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Capabilities and Operation
The Sapphire infusion pump system provides a complete solution for multiple clinical settings and multiple clinical uses. It can be programmed for various clinical infusion therapies, as well as pre-programmed to specific treatments. Sapphire can be tailored per patient with six different delivery modes (Continuous including piggyback option, PCA, intermittent, TPN, PCEA, epidural intermittent and multi-step) and flexible treatment parameters for each mode.
Yes. The Sapphire multi-therapy pump is the flagship product in a line that also includes dedicated models for TPN, PCA and Epidural, as well as pumps dedicated to specific needs of various market segments, such as SapphirePlus and SapphireH100. Details about the different pumps in the product line can be found here.
The Sapphire user interface is available in several languages, including English, French, French-Canadian, Italian, Swedish, German, Polish and more. The Sapphire technology enables Eitan Medical to implement a new language within a very short period of time, once a qualified translation of the relevant strings is completed.
The Sapphire pump stands out from other volumetric infusion pumps on the market in several key areas. While most volumetric infusion pumps are relatively large and heavy, the Sapphire is one of a very few that provides high-end volumetric pump functionality in a lightweight and compact form. Specific areas in which Sapphire provides top performance compared to others include:
Small size and low weight of 418 g (14.74 oz), without the battery (504 g with the battery) – Enables easy handling and transfer around the ward/hospital, and saves a lot of real estate where many pumps are needed
Accuracy of ±2.5% at all rates vs.5-10%
Battery life of 24hr vs.4-8hr
Full-color screen – Use of color scheme enhances ease of use and clarity, helping to eliminate operation errors.
Future ready – The Sapphire features built-in extra slots for all forms of connectivity, pump locator and other smart capabilities, and software that can be easily adapted and upgraded
Full care area solution – Sapphire can be configured and tailored to specific clinical needs
Easy and intuitive setup, navigation and programming, designed and tested by Human Factors standards
Safe to use – programmed to diminish the risk of human error by offering a step-by-step decision making process to the user.
Additional benefits include:
Double free flow protection
Very clear and visible alarms that are easily distinguished
Single-handed insertion of administration set
Display of “Time to End of Treatment”, keeps patients informed of how long treatment will continue
No restriction on operating position
Easy patient mobility – Support for manual priming, small size and weight, and position-independent operation allows patients to move around and continue daily activities while attached to the pump
Fast prime (600 ml/hr)
The Sapphire infusion system is controlled via an intuitive touch-screen interface. The interface is designed to enable fast setup and adjustment, simplifying the user decision-making process in order to eliminate complexity and errors. Changing parameters mid-infusion is also very easy, requiring just a few strokes on the touch-screen.
The pump mechanism in a volumetric infusion pump must create a continuous accurate flow even as different levels of force are required during different stages of the peristaltic cycle. The inherent challenges in achieving this mean that most volumetric pumps utilize highly complex mechanisms that carry a high cost of ownership in terms of energy consumption and wear and tear; or they have more simple, but significantly less accurate systems with non continuous and non linear flow control capabilities. Eitan Medical’s magnetic flow control mechanism is by comparison, a streamlined design that ensures exceptionally accurate flow, with low energy consumption.
The Sapphire offers high accuracy of ± 2.5% at all ranges (subject to external conditions such as tubing, rate, bag position relative to the pump, humidity and temperature). This is similar to leading syringe pumps, and is better than most volumetric large volume and ambulatory pumps.
The Sapphire might look like an ambulatory pump but it is a large-volume infusion pump, used for ambulatory needs as well. It is small in size, but it is big in performance! It provides all the functionality of a volumetric infusion pump, with the advantages of a much smaller size and lighter weight.
The Sapphire infusion pump is designed primarily for hospitals, where bedside space is often at a premium. The small size of the pump leaves more room for using multiple pumps on a single IV pole and other devices and monitors, enabling a more organized bedside area, which is easier for health care teams to manage. Additionally, its small size and light weight facilitate patient mobility. Patients can more easily push around the pole (or move without a pole altogether) as they walk on the ward, with less likelihood the pump will be bumped into walls and doors.
