GALAXY MEDICAL CENTAURI GTI-00022-03 Electrosurgical System User Manual

GALAXY MEDICAL CENTAURI GTI-00022-03 Electrosurgical System

Product Information

The CENTAURITM Connect Model GTI-00022-03 is a component of the CENTAURI System, an electrosurgical system used in conjunction with cardiac ablation catheters to deliver energy to cardiac tissue. It is used to connect a catheter to the CENTAURI Generator as well as to an electroanatomic mapping (EAM) system and EP recording system amplifiers. The CENTAURI Connect isolates the energy output of the CENTAURI Generator from the EP recording and EAM systems. It should not come in contact with the patient and therefore is not provided sterile.

The CENTAURI Connect comes with a power cord and instrumentation cables for powering the CENTAURI Connect and interconnecting various instrumentation signal lines of the System. The interconnect power and instrumentation cables have been specified and tested for use with the CENTAURI System and should not be substituted with any non-Galaxy Medical specified cables.

Product Usage Instructions

Before using the CENTAURITM Connect Model GTI-00022-03, please refer to the CENTAURI Generator User Manual for full information and instructions on the CENTAURI Generator.

WARNING: Do not substitute cables, equipment, or disposables with any cables, equipment, or disposables not provided or specified by Galaxy Medical, Inc. Doing so could potentially damage the system or cause injury.

To use CENTAURI Connect, follow these steps:

1. Connect the catheter to the CENTAURI Generator (see the CENTAURI Generator User Manual).

2. Connect the electroanatomic mapping (EAM) system and EP
   recording system amplifiers to the CENTAURI Connect.

3. Ensure that the CENTAURI Connect is powered on by connecting it to AC mains using the power cord provided.

4. Follow the instructions for use provided in the CENTAURI Generator User Manual for delivering energy to cardiac tissue.

NOTE: The CENTAURI Connect is not intended to come in contact with the patient and should not be provided sterile.

Copyright © 2022 Galvanize Therapeutics, Inc. All rights reserved. CENTAURI is a trademark of Galvanize Therapeutics, Inc. Patents pending in the United States and internationally. GALAXY Medical is a trademark of Galvanize Therapeutics, Inc.

Introduction

List of Symbols
The following is a list of symbols used on the CENTAURI Connect and throughout this user manual.

• Catalogue number
• Serial number
• Follow instructions for use
• Manufacturer
• Date of manufacture
• Alternating current
• Power On (Connect to AC mains)
• Power Off (Disconnect from AC mains)
• Potential equalization terminal
• Fuse information
• Caution
• Warning
• WEEE compliant
• CE marking
• Importer

• Defibrillator proof type CF applied part
• Electric shock hazard
• Foot switch
• Digital signal cable connection
• Do not use if packaging is damaged
• Keep dry during shipping
• Humidity limits during transportation
• Temperature limits during transportation
• Atmospheric pressure limits during shipping
• Mapping system connections
• Catheter connections
• Electrogram output connection
• Medical device
• Authorized representative in the European Community
• Swiss Authorized representative

System Overview

• The CENTAURI™ System is an electrosurgical system used in conjunction with cardiac ablation catheters to deliver energy to cardiac tissue. The CENTAURI System is comprised of the CENTAURI Generator (“Generator”), the CENTAURI Connect, and the
• IVY Cardiac Monitor
  (“Cardiac Monitor”). This user manual describes the use of the CENTAURI Connect (GTI-00022-03). For full information and instructions on the CENTAURI Generator, see the CENTAURI Generator User Manual.

Application Specification Summary

• The CENTAURI System is intended to be used by a healthcare professional within an Electrophysiology (EP) Laboratory to treat patients in need of conventional cardiac ablation procedures. A cardiac ablation catheter is connected to the CENTAURI System and positioned at the target ablation site within the heart. The user presses and holds the foot switch to deliver energy to the target tissue resulting in tissue ablation. The user then repositions the catheter at subsequent target ablation sites and the process is repeated until all targeted tissue is treated.

CENTAURI Connect (GTI-00022-03)

• CENTAURI Connect is used to connect a catheter to the CENTAURI Generator (see the CENTAURI Generator User Manual) as well as to an electroanatomic mapping (EAM) system and EP recording system amplifiers. CENTAURI Connect isolates the energy output of the CENTAURI Generator from the EP recording and EAM systems. The Connect is not intended to come in contact with the patient and therefore is not provided sterile.

