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What Is a LUCAS Device? Chest Compression System Explained

LUCAS device explained: FDA class, its 510(k) clearance record, parts and LUCAS 3 specifications from the instructions for use.

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This page describes products and general use; it is not medical advice.

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A LUCAS device is a powered chest compression system made by Jolife AB and distributed by Physio-Control (Stryker). In US regulation it is an external cardiac compressor, a prescription device cleared by the FDA as an adjunct to manual CPR. This page gives its regulatory identity, its parts, a dated clearance record and the specifications printed in its instructions for use. It is written for clinic staff, buyers and students; it does not teach compression technique.

What is a LUCAS device?

A LUCAS device (also searched as “LUCAS CPR”, “LUCAS CPR device” or “LUCAS chest compression system”) is a machine that delivers external chest compressions to an adult in cardiac arrest. The FDA’s 510(k) summaries for LUCAS 3 state its indication as performing external cardiac compressions on adult patients with acute circulatory arrest, defined as absence of spontaneous breathing and pulse and loss of consciousness, and that it must only be used where chest compressions are likely to help the patient.

It is an adjunct, not a replacement. The regulation it falls under, 21 CFR 870.5200, describes an external cardiac compressor as a prescription device used to compress the chest periodically to provide blood flow during cardiac arrest, as an adjunct to manual CPR when effective manual CPR is not possible, for example during patient transport, when fatigue may prohibit extended CPR, or when too few EMS personnel are available. For the general category, see CPR machines: types, FDA class and trial evidence.

Who uses a LUCAS device

The 510(k) summary lists the places of use as on the scene, during patient movement, during transportation in road and air ambulances, in hospitals and in catheterization laboratories. In practice that means emergency medical services, hospital resuscitation teams and cardiac catheterization teams. It is a different product from a CPR feedback device, which coaches a human rescuer, and from a defibrillator, which delivers a shock.

How a LUCAS device is built and works

The 510(k) summary describes the LUCAS 3 system as these parts:

  • A Back Plate that sits under the patient.
  • An Upper Part holding a rechargeable LUCAS Battery and the compression mechanism, fitted with a disposable Suction Cup.
  • A Stabilization Strap and a Carrying Case.
  • Optional items: spare battery, power supply, 12 to 28 V DC car cable, PCI Back Plate, charger, Anti Slip Slim Back Plate and trolley.

The summary states that the actuator is a suction cup moved by the nut of a ball screw drive, which an electric motor turns through a cog belt transmission. The device contains four processors (control, protective, charger and communication). The battery is documented as complying with IEC 62133:2012.

LUCAS 3 and earlier models: the FDA clearance record

All LUCAS clearances are Traditional 510(k) submissions by Jolife AB under product code DRM (“Compressor, Cardiac, External”), regulation 21 CFR 870.5200, Class II, per the openFDA database.

Model 510(k) number Decision date What the record states
LUCAS K053403 2006-02-01 Original clearance
LUCAS (modification) K062401 2006-09-28 Modification of the original
LUCAS 2 K090422 2009-06-17 Cleared as LUCAS 2
LUCAS 3 K161768 2016-11-09 Cleared as LUCAS 3
LUCAS 3, v3.1 K173553 2018-02-08 Same device as LUCAS 3, with the option to change factory defaults (rate, depth, ventilation alerts, ratio) wirelessly when not in treatment

The v3.1 summary says those defaults should be changed only under the direction of a physician knowledgeable in cardiopulmonary resuscitation, and that event data can be sent to Physio-Control tools (LIFENET) when the device is powered off.

LUCAS 3 specifications

These values come from the LUCAS 3 instructions for use (Rev G, 2017, version 3.0).

Item Stated value
Patients Adults; sternum height 6.7 to 11.9 in (170 to 303 mm); maximum chest width 17.7 in (449 mm); not restricted by patient weight
Compression depth 2.1 ± 0.1 in (53 ± 2 mm) when sternum height is over 7.3 in (185 mm); 1.5 to 2.1 in (40 to 53 mm) for smaller patients
Rate and duty cycle 102 ± 2 per minute; 50 ± 5%
Modes 30:2 (30 compressions then a 3-second ventilation pause) or continuous
Assembled size 22.0 × 20.5 × 9.4 in (56 × 52 × 24 cm), H × W × D
Weight with battery 17.7 lb (8.0 kg)
Deployment time Under 20 seconds
Operating temperature 32 to 104 °F (0 to 40 °C); humidity 5 to 98% non-condensing
Ingress protection IP43 device, IP44 battery
Power 12 to 28 V DC input; internal battery; defibrillator-proof type BF

MRI: the AccessGUDID record for the LUCAS 3 (DI 00883873762370) states that labeling does not contain MRI safety information, so this page makes no MRI compatibility claim. The same record lists it as not single-use, not sterile and not labeled with latex.

Handling basics

  • The device runs a self-test at power on, and the instructions recommend keeping a spare charged battery.
  • Changing rate, depth or ventilation defaults is a clinical-governance decision, per the v3.1 summary.
  • Use is governed by the manufacturer’s instructions and the user’s clinical protocols; this page gives no placement or technique steps.

Common mistakes

  • Treating it as a replacement for manual CPR. The regulation and clearances describe an adjunct for when effective manual CPR is not possible.
  • Assuming MRI compatibility. The GUDID record carries no MRI safety labeling.
  • Confusing it with a feedback device or a defibrillator, which do different jobs.
  • Assuming specifications from one version apply to another. The table above is for LUCAS 3 version 3.0; check the instructions for the model in hand.

FAQ

What is a LUCAS device?

A LUCAS device is a battery-powered mechanical chest compression system from Jolife AB and Physio-Control (Stryker). The FDA classifies it as an external cardiac compressor (Class II, product code DRM) for adults in cardiac arrest, as an adjunct to manual CPR when effective manual CPR is not possible.

What is the LUCAS device?

“The LUCAS device” usually means the LUCAS 3, the most recent model in the FDA clearance record, cleared in 2016 (K161768) and updated as version 3.1 in 2018 (K173553). It uses a suction cup driven by an electric motor to compress the chest, at a stated rate of 102 per minute and a depth of 1.5 to 2.1 in depending on patient size.

What is the LUCAS 3?

It is the third LUCAS generation, after the original 2006 device and the LUCAS 2 cleared in 2009. See the clearance table above.

Sources

Related: what is a crash cart and FDA 510(k) premarket notification.

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