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Capabilities and Operation
What therapies can the Sapphire infusion pump be used for?
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.
Does Eitan Medical also offer dedicated pumps for specific therapies?
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 foundhere.
What languages is the Sapphire user interface available in?
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.
How is the Sapphire different to other volumetric infusion pumps?
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)
Why is Sapphire easier to use than standard volumetric infusion pumps?
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.
How is the Sapphire pump mechanism different to the mechanism in standard volumetric pumps?
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.
How accurate is the Sapphire pump?
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 is so small and lightweight. Is it an ambulatory pump?
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.
Why does size matter?
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.
Can standard administration sets be used with the Sapphire infusion pump?
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.
Is the drug library programmed by Eitan Medical into the pump?
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.
Infusion pumps are a significant investment for any hospital. Will the Sapphire adapt to meet changing needs?
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
How does the Sapphire infusion pump ensure patient 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.
How is air prevented from entering the system at the end of the treatment?
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.
Is it safe to administer narcotics or opioids with Sapphire?
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 clickhere.
Durability and Reliability
How durable is the Sapphire pump?
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.
How is the Sapphire pump protected against damage due to a drop or as can occur with daily use?
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
What sorts of facilities already use Eitan Medical’s volumetric infusion pump systems?
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; pleasecontact usto receive more information.
What clinical study and trial results are available showing the performance of the Eitan Medical pump?
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
Are Eitan Medical's Infusion Pumps available for lease instead of purchase?
Eitan Medical and its distributors offer different leasing and purchasing options in different countries. Please contact your local Eitan Medical customer support representative or distributor to explore available options.
Can Eitan Medical's Infusion Pumps be rented when additional pumps are required to handle peak demand?
Eitan Medical and its distributors offer different leasing and purchasing options in different countries. Please contact your local Eitan Medical customer support representative or distributor to explore available options.
What is the process of getting pumps serviced or repaired?
Eitan Medical has contracted with independent certified service providers to provide service and repairs on its Infusion Pumps. To send your device in for servicing, please contact one of Eitan Medical’s certified service providers from this list
What is Eitan Medical's service structure?
Eitan Medical has established a three-tiered process to provide service for its pumps:
Level 1 – The local biomed engineering department performs first-level service at the client site.
Level 2 – The regional certified service centers perform second-level service.
Level 3 – The Eitan Medical service department performs third-level service.
The majority of problems occurring with the Sapphire Infusion 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’s service department.
Eitan Medical offers Preventive Maintenance Technician training programs and certifications. Contact ustoday to learn more.
What fixtures/jigs are required for testing and/or repair?
No dedicated fixtures or jigs are required for testing and/or repair. The FasTest PM application and its related kit are required for performing annual certification.
Are technician training programs available to enable in-facility repair including tools and parts?
Eitan Medical offers different levels of technician training to support onsite independent maintenance and repair activities. Pleasecontact us at service@eitanmedical.comfor details regarding the available support tools and services.
What specific test procedures/equipment are needed to test the functions of the Sapphire Infusion Pump and calibrate the device?
Testing and recertifying the Sapphire Infusion Pump is easy, fast and cost effective. Annual certification at point of care (POC) is available with a patented kit from Eitan Medical, the FasTest PM kit (P/N 16024-000-0002). This eliminates shipping costs and maximizes pump uptime.
In general, service to the Sapphire Infusion Pump is provided via a 3-tier procedure:
Level 1 – is provided at the client site by the local biomed engineering department
Level 2 – is provided by regional certified service centers
Level 3 – which includes calibration, is provided at Eitan Medical’s service department. In general, less than 5% of Sapphire Infusion Pumps need annual calibration.
How easy is it to update the system with new drugs, safety information, etc.?
It is 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 Drug Library Editor and other information onsite, with up to 8 pumps being updated simultaneously. For more information click here
What IT/software support does Eitan Medical provide to ensure the Sapphire Infusion Pumps work with the organization's internal IT personnel and systems?
Eitan Medical provides the following software and support tools:
- Drug Library Editor
- Event Viewer
- FasTest PM
- Sapphire Configuration Manager
- Pump Loader- softwareversion uploader (up to eight pumps in parallel)
For Instructions on how to allow access to the Service Software Tools (PC Tools), please click here
What reports, information, and feedback can be retrieved from the Sapphire Infusion Pump and how?
