CE Mark Approved n. 1282 and ISO 13485 certified. The entire line of products are CE Marked for sales throughout Europe (CE n. 1282 and ISO 13485). The Insignis Subcutaneous Administration needle set has received clearance from the FDA (K202279). The remainder of the
system is the subject of a full 510(k) submission, which the Company expects in the next quarter.
The Insignis™ Syringe Infusion System for the intravenous and subcutaneous administration of medications consists of:
1. A selectable rate flow control element,
2. Or high accuracy fixed rate flow control tubing,
3. And a safe 13.5psi constant pressure mechanical infusion pump designed for use with the 50 ml BD syringe (US Reference # 309653; EU Reference #300865).
For intravenous administration:
the Insignis IV Controller (a combination of a selectable rate flow dial and tubing) may be directly connected to a catheter set (provided separately by the catheter manufacturer). IHS also offers the Insignis™ Fixed Rate Tubing for applications requiring more precise flow rates or in instances where the flow rate should not be modified (flow rates from 0.5 ml/hr – 300 ml/hr, or other flow rates upon request).
For subcutaneous immunoglobulin (SCIg) administrations:
IHS offers the OneSett™ Subcutaneous Administration Set, which consists of a calibrated selectable rate flow dial, connected directly to an administration set comprised of one (1) to up to four (4) needle set configurations (6mm, 9mm, 12 mm, and 14mm lengths), which meet the drug manufacturer’s package insert(s) maximum flow rate limits. The flow rate depicted on the flow dial is the exact flow rate delivered to each subcutaneous needle site. For generic subcutaneous applications, IHS also offers Subcutaneous Needle Sets (same configurations as above) as well as high accuracy fixed rate flow tubing for precise, slow flow rates and/or for instances where the flow rate should not be modified for the subcutaneous administration of certain medications.
Insignis™ Syringe Infusion System Components
“What’s powering your infusion?” “What’s driving your infusion”
The Insignis Infusion Pump is a 13.5psi safe constant pressure infusion pump that operates independent of battery power or electricity.
- User friendly infusion pump with low force, easy to grip lever with smooth, rounded edges for patient comfort
- Compact, convenient, portable infusion pump designed for use in all positions and on all surfaces
- Consistent, reliable performance throughout entire life cycle of device (2,000 infusions under standard use)
- Syringe is held in alignment and cannot be inadvertently moved or ejected
- Clear, visual indication of internal working mechanism to aid in tracking infusion progress
- Emergency brightly colored safety lock tab used to engage and disengage mechanism in the event the infusion needs to be prematurely stopped.
Syringe infusion system enables partial or “intermittent” pause dosing for both intravenous and subcutaneous use.
- Intravenous: especially advantageous when infusing smaller volumes of antibiotics over an extended period of time
- Subcutaneous: beneficial and effective way to test and deliver medication at a fast flow rate without causing injury to the patient. This method allows the patient to safely maximize therapeutic benefit while minimizing discomfort.
Flow Control Element:
“What’s controlling your infusion?” “How is the drug getting to you?”
Intravenous & Subcutaneous
The Fixed Rate Tubing is specifically calibrated for sterile water for injection and is intended for intravenous and subcutaneous use.
Certain medications for may require slower and/or more precise flow rates. In this case and for instances where the flow rate should not be modified, it is recommended to use the Fixed Rate Tubing.
The OneSett is a combination of a selectable rate flow dial and a subcutaneous administration set, which includes high accuracy tubing. The OneSett is specifically calibrated for 20% IgG drugs, including Hizentra®, Cuvitru®, and Xembify®.
- The flow rate on the flow dial indicates the exact flow rate delivered to each subcutaneous needle site.
- The OneSett is accurately calibrated for flow rates up to 50ml/hr/site.
- There is no need for complicated tables, graphs, computations, or calculators! Regardless of needle configurations, flow rate, and needle size, no calculations are required; the flow rate that appears on the dial is the flow rate delivered to the patient
- Training is a breeze – simply set the flow rate by a turn of the dial and begin the infusion.
Always consult your provider before beginning the infusion and/or adjusting the flow dial.
- The OneSett is offered in one (1) to up to four (4) needle set configurations (6mm, 9mm, 12 mm, and 14mm lengths), which meet the drug manufacturer’s package insert(s) maximum flow rate limits.
Cleared by the FDA K202279 and Available for sale in the U.S.
- Less user interaction/connections = less contamination
- Tricuspid needle tip = no coring, least pain insertion
- low memory butterfly = wings will not have tendency to move and push away from skin thus pulling needle out and cause pain (if not used with a dressing)
- tactile/audible butterfly snap
- butterfly snap guidance features that ensure a 1-attempt snap guidance and closure = no extra attempts to snap close = no increased needle stick injury opportunity
- smooth butterfly surface on skin – well placed snap closure features that are imperceptible to the skin = butterfly features does not cause irritation
- needle guiding channel to ensure needle is received straight and not crooked = user does not attempt to straighten a bent needle = reduce NSI, = drug will be delivered to correct tissue depth = reduce site irritation
- Flow capacity of a 24G needle in a 26G = faster flows and less site (more appropriate in plain needle set)
- -Easy to grip and maneuver butterfly wings for needle insertion
- Needle protector designed to reduce dulled needles = less insertion pain
- Tubing is soft, pliable, feels strong = gives user impression of a secure infusion – tubing won’t snap
- easy to rotate controller (does not shift)
- all iso specs are met
- The Subcutaneous Needle Sets are recommended for generic subcutaneous applications.
- The Subcutaneous Needle Sets are intended for use with the Insignis Fixed Rate Tubing.
- Offered in four configurations: Single, Bi-, Tri-, and Quad-furcated sets
- Offered in four needle lengths: 6mm, 9mm, 12mm, 14mm