Interconnect power and instrumentation cables

• The CENTAURI Connect is provided with a power cord and instrumentation cables for powering the CENTAURI Connect and for interconnecting various instrumentation signal lines of the System.
• The interconnect power and instrumentation cables have been specified and tested for use with the CENTAURI System and should not be substituted with any non-Galaxy Medical specified cables.

Other Devices Used with the CENTAURI Connect

• WARNING: Do not substitute cables, equipment, or disposables with any cables, equipment, or disposables not provided or specified by Galaxy Medical, Inc. Doing so could potentially damage the system or cause injury.
• The CENTAURI Connect is designed to work with the devices listed in the following table.

Sensor Enabled

A-TCSE-XX*

Cardiac Ablation Catheter| Biosense Webster| THERMO COOL SMARTTOUCH™ Catheter D13360X or D13270X
Cardiac Ablation Catheter| Boston Scientific| INTELLANAV STABLEPOINT™ Ablation

Catheter

M004 ERFSDS9620 0 or M004 ERFSDS9620K2 0

Electrophysiology Cable| Abbott (St. Jude Medical)| Electrophysiology Cable 1804-S IBI-85809
Interface Cable| Biosense Webster| CARTO3 System Interface Cable CR3434CT
Interface Cable| Boston Scientific| INTELLANAV STABLEPOINT Catheter Cable M004 RARC03 0
Interface Cable| Galaxy Medical| Compatibility Cable, BW ThermoCool ST GTI-00038

• Applicable Abbott product codes include A-TCSE-D, A-TCSE-F, A-TCSE-J, A-TCSE-DD,
• A- TCSE-DF, A-TCSE-FF, A-TCSE-FJ, and A-TCSE-JJ.
• Applicable Biosense Webster product codes include D133601, D133602, D133603, D132701, D132702, D132703, D132704, D132705.

Compatible Mapping Systems

• The CENTAURI Connect is designed for use with the cardiac mapping systems listed in the following table.

• While the foot switch is depressed, ablation catheter visualization and contact force measurement will be unavailable. In addition, the cardiac mapping system may display warnings (e.g., connection to the ablation catheter is lost). If warnings on the cardiac mapping system do not resolve when the foot switch is released, refer to the user manual of the respective mapping system.
• When the CENTAURI System is used with a mapping system, an increase to contact force measurement may be observed within published manufacturer tolerances.

Intended Purpose and Training

Intended Purpose

• The CENTAURI System is intended for use in intracardiac ablation procedures with commercially available compatible ablation catheters for the treatment of atrial fibrillation. Refer to the CENTAURI Generator User Manual and the instructions for use (IFU) supplied with the cardiac ablation catheter to be used with the CENTAURI System.

Training

• The setup of the CENTAURI System shall be performed by qualified Galaxy Medical personnel. The CENTAURI System may be used only by medical personnel trained and experienced in the techniques of electrophysiology. Before using the CENTAURI System, review this User Manual thoroughly and completely. For further information, please contact Galaxy Medical, Inc.

Warnings and Precautions

• THIS USER MANUAL SHOULD BE READ IN CONJUNCTION WITH THE IFU OF A COMPATIBLE CATHETER AND THE CENTAURI GENERATOR USER MANUAL BEFORE USING THE CENTAURI SYSTEM. FAILURE TO FOLLOW INSTRUCTIONS OR FAILURE TO HEED WARNINGS OR PRECAUTIONS MAY RESULT IN HARM TO THE PATIENT.

