LIGER MEDICAL HTU-IFU-001 TC Thermocoagulator Instruction Manual

LIGER MEDICAL HTU-IFU-001 TC Thermocoagulator

Product Information

The Liger Medical Handheld TC Thermocoagulator is a type B thermal coagulator that is designed to treat human tissue lesions by destroying the tissue with high temperatures through tissue contact with an electrically heated probe tip. This compact, portable, and battery-powered device is intended for professional use in hospital and non-hospital professional healthcare locations. The device is reusable and non-sterile and can only be sold by or on the order of a physician due to federal (USA) law restrictions.

User Qualification
The Liger Medical Handheld TC Thermocoagulator must only be used by a physician or medical personnel under the supervision of a physician. The user must have sufficient training in clinical procedures as Liger Medical does not provide any explanation or discussion of clinical procedures.

Indications and Contraindications
The Liger Medical Handheld TC Thermocoagulator is indicated for low-power destruction of human cervical or other tissue lesions. The device should only be used by someone familiar with electrical surgical instruments, and proper precautions should be taken accordingly. The device should not be used near MRI equipment or on external labia and inner vagina. There are no serviceable parts, and no modifications of the equipment are allowed.

How Supplied
The Liger Medical Handheld TC Thermocoagulator comes with a device and no other accessories. The device is battery-operated, portable, and the handle, charging base, and power supply are reusable and should be routinely cleaned with a clean damp cloth or an anti-microbial wipe. The battery should not be submerged in fluid of any type as it may cause an electrical shock to the user.

Service and Maintenance
If any failure has developed, contact Liger Medical to purchase a replacement part or system. The device handle, charging base, and power supply are reusable and should be routinely cleaned. The device should not be submerged in fluid of any type as it may cause an electrical shock to the user.

Handling and Preparation
Before each use, the device should be inspected, and all accessories and connections should be checked to ensure that they function properly. The device should not be placed near high-temperature locations or exposed to water. The battery can be removed by compressing the two locking tabs on the sides near the battery base, releasing the lock, and pulling the battery down and out of the handle.

Product Usage Instructions

1. Before each use, inspect the device and all accessories to ensure that they function properly.
2. The device should not be placed near high-temperature locations or exposed to water.
3. The battery can be removed by compressing the two locking tabs on the sides near the battery base, releasing the lock, and pulling the battery down and out of the handle.
4. Activate the unit by following the steps outlined in the instruction manual.
5. The device should only be used by someone familiar with electrical surgical instruments and proper precautions should be taken accordingly.
6. The device is indicated for low-power destruction of human cervical or other tissue lesions.
7. The device should not be used near MRI equipment or on external labia and inner vagina.
8. After use, clean the device handle, charging base, and power supply with a clean damp cloth or an anti-microbial wipe.

For professional use.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

USER QUALIFICATION
The handheld  tC thermocoagulator (TC) must be used by a physician or by medical personnel under the supervision of a physician. The user must have received sufficient training in clinical procedures. Liger Medical does not discuss or provide explanation of clinical procedures.

CAUTION:
Read all warnings and cautions provided in these instructions before using the TC device.

DESCRIPTION

The Liger Medical handheld tC thermocoagulator (TC) device is used to treat human tissue lesions. It is a type B thermal coagulator which is compact, portable, battery powered device which can be used in hospital and non-hospital professional healthcare locations.

The TC, which is reusable and provided non-sterile, is designed to perform low-power destruction of human cervical or other tissue with high temperatures by tissue contact with an electrically heated probe tip.

Heated Probe Tip
The TC probe tip contains a heating element which is heated to approximately 100°C (212°F) for the destruction of human tissue. The probe tip should only be applied to tissue which is intended to be ablated and care should be taken to avoid touching any other tissue with the heated probe tip. The TC probe shaft is not intended to deliver heat. The probe shaft has a maximum temperature of 43°C (109°F). Contact with the probe shaft should be avoided during the procedure.

