Surdial DX Hemodialysis System

K182940 · Nipro Medical Corporation · KDI · Jul 19, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K182940
• Device Name: Surdial DX Hemodialysis System
• Applicant: Nipro Medical Corporation
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jul 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SURDIAL DX Hemodialysis System is indicated for implementing hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.

Device Story

Electromechanical hemodialysis system; performs extracorporeal blood treatment. Inputs: purified water, dialysate concentrates, patient blood via extracorporeal circuit. Operation: quantitative mixing of dialysate; piston pump for ultrafiltration (UF) control; monitors hydraulic and blood circuits. Outputs: treated blood returned to patient; real-time monitoring of venous/arterial pressures, dialysate conductivity, temperature, and air detection. Used in hospitals/clinics by qualified operators. Healthcare providers use output data to manage treatment parameters and ensure patient safety. Benefits: toxin removal and fluid balance for renal failure patients.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), electrical safety/EMC (IEC 60601 series), software verification/validation, and human factors testing.

Technological Characteristics

Electromechanical system; materials include PPS, FKM, PSU, VMQ, PP, PPSU, PTFE, PVDF, FEP, GFRPPS, stainless steel, glass, ceramic. Features piston pump UF control, vacuum deaeration, and ultrasonic air detection. Connectivity via CAN bus. Safety class I, Type BF. Software-controlled fluid flow, mixing, and alarms.

Indications for Use

Indicated for patients with acute and chronic kidney (renal) failure requiring hemodialysis treatment.

Regulatory Classification

Identification

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”

Predicate Devices

• B Braun Dialog+ Hemodialysis System (K083460)

Reference Devices

• NIPRO ELISIO series dialyzer (K131935)
• NIPRO Cellentia series dialyzers (K140191)
• NIPRO Cellentia series dialyzers (K160444)
• NIPRO DISPOSABLE LUER LOCK SYRINGE 10, 20, 30 mL (K944355)

Submission Summary (Full Text)

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July 19, 2019

Nipro Medical Corporation Jessica Oswald-McLeod Director, Quality and Regulatory 3150 NW 107th Ave. Doral, FL 33172

Re: K182940

Trade/Device Name: Surdial DX Hemodialysis System Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: June 14, 2019 Received: June 17, 2019

Dear Jessica Oswald-McLeod:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Carolyn Y. Neuland, Ph.D. Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182940

Device Name Surdial DX Hemodialysis System

#### Indications for Use (Describe)

The SURDIAL DX Hemodialysis System is indicated for implementing hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.

Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Section 5 510(K) SUMMARY

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR §807.92.

### 5.1. Submitter's Information

| Name: | Nipro Medical Corporation |
|-------------------|-----------------------------------------------------------------------------|
| Address: | 3150 NW 107th Ave.<br>Doral FL 33172 USA |
| Phone: | 305-599-7174 |
| Contact Person: | Jessica Oswald-McLeod<br>Director, Quality Assurance and Regulatory Affairs |
| Email: | [e-mail] |
| Preparation Date: | July 19, 2019 |

#### 5.2. Device Name

| Trade Name: | SURDIAL DX Hemodialysis System |
|-----------------------|---------------------------------------------------------------------|
| Common Name: | Dialyzer, High Permeability with or without Sealed Dialysate System |
| Classification Name: | High Permeability Hemodialysis System |
| Regulatory Class: | Class II per 21 CFR §876.5860 |
| Product Code: | KDI |
| Classification Panel: | Gastroenterology/Urology |

### 5.3. Legally Marketed Predicate Device

B Braun Dialog+® Hemodialysis System (K083460) is the predicate for the SURDIAL DX Hemodialysis Machine.

### 5.4. Device Description

The SURDIAL DX Hemodialysis System is a single patient dialysis unit that incorporates the mechanism of mixing and producing of dialysate by quantitative mixing method and the mechanism of ultrafiltration control by use of a piston pump. The SURDIAL DX consists of 4 sections: Panel operating section, Blood circuit control section, Liquid circuit control section and Power source control section. CAN communication is used for communication between each section.

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# 5.4.1. Device Characteristics

The SURDIAL DX Hemodialysis System is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, and alarms.

## 5.4.2. Environment of Use

The SURDIAL DX Hemodialysis System is to be used in hospitals and healthcare facilities by qualified operators.

