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Summary of Contents for Droper FIELD 1000
- Page 1 INSTRUCTIONS FOR USE DROPER FIELD 1000 ® MECHANICAL PRESSURE INFUSER PROMOVET sarl ZAC de la Route de Beauraing, 1 08600 GIVET (France) contact @ promovet.fr...
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Page 2: Table Of Contents
Table of contents Description of the Droper Field Purpose Performances Warnings Materiovigilance Infusion : choice of line and operating mode Transfusion : operating mode Operating issues Cleaning / Disinfection Periodic inspection Conditions of transport, storage and use Warranty Lifetime and Disposal... -
Page 3: Description Of The Droper Field
1. DESCRIPTION OF THE DROPER FIELD Instructions for use - Version 2 3/15... -
Page 4: Purpose
Air embolism : the Droper Field working by pressurising the infusion bags, there is a risk of residual air injection to the patient, as with other infusion or transfusion devices working under pressure, like the pressure cuffs. -
Page 5: Materiovigilance
5. MATERIOVIGILANCE Any incident during the use of the Droper Field must be reported to the manufacturer whose details appear at the end of these instructions for use, as well as to the National Agency for the Safety of Medicines and Health Products (ANSM) on materiovigilance@ansm.sante.fr. - Page 6 Placing the infusion / transfusion bag in the device With the cover fully open, position the previously perforated bag on the plate. If the bag model allows it, use the fixing hook on the plate. Otherwise, with your hand, hold this pocket in place to prevent it from sliding forward when closing the system.
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Page 7: Infusion : Choice Of Line And Operating Mode
Once administration is completed, close the roller clamp of the infusion / transfusion line, open the Droper Field using the same method as described in point Opening the cover, and remove the empty bag from the device. Handle then the flexible bag and the infusion / transfusion lines wastes as when with classical delivery by gravity or with pressure infusion cuffs. - Page 8 2. Insert the spike into the infusion bag like for a classic infusion Place the bag in the horizontally arranged Droper Field 4. Close the Droper Field 5. Install the Droper Field on its back side by placing it vertically Open the infusion line roller clamp 7.
- Page 9 1. Close the infusion line roller clamp 2. Insert the spike into the infusion bag like for a classic infusion 3. Place the bag in the horizontally arranged Droper Field 4. Close the Droper Field 5. Fill the drip chamber halfway by pinching it between thumb and index finger 6.
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Page 10: Transfusion : Operating Mode
Transfusion : for residential practice only, with classic transfusion lines by hanging the Droper Field to a pole by the mean of the hanging ring on the Droper Field rear side. The drip chamber MUST stay in a vertical position, with... -
Page 11: Operating Issues
- if the drip chamber is not used - by the absence of blood reflux in the tubing if the Droper Field is disarmed and installed at the patient’s level or even below. -
Page 12: Cleaning / Disinfection
Disinfection The Droper Field does not come into direct contact with the patient and therefore does not need to be disinfected before use. The Droper Field is a "non-critical" medical device (low infectious risk). It must be carefully cleaned, disinfected if necessary and dried. -
Page 13: Periodic Inspection
Place a 1,000 ml bag of NaCl 0.9%, the design of which corresponds to the plate's surface in the Droper Field and introduce the spike of a classic infusion line without a catheter or needle, and with the roller clamp in the OFF position. Open the infusion line into a recipient placed at the same height as the device and measure the time required to drain the bag. -
Page 14: Lifetime And Disposal
14. LIFETIME and DISPOSAL The Droper Field was designed to operate for a period of 2 years, calculated based on a daily usage rate of 8 infusions per day from its commissioning date and for a period of 10 years from its date of manufacture. -
Page 15: Useful Contacts
17. USEFUL CONTACTS Sales Department and After-Sales Service: Promovet sarl 1 ZAC de la Route de Beauraing, 1 08600 GIVET (France) Tél. :+ 33 (0)3 24 42 15 71 E-mail : contact@promovet.fr Website : www.dro per.be 2854 Year of first commissioning : 2015 Instructions for use v.2 -02/2021 Instructions for use - Version 2 15/15...
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