INDICATIONS

The is intended tC thermocoagulator for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe.

HOW SUPPLIED
The following components are included with the Liger Medical

• Liger’s tC thermocoagulator Device
• Two Probes: 19mm flat, 19mm nipple, or 16mm flat (preference specified at time of order)
• Two Removable Lithium Ion Battery Packs
• Instructions for Use
• Charging Base with A/C adapter
• Hard Shell Carrying Case

No other accessories are compatible with the TC device.

CONTRAINDICATIONS

The user should be familiar with the use of electrical surgical instruments and should take precautions accordingly.

WARNINGS AND PRECAUTIONS:

• Proper surgical procedures and techniques are the responsibility of the medical professional. Each practitioner must determine the appropriate use of this device for each patient based on medical training, experience, the type of procedure employed, and the benefits and risks associated with device use.
• Always have spare TC probes available in order to replace the equipment in case of a malfunction or break.
• Dispose of expired TC handle and probes according to national and local regulations and guidelines for electrical medical equipment.
• Temperatures at the probe’s distal tip may be hot enough to damage tissue.
• Do not use excessive force or in a manner not consistent with normal instrumentation use.
• Although the TC complies with IEC 60601-1-2:2007 standard for electromagnetic compliance (EMC) for the home healthcare environment, the device may emit electromagnetic radiation that may affect the performance of other electrically powered equipment, or the performance of the device may be affected by electromagnetic radiation from other electrically powered equipment in the vicinity.
• The TC batteries should only be connected to the provided recharging base.
• In some circumstances, potential exists for alternate site burns at points of skin contact (e.g. between the legs or on the external labia and inner vagina).
• To avoid burn, always remove the probe from the handle prior to cleaning.
• The TC device and accessories have not been tested for magnetic resonance imaging (MRI) safety. Avoid use near MRI equipment.
• The Liger Medical TC device contains a lithium-ion battery pack. Please observe the following practices:
  • Do not place the device on or near fires, heaters, other high-temperature locations, or apply heat directly to the unit or battery pack.
  • Do not pierce the unit or battery pack with any sharp objects, strike the unit or battery pack with a hammer, tools, or heavy objects, step on the unit or battery pack, or otherwise damage the unit or battery pack.
  • Do not subject the unit to strong impacts or shocks.
  • Do not expose the unit or battery to water or any other types of liquid, or allow the battery to get wet.
  • Do not leave the unit or battery in direct sunlight, and avoid storing in vehicles in extreme hot weather. Doing so may cause the battery to generate heat, rupture, or ignite. Using the battery in this manner may result in a loss of performance and short battery life.

SERVICE AND MAINTENANCE
There are no serviceable parts. If any failure has developed, contact Liger Medical to purchase a replacement part or system. No modifications of this equipment is allowed.
The TC handle, charging base, and power supply are reusable and should be routinely cleaned with a clean damp cloth or with an anti-microbial wipe.

WARNING:
Do not submerge the TC handle, battery charger, or battery in fluid of any type. It may short the electronics and cause an electrical shock to the user.

REQUIRED EQUIPMENT
Before using the TC, the following equipment should be accessible:

• Battery Pre-charged, full charge is recommended but not required.
• TC Device Probes (Sterilized or High Level Disinfection)

HANDLING AND PREPARATION

Inspection Before Each Use
Before each use, perform the following:

General Inspection.

• Inspect for visible damage to the TC handle, battery and probes and all its connections.
• Make sure that no parts are missing or loose.
• Make sure that connecting elements between instruments function properly.
• Verify that the TC and accessories are in good working order by following the “Activating the Unit” steps outlined in the following section.
• WARNING: Examine all accessories and connections to the TC before use. Ensure that the accessories function as intended. Improper connection may result in accessory malfunction.
• If the battery is not already installed, insert a charged battery into the handle of the unit. The battery can only be inserted in a single orientation. Push the battery into place until the locking tabs snap; these tabs lock the battery into the handle.