# 5.4.3. Brief Written Description of the Device

The SURDIAL DX Hemodialysis System has a built-in dialysate preparation system and piston pump ultrafiltration (UF) control system. The SURDIAL DX controls and monitors the hydraulic circuit and extracorporeal blood circuit. It provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit containing the dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the dialysate circuit. The dialysate is mixed with purified water, then heated and degassed for delivery to the dialyzer. During hemodialysis, the venous and arterial blood pressures are monitored.

### Accessories

- Pole and hanger ●
- Tray
- Dialyzer holder
- Chemical solution tank belt
- Potential equalization conductor cable
- Disinfection suction tubes ●
- Blood pressure cuff and hose,
- Nipro Blood Tubing Set A430/V912 with transducer protectors and priming set
- NIPRO ELISIO series dialyzer K131935
- NIPRO Cellentia series dialyzers K140191 and K160444
- NIPRO ULTRA FILTER CF+609N and NIPRO ULTRA FILTER CF+220
- NIPRO DISPOSABLE LUER LOCK SYRINGE 10, 20, 30 mL K944355

### 5.4.5. Materials of Use

The SURDIAL DX Hemodialysis System is composed of the following indirect, permanent contact, externally communicating materials:

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#### Plastic/rubber:

PPS Poly Phenylene Sulfid FKM Fluororubeer PSU Poly Sulfone VMQ Silicone Rubber PP Polypropylene PPSU Poly phenyl Sulfone PTFE Poly Tetra Fluoro Ethylene PVDF Poly Vinylidene Difluoride FEP Fluoropolymer GFRPPS Poly Phenylene Sulfid added glass fiber PPS (CF+PTFE) Poly Phenylene Sulfid added CF and PTFE

Stainless Steel Glass Ceramic

The hydraulic lines of the machines are in contact with the dialysate circuit. The dialysate circuit has prolonged, indirect blood contact. Biocompatibility testing was conducted on the contacting materials.

#### 5.6. Indications for Use

The SURDIAL DX Hemodialysis System is indicated for implementing and monitoring hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.

### 5.7. Comparison of Technological Characteristics with the Predicate Device

A comparison of the technological characteristics of the SURDIAL DX Hemodialysis Machine with the B. Braun Dialog+ Hemodialysis Machine predicate device is provided in the following table.