1. Hazardous electrical output. The CENTAURI System is for use only by qualified medical personnel trained in the use of this equipment.
2. Do not use the CENTAURI System if there are any signs of damage to any of its components. Visually inspect all accessories and verify cables are not damaged.
3. Do not substitute cables, equipment, or disposables with any cables, equipment, or disposables not provided or specified by Galaxy Medical, Inc. Doing so could potentially damage the system or cause injury.
4. Do NOT connect the catheter to the front panel of the CENTAURI Connect when powering on the CENTAURI Generator and preparing it for use. If the catheter is connected to the CENTAURI Connect while preparing the device for use, injury to the operator or the patient could happen.
5. Do not use sharp towel clips or metal instruments to attach cables to drapes. Sharp metal clips can damage electrical cables or provide an unwanted point of contact with the patient’s skin. Overlapping electrical wire around a metal clip creates an electrical transformer that can cause a hazard and may ignite drapes.
6. Cables should never be wrapped around metal instruments, as the current running through them can pass into the metal instrument and may result in harm to the patient and/or operator.
7. Do not use steam or heat sterilization to clean any system component. Do not soak any component in disinfectants or fluids. Do not allow liquid to enter into any of the electrical connections or the interior of any component.
8. To avoid the risk of electric shock, the CENTAURI System must only be connected directly to AC supply mains with protective earth.
9. Do not disassemble the system. Modification of this equipment is not permitted as serious injury to the operator or damage to the unit may result.
10. Electric shock hazard. Do not remove the cover of any equipment or any components from the equipment. Refer servicing to qualified personnel. There are no user-serviceable parts inside the CENTAURI Connect or any of the components of the CENTAURI Connect.
11. Position the connection cables of the ablation catheter in such a way that they do not touch either the patient or other cables. Keep active electrodes that are temporarily not in use at a safe distance from the patient.
12. Interference produced by the operation of the CENTAURI System may adversely influence the operation of other electronic equipment. For patients with cardiac pacemakers or other active implants, interference with the action of the active implant may occur, or the active implant may be damaged. In case of doubt, consult the manufacturer of the device. See the Technical Specifications section for Warnings related to Electromagnetic Compatibility.

Note: Any serious incident that occurs in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

System Connections and Receptacles

CENTAURI Connect

1. MAPPING: Receptacle for connecting the CENTAURI Connect to the compatible mapping system equipment.
2. EGM: Receptacle for electrophysiology cable to provide electrogram (EGM) signals to the mapping and EP recording systems
3. CATHETER (Type CF Applied Part): Connection for compatible catheters.
4. INPUT: Connection to PEF output of the CENTAURI Generator
5. Foot Switch : Receptacle for connecting the foot switch, which is used to activate and deactivate energy delivery.
6. Digital Signal Connection: Receptacle for connecting the digital signal cable between the Generator and CENTAURI Connect.
7. Power Switch: Switch for turning the CENTAURI Connect on and off
8. Fuse Access Panel: Provides access to replaceable fuses
9. Power Cable: Receptacle to connect the Generator to an AC mains power outlet
10. Potential Equalization Terminal: A connection that provides a common electrical ground for other electronic devices used during the procedure

CENTAURI Generator

• Refer to the user manual provided with the CENTAURI Generator for a description of receptacles and connections.

Cardiac Monitor

• Refer to the user manual provided with the Cardiac Monitor for a description of receptacles and connections.

System Setup

• Prior to initial use of the CENTAURI System, the system should be unpacked and set up by qualified Galaxy Medical personnel according to the typical setup as shown in the System Connection Diagram.
• WARNING: Do not use the CENTAURI System if there are any signs of damage to any of its components. Visually inspect all accessories and verify cables are not damaged.
• WARNING: Do not substitute cables, equipment, or disposables with any cables, equipment, or disposables not provided or specified by Galaxy Medical, Inc. Doing so could potentially damage the system or cause injury.

System Connection Diagram

System Power-on Self-test

1. Complete the Pre-Procedure Power-On Sequence as specified in the System Operation section to confirm the system has been set up correctly.

Electrical Safety Inspection

• As applicable, follow any site and / or country specific requirements for equipment qualification for use within the facility prior to use.
• See the Electrical Safety Inspection section for recommended guidance and testing specific to on-site electrical safety testing.

System Operation

• Pre-Procedure Preparation and Power-On Sequence
• Complete the following steps prior to preparing the patient for the cardiac ablation procedure and any time the system is turned off during a procedure.
• WARNING: When powering on the CENTAURI Generator and preparing it for use, do NOT connect the catheter to the CENTAURI Connect. If the catheter is connected to the Generator while preparing the device for use, injury to the operator or the patient could happen.
• WARNING: Do not use sharp towel clips or metal instruments to attach cables to drapes. Sharp metal clips can damage electrical cables or provide an unwanted point of contact with the patient’s skin. Overlapping electrical wire around a metal clip creates an electrical transformer that can cause a hazard and may ignite drapes.
• WARNING: Cables should never be wrapped around metal instruments, as the current running through them can pass into the metal instrument and may result in harm to the patient and/or operator.