NOTE:
The battery is removed by compressing the two locking tabs on the sides near the battery base releasing the lock and, while firmly holding the unit head, pulling the battery down and out of the handle.

DIRECTIONS FOR USE

• Read all instructions before use.

Figure 3: Activation Button and Indicator Lights

Activation (ON/OFF) Button: Press once to turn unit on. The activation button will illuminate green and one of the blue lights flashes to indicate unit is turned on. White illumination LED’s on front of unit will also turn on. Press a second time to begin treatment cycle. Probe tip will heat and timer lights will indicate progress of treatment cycle. The unit will shut itself off after the treatment cycle completes. Press a third time to shut unit off if needed.

NOTE:
There is no need to continuously depress the activation button.

Timer Lights:
When the activation button is pressed a second time, the lights will all illuminate blue. After each ¼ of the treatment cycle is completed one light will turn off. An audio sound is also given to indicate cycle count down. When all timer lights are turned off the treatment cycle is complete and the unit shuts itself off.

Low Battery Indicator:
When the battery reaches its low threshold, this indicator will illuminate. Replace the battery with a fully charged battery after completing the current procedure.

Activating the Unit

Step 1:
Insert the desired treatment probe (19mm flat, 19mm nipple, or 16mm flat) connector into the mating connector at the front of the unit. Ensure that the probe is tightly inserted. If the probe is not securely connected, inserted improperly, missing, or is broken when the ON/OFF button is pressed, the TC will power on briefly, flash all lights three times, then shut itself off.

Step 2:
Turn ON the TC by pressing the ON/OFF button located on the handle, one time, and verify that the green LED is on. The white illumination LED’s on the front of the unit will also turn on, and one blue light will
flash showing unit is ready for placement (tip not heated yet).

Step 3:
When the probe has been placed against the tissue needing treatment, press the ON/OFF button a second time to start the procedure. Four blue timer LEDs will flash sequentially from left to right for a few seconds indicating that the probe tip is heating. When the blue timer LEDs turn solid and a single audible beep is heard, the treatment cycle is running. The blue timer LEDs turn off with an audible beep, one at a time, after each 1/4 of the procedure has finished. When all four (4) blue timer LEDs are turned off a longer audible beep is heard, the unit is no longer applying heat. It has commenced its cool down cycle. Once the cool down cycle is complete, the front white LED lights will turn off, and the probe may then be removed from the treatment area. If a second treatment area is needed, repeat the above steps before removing the probe.

WARNING:
Do not touch the active (heated) probe tip, as it may potentially cause burned tissue damage.

The unit checks the functionality of each probe during heat-up mode. If the probe is unable to reach and maintain sufficient temperature the unit will flash the blue timer LEDs three (3) times and then shut off the unit. If this occurs, the probe or battery may be faulty and need replacing. The following actions should be taken:

1. Replace the probe with a new one
2. Replace the battery
3. Re-activate the unit.

If the unit gives you the same message a second time and the battery appears charged, the probe has exceeded its use life and is no longer functional. The treatment cycle for the Liger Medical TC is a warm up time of ~8 seconds, treatment time of 20 seconds of constant heat at 100°C (212°F), and cool down ~10 seconds.

• NOTE: The probe is intended to be applied to tissue prior to being heated.
• NOTE: The Liger Medical TC is capable of performing 30-60 procedures per battery charge. When the battery is low, a yellow LED indicator will illuminate. The battery in the unit should be replaced with a charged battery soon after the low battery indicator is illuminated. If the yellow LED illuminates during a procedure, the procedure in process should be completed first. Once completed, replace the battery.

NOTE:
With continued use after the low battery LED is illuminated the unit will go into a ‘sleep mode’ turning off to protect the battery from being overly discharged. Over-discharge of the battery could reduce the life of the battery. Recharge or put in a charged battery to get out of ‘sleep mode’.

Recharging the Batteries

• The batteries should only be recharged when the battery and charger are dry.