Sapphire is also widely used for homecare and for ambulation in hospitals. It can easily be carried in a pouch, allowing the patient to move around easily.
No. Eitan Medical’s dedicated sets must be used with the Sapphire pump.
Alternatively, administration sets from different manufacturers that are regulatory cleared and labeled for use with the Sapphire infusion system, can be used as well. The list of regulatory cleared sets needs to be obtained from the official manufacturer’s publication such as manufacturer’s website, catalog or any other formally published document.
Using dedicated sets provides several advantages:
Eitan Medical sets have built in safety features that standard IV sets do not have and that provide free flow protection.
Eitan Medical sets play a key role in the superior accuracy of Eitan Medical infusion pumps.
Gravity operation can be performed with many of Eitan Medical sets, when the Anti-Free-Flow Valve (AFFV) is in the open position, reducing the need to switch sets and reducing wastage.
Eitan Medical sets reduce power consumption due to the unique design of the AFFV.
Unlike other pumps, with Eitan Medical sets there is no need to move or rearrange the tubing in order to ensure ongoing accuracy and safety.
The drug library is programmable according to the requirements of each individual hospital. The Drug Library Editor (DLE) allows each hospital to customize its own drug library per clinical care area, including drug profiles and pump configuration settings and download it to one pump or a group of pumps within the hospital.
Yes, the Sapphire infusion pump is ready for the future. Software-driven control and the touch-screen user interface ensure ready adaptability to meet evolving market and regulatory requirements. The Sapphire is ready for enhanced connectivity, including Wi-Fi, enabling online calibration, upgrades and service. It is barcode reader-ready, to facilitate infusion management and improve safety; and it is locator technology-ready, which reduces the risk of loss. It also can be cost-effectively upgraded, including the addition of new infusion modes of operation.
Safety
The Sapphire features a unique, dual anti-free-flow mechanism in the pump and administration set, which prevents fluid free flow. The pump also has built in systems to stop the infusion and alert the clinician when the infusion is interrupted due to upstream or downstream occlusions or should air enter the line.
A common cause of problems with infusion delivery is the complexity of using standard volumetric pumps. With its intuitive, full-color touch-screen interface, the Sapphire is very simple to use, making it easier for staff to ensure medication infusions are delivered correctly, thus reducing risk to the patient. The interface provides clearly visible indications of activity and infusion parameters, making it easy for medical staff to confirm the correct dosage and mode.
Set up is simple, requiring minimal steps and any adjustment needed in mid-infusion, such as changing infusion parameters in the event of an alarm, is also fast and easy to manage
The integrated drug library, high accuracy and very short startup time help ensure medication infusions are delivered efficiently, at the correct dosage and rate for the patient.
Password protected screens and four authorization levels ensure only authorized users can activate, adjust or stop the pump.
The Sapphire pump includes several safety mechanisms that prevent air from entering the system when the treatment is concluded.
The pump issues an audible and visual alert ten minutes (configurable) before end of treatment.
The pump issues an audible and visual alert for upstream occlusion
VTBI entry ensures that treatment is complete before the bag empties, eliminating the risk of air entering the tubing.
To ensure patient and clinician safety while administering narcotics or opioids, Eitan Medical has developed a line of PCA Lockboxes which secure the pump and the IV bags and prevent undesired access to the materials. The Lockboxes are designed for different sizes of IV bags (100 mL, 250 mL and 500 mL) and are either portable or mountable on an IV pole. For more details about the available lockboxes click here.
Durability and Reliability
The Sapphire pump is very durable. It has been proven in external tests to provide seven years mean time between failures (MTBF). It carries a dust and water ingress rating of IP24 – which is better than most infusion pumps. In the event liquid is spilled on the pump, ongoing treatment is not affected. The Sapphire pump has been extensively drop-tested and certified according to the most stringent relevant standards. In addition, the unique dual processer provides another layer of protection, as proper pump operation continues even if one processor fails.