| Item of<br>Comparison | Subject Device:<br>SURDIAL DX | Predicate Device: B:<br>Braun Dialog+ | Discussion of<br>differences |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Specification | | | |
| Water supply | Water suitable<br>for dialysis per | Water suitable for<br>dialysis | Same |
| Item of<br>Comparison | Subject Device:<br>SURDIAL DX | Predicate Device: B<br>Braun Dialog+ | Discussion of<br>differences |
| | ANSI / AAMI<br>13959:2014 | | |
| Water supply<br>Pressure range | 0.5 – 7.4 bar | 0.5 - 6 bar | Subject device can<br>handle a larger range<br>of water supply<br>pressure, controlled<br>by regulator. No<br>impact on safety or<br>effectiveness. |
| Water supply<br>Temperature<br>range | 5 - 30 °C / 41-<br>86 °F | 10-30 °C /50-86 °F | Similar. The dialysis<br>fluid is controlled<br>with a heater. No<br>impact on safety or<br>effectiveness |
| Water supply<br>Alarm "No<br>water" | Internally<br>monitored by<br>pressure sensor<br>and flow<br>regulator | from separate<br>monitoring device | Similar. No impact on<br>safety or<br>effectiveness. |
| Concentrate<br>supply | 5 to 98 kPa<br>(0.05 - 0.98 bar) | from container or<br>central supply 0 - 1<br>bar | Similar. No impact on<br>safety or<br>effectiveness. |
| Extracorporeal circulation | | | |
| Blood pump | 2-roller<br>SDX only<br>available for 8/12<br>mm pump tube | 2-roller pump with<br>automatic motor<br>switch-off when lid<br>is opened,<br>backstop, low<br>hemolysis.<br>For 8/12 mm or<br>(optional) 7/10 mm<br>pump tubes | SDX only available for<br>8/12 mm pump tube |
| Blood pump<br>pumping rate | 0, 10 to 600<br>mL/min (5<br>mL/min<br>increment) | 50 - 600 mL/min<br>(8/12 mm)<br>50 - 400 mL/min<br>(7/10 mm) | Similar with finer<br>increments of<br>adjustments. |
| Item of<br>Comparison | Subject Device:<br>SURDIAL DX | Predicate Device: B<br>Braun Dialog+ | Discussion of<br>differences |
| | | Adjustable in 10 mL<br>steps | No impact on safety<br>or effectiveness. |
| Tolerance<br>interval | < 10 % for<br>blood pressure<br>up to -200<br>mmHg | < 10 % for blood<br>pressure up to -150<br>mm Hg<br>Tolerance between<br>10% and 25% for<br>blood pressure up<br>to -200 mmHg | Better control, tighter<br>tolerance. |
| Working<br>pressure range | Inlet pressure up<br>to: -500 mmHg<br>Max. outlet<br>pressure<br>(pumping<br>pressure) :<br>+500 mmHg | Intake pressure up<br>to –390 mmHg<br>Pumping pressure<br>0 – 1725 mmHg | Represents pump<br>pressure which is<br>sufficient for<br>maximum arterial and<br>venous pressure<br>clinical requirements<br>and capable of<br>meeting alarm<br>requirements. also<br>safe for use<br>considering maximum<br>transmembrane<br>pressure (TMP) of the<br>dialyzer which is<br>limited to max 500<br>mmHg. |
| Heparin pump | Nipro syringe<br>10 mL, 20 mL,<br>30 mL | 10 – 30 mL syringes | Same |
| Heparin pump<br>pumping rate | 0.0 to 10.0 mL/h<br>(0.1 mL/h<br>increment)<br>Default 2.0 ml/h<br>Bolus<br>10 mL: Approx.<br>550 mL/h<br>(Approx. 9<br>mL/min) | 0.1 – 10 mL/h in<br>steps of 0.5 mL/h<br>or 0.1 mL/h,<br>at bolus: 600 mL/h | Similar with greater<br>capacity of bolus,<br>operator selectable.<br>Finer increments of<br>control available to<br>operator. |
| Item of<br>Comparison | Subject Device:<br>SURDIAL DX | Predicate Device: B<br>Braun Dialog+ | Discussion of<br>differences |
| | 20 mL: Approx.<br>900 mL/h<br>(Approx. 15<br>mL/min)<br>30 mL: Approx.<br>1200 mL/h<br>(Approx. 20<br>mL/min) | | |
| Tolerance<br>interval | Flow accuracy +/-<br>10 % | < ±10 % | Same |
| Pressure range | 0 to 450 mmHg | 0 to +480 mmHg | Similar. No impact on<br>safety or<br>effectiveness. |
| Dialysate system | | | |
| Flow (dialysate) | 100 to 800 mL/min<br>(100 mL/min<br>increment) | 300 – 800 mL/min | Similar. Lower flow<br>rate available.<br>No safety or<br>effectiveness impact. |
| DF tolerance at<br>dialysis machine | 0 to +10 % from<br>the set value | ±5 % (of specified<br>value) at 300 - 800<br>mL/min | The SURDIAL DX DF<br>tolerance is selected<br>to comply with<br>IEC60601-2-16 clause<br>201.4.3.103 DIALYSIS<br>FLUID flow |