1. See the CENTAURI Generator User Manual for power on instructions of the Generator.
2. Power on the CENTAURI Connect module by turning the power switch on the rear panel to the On position. Confirm the status light on the front panel is illuminated.
3. Connect the PEF output of the CENTAURI Generator to the PEF input of the CENTAURI connect.
4. Connect the CENTAURI Connect digital signal output to the CENTAURI Generator.
5. Connect the footswitch to the front panel of the CENTAURI Connect.
6. Connect the cardiac ablation catheter to the CATHETER input of the CENTAURI Connect.
7. Connect the electrophysiology cable from the CENTUARI Connect EGM output to the input of the EP recording system being used.
8. Connect the CENTAURI Connect MAPPING output to the mapping system being used.

Post Procedure

Perform the following steps after the procedure is complete.

1. Disconnect the catheter from the CENTAURI Connect module.
2. Switch the power toggle on the rear of CENTAURI Connect to the Off position.
3. Refer to the Cleaning and Maintenance section for cleaning of the CENTAURI Connect components.
4. For troubleshooting, see the Troubleshooting section in the CENTAURI Generator User Manual.

Cleaning and Maintenance

Cleaning
Clean components of the CENTAURI Connect per the instructions below.
CAUTION: Do not use steam or heat sterilization to clean any system component. Do not soak any component in disinfectants or fluids. Do not allow liquid to enter into any of the electrical connections or the interior of any component.
CENTAURI Connect

1. Disconnect the unit from the wall outlet before cleaning.
2. Wipe the exterior surface of the unit with 70 % to 90 % isopropyl alcohol or an equivalent alcohol-based wipe.
3. Allow all surfaces and connections to dry before reconnecting.

Cables

1. Disconnect all cables from the system components.
2. Wipe down all cables with 70 % to 90 % isopropyl alcohol or an equivalent alcohol-based wipe.
3. Allow cables to dry before reconnecting.

Maintenance

• Do not perform maintenance or service when the CENTAURI Connect is in use with a patient.

Routine Maintenance

• The CENTAURI Connect does not require routine maintenance or servicing.

Electrical Safety Inspection: EN 62353

• Follow test instructions in the appropriate area of the standard. The acceptable limits (normal condition) for the CENTAURI System can be found in Table 1 of Appendix A.

Fuse Replacement

• The CENTAURI Connect has two fuses that can be replaced in the field by qualified personnel. Replace the fuses with the same value fuses (see table below). Replacing with incorrect fuse rating could damage the Connect or create a fire hazard. To replace the fuses, open the fuse access panel on the back of the Connect, remove fuse housing with fuses, and replace the fuses. Reinstall the fuse housing and close the fuse access panel.

Service and Returns

• Should service or repair be necessary, contact a Galaxy Medical representative.

End of Life Disposition

• Do not dispose of CENTAURI System components in the unsorted municipal waste stream. Follow local regulations for proper disposal.

Technical Specifications

• Input Power 100 V – 240 V ~, 50 Hz – 60 Hz universal power supply, 2 A input power rating.
• The power cord is used for removing AC mains power from the unit.
• Dimensions CENTAURI Connect: 48.3 cm wide x 17.8 cm high x 45.7 cm deep
• Weight CENTAURI Connect: 7.5 kg
• Rear Controls Line Power On/Off
• Connections AC Line power, foot switch, catheter connector (x3), mapping connector (x3), pulsed-field generator input, and electrogram output
• Classifications Class 1, Defibrillator Proof – Type CF, IPX0. Applicable general test and electrical safety requirements for Class 1 protection of ANSI AAMI ES60601-1, EN 60601-1, and CAN/CSA C22.2 No. 60601-1. Safety requirements of high-frequency surgical equipment of ANSI AAMI IEC 60601-2-2 and EN 60601-2-2. Electromagnetic compatibility (EMC) requirements of ANSI AAMI IEC 60601-1-2 and EN 60601-1-2.