The Sapphire pump has been certified to be resilient against damage in drop tests; and we have growing field experience and usage history that highlights its resistance to damage. Unlike other pumps, the door does not influence the correct operation of the pumping mechanism. Therefore should the door have sustained damage due to a fall, it will not adversely affect the correct operation of the pump or negatively influence treatment. Looking back at usage experience, it is safe to say that breakage of the pump door is extremely rare, yet in case it is indeed required, replacement of the door takes less than five minutes.
Clinical Experience and Regulatory Approvals
Eitan Medical volumetric infusion pump systems are in use at numerous medical sites around the world, including leading hospitals and oncology clinics, varied homecare sites and top research institutes in Israel, France, Italy, Turkey, UK, Canada and the US. The list of Eitan Medical users is growing quickly; please contact us to receive more information.
Eitan Medical is committed to a rigorous program of testing and trials covering all aspects of pump safety, performance, and efficacy. Results from the following evaluations are available:
Bench testing – performed at hospitals around the world
Data-log analysis
On-going clinical testing – References will be provided upon request
Warranty, Supply and Maintenance
It depends on the policy of the individual distributor. Please contact us to find a distributor in your area.
It depends on the policy of the individual distributor. Please contact us to find a distributor in your area.
Service to the pump is provided via a 3-tier procedure: 1st level of service is provided at the client site by the local biomed engineering department, 2nd level of service is provided by the regional service centers, and the 3rd level of service is usually provided at Eitan Medical Service department. Most of the problems occurring with the Sapphire pump can be fixed at the client site, and usually do not require sending the pump out to a service center or to Eitan Medical Service department. We offer technicain training programs and certifications, contact us today to learn more.
No dedicated fixtures or jigs are required for testing and/or repair
Yes, Eitan Group offers different levels of tecnician training to support on site independant maintenance and repair activities. Please contact us for complete details regarding the available support tools and services
Testing and recertifying the Sapphire pump is easy, fast and cost effective. Annual Certification at point of care (POC) is available with a patented kit from Eitan Medical. This eliminates shipping costs and maximizes pump uptime.
In general, service to the pump is provided via a 3-tier procedure: 1st level of service is provided at the client site by the local biomed engineering department, 2nd level of service is provided by the regional service centers, and the 3rd level of service, which includes calibration, is usually provided at Eitan Medical Service department. It is important to mention that calibration is rarely needed. In general, less than 5% of Sapphire pumps will need annual calibration in addition to the certification.
It is very easy to update and load new information to the Sapphire Infusion pumps. The Drug Library can be updated by a certified hospital user via any PC. Pumps can be updated with the new library and other information onsite, with up to 8 pumps being updated simultaneously.
Eitan Medical provides the following software and support tools:
Drug library editor
Event viewer
Software version uplodader (up to eight pumps in parallel)
Annual Certification Kit
The Sapphire pump keeps a history log of 8,000 events. The log is retrievable through both a View System option on the pump and a Log Downloader on any PC.
Not directly in the pump. Rechargeable batteries must be used with the Sapphire infusion pump. The rechargeable batteries ensure excellent performance and reduce cost. The Sapphire infusion pump uses a rechargeable Li-Ion battery that has a life of 24 hours at 125 ml/hr. Full battery charge takes up to four hours and it can be done while the pump is running. The battery needs to be replaced only once every two years.
Using rechargeable batteries provides an important environmental benefit, as a fleet of 1000 pumps using AA batteries would create almost three tons of battery waste every year.
Disposable batteries can be used with the Sapphire External Battery Pack, which provides a power solution when a stable power source is not available.
The following materials are approved for use with the Sapphire infusion pumps:
Approved for cleaning and disinfection – Material (Manufacturer)
Dispatch® (Caltech) ready-to-use towels (Caltech)
Virex ® II 256 (Diversey)
Klor DE™ – Chlorine tablets (Concept)
70% Isopropyl alcohol (Veltek Associates, Inc.)
