TECHNICAL DATA SHEET 20 \ 02 \ 2020
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COD ST.60.XX HEALTHPICC® Rev.0
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PLAN 1 HEALTH, A POLYMEDICURE COMPANY GROUP
HEALTHPICC®
ISSUED (RT) VERIFIED BY (PMIN, PSI) APPROVED (RGQ)
DATE (Date)
SIGNATURE
ALL73.06 - Rev.00 - 11.02.2020
TECHNICAL DATA SHEET 20-02-2020
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GENERAL INFORMATION
Effective length (L)
Intended use
HEALTHPICC is a polyurethane catheter up to 55cm long, indicated for peripheral implantation for central use for
short- and long-term use.
It allows the intravenous administration of fluids and drugs compatible with central positioning and also allows the
collection of blood samples.
It allows the infusion of high-pressure contrast media (starting pressure> = a 300 PSI at 37 ° C with a viscosity of
the medium equal to 12cp).
It is a Central Catheter suitable for the infusion of:
• drugs and other substances, even those that require this type of central access, also with osmolarity> 800
mOsm / l, pH <5 and pH> 9;
• blistering and irritating drugs for the endothelium (INS guidelines 2016)
Device Description
Catheter
• All catheters allow high flow Power infusions as indicated in the table, at conditions of 300 psi, 12 cP and 37 °
C.
• It is possible to choose the type of venous access:
1. Proximal reverse tapering without steps and well distributed in its length with codes 201.60.10.XX
2. No Reverse Tapering with codes 201.65.10.XX
• Polyurethane catheter of the latest generation totally biocompatible in the long term marked in all its length.
• The extension tubes are 9 cm long and report the maximum performance tolerated by that lumen.
• The double lumens have an internal conformation such as symmetrical geometry (see Fig. 1) and allow Power
infusions on each of them, with limits indicated on the tube and on the respective clamps.
CONFIDENTIAL INFORMATION OF PLAN 1 HEALTH SRL
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These performances are shown in the table next to each code and description.
• The triple lumen allows power infusion only in the central lumen as shown on it.
• Clamp closure on each lumen, with indication of the diameter and the maximum achievable flow.
• Pre-assembled metal stylet facilitates the advancement of the catheter in the vascular bed. The mandrel in its
proximal part is adjustable in length and has a screw-type safety system for its fixing (chuck-mandrel) with T-
connector for lateral connection.
Characteristics of the HEALTHPICC catheter
• Long-term totally biocompatible polyurethane catheters made of
radiopaque polyurethane such as Tecothane® which confers high
mechanical properties.
Material and
• Latest generation thermosensitive, able to be softer and more comfortable
Biocompatibility inside the human body.
• Marked along its entire length with a dot every cm and a number every
5cm
• Integrated extensions about 9 cm in length and marked with the maximum
performance that that lamp can withstand
• Without steps and well distributed in its extension, it avoids variations in
Reverse Tapering flow inside the vessel
• Promotes haemostasis from the insertion site
• Helps pressure distribution during high flow infusions
Microintroduction kit
• 4cm thin wall echogenic needle for paediatric or 7cm sizes.
• Microintroducer / Dilator of variable length and diameter according to the catheter to be used. The dimensions
are shown in the Codes and Descriptions Table.
• 40cm nitinol straight guide.
CONFIDENTIAL INFORMATION OF PLAN 1 HEALTH SRL
ALL73.06 -Rev. 00 - 11.02.2020
TECHNICAL DATA SHEET 20-02-2020
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Features of the microintroduction kit
• Thin-walled and sharp steel needle for perfect passage through fabrics
• Length equal to 4 cm for the 3Fr and 4Fr double lumen sizes, ideal for
paediatric patients or patients with superficial veins. Length of 7 cm for the
Introducer needle other measures.
• Echogenic tip with surface finish in order to allow better visualization
under ultrasound guidance
• A practical arrow on the handle allows a quick identification of the
direction of the cutting edge
• The micro-introduction system is tapered at the tip and in the passage area
of the two components
• The length varies according to the catheter and codes, and are shown in
Micro-introducer / Dilator the table below
• Flexible and at the same time resistant so as not to be damaged during the
passage of fabrics
• A practical locking system fixes the two components together
• Nitinol straight guide with floppy tip and no shape memory (able to
recover its straight shape even after repeated deformation attempts)
Drive straight
• 40cm length suitable for insertions of this type, limiting the risk of
contamination
THE HEALTHPICC KIT consists of:
• 21G introducer needle
• Peel away introducer
• Grip lok® type sutureless fastening system
• Guide in nitinol
• 11 blade scalpel with integrated safety system
• Sterile paper meter
• 4 adhesive labels for traceability
• Instructions for Use (IFU)
• Neutral pressure valves MicroClave®
• Patient Card.
