(260 days)
Not Found
No
The description focuses on pressure sensing, a peristaltic pump, and control logic based on preselected target pressure, which are traditional engineering principles, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
Yes
The device is used to reduce intrathecal pressure by draining cerebrospinal fluid, which is a direct therapeutic intervention.
No
Explanation: The device is described as a CSF drainage system that controls and monitors CSF pressure. While it monitors physical parameters (CSF pressure and flow), its primary function is therapeutic (drainage) rather than providing information for diagnosis of a disease or condition. It is used to "reduce intrathecal pressure" in "selected patients," implying patients already diagnosed with a condition requiring CSF drainage.
No
The device description explicitly states it consists of a pump, a disposable drainage tube set, and pressure sensors, which are hardware components.
Based on the provided information, the LiquoGuard 7 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the "external drainage of cerebrospinal fluid (CSF)" and "monitors CSF pressure and cerebrospinal fluid flow during CSF drainage". This involves interacting directly with the patient's body (draining fluid from the brain or spinal cord) and monitoring physiological parameters.
- Device Description: The device is a "CSF Drainage System" consisting of a pump and tubing set that connects to a drainage catheter inserted into the patient. It measures pressure and operates a pump to drain fluid.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The LiquoGuard 7 does not examine specimens in vitro (outside the body); it interacts with and drains fluid in vivo (within the body).
The LiquoGuard 7 is a medical device used for therapeutic and monitoring purposes related to cerebrospinal fluid drainage, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LiquoGuard 7 is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intrathecal pressure. The LiquoGuard 7 controls CSF pressure using pressure sensors and a pump and also monitors CSF pressure and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
Cerebrospinal fluid (CSF) drainage and pressure monitoring in lumbar and ventricular applications is the "gold standard" for cases involving trauma, post-operation, shunt infection, subarachnoid hemorrhage (SAH) therapy, neurophysiological monitoring during vascular surgery (e.g. TAA and TAAA) and normal-pressure hydrocephalus (NPH) diagnosis.
The LiquoGuard 7 CSF Drainage System consists of a pump and a corresponding disposable drainage tube set, including two pressure sensors. The dynamic range of this system is from -75 mmHg to +100 mmHg. The drainage tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via a 3way stopcock and the LiquoGuard 7 device via cable connector. The device continuously measures the pressure of CSF due to the fluid column inside the tube and operates the peristalticpump of LiguoGuard 7 whenever the current patient's CSF pressure is higher than a preselected target pressure. Thus the LiguoGuard 7 combines CSF drainage and intracranial pressure (ICP) monitoring like the predicate device, the LiquoGuard CSF System, with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient's mobility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral or third ventricle of the brain or lumbar subarachnoid space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The LiquoGuard 7 has the same indication for use as the predicate devices (measurement and drainage of CSF). In addition, the LiquoGuard 7 tubing set is made from the same materials as the predicate devices, and because the risks associated with the surgical insertion of a CSF drain are not dependent on the CSF drainage system chosen, no new safety or effectiveness concerns are introduced over the predicate devices. Please refer to Table 3 for the list of bench tests – there you find a list of all bench tests that have been performed.
The test series exhibits a very wide range of performance tests and all necessary and required tests for the LiquoGuard 7 were appropriate performed and all tests passed according to the predetermined pass/fail criteria. Particularly highlighting are tests which serve to check the pressure and alarm systems. For this purpose, a plurality of measurements has been carried out to verify the critical components.
Study Type: Bench Tests
Accuracy of measured and displayed pressure:
Test method summary: Verify precision of displayed pressure at various pump rates and pressure loads. Criterion: Deviation of displayed pressures less than ± 2mmHg to water column.
Results: All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Endurance test with in-vitro simulated patient:
Test method summary: Verify long term stability of the device with simulated patient > 30 days (includes 3 tube set changes). Criterion: No malfunction of the device.
Results: All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Verify pump stopping:
Test method summary: Verify reliability of pump stopping with negative pressure at different flow rates. Criterion: Pump stops at the predefined pressure level Pmin.
Results: All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Pressure stability while patient movement:
Test method summary: Verify device function depending of pressure sensor position. Criterion: Displayed pressure changes with a deviation of ± 1mmHg while movement.
Results: All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Minimum and maximum flow rate and accuracy of the measured and displayed volume at adjusted flow rate:
Test method summary: Verify accuracy of the total volume measurement at different pump rates. Deviations of the real flow from the adjusted flow and deviations of the displayed flow and the actual flow are measured. Criterion: Deviations are smaller than ± 15%.
Results: All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
AAMI NS28:1988 (Revision 2010):
Test method summary: Verify all applicable requirements of AAMI NS28:1988 (3.1.2.1, 3.1.2.2, 3.1.2.3, 3.1.3 and 3.2). Criterion: According to AAMI NS28:1998 (Revision 2010).