Virox® AHP 5 RTU (Diversey)
Confirmed to have no adverse effect on the pump – Material (Manufacturer)
Dispatch® (Caltech) ready-to-use towels (Caltech)
Virex ® II 256 (Diversey)
Klor DE™ – Chlorine tablets (Concept)
70% Isopropyl alcohol (Veltek Associates, Inc.)
Virox® AHP 5 RTU (Diversey)
Oxivir Tb (Diversey)
CaviCide™ (Metrex™ Research)
Accel TB Wipes (US) and Accel TB RTU (Canada) (Virox Technologies Inc.)
Aniospray Surf 29 (Laboratoires Anios™)
Clinell Universal Sanitising Wipes (Gama Healthcare)
Sani-Cloth Plus® Germicidal Disposable Cloth (PDI)
Clorox Healthcare® Bleach Germicidal Wipes (Clorox Healthcare)
Concentrate Wexcide 128 (Wexford Labs,inc) – Diluted at ounce of Wexcide 128 to a gallon of water
Cleaning the electrical connectors of all accessories is restricted to use of 70% isopropyl alcohol (IPA) only. For further details See – Best practices for cleaning electric connectors of Sapphire accessories.
Spare parts for the Sapphire Mini Cradle are available,
Connection knob flange key, PN 05040-380-0019
Connection knob key, PN 05040-380-0018
AVP Connection Bolt Knob Tip, PN 05040-380-0027 – Assembly instructions
AVP Press Plane, PN 05040-380-0026 – Assembly instructions
To receive access to the drug Library Editor software, please complete the form on the following Link, https://download.qcore.com/dle/. Please contact to local Eitan Group representative to get the access code for the download.
Sapphire Infusion Pump Service
To report a complaint, please contact Eitan Medical Complaint management team at complaints@eitanmedical.com or via the following phone numbers.
USA
+1 833 771 2995
France
+33 4 88 92 51 03
United Kingdom
+44 800 260 5940
Canada
+1 833 529 6861
Israel
+972 1 809 461 698
Spain
+34 936 06 40 25
Portugal
+351 800 783 374
Switzerland
+41 43 216 16 60
Sweden
+46 8 502 413 85
Greece
+30 21 1198 6873
Italy
+39 02 3045 6287
Austria
+43 800 296672
Turkey
+90 800 142 034791
Poland
+48 22 163 96 43
Belgium
+32 2 897 76 94
Ireland
+353 1 582 4094
Australia
+61 8 6186 3615
Denmark
+45 32 72 69 96
Northern Macedonia
+389 800 9 21 16
Taiwan
+886 2 5594 0239
Thailand
+66 1800 012 031
Colombia
+57 1 800 5189451
As of October 1, 2020, Eitan Medical affiliate company Q Core Medical Ltd. and its partners will provide exclusive service, repair, and preventative maintenance for your Sapphire pump fleet. From that point forward, ICU Medical will no longer provide repair and maintenance services for your Sapphire infusion pumps. Contact your local provider to learn more
Eitan Medical has contracted with independent service providers to provide service on the Sapphire Infusion pumps who may offer the option to swap or loan devices when sending a pump in for repair. For details contact your local Eitan Medical sales representative
Eitan Medical has contracted with a national service provider that can perform on site repairs and preventive maintenance. Find your local provider here, or Contact us for more details
We recommend that you contact ICU medical for the disposition of your device. If you are not receiving the information you need and need our support, Eitan Medical will attempt to locate it.
Original warranty periods will, of course, be honored, and Eitan Medical offers a variety of service protection plans for customers in need of additional protection beyond initial warranty periods. In addition, all updates to Sapphire software will now be available at no additional cost upon your transition to Eitan Medical from your current vendor
Discover how you can partner with Sapphire™ for your dedicated therapy delivery solution