Question 1

What space and electrical installation does GEMMA need?

Accepted Answer

GEMMA measures 320 × 200 × 200 mm and weighs 8 kg. The brochure gives a reference input of 220 V / 50 Hz, a typical apparent-power consumption of ≤ 60 VA, an operating temperature of 10–35 °C and relative humidity up to 80%. Review site conditions and any regional electrical integration with our technical team before installation.

Question 2

Which procedures does the equipment support?

Accepted Answer

GEMMA performs membrane plasmapheresis with PFM-500 or PFM-800 filters and the SM-PF-01 circuit. The SM-PF-01U configuration adds an optional second stage, such as hemosorption, selective filtration or cascade. Clinical use, suitability and available components depend on the configuration, the current Instructions for Use and local requirements.

Question 3

Can it be operated with peripheral venous access?

Accepted Answer

The brochure describes one- and two-needle operation, which allows peripheral venous access where clinical judgement allows. The clinical team selects access and configuration under the applicable Instructions for Use and institutional protocol.

Question 4

How long does a typical procedure take?

Accepted Answer

It depends on the protocol, the volume to be processed and the configured flow (2–200 mL/min). Our clinical team gives you reference times for your protocol.

Question 5

What training does my staff receive, and how long is it?

Accepted Answer

Three days of hands-on training at your clinic. Training happens on real procedures: your team performs plasmapheresis from the first day, and from the second day it works on its own while we review and guide.

Question 6

Is training given on site or remotely?

Accepted Answer

On site, at your clinic, over three days. Afterwards our specialists stay available through our medical network platform, 24/7.

Question 7

Which professional profile should operate the equipment?

Accepted Answer

Clinical staff trained on GEMMA, under the responsible physician and the current Instructions for Use. Local regulations define who may perform apheresis procedures.

Question 8

What technical support is there, and when?

Accepted Answer

Support through our medical network platform 24/7, in any region, in Spanish, English, Portuguese, Russian and Italian, as well as by phone, email and WhatsApp.

Question 9

Which consumables do I need for each procedure?

Accepted Answer

One SM-PF-01 circuit and one PFM-500 or PFM-800 membrane filter, both single use, plus the anticoagulant and solutions your protocol specifies.

Question 10

What is the resupply lead time for PFM-500 and PFM-800 filters in my country?

Accepted Answer

Lead times depend on the destination country and its import requirements. We confirm them, with a resupply plan, in your proposal.

Question 11

Is long-term availability of consumables committed?

Accepted Answer

Supply continuity is planned with each centre as part of implementation. Ask our team for the current supply terms for your market.

Parameter	Value	Source
Configurable total flow	2–200 mL/min	GEMMA · p. 4
Flow increment: 2–50 mL/min	1 mL/min	GEMMA · p. 4
Flow increment: above 50–200 mL/min	5 mL/min	GEMMA · p. 4
Blood : anticoagulant ratio	5:1–25:1	GEMMA · p. 4

Parameter	Value	Source
Displayed pressure	Up to 300 mmHg	GEMMA · p. 4
Single-needle return pressure	60–240 mmHg	GEMMA · p. 4
Dual-needle pressure threshold	60–300 mmHg	GEMMA · p. 4
Single-needle draw volume	3–10 mL	GEMMA · p. 4
Access modes	One / two needles	GEMMA · p. 4

Parameter	Value	Source
Device weight	8 kg	GEMMA · p. 4
Dimensions	320 × 200 × 200 mm	GEMMA · p. 4
Operating temperature	10–35 °C	GEMMA · p. 4
Relative humidity	≤ 80%	GEMMA · p. 4

Parameter	Value	Source
Typical apparent-power consumption	≤ 60 VA	GEMMA · p. 4
Reference electrical input	220 V / 50 Hz	GEMMA · p. 4
Continuous operation	> 8 h	GEMMA · p. 4
Specified MTBF	5 000 h	GEMMA · p. 4

Criterion	Membrane · GEMMA	Centrifuge	Source
Extracorporeal volume	Filter priming ≤ 20 mL (PFM-500) or ≤ 25 mL (PFM-800); single-needle draw 3–10 mL per cycle. Total circuit volume: confirm with our team.	Set by each model's separation chamber and lines.	MEMBRANA p. 10 · GEMMA p. 4
Vascular access	One or two needles; peripheral venous access where clinical judgement allows.	Depends on the model and the protocol.	GEMMA pp. 3–4
Procedure time	Depends on the protocol and the volume processed.	Depends on the protocol and the volume processed.	—
Space required	320 × 200 × 200 mm, 8 kg.	Depends on the model; check its specification.	GEMMA p. 4
Consumables	SM-PF-01 circuit and a PFM-500 or PFM-800 filter, single use.	A model-specific disposable set.	GEMMA pp. 4, 8 · MEMBRANA p. 1
Mobility	Bedside, ICU, therapy room, ambulatory and mobile settings, as described by the manufacturer.	Depends on the model.	GEMMA pp. 2, 10–12

Configured for your protocol.

Parameters, with their source.

01Fluid control

02Access & pressure

03Physical & operating environment

04Electrical & continuity

Membrane or centrifuge.

Your settings, on the equipment.

Every component, with its reference.

PFM-500

PFM-800

SM-PF-01

Source documents.

GEMMA

PFM-500 / PFM-800

Practical questions.

01Clinical integration

02Operation and training

03Consumables and continuity

See GEMMA working in your clinic.

Technical brochure

Demonstration

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