Results: All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Alarm: pressure too low:
Test method summary: Verify pressure alarms: PCSF stays below the defined limit of PLOW an alarm has to activate. Increase of PCSF > PLOW alarm has to deactivate automatically. Criterion: Alarm is issued reliably after intentional delay of 20 seconds.
Results: All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Alarm: pressure too high:
Test method summary: Verify pressure alarms: PCSF stays over the defined limit of PHIGH an alarm has to activate. Increase of PCSF
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
Möller Medical GmbH Ms. Juliane Dragon Regulatory Affairs Manager Wasserkuppenstr. 29-31 Fulda, Hessen 36043 Germany
Re: K150898
Trade/Device Name: LiquoGuard 7 Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: November 12, 2015 Received: November 20, 2015
Dear Ms. Dragon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150898
Device Name LiquoGuard 7
Indications for Use (Describe)
The LiquoGuard 7 is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intrathecal pressure. The LiquoGuard 7 controls CSF pressure using pressure sensors and a pump and also monitors CSF pressure and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
1. Submitter
| Submitter: | Möller Medical GmbH
Wasserkuppenstraße 29-31
36043 Fulda, Germany
Tel.: +49 (0) 661-94195-0
Fax: +49 (0) 661-94195-850 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: 3006611221 | |
| Contact Person: | Grant Geckeler
Free lance consultant
1612 Jenks Drive
Corona, CA 92880
Phone: +1 858 603 1838
E-mail: grant.geckeler@gmail.com |
| Date Prepared: | March 24, 2015 |
2. Device
| Trade name: | LiquoGuard 7
Consists of: LiquoGuard 7 pump and LiquoGuard 7
disposable drainage tube sets |
|-----------------------|--------------------------------------------------------------------------------------------------|
| Common or Usual Name: | External CSF Drainage System |
| Classification Name: | Shunt, Central Nervous System and Components (21 CFR
882.5550) |
| Regulatory Class: | II |
| Product Code: | JXG |
3. Predicate Device
The Möller Medical LiquoGuard 7 is substantially equivalent to the LiquoGuard CSF System listed below with regard to intended use, design, operating principles, materials, CSF pressure monitoring, semiconductor sensor principle, display, alarm functions and data recording.
LiquoGuard CSF System: K121248
4. Device Description
Cerebrospinal fluid (CSF) drainage and pressure monitoring in lumbar and ventricular applications is the "gold standard" for cases involving trauma, post-operation, shunt infection, subarachnoid hemorrhage (SAH) therapy, neurophysiological monitoring during vascular surgery (e.g. TAA and TAAA) and normal-pressure hydrocephalus (NPH) diagnosis.
4
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The LiquoGuard 7 CSF Drainage System consists of a pump and a corresponding disposable drainage tube set, including two pressure sensors. The dynamic range of this system is from -75 mmHg to +100 mmHg. The drainage tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via a 3way stopcock and the LiquoGuard 7 device via cable connector. The device continuously measures the pressure of CSF due to the fluid column inside the tube and operates the peristalticpump of LiguoGuard 7 whenever the current patient's CSF pressure is higher than a preselected target pressure. Thus the LiguoGuard 7 combines CSF drainage and intracranial pressure (ICP) monitoring like the predicate device, the LiquoGuard CSF System, with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient's mobility.
5. Indications for Use
The LiguoGuard 7 is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intrathecal pressure. The LiquoGuard 7 controls CSF pressure using pressure sensors and a pump and also monitors CSF pressure and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions.
6. Comparison of Technological Characteristics with the Predicate Device
The LiquoGuard 7 is working equivalently to the predicate device, with the additional safety that, using LiquoGuard 7, a bleeding or swelling of the brain may be detected in many cases (flow control and alarm). The principles of measurement are exactly the same as both systems measure the pressure of the surrounding liquid.
The LiguoGuard 7 behaves comparable to the predicate device. It is able to sound and display alarms to operators, is portable, can be used while not connected to the mains, records and stores data and can be connected to bedside monitoring systems.
The LiquoGuard 7 and its predicate device both utilize components such as sterile tubing's, pressure sensors, CSF drainage bags, microcontroller and interfaces. The LiquoGuard 7 tubing set is made from polyvinyl chloride, the same material that the predicate devices tubing sets are made of, along with numerous marketed IV administration tubing sets. The LiquoGuard 7 tubing set has two pressure transducers, such as the predicate device tubing's. Both systems include CSF drainage bags to collect drained CSF.
Both systems display values, curves and trends on a built in monitor, sound alarms via speaker and light emitting LED, are operated by pressing foil keypad buttons or a touch display and are basically computer and software controlled.
