isopropyl alcohol pad, and let it air dry. Make sure the
infusion site is completely dry before proceeding. The use of 70 % isopropyl
alcohol pads supports the optimal adhesion of the tape. The use of other
alcohol pads may result in premature tape failure and interruption of
medication de-livery.
After connection of the tubing to the infusion pump make sure all air is removed by priming the tubing assembly according to your pump manufacturer’s priming instructions.
Remove tape
backing and be careful not to touch adhesive. Care-fully remove the cannula
protector from the cannula.
Stabilize the
infusion site and insert the Orbit®micro cannula with an angle of 90°. For
insertion of the cannula, you may also use the Orbit®Inserter from Ypsomed.
For maximum adhesion, press the tape to your skin and run your fingers over
the adhesive for some seconds.
Hold tape
against skin with two fingers of one hand. Gently squeeze tabs and remove the
introducer cap carefully with the other hand.
Attach the tubing cap straight to the cannula base. One to two
clicks should be heard.
Rotate the tubing left and right, at least one full turn in each direction,
while pulling upward on cap to ensure the tubing cap is fully engaged and the
fluid path is opened.
After proper connection of the tubing to the cannula base, the newly inserted
cannula has to be filled with medication by prim-ing the cannula head with the
priming volumes indicated below. Failure to do so results in missed
medication.
Disconnection
To disconnect the tubing, gently squeeze tabs on both sides of the tubing cap
and remove it. There is no need to cover the infusion base as the septum
provides closure.
Before you reconnect the tubing cap, remove the air bubbles from the tubing
according to the priming instructions of your infusion pump and swab septum
with a 70 % isopropyl alcohol pad. Proper swabbing of the septum reduces germs
ingress into the fluid path. To reconnect, follow instructions in figures 10 –
12.
Monitor your blood glucose levels when disconnected and about 2 – 3 hours
after reconnecting.
Priming volume for the tubing assembly (volumes are approximate):
- 45 cm (18 inch): 11 units* (0.11 ml)
- 60 cm (24 inch): 14 units* (0.14 ml)
- 75 cm (30 inch): 17 units* (0.17 ml)
- 105 cm (42 inch): 25 units* (0.25 ml)
Priming volume for the cannula part (head) (volumes are approximate):
- 5.5 mm cannula with base: 0.2* units (0.002 ml)
- 8.5 mm cannula with base: 0.2* units (0.002 ml)
- 8 mm (27G) cannula with base: 0.3* units (0.003 ml)
U-100 Insulin
Orbit®micro products are available as a whole infusion set and as cannula
(head) only.
Ypsomed Ltd.
1 Park Court // Riccall Road // Escrick // North Yorkshire // YO19 6ED
Customer Care : 0344 856 7820
[email protected]
Infirst Healthcare Inc.
8 Church Ln // Westport, CT 06880 Service-Hotline:
866-948-5888
Ypsomed AG Brunnmattstrasse 6 CH-3401 Burgdorf Switzerland
www.mylife-diabetescare.com/orbit