• Plug the charger into an A/C outlet.
  NOTE: The charger can be plugged into an A/C power outlet of 100 – 240 VAC, 50/60 Hz, with the proper country adapter. (see TABLE 1)

• The green ‘power’ LED should illuminate.

• Place the battery into the charging base. The red ‘charging’ LED should illuminate after a brief moment.

• A completely discharged battery should fully recharge in about two (2) hours.

• When the battery is fully charged, the red ‘charging’ LED will turn off.

• Remove the battery from the charger base and disconnect the charger from the A/C outlet when the battery has been fully charged.
  NOTE: The battery will not be damaged by leaving the battery in the charger after the battery is fully charged making overnight charging convenient.

• The TC batteries are Lithium ion batteries and cannot be charged while connected to the TC handle. The TC handle cannot be connected to supply mains.

PATIENT PREPARATIONS
The patient should be prepared according to clinic protocol for the appropriate type of procedure.

COMPLICATIONS
The following complications may occur during or following use of the device:

• Infection
• Pain
• Tissue burn

CLEANING AND INSPECTION

The TC handle and probes are reusable, and require specialized cleaning after each use. The probe must undergo cleaning and either high level disinfection or sterilization (per hospital or clinical requirements) prior to use. Follow the proper cleaning instructions for cleaning the device using the following procedure:

Handle and Battery Cleaning Procedure:

• Disassemble the TC into three separate parts (handle, battery and probe).
• Thoroughly wipe all surfaces of the TC handle and battery with a mild cleaning solution (i.e. 70% isopropyl alcohol) or disinfectant and damp cloth. The cleaning solution or disinfectant should not be applied directly to the unit. Pour/spray the cleaning solution or disinfectant onto a cloth and ensure that the cloth is evenly damp prior to cleaning the unit.
• Do not allow fluids to enter the device. Do not sterilize the TC handle or battery.

Probe Cleaning Procedure:
The probes require specialized cleaning after each use to remove all visible soil. After cleaning, additional sterilization or high level disinfection (HLD) processing must be completed before each individual use of the probe, see below for directions.

• If possible, initiate instrument cleaning within 30 minutes following use.
• Place silicone cap on probe connector.

CAUTION:
Only use a soft brush or cloth to manually remove impurities; never use abrasive materials as they may damage the probes.

• Perform the final instrument rinse with clean water (i.e. Reverse Osmosis/ De-ionized (RO/DI) water) that does not contribute to device staining or contamination.
• If an alkaline based detergent is used during the cleaning process, a neutralization solution may be used to remove alkaline-based residues and deposits. Follow the manufacturer’s recommendations.

Manual Cleaning

Equipment:
Personal protective equipment, enzymatic detergent, brush/cloth, running water

• Place silicone cap on probe connector.
• Rinse probe shaft using cool running water to remove gross soil. A soft bristled brush or cloth may be used to aid in the removal of soil. Run water over shaft, crevices, hard to reach areas until water runs clear.
• Prepare an enzymatic detergent such as Enzol® per manufacturer’s recommendations. Fully immerse the probe in the prepared detergent. Allow probe to soak for a minimum of one (1) minute.
• Following the soak time, while still immersed, use a soft bristled brush or cloth to thoroughly clean the probe. Pay particular attention to hard-to-reach areas.
• Remove the probe from the detergent solution and rinse with running water.
• Visually inspect each probe for visible soil. If soil remains, repeat the cleaning procedure outlined above.

Liger Medical validated the manual cleaning method using an independent accredited test laboratory and has the data on file. The validation was accomplished using Enzol® as the enzymatic detergent. Use of an automated cleaning system was not validated by Liger Medical, and use of such a system is at the risk and discretion of the user.

Drying
Ensure the probes are free from residual moisture prior to sterilization. If moisture remains on the probe, dry using a clean lint-free cloth and/or filtered pressurized air.

WARNING: Failure to properly clean and dry the probes may lead to inadequate sterilization or a reduction in instrument life.