Environmental Conditions

• Transport or Storage Operating
• Temperature -29 °C to +60 °C 15 °C to 40 °C
• Humidity (non-condensing) 30 % to 85 % 30 % to 70 %
• Atm. Pressure 600 hPa to 1060 hPa 700 hPa to 1060 hPa

Replacement Part Numbers

• WARNING: Do not substitute cables, equipment, or disposables with other cables, equipment, or disposables not provided by Galaxy Medical, Inc. Doing so could potentially damage the system or cause injury.

Electromagnetic Compatibility (EMC)

• The CENTAURI System has been verified to the electromagnetic compatibility requirements of ANSI AAMI IEC 60601-1-2 and EN 60601-1-2.

• This equipment uses non-ionizing radiation for treatment. Interference produced by the operation of high-frequency surgical equipment, such as the CENTAURI Generator, may adversely influence the operation of other electronic medical equipment such as monitors and imaging systems and special precautions should be taken. Portable and mobile RF communications equipment (e.g., cellular phones) can affect electronic medical equipment. The CENTAURI System should be setup and put into service according to the EMC information provided in this section.

• The CENTAURI System is suitable for use in all establishments other than domestic (i.e., residential) and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

• Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals
  (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

• If any of the essential performance characteristics are lost or degraded due to electromagnetic disturbances, the user may see any of the following conditions:

• Distortion and/or lock-up of the generator front panel display screen

• Distortion and/or lock-up of the cardiac synchronization monitor

Warnings

• The CENTAURI System is intended for use by healthcare professionals only. This device may cause radio interference and disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the CENTAURI System or shielding the location. Interference with electronic medical equipment such as monitors and imaging systems is usually resolved or minimized by rearranging the cables such that the unit cables do not overlap with the cables from the monitoring equipment.
• Use of the device adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to confirm that they are operating properly.
• Use of accessories and cables other than those specified and provided by Galaxy Medical, Inc. could result in increased electromagnetic emissions or decreased electromagnetic immunity of the device and result in improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm to any part of the device including cables specified by the manufacturer. Otherwise, degradation of the performance of the device could result.

CENTAURI Connect Cables

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The CENTAURI System is suitable for use in the electromagnetic environment specified below. The user should ensure that it is used in such an environment.

The CENTAURI System is suitable for use in the electromagnetic environment specified below. The user should ensure that it is used in such an environment.

Emissions Test| Compliance| Electromagnetic Environment – Guidance
RF emissions CISPR 11 (EN55011)| Group 1†| When the Generator is in the STANDBY state, radio frequency [RF] energy is only used for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference in nearby electronic equipment.

When Generator is delivering energy, the device must emit electromagnetic energy to perform its intended function.

Nearby electronic equipment may be affected.

RF emissions CISPR 11 (EN55011)| Class A| **** The CENTAURI System is suitable for use in all establishments other than domestic (i.e., residential) and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions EN 61000-3-2| Class A
Voltage fluctuations/flicker emissions

EN 61000-3-3

| ****

Complies

Conducted emissions may exceed limits specified in CISPR 11 by up to 14.2 dB when the system is connected to a compatible mapping system.

Guidance and Manufacturer’s declaration – Electromagnetic Immunity
The information provided within this section is applicable to the CENTAURI System.

The CENTAURI System has been verified and found to be in compliance with the immunity standards at the test levels specified below. It is suitable for use in the electromagnetic environment specified below. For maintaining the Essential Performance of the device with regards to electromagnetic disturbances, the user must ensure it is used in such an environment.

The CENTAURI System has been verified and found to be in compliance with the immunity standards at the test levels specified below. It is suitable for use in the electromagnetic environment specified below. For maintaining the Essential Performance of the device with regards to electromagnetic disturbances, the user must ensure it is used in such an environment.

Immunity test

|

Level Required

|

Level Tested

| Electromagnetic environment – guidance
EN 61000-4-2

Electrostatic discharge (ESD)

| ±8 kV contact

±15 kV air

| ± 8 kV contact

± 15 kV air

| Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
EN 61000-4-3

Radiated, radio- frequency, electromagnetic field immunity

| 80 MHz – 2700 MHz,

3 V/m, 80 % 1 kHz AM

Various per Table 9 of ANSI AAMI IEC 60601-1-2 and EN 60601-1-2.

| 80 MHz – 2700 MHz,

3 V/m*, 80 % 1 kHz AM

As per Table 9 of ANSI AAMI IEC 60601-1-2 and EN 60601-1-2.

| Radio frequency and electromagnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

EN 61000-4-4

Electrical fast Transient/burst

| For AC / DC power ports:

±2 kV

±1 kV for signal ports

| ±2 kV for AC power ports

Equipment does not have DC power ports therefore no test.