Both systems measure intrathecal pressure the same way; critical intrathecal pressure increase in the patient can be recognized, thereby enabling the required diagnostic and treatment steps to be taken. Since the pressure measurement in systems is done via piezo-resistive pressure sensors that are attached at reference height to the patient, there is no difference in intrathecal pressure measurement. Additional details for comparing these CSF Systems are contained in Table 1 and Table 2.
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| Product
Component | Predicate device
(LiquoGuard CSF
System) | LiquoGuard 7 |
|----------------------|------------------------------------------------|--------------|
| Tube set disposable | ● | ● |
| CSF drainage bag | ● | ● |
| Pressure transducer | ● | ● |
| Micro controller | ● | ● |
| Software operated | ● | ● |
| Data storage | ● | ● |
| Screen | ● | ● |
| Ports | ● | ● |
| Casing | ● | ● |
| Power supply | ● | ● |
Table 1: System Comparison
Table 2: Device Comparison
| Predicate device | LiquoGuard 7 | |
|---|---|---|
| Indication | External drainage of | |
| cerebrospinal fluid (CSF) from | ||
| the lateral ventricles of the | ||
| brain or the lumbar | ||
| subarachnoid space to reduce | ||
| intracranial pressure and | ||
| measurement of CSF pressure. | External drainage of | |
| cerebrospinal fluid (CSF) from | ||
| the lateral ventricles of the brain | ||
| or the lumbar subarachnoid | ||
| space to reduce intracranial | ||
| pressure and measurement of | ||
| CSF pressure. | ||
| CSF sterile tubing set with | ||
| pressure sensor and | ||
| drainage bag | Tubing material: Polyvinyl | |
| chloride (PVC). | ||
| Pressure sensor: Dual | ||
| transducers. | ||
| CSF Collection Bag: 500ml. | Tubing material: Polyvinyl | |
| chloride (PVC). | ||
| Pressure sensor: Dual | ||
| transducers. | ||
| CSF Collection Bag: 500ml. | ||
| Pressure controlling | ||
| mechanism | Based on pressure equivalence | |
| (Pascal's law of fluid statics) | ||
| between patient and pressure | ||
| sensors inside the tubing. | ||
| From the sensor location, | ||
| drainage is performed using a | ||
| peristaltic pump controlled by | ||
| the sensed pressure inside the | ||
| tubing. | Based on pressure equivalence | |
| (Pascal's law of fluid statics) | ||
| between patient and pressure | ||
| sensors inside the tubing. | ||
| From the sensor location, | ||
| drainage is performed using a | ||
| peristaltic pump controlled by | ||
| the sensed pressure inside the | ||
| tubing. | ||
| Height alignment of patient | ||
| and device | Device can be positioned | |
| arbitrarily, only the pressure | ||
| sensor needs to be aligned. | Device can be positioned | |
| arbitrarily, only the pressure | ||
| sensor needs to be aligned. | ||
| Device adjusting fluid flow | LiquoGuard CSF System | |
| peristaltic pump controlled by | ||
| pressure at sensor location. | LiquoGuard 7 peristaltic pump | |
| controlled by pressure at sensor | ||
| location. | ||
| Predicate device | LiquoGuard 7 | |
| Monitoring functions | Drained volume and pressure | |
| curve inside tubing (equal to | ||
| intracranial pressure unless | ||
| blockage) are monitored and | ||
| recorded by LiquoGuard CSF | ||
| System. | Drained volume and pressure | |
| curve inside tubing (equal to | ||
| intracranial pressure unless | ||
| blockage) are monitored and | ||
| recorded by LiquoGuard 7. | ||
| Alarm functions enhancing | ||
| patient safety | Many alarm functions | |
| integrated in the system: |
- Pressure too high.
- Pressure too low.
- Physiological pressure
pulsation lost. - Pressure remains constant for
too long. - Dual sensors deviate in
readings (defective sensor). - Watchdog or main controller
does not respond to each
other's requests (device or
software malfunction). - Battery low | Many alarm functions integrated
in the system: - Pressure too high.
- Pressure too low.
- Physiological pressure
pulsation lost. - Pressure remains constant for
too long. - Dual sensors deviate in
readings (defective sensor). - Watchdog or main controller
does not respond to each other's
requests (device or software
malfunction). - Battery low
- Sensor difference ICP vs.
PCSF - No ICP sensor connected
- High Flow Alarm
- Low Flow Alarm |
| Measured pressure range | -15mmHg to +75mmHg. | -75mmHg to +100mmHg |
| Physical dimensions | 315mm x 210 mm x 280 mm (H
x W x D).
4.8 kg. | 145mm x 238.1mm x 212.8mm
(H x W x D).