Probe Sterilization

• Sterilize probes in sterilization trays/pouch and containers. Disposable sterilization packages may also be used.
• Place silicone cap on probe connector.
• Insert probe(s) into sterilization tray/pouch following sterilizer manufacturer guidelines for appropriate tray/pouch and packaging instructions.
• Ensure that all surfaces will be exposed to the sterilizing agent. Ensure that probes do not contact each other if multiple probes are packaged together.
• Control the water purity dedicated to steam production to prevent damage to the instruments.
• Sterilization temperatures higher than 121°C (250°F) may damage the instruments.

To achieve a sterility assurance level of 10-6, use of the following sterilization parameters is recommended:

Gravity Steam Sterilization **Method*| Minimum Temperature**|

Time

| Min. Drying

time**

---|---|---|---
Gravity Steam| 121 °C| 30| 30
(250 °F)| min| min

• Liger Medical validated this sterilization cycle using an independent accredited test laboratory and has the data on file. The validation was accomplished with probes individually double pouched and placed on edge in the sterilizer. Other sterilization cycles may be suitable; however, individuals or hospitals not using the recommended method are advised to validate an alternative method using appropriate laboratory techniques. Steam sterilization will reduce the useful life of the probe.
• Liger Medical validated this dry time using probes individually double pouched, weighing approximately 17g (0.6 oz.). Longer dry times may be required for instrument trays exceeding this weight.

Probe High Level Disinfection (HLD)

Materials (not provided):

• A High Level Disinfectant , such as Cidex®, in a basin large enough for submerging the probe.
• Tongs
• Pure water (boiled) at room temperature.
• Sterile cloths for drying and storage.

Disinfection Procedure:

1. Ensure minimum effective concentration (MEC) of the glutaraldehyde following manufacture’s guidelines.
2. Place silicone cap on probe connector.
3. Immerse the end of the heating tip of the probe into a cup of disinfectant solution approximately ~5 inches (12cm) deep
4. Allow the probe to soak in glutaraldehyde following manufacturer’s guidelines (i.e., 20 minutes at room temperature (20°C) for Cidex®).
5. Thoroughly rinse the probe(s) in pure water agitating and allowing them to set for a minimum of 5 minutes.
6. Repeat the previous rinsing step (6) two more times for a total of 3 rinses using a fresh batch of pure water each time.
7. Dry with sterile lint-free cloth.
8. Store in sterile lint-free cloth until next use.

Liger Medical validated the High Level Disinfection cleaning method using an independent accredited test laboratory and has the data on file. The validation was accomplished using Cidex® as the disinfectant.

INSPECTION
Liger Medical recommends that the TC handle and probes be regularly inspected every month for visible damage. The following concerns should be immediately addressed:

• Signs of deterioration or obvious damage to the unit
• Signs of damage to any connector
• Accumulation of lint or debris on or around the unit

In each case, discontinue using the unit. If the unit is damaged externally or has a damaged connector, please contact Liger Medical. If the unit has accumulated dust or debris, follow the cleaning procedure to remove the debris.

TROUBLESHOOOTING

The Liger Medical TC has no user-adjustable controls or diagnostic tests. If the unit fails to respond as expected, try the following steps before contacting Liger Medical.

1. If the Liger Medical TC will not turn on, please verify that the battery is fully charged and that the probe is properly connected and not faulty.
2. To determine whether the handle or probe are faulty, turn on the TC unit with a probe. If the probe is faulty, the TC will flash all four (4) blue LEDs indicating a non-functional probe. If this fails to happen then turn on the TC unit again WITHOUT a probe. The TC will flash all four (4) blue LEDs indicating absence of a probe. If this fails to occur, either the battery or the TC is faulty.

DEVICE DISPOSAL:
When the TC handle, probe, battery, or power supply no longer are functional, or show signs of wear and damage, they should be disposed of in the same manner as electrical waste.
To order additional devices/ accessories, or replacement accessories go to www.ligermedical.com.