Equipment does not have cables > 3 m connected to signal ports

| Mains power quality should be that of a typical commercial or hospital environment.
The CENTAURI System has been verified and found to be in compliance with the immunity standards at the test levels specified below. It is suitable for use in the electromagnetic environment specified below. For maintaining the Essential Performance of the device with regards to electromagnetic disturbances, the user must ensure it is used in such an environment.

Immunity test

|

Level Required

|

Level Tested

| Electromagnetic environment – guidance

EN 61000-4-5

Surge

| For AC / DC power ports:

±1 kV differential mode

±2 kV common mode 1.2/50 µs

| For AC power port:

±1 kV differential mode

±2 kV common mode 1.2/50 µs

Equipment does not have DC power ports therefore no test.

|

Mains power quality should be that of a typical commercial or hospital environment.

EN 61000-4-6

Conducted, radio- frequency immunity

|

For AC / DC power ports, signal ports, and patient ports:

0.15 MHz – 80 MHz,

3 Vrms, 80 % 1 kHz AM, 6

Vrms in ISM/Amateur bands

| For AC power, signal, and patient ports:

0.15 MHz – 80 MHz, 3 Vrms*, 80 % 1 kHz AM, 6 Vrms in ISM/Amateur bands

Equipment does not have DC power ports therefore no test.

|

Radio frequency and electromagnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

EN 61000-4-8

Power frequency magnetic field

|

30 A/m

|

30 A/m

| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
EN 61000-4-11

Voltage dips, short interruptions, and voltage variations on power supply input lines,

U T = AC 230V/50Hz

|

95 % dip in U T for 0.5 cycle

60 % dip in U T for 5 cycles 30 % dip in U T for 25 cycles

95 % dip in U T for 250 cycles

|

95 % dip in U T for 0.5 cycle

60 % dip in U T for 5 cycles 30 % dip in U T for 25 cycles

95 % dip in U T for 250 cycles

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the CENTAURI System requires continued operation during mains power interruptions, it is recommended that the CENTAURI System is powered from an uninterruptible power supply.

EN 61000-4-39

Radiated fields in close proximity, magnetic field

|

134.2 kHz, 2.1 kHz pulse mod, 65 A/m

13.56 MHz, 50 kHz pulse mod, 7.5 A/m

|

134.2 kHz, 2.1 kHz pulse mod, 65 A/m

13.56 MHz, 50 kHz pulse mod, 7.5 A/m

|

Radiated magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Appendix A

Electrical Safety Tests (Optional)
Only qualified individuals should perform electrical safety testing. Measurements should be made per local electrical safety standards.

Note: These tests are not required for planned preventative maintenance
Table 1. Acceptable Safety Test Limits (normal condition) per EN 62353

Protective earth resistance

(resistance between Mains Plug protective earth connector and protectively earthed accessible conductive parts)

|

0.3 ohm

Earth (or Equipment) leakage current (NFPA99/120VAC operation)*| 0.3 mA (300 μA)
Earth (or Equipment) leakage current (all other AC operating voltages)**| 0.5 mA (500 μA)
Enclosure (or Touch) leakage current| 0.1 mA (100 μA)
Patient (or Applied Part) leakage current| 0.01 mA (10 μA)

• Applicable only for the United States.
• Applicable for all geographies outside of the United States.

• ICON (LR) Limited
• South County Business Park Leopardstown, Dublin 18
• D18 X5R3, Ireland
• MedEnvoy Switzerland
• Gotthardstrasse 28
• 6302 Zug
• Switzerland
• Galvanize Therapeutics, Inc.
• 1531 Industrial Road
• San Carlos, CA 94070, USA
• +1 650-268-4252
• MedEnvoy
• Prinses Margrietplantsoen 33 – Suite 123 2595 AM, The Hague
• The Netherlands
• MedEnvoy Switzerland
• Gotthardstrasse 28
• 6302 Zug
• Switzerland

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