PURPOSE AND COMPOSITION The "Gemma" device is designed for conducting membrane plasmapheresis and other procedures in efferent therapy such as hemosorption, plasmasorption, isolated ultrafiltration, active infusion, hemoperfusion, plasma exchange, erythrocytapheresis, hemofiltration, oxygenation, electrochemical oxidation of blood, and more. The device is intended for plasmapheresis operations in patients for the purposes of detoxification, immune correction, and blood aggregation state regulation, as well as for donors for plasma collection.
APPLICATION AREAS - In practical healthcare across departments such as toxicology, transfusiology, cardiology, nephrology, endocrinology, allergology, pulmonology, oncology, dermatology, addiction treatment, neurology, intensive care, surgery, obstetrics, gynecology, pediatrics, and others; - In blood services and donor programs; - In military-field medicine, in urgent cases, and disaster medicine (pre-hospital and hospital stages).
CONDITIONS OF USE - Stationary, outpatient, field, mobile, and home care; - Ambient temperature from +10 to +35°C, relative humidity no more than 80%, and atmospheric pressure of 100 ± 4 kPa (750 ± 30 mm Hg).
The device consists of a perfusion unit with two peristaltic roller pumps (a blood pump and an anticoagulant pump), a dosing container squeezing device with a built-in pressure sensor, and a safety and control system. The plasmapheresis procedure is performed with the use of disposable materials, including a transfusion line and a membrane plasma filter.
TECHNICAL SPECIFICATIONS OF THE "GEMMA" DEVICE 1. Blood pump flow rate range, ml/min: 2 ÷ 200 2. Anticoagulant to blood flow volume ratio range: 5:1 ÷ 25:1 3. Single blood draw volume range (in single-needle perfusion), ml: 3 ÷ 10 (adjustment step - 1 ml) 4. Blood pressure range, mm Hg: 60 ÷ 300 5. Blood volume indication range, liters: 0.01 - 9.99 6. Power consumption, VA, no more than: 60 7. Dimensions, mm, no more than: 320×200×200 8. Power supply voltage, V: 220 ± 10% 9. Weight, kg, no more than: 8
The device allows plasma collection of 1-1.2 L/h at a nominal blood flow rate of 50-60 ml/min during single-needle perfusion. During intensive therapy with blood flow rates of 160-180 ml/min using two-needle perfusion, plasma collection can reach 2 L/h.
SAFETY REQUIREMENTS The device ensures activation of sound and visual alarms and pump shutdown in the following abnormal situations: - When the blood level in the air trap of the line drops; - When air enters the line.
The device ensures activation of visual alarms and pump shutdown in the following abnormal situations: - When the vacuum pressure at the blood pump inlet is between minus 60 and minus 200 mm Hg; - When the protective glass is open; - When the dosing container line is not filled during single-needle perfusion.
The device provides an indication of current and set parameters, as well as current and emergency states, including: - Operating modes of the device; - Duration of blood withdrawal and return phases; - Emergency situation codes; - Blood pump flow rate; - Blood and anticoagulant pump flow ratios; - Calculated pumped blood volume; - Calculated pumped anticoagulant volume; - Set single blood draw volume in single-needle perfusion mode; - Set pressure threshold values; - Current pressure level.
The device includes the disposable transfusion system "SMPF-01", available in two versions: "SMPF-01" and "SMPF-01 Universal". This disposable system is sterile, pyrogen-free, and designed for drawing blood from the patient (donor), delivering it and transfusion media to the membrane plasma filter, extracting plasma from the membrane plasma filter, and returning the red blood cells along with blood substitutes to the patient (donor) during plasmapheresis.
Portable Transfusion Device "Gemma" with a Set of Consumables
To Department Heads and Doctors: Specialists in Extracorporeal Hemocorrection
For over 10 years, our company has been one of Russia's leading manufacturers of medical devices for highly effective treatment methods such as membrane plasmapheresis and hemo-plasmosorption. We propose introducing into your medical institution the latest development—a portable transfusion device "Gemma" with a set of consumables (hereinafter referred to as CM) for membrane plasmapheresis. The CM includes a blood-conducting line set, CM-PF-01, and a membrane plasma filter, PFM-800. The design and ergonomics of the device incorporate recommendations from doctors based on the operational experience of Russian devices "Hemos" and "Hemophenix."
The distinguishing features of the "Gemma" device are: - Versatility: The ability to operate both with a single-needle connection scheme, where blood collection and return are done through one vein of the patient, and a double-needle connection scheme, using two veins. One universal disposable set is used in both cases. - Automatic anticoagulant supply synchronized with blood flow: This allows for a wide range of adjustments in blood collection speed, volume, and blood-anticoagulant ratios, enabling optimal plasmapheresis modes for both adults and newborns. - No recirculation in the extracorporeal circuit. - Advanced safety system: Including vacuum, pressure, level, air, pump malfunction sensors, container underfilling, and a safety valve. - During the plasmapheresis procedure, the device displays or can display on demand a dozen parameters: the duration of the blood collection and return phases, the blood pump flow rate, the threshold pressure before the plasma filter, container pressure, blood/anticoagulant volume ratios, blood collection volume, and more. - Cost: 1.5 to 2 times lower than Russian analogs.
Comparative characteristics of transfusion devices are presented below.
Main Parameters and Characteristics | Parameter | Gemma, ZAO Plazmofilter, Russia | Hemos-PF, NPP Biotech-M, Russia | Hemophenix, ZAO Trekpor Technology, Russia | Hemofer, LLC Nord Medicom, Ukraine | |-----------------------------------------|-------------------------------------|-------------------------------------|---------------------------------------------|------------------------------------------| | Device weight, kg | 8 | 6 | 22 | 6 | | Device dimensions, cm | 32×20×20 | 24×17×11 | 45×32×12 | 30×19×13 | | Venous connection method | Single-needle, double-needle | Single-needle | Single-needle | Single-needle | | Initial external circuit fill volume (without plasma filter), ml | 40 | 40 | 60 | 40 | | Blood-anticoagulant volume ratio adjustment range | 5:1 to 25:1 (20 settings, 1-step adjustment) | Manual drip | 12:1, 10:1, 6.6:1, 5:1 (4 settings) | Manual drip |
It is important to note that the "Gemma" device is the first in a series of extracorporeal perfusion devices being developed by APHERESIS TECH.
With extensive experience producing membrane plasmapheresis products used in 650 medical institutions across Russia and the CIS countries, the company offers the following free additional services: - Organization of physician training in anesthesiology and resuscitation, and transfusiology, at universities in St. Petersburg, with a state certificate for work in efferent therapy. - Familiarization with membrane plasmapheresis techniques using PFM-800 plasma filters in major clinics in St. Petersburg and other regions of Russia, as well as in Belarus, Ukraine, Moldova, and Azerbaijan. - Provision of methodological and informational materials on the use of "Gemma" devices and other membrane plasmapheresis devices manufactured by the company.
The company regularly participates in tenders and competitions within the framework of state orders, and its products successfully compete with both Russian and Western analogs.
We are always pleased to collaborate with you, esteemed doctor, for the health of the Russian people.