WARRANTY AND RETURN POLICY

Liger Medical warrants each product manufactured by it to be free from defects in material and workmanship under normal use and service for the period(s) set forth below. Liger Medical’s obligation under this warranty is limited to the repair or replacement, as its sole option, of any product, or part thereof, which has been returned to it or its Distributor within the applicable time period shown below, after delivery of the product to the original purchaser, and which examination discloses, to Liger Medical’s satisfaction, that the product is indeed, defective.

This warranty does not apply to any product, or part thereof, which has been repaired or altered outside Liger Medical’s factory in a way so as, in Liger Medical’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident.

The warranty periods for Liger Medical products are as follows:

• The tC thermocoagulator : Two (2) years from date of shipment

This warranty is in lieu of all other warranties, express or implied, including without limitation, the warranties of merchantability and fitness for a particular purpose, and of all other obligations or liabilities on the part of Liger Medical.
Liger Medical neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Liger Medical’s products. Notwithstanding any other provision herein or in any other document or communication, Liger Medical’s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Liger Medical to the customer.

Liger Medical disclaims any liability hereunder or elsewhere in connection with the sale of this product, for indirect or consequential damages. This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Utah, United States of America (USA). The sole forum for resolving disputes arising under or relating in any way to this warranty is the 3rd District Court of Utah, USA.
Liger Medical, its dealers, and representatives reserve the right to make changes in equipment built and/or sold by them at any time without incurring any obligation to make the same or similar changes on equipment previously built and/or sold by them.

TECHNICAL ASSISTANCE:
For Technical Assistance, please call Liger Medical Technical Support at the following telephone number: (1)801-256-6576, email to sales@ligermedical.com, or visit us at www.ligermedical.com.

TECHNICAL SPECIFICATIONS

All specifications are nominal and subject to change without notice. A specification referred to as “typical” is within ±20% of a stated value at room temperature (25°C/77°F) and utilizing a sufficiently charged battery pack.

TABLE 1: Device Parameters

Power Parameters
Power Supply:| 11.1 VDC

Battery Pack:

| Rechargeable Lithium-Ion

3-cell 2AH Battery Pack BMS overcharge protection

Battery Charger:

| 100 – 240 VAC, 1.0A, 50-60Hz Input

12.6VDC, 1.8 amp, Output

Charge Time: Two(2) hours

Full-Charge

Activation:

| Until low-battery indicator illuminates
Power Output:| 30 Watts
Treatment (Duty) Cycle| ~8 seconds of heat up, 20 seconds of therapy at 100°C, and ~10 seconds of cool

down

Dimensions and Weight
Width:| 1.5 inches (4 cm)
Height:| 8 inches (20 cm)
Depth:| 2 inches (5 cm)
Weight:| 11 oz (240 g) –
Operating Conditions
Ambient

Temperature:

| 16° to 45°C
Relative Humidity:| 0% to 80% non-condensing
Transport and Storage
Ambient Temperature:| -5° to 45°C
Relative Humidity:| 0% to 80% non-condensing
General Info
Type B Applied Parts

IP21 Rating

| Solid particle protection: Level 2 (>12.5mm)

Liquid ingress protection: Level 1 (dripping

water)

Electromagnetic Compatibility Guidance (in accordance with EN/IEC 60601-1-2:2007)

TABLE 2: Manufacturer’s Declaration – Electromagnetic Emissions

The TC is intended for use in the electromagnetic environment specified below. The customer or the user of the TC should ensure that it is

used in such an environment.

Emissions Test| Compliance| EMC Environment Compliance
RF Emission

CISPR 11

| Group 1| The TC uses RF energy only for its internal function. Therefore, its RF emissions are very low and

not likely to cause any interference in nearby electronic equipment.