3.7 kg. |
| Displayed parameters | Actual ICP value, ICP
waveform, ICP trend.
Display resolution of 1 mmHg. | Actual ICP and PCSF value, ICP
and PCSF waveform, ICP and
PCSF trend.
Display resolution of 1 mmHg. |
| Sensor type | Dual transducer. | Dual transducer. |
| Scheduled preventive
maintenance | Every 12 months | Every 12 months |
| Battery | Rechargeable sealed lead acid.
Operation time: 3h. | Rechargeable Lithium Ion.
Operation time: 2h. |
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510(k) Summary
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7. Performance Data
The LiquoGuard 7 has the same indication for use as the predicate devices (measurement and drainage of CSF). In addition, the LiquoGuard 7 tubing set is made from the same materials as the predicate devices, and because the risks associated with the surgical insertion of a CSF drain are not dependent on the CSF drainage system chosen, no new safety or effectiveness concerns are introduced over the predicate devices. Please refer to Table 3 for the list of bench tests – there you find a list of all bench tests that have been performed.
The test series exhibits a very wide range of performance tests and all necessary and required tests for the LiquoGuard 7 were appropriate performed and all tests passed according to the predetermined pass/fail criteria. Particularly highlighting are tests which serve to check the pressure and alarm systems. For this purpose, a plurality of measurements has been carried out to verify the critical components.
| Test | Test method summary | Results |
|---|---|---|
| Accuracy of | ||
| measured and | ||
| displayed | ||
| pressure | Verify precision of displayed pressure at | |
| various pump rates and pressure loads. | ||
| Criterion: Deviation of displayed | ||
| pressures less than ± 2mmHg to water | ||
| column. | All samples passed the | |
| acceptance criteria. In | ||
| relevancy of the test results the | ||
| substantial equivalence is | ||
| verified. | ||
| Endurance test | ||
| with in-vitro | ||
| simulated | ||
| patient | Verify long term stability of the device | |
| with simulated patient > 30 days | ||
| (includes 3 tube set changes). | ||
| Criterion: No malfunction of the device. | All samples passed the | |
| acceptance criteria. In | ||
| relevancy of the test results the | ||
| substantial equivalence is | ||
| verified. | ||
| Verify pump | ||
| stopping | Verify reliability of pump stopping with | |
| negative pressure at different flow rates. | ||
| Criterion: Pump stops at the predefined | ||
| pressure level Pmin- | All samples passed the | |
| acceptance criteria. In | ||
| relevancy of the test results the | ||
| substantial equivalence is | ||
| verified. | ||
| Pressure | ||
| stability while | ||
| patient | ||
| movement | Verify device function depending of | |
| pressure sensor position. | ||
| Criterion: Displayed pressure changes | ||
| with a deviation of ± 1mmHg while | ||
| movement. | All samples passed the | |
| acceptance criteria. In | ||
| relevancy of the test results the | ||
| substantial equivalence is | ||
| verified. | ||
| Minimum and | ||
| maximum flow | ||
| rate and | ||
| accuracy of the | ||
| measured and | ||
| displayed | ||
| volume at | ||
| adjusted flow | ||
| rate | Verify accuracy of the total volume | |
| measurement at different pump rates. | ||
| Deviations of the real flow from the | ||
| adjusted flow and deviations of the | ||
| displayed flow and the actual flow are | ||
| measured. | ||
| Criterion: Deviations are smaller than | ||
| ± 15%. | All samples passed the | |
| acceptance criteria. In | ||
| relevancy of the test results the | ||
| substantial equivalence is | ||
| verified. | ||
| AAMI | ||
| NS28:1988 | ||
| (Revision 2010) | Verify all applicable requirements of | |
| AAMI NS28:1988 (3.1.2.1, 3.1.2.2, | ||
| 3.1.2.3, 3.1.3 and 3.2). | ||
| Criterion: According to AAMI NS28:1998 | ||
| (Revision 2010). | All samples passed the | |
| acceptance criteria. In | ||
| relevancy of the test results the | ||
| substantial equivalence is | ||
| verified. | ||
| Test | Test method summary | Results |
| Alarm: pressure | ||
| too low | Verify pressure alarms: PCSF stays below | |
| the defined limit of PLOW an alarm has to | ||
| activate. Increase of PCSF > PLOW alarm | ||
| has to deactivate automatically. | ||
| Criterion: Alarm is issued reliably after | ||
| intentional delay of 20 seconds. | All samples passed the | |
| acceptance criteria. In | ||
| relevancy of the test results the | ||
| substantial equivalence is | ||
| verified. | ||
| Alarm: pressure | ||
| too high | Verify pressure alarms: PCSF stays over | |
| the defined limit of PHIGH an alarm has to | ||
| activate. Increase of PCSF |