Sapphire users have the option to retrieve event logs by using the Events Viewer software which allows the caregiver or authorized technician to review the history of the Infusion Pump operation via a serial connection to a PC. The Events Log can hold up to 8000 entries that can be sorted and filtered by description or date. Users can also get remote treatment visibility by using Sapphire™ Connect and Eitan Insights™, Eitan Medical’s digital cloud-based software platform. With Sapphire™ Connect, Sapphire Infusion Pumps are within reach, transmitting data to the cloud through universal plug and play cellular technology. The platform support clinicians in tracking treatment status, progress, and adherence as well as geolocation data. To learn more about Eitan Insights™, please click here
Can disposable batteries be used with the Sapphire Infusion Pump?
The Sapphire Infusion Pump uses a proprietary rechargeable Li-ion battery. 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.
Disposable batteries can be used with the Sapphire External Battery Pack, which provides a power solution when a stable power source is not available.
What materials can be used for cleaning the Sapphire Infusion Pump?
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 (Laboratories 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
What materials can be used for cleaning the electrical Sapphire accessories?
Cleaning the electrical connectors of all accessories is restricted to use of 70% isopropyl alcohol (IPA) only. For further details click here
Does Eitan Medical provide spare parts for the Sapphire Mini Cradle?
The following 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
AVP Press Plane, PN 05040-380-0026
Who should I contact to get access to the Drug Library Editor software?
To receive access to the Drug Library Editor software, please complete the form here
Where can I download the Sapphire user manual?
The Sapphire user manuals can be found here
Where can I find instructions and links related to Eitan Medical's Service Software Tools (PC Tools)?
You can register and download the Service Software Tools (PC Tools) here
You can download instructions to the Service Software Tools (PC Tools) here
How do I upgrade my Sapphire Infusion Pump software?
The Sapphire Infusion Pump software can be upgraded by any Preventive Maintenance certified technician. Once certified, you will have access to download the Pump Loader and necessary software package from our website which can then be uploaded to the Sapphire Infusion Pump. To register to become a certified Sapphire Preventive Maintenance Technician, please fill out this form here
How do I get a Preventive Maintenance Technician certification?
To register to become a certified Sapphire Preventive Maintenance Technician, please fill out the form here
After completing the registration form, you will receive an email with a link to a training presentation.
At the end of the self-training deck, a hyperlink will direct you to the Preventive Maintenance qualification test. Complete the test based on the knowledge acquired during the self-training.
Based on the qualification test and registration form, you will receive an additional email from our team providing you with the information you require as a certified Sapphire Preventive Maintenance Technician.
Why do only certified service centers have access to spare parts?
Spare parts are only supplied to certified service providers as repairs and replacement of Sapphire parts require full qualification and periodic control by Eitan Medical.
My company's firewall blocks access to the Service Software Tools (PC Tools). What do I do?
For Instructions on how to allow access to the Service Software Tools (PC Tools), please click here
Who do I contact for Sapphire Infusion Pump user training?
To get access to the Sapphire Infusion Pump user training, please contact your Eitan Medical sales representative or local distributor.
Sapphire Infusion Pump Service
Who should I contact to report a complaint or an adverse event on Sapphire?
To report a complaint, please contact Eitan Medical’s Complaint management team at complaints@eitanmedical.com or via the following phone numbers:
USA: +1-877-541-9944
France: +33 4 88 92 51 03
United Kingdom: +44 800 260 5940
Israel: +972-73-2388870
Latin America: +1-877-541-9944
Any other country: +972-73-2388870
Does Eitan Medical offer extended warranty or service contracts?
Eitan Medical provides warranties on new devices sold based on local regulations. In addition, Eitan Medical offers extended service agreements for repair and maintenance of your devices in selected countries. Contact your local representative or service@eitanmedical.com to learn more about our service programs.
Does Eitan Medical have field service engineers that can do on-site service?
Eitan Medical has contracted with certified service providers that may perform onsite preventive maintenance. Find your local service provider here, or Contact us for more details
How do I send my device in for servicing or repair?
To send your device in for servicing, please contact one of Eitan Medical’s certified service providers from this list
How do I gain access to the Eitan Medical’s service portal?
Please register at login.eitanmedical.com to gain access to Eitan Medical’s service platforms.
How can I get Level 1 certification?
To register to become a certified Sapphire Preventative Maintenance technician, please fill out this here
What is the recommended service procedure for the Sapphire Infusion Pumps?
Eitan Medical recommends performing preventive maintance (PM) on the Sapphire Infusion Pumps once a year. This can be done in-house using the FasTest PM kit and software or it can be outsourced to one of Eitan Medical’s certified service providers from this list
Does Eitan Medical offer loaner pumps or an option to swap during the time of repair?
Eitan Medical has contracted with independent service providers to service Sapphire Infusion pumps, some of whom might let you borrow pumps during time of replair. Please speak with a local Eitan Medical service provider to find out.
Where can I find my local service provider for Sapphire servicing and repairs?
Find your nearest service provider from our list
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