RF Emission

CISPR 11

| Class B|

The TC is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic Emissions

-IEC 61000-3-2

| Not Applicable
Voltage Fluctuation & Flicker –

IEC 61000-3-3

|

Not Applicable

TABLE 3: Manufacturer’s Declaration – Electromagnetic Immunity

The TC is intended for use in the electromagnetic environment specified below. The customer or the user of the TC should ensure that it is

used in such an environment.

Immunity Test| IEC 60601 Test

Level

| Compliance

Level

| Electromagnetic Environment – Guidance
IEC 61000-4-2 – Electrostatic discharge (ESD)| ±6kV contact

±8kV air

| ±6kV contact

±8kV air

| Floor should be wood, concrete, or ceramic tile. If floors are covered with a synthetic material, the relative humidity should be at least 30%.
IEC 61000-4-4 – Electrical fast

transient/burst

| Not Applicable| Not Applicable| Not applicable
IEC 61000-4-5 – Surge| Not Applicable| Not Applicable| Not applicable
IEC 61000-4-11 – Voltage dips, short interruptions and voltage variations on power supply

input lines

|

Not Applicable

|

Not Applicable

|

Not applicable

Power frequency

(50/60Hz) magnetic field

| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels characteristic of a

typical location in a typical commercial or hospital environment.

NOTE:      UT is the a.c. mains voltage prior to application of the test level.
TABLE 4: Manufacturer’s Declaration – Electromagnetic Immunity

The TC is intended for use in the electromagnetic environment specified below. The customer or the user of the TC should assure that it is used

in such an environment.

IMMUNITY Test| IEC 60601

test level

| Compliance

Level

| Electromagnetic Environment – Guidance

Conducted RF IEC 61000-4-6

|

Not applicable

|

Not applicable

| Portable and mobile RF communications equipment should be used no closer to any part of the TC including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter.

Recommended separation distance

Radiated RF IEC 61000-4-3|

3 V/m

80 MHz to 2.5GHz

|

3 V/m

| For 80 MHz to 800 MHz                                         For 800 MHz to 2.3 GHz

? = 1.17√?                                                          ? = 2.33√?

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1:      At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2:      These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,

objects, and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TC is used exceeds the applicable RF compliance level above, the TC should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the TC.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

TABLE 5: Recommended separation distanced between portable and mobile RF communications equipment and the TC

The TC is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the TC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications

equipment (transmitters) and the TC as recommended below, according to the maximum output power of the communications equipment

Rated maximum output power of transmitter

W

| Separation distance according to frequency of transmitter m
150 kHz to 80 MHz

3.5

? = [ ? ]√?

1

|

80 MHz to 800 MHz

? = 1.17√?

|

800 MHz to 2.5 GHz

? = 2.33√?

0.01| N/A| 0.117m| 0.233m
0.1| N/A| 0.37m| 0.74m
1| N/A| 1.17m| 2.33m
10| N/A| 3.70m| 7.37m
100| N/A| 11.7m| 23.3m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1:      At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Symbol

• Attention, See Instructions for Use
• Warning, Electricity
• Serial Number
• Lithium-Ion Battery Enclosed
• CAUTION: Federal (USA) law restricts the sale of this device by or on the order of a physician. Manufacturer & date of manufacturing
• Authorized Representative in the European Community
• Type B Applied Parts
• MRI Unsafe: Keep away from magnetic resonance imaging (MRI) equipment
• Solid particle protection:
• Level 2 (>12.5mm) Liquid ingress protection: Level 1 (dripping water)

© 2017, Liger Medical, LLC. All Rights reserved. Printed in the U.S.A.

The handheld  tC thermocoagulator device products are protected by U.S. patents and patents pending. Please direct any inquiries to Liger Medical, LLC.

Liger Medical, LLC
3300 N. Running Creek Way Building G Lehi, UT 84043
www.ligermedical.com.

SMIDGEN
Millhouse, Bleach Road, Kilkenny, Eire Ireland.

References

• Liger Medical | Caring For Life, GIVING HOPE | (801) 256-6576
• Liger Medical | Caring For Life, GIVING HOPE | (801) 256-6576

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