The HEALTHPICC product is:
• compatible with nuclear magnetic resonance scans
• LATEX FREE
• DEHP free
• Sterilized with EtO gas (Ethylene oxide).
The product and / or the product packaging does not contain components of animal origin.
CONFIDENTIAL INFORMATION OF PLAN 1 HEALTH SRL
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SKU / Catalog # # of Lumens Catheter Size (Fr) Catheter Catheter Effective Max Power Reverse Inner Guideware Guidewire Box
Material Length Length Flow Rate Taper Diameter Material Length Quantity
(cm) (mm) (mL / sec) Diameter (mm) (cm)
(Fr)
201.60.10.13 1 3 WHILE 450 450 2 4 1.15 nitinol 40 1
201.60.10.14 1 4 WHILE 550 550 5 6 1.42 nitinol 40 1
201.60.10.15 1 5 WHILE 550 550 7 7 1.7 nitinol 40 1
201.60.10.24 2 4 WHILE 450 450 2 6 1.42 nitinol 40 1
201.60.10.25 2 5 WHILE 500 500 5 7 1.8 nitinol 40 1
201.60.10.36 3 6 WHILE 550 550 5* 7 1.98 nitinol 40 1
for the 6FR catheter, only one lumen can be used for Power flows
SKU / Catalog # # of Lumens Catheter Catheter Catheter Effective Max Reverse Inner Guideware Guidewire Box
Size (Fr) Material Length Length Power Taper Diameter Material Length Quantity
(cm) (mm) Flow Rate Diameter (mm) (cm)
(mL / sec) (Fr)
201.65.10.13 1L 3 WHILE 450 450 2 4 1.15 nitinol 40 1
201.65.10.14 1L 4 WHILE 550 550 5 6 1.42 nitinol 40 1
201.65.10.15 1L 5 WHILE 550 550 7 7 1.7 nitinol 40 1
201.65.10.24 2L 4 WHILE 450 450 2 6 1.42 nitinol 40 1
201.65.10.25 2L 5 WHILE 500 500 5 7 1.8 nitinol 40 1
201.65.10.36 3L 6 WHILE 550 550 5 7 1.98 nitinol 40 1
CONFIDENTIAL INFORMATION OF PLAN 1 HEALTH SRL
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Manufacturer
Plan 1 Health Srl, via Solari 5, 33020 Amaro (UD) ITALY
Production Site
Plan 1 Health Srl, via Solari 5, 33020 Amaro (UD) ITALY
Certifications:
CE Certificate No 2126204CE01: CE marked in accordance with the provisions of Legislative Decree 46 of
24.2.1997 (in implementation of the European MDD Directive 93/42/EEC) and subsequent amendments
and additions
ISO 13485: 2016 Certificate No.:2182609
Notified Body: DEKRA
Notified Body identification Number: 0344
Device Class: Class III
Classification GMDN: 36257
Bd / rdm registration identifier:
• 1047949 (HEALTHPICC single lumen)
• 1048006 (HEALTHPICC bilume)
• 1235620 (HEALTHPICC trilume)
• 1564642 (cod. 201.65.10.1x)
• 1564646 (cod. 201.65.10.2x)
• 1564654 (cod. 201.65.10.3x)
CND code:
• C01020101 (HEALTHPICC single lumen)
• C01020102 (HEALTHPICC multilume)
CONFIDENTIAL INFORMATION OF PLAN 1 HEALTH SRL
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SPECIFICATION INFORMATION
Approved Materials of Constructions
Part Base material
Catheter Tecothane® type polyurethane
Introducer needle 40-70mm stainless steel
Needle grip polycarbonate
Extension tube DEHP free PVC
Female Luer Connector Isoplast 2510 red or natural
Scalpel blade Stainless steel
Connection hub Polyurethane type Pellethane®
Clamp / tubing clamp Acetal blue
Metallic guide Nitinol
Metallic guide dispenser HDPE polyethylene
Spindle AISI 302 steel
Spindle lock T connector Triax / PVC / Silicone / Pellethane®
Micro-introducer polypropylene
Peel away introducer Polypropylene / HDPE
Body / seal neutral pressure valve Polycarbonate / latex free silicone
Grip lok® type fixing system Psa / foam / paper / hook
Handle / cap scalpel Polypropylene / polycarbonate
Sterilization Method / Shelf Life:
Sterilization Method: Ethylene Oxide Sterilization.