| Bridging time of<br>protection<br>system | Not bridgeable<br>during dialysis | Not bridgeable via<br>balance chamber<br>filling times during<br>dialysis | Same |
| Ultrafiltration | Volume-<br>controlled via<br>balance<br>chambers,<br>ultrafiltration<br>through<br>ultrafiltration<br>pump UF profile<br>feature<br>incorporated | Volume-controlled<br>via balance<br>chambers,<br>ultrafiltration<br>through<br>ultrafiltration<br>pump<br>Sequential<br>ultrafiltration | Same |
| Item of<br>Comparison | Subject Device:<br>SURDIAL DX | Predicate Device: B<br>Braun Dialog+ | Discussion of<br>differences |
| Operating range | 0 to 4,000 mL/h | 0 - 4,000 mL/h | Same |
| Overall accuracy<br>* | F= Fbal + FUF<br><br>Fbal ± 0.15<br>mL/chamber<br>cycle<br><br>FUF<br>Ultrafiltration<br>pump<br>tolerance <1 % | F= Fbal + FUF<br><br>Fbal ± 0.2<br>mL/chamber cycle<br><br>FUF Ultrafiltration<br>pump tolerance<br><1 %<br><br>* The overall<br>accuracy F is the<br>sum of two<br>different errors: F<br>= Fbal +FUF<br><br>Fbal = balance<br>chamber deviation<br>(measures per<br>chamber cycles<br>and depends on<br>the dialysate flow)<br><br>FUF = UF pump<br>error | Similar |
| Dialysate Temperature | | | |
| Temperature<br>setting range | 34 - 39 °C/93 -<br>102 °F | 33 - 40 °C/91 -<br>104 °F | The SURDIAL DX<br>Temperature setting<br>range is selected to<br>comply with IEC<br>60601-2-16 clause<br>201.12.4.4.102<br>DIALYSIS FLUID and<br>SUBSTITUTION FLUID<br>temperature |
| Temperature<br>tolerance | -0.5 °C to | -0.5 °C to +1.5 °C/<br>+29 °F to 33 °F | Similar. |
| Item of<br>Comparison | Subject Device:<br>SURDIAL DX | Predicate Device: B<br>Braun Dialog+ | Discussion of<br>differences |
| standard<br>ambient<br>temperature | +31 °F to 33 °F | | No impact on safety<br>or effectiveness. |
| Heating power | 1800 W | 1800 W | Same |
| Dialysate conductivity | | | |
| Operating range | Bicarbonate<br>2.4 – 7.0 mS/cm<br>Total dialysate<br>12.5 – 16.5<br>mS/cm | Conductivity<br>bicarbonate 2-4<br>mS/cm, 4-7 mS/cm<br>Overall<br>conductivity<br>12.5 – 16 mS/cm | Similar.<br>No impact on safety<br>or effectiveness. |
| Tolerance | ±0.2 mS/cm or<br>less | ±0.2 mS/cm | Same |
| Measurement | Temperature-<br>compensated<br>(reference<br>temperature<br>25 °C/77 °F) | Temperature-<br>compensated<br>(reference<br>temperature<br>25 °C/77 °F) | Same |
| ABPM blood pressure monitoring | | | |
| Cuff pressure<br>range | 0 - 300 mmHg | 0 – 320 mmHg | Similar.<br>No impact on safety<br>or effectiveness. |
| Inflation<br>pressure during<br>first cuff<br>inflation | 180 mmHg | 200 mmHg | Similar.<br>No impact on safety<br>or effectiveness. |
| Inflation<br>pressure during<br>subsequent<br>measurements | Last SYS pressure<br>+40 mmHg | Last SYS pressure<br>+30 mmHg | Similar.<br>No impact on safety<br>or effectiveness. |
| Blood pressure<br>measurement<br>range | Systolic (SYS)<br>60 – 250 mmHg<br>Average (MAP)<br>45 – 235 mmHg<br>Diastolic (DIA)<br>40 – 200 mmHg | Systolic<br>45 – 280 mmHg<br>MAP 25 – 240<br>mmHg<br>Diastolic<br>15 – 220 mmHg | Similar.<br>No impact on safety<br>or effectiveness. |
| Item of<br>Comparison | Subject Device:<br>SURDIAL DX | Predicate Device: B<br>Braun Dialog+ | Discussion of<br>differences |
| Accuracy | Within ±3 mmHg | ±3 mmHg or ±2% | Same |
| Blood pressure<br>determination<br>time | Typical 25 seconds<br>(Adult with blood<br>pressure 120/80<br>and 80 BPM) | Typical 25 seconds<br>(Adult with blood<br>pressure 120/80<br>and 80 BPM) | Same |
| Pulse rate<br>determination | 40 – 200 bpm | 30 – 240 bpm | Similar.<br>No impact on safety<br>or effectiveness. |
| Pulse rate<br>accuracy | The smaller of<br>±2% or ±2 bpm | ±2% or 2 BPM | Same |
| Overpressure<br>cut-off | In normal<br>operation:<br>300 mmHg<br>In single failure:<br>330 mmHg | 300 mmHg + 10% | Similar.<br>No impact on safety<br>or effectiveness. |
| Time of alarm<br>suppression | < 1 second | < 1 second | Same |
| Deactivation of<br>acoustic signal | 120 seconds | 120 seconds | Same…