Shelf Life: 3 years from the date of manufacturing.
CONFIDENTIAL INFORMATION OF PLAN 1 HEALTH SRL
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Standards compliance:
Document Code Document Description
ISO 13485: 2016 Quality system Medical Devices - Requirements for the Regulatory Purposes
ISO 14971: 2019 Application of Risk Management for Medical Devices
EN ISO 11135-1: 2007 Validation and routine control of EO Sterilization
Medical Devices - Symbols to be used with medical devices labels, labeling and
EN ISO 15223-1: 2016
information to be supplied Part 1: General requirements
Packaging for terminally sterilized medical devices - requirements for materials, sterile
EN ISO 11607-1: 2009
barrier & packaging systems.
EN 62366-1: 2008 Medical Devices - Application of usability engineering to medical devices
EN ISO 10993 -1: 2009 / Biological evaluation of medical devices - Evaluation and testing within a risk management
AC: 2010 process.
EN ISO 10993-7: 2008 / AC: 2009 Biological evaluation of medical devices - Ethylene oxide sterilization residuals
ISO 14644-1: 2015 Cleanroom and associated controlled environments - Classification of air cleanliness
EN 556-1: 2002 Sterilization
EN 1041: 2013 Information to be provided in medical devices
Intravascular Catheters - Sterile Disposable Intravascular Catheters - Part 1: General
EN ISO 10555-1: 2018
Requirements
Packaging Characteristics:
Single sterile package with label conforming to the essential requirements of Directive 93/42/EEC and subsequent
integration and amendments 2007/47/EEC.
The package guarantees double sterility: external barrier consisting of a Tyvek envelope on PE, and internal barrier
supplied by a PETG blister sealed on a Tyvek sheet. The adhesive labels bearing the code and lot number, also used
in the patient record, allow perfect traceability.
Unit
Quantity No. 1
Carton
Quantity No. 1
Dimensions - L x H x W (mm) 150x25x335
Storage conditions:
Store between 5°C and 35°C
CONFIDENTIAL INFORMATION OF PLAN 1 HEALTH SRL
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Materials of Concern:
No/ Yes
DEHP No, DEHP free
Latex No, Latex free
BSE / TSE substances of animal origin No
Codes and descriptions:
Code Description Maximum flow
HEALTH PICC 1L 3FR Reverse taper L45 cm, needle 2ml / s
201.60.10.13
21Gx40mm, dilator 4FRx50mmx guide wire 0,45x400mm
HEALTH PICC 1L 4FR Reverse taper L55 cm, needle 5ml / s
201.60.10.14
21Gx70mm, dilator 4,5FRx70mm guide wire 0,45x400mm
HEALTH PICC 1L 5FR Reverse taper L55 cm 21Gx70mm 7ml / s
201.60.10.15
needle, 5,5FRx70mm dilator guide wire 0,45x400mm
HEALTH PICC 2L 4FR Reverse taper L45 cm needle 2ml / s for each lumen
201.60.10.24
21Gx40mm, dilator 4,5FRx50mm guide wire 0,45x400mm
HEALTH PICC 2L 5FR Reverse taper L50 cm needle 5ml / s for each lumen
201.60.10.25
21Gx70mm, dilator 5,5FRx70mm guide wire 0,45x400mm
HEALTH PICC 3L 6FR Reverse taper L55 cm needle 5ml / s *
201.60.10.36
21Gx70mm, 6FRx70mm dilator guide wire 0,45x400mm
201.65.10.13 HEALTH PICC 1L 3FR NO Reverse taper L45 cm 2ml / s
201.65.10.14 HEALTH PICC 1L 4FR NO Reverse taper L55 cm 5ml / s
201.65.10.15 HEALTH PICC 1L 5FR NO Reverse taper L55 cm 7ml / s
201.65.10.24 HEALTH PICC 2L 4FR NO Reverse taper L45 cm 2ml / s for each lumen
201.65.10.25 HEALTH PICC 2L 5FR NO Reverse taper L55 cm 5ml / s for each lumen
201.65.10.36 HEALTH PICC 3L 6FR NO Reverse taper L55 cm 5ml / s *
* Only the central lumen is suitable for high flow Power infusions with the specified specifications
Table 1: code table and descriptions.
CONFIDENTIAL INFORMATION OF PLAN 1 HEALTH SRL
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ANNEX A: product labels
CONFIDENTIAL INFORMATION OF PLAN 1 HEALTH SRL
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ANNEX B: Finished product photo
CONFIDENTIAL INFORMATION OF PLAN 1 HEALTH SRL
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