IRRAS IRRAflow User manual

IRRAflow Laser Leveler
7000494 Rev C, USA
IRRAflowLaser Leveler
(REF ICLS 010)
User Manual
0344

2IRRAflow Laser Leveler User Manual
7000494 Rev C, USA
Table of Contents
Scope ................................................................................................4
IRRAflow Laser Leveler Accessory Device Description......................4
Figure 1. IRRAflow Laser Leveler ..............................................................5
Labels................................................................................................7
3.1 IRRAflow Laser Leveler Symbols............................................................. 7
Safety Regulations ............................................................................8
4.1. General Safety Regulations and Warnings .......................................8
Environmental and Handling Conditions ........................................10
Installation Procedure ....................................................................10
Instructions for Use ........................................................................11
Disposal...........................................................................................11
Cleaning and Disinfection ...............................................................12
Appendix.........................................................................................13
10.1. Laser Technical Specifications ........................................................13
10.2. Electromagnetic Compatibility..................................................... 13
10.3. Laser Levelers and Manual .......................................................... 14
Contact15

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7000494 Rev C, USA
Please note the components included in this package are meant to be used
in conjunction with the IRRAflow Control Unit and IRRAflow instructions for
use. The Laser Leveler is attached to the IRRAflow Control Unit for height
positioning, activated after pushing on the switch and automatically turns
off after 20 seconds.
IRRAS only accepts responsibility for the equipment's safety, usability and
performance if:
- the equipment is used in accordance with its intended use, and
- the equipment is used in accordance with the
product documentation.
WARNING
Read all instructions and warnings prior to use.
Users of the IRRAflow

Laser Leveler shall be trained medical personnel with
training and experience in neurosurgical medical care.

4IRRAflow Laser Leveler User Manual
7000494 Rev C, USA
Scope
This manual describes the usage of the IRRAflow Laser Leveler model
number ICLS 010. The IRRAS Laser Leveler is intended to be used with the
IRRAflow CNS System. The Laser Leveler is used to target the tip of the
IRRAflow catheter in use.
Users must read this manual carefully prior to using the IRRAflow Laser
Leveler for the first time so that the features are thoroughly understood.
Warning - Failure to follow the instructions in this manual may endanger
the patient and/or the operator!
IRRAflow Laser Leveler Accessory Device
Description
The IRRAflow Laser Leveler is a reusable accessory to the IRRAflow CNS
System and consists of a laser leveler as shown in Figure 1 below.

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7000494 Rev C, USA
Figure 1. IRRAflow Laser Leveler
The laser leveler generates a laser mark to assist in setting the height of the
control unit. The laser leveler has a power button and auto shuts off after
approximately 20 seconds. The control unit auto aligns the laser when
attached to an IV pole.

6IRRAflow Laser Leveler User Manual
7000494 Rev C, USA
The laser leveler is packaged with accessories and an IFU (Instructions for
Use) in a product box as show in Figure 2 below. This product box includes:
- Laser Leveler
- Shoulder screw
- Push on cap
- Allen wrench
- Instructions for use
The device does not include software. It is non-sterile, can be re-used
multiple times based on battery life, and has no patient contact.
Figure 2. IRRAS Laser Leveler packaged with accessories and IFU

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7000494 Rev C, USA
2.1 Intended Use
The IRRAflow Laser Leveler is intended to be used with the IRRAflow CNS
System. The Laser Leveler is used to adjust the height of the IRRAflow
Control Unit such that the zero point of the Control Unit is at the same
elevation as the patient’s auditory meatus (or ear canal) prior to beginning
treatment.
Labels
3.1 IRRAflow Laser Leveler Symbols
Symbol and text
Meaning
Warning
Refer to the manual
Manufacturer
European Authorized Representitive
Date of Manufacture
Ingress Protection Level
Do not dispose of device in trash
Catalogue number

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7000494 Rev C, USA
The IRRAflow Laser Leveler has been labeled with the following symbols:
Safety Regulations
4.1. General Safety Regulations and Warnings
Device is not MRI compatible.
Do not attach other pieces (other than those specified) to the system.
Do not touch parts that could result in excessive leakage currents and the
patient at the same time.
All specified cleaning and disinfection procedures must be performed.
Contraindication: Use of this equipment 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 verify that they are operating normally.
Contraindication: Use of accessories, transducers and cables other than
those specified or provided by the manufacturer of this equipment could
Serial number
Laser Warning/Rating Label
Store within given temperature range
Transport/ship within given
temperature range
Humidity Range Limitations
Laser symbol
Laser aperture location
Unique Device Identifier (UDI) 2D
Barcode, unique to each device

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7000494 Rev C, USA
result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment, result in improper operation
and/or hazardous radiation exposure.
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the Laser Leveler, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this
equipment could result.
This is not a toy, keep away from children.
Do not stare into laser. Do not point laser into someone’s eyes.
Device contains lithium metal battery.
Device is not rechargeable and should not be recharged.
Do not open, crush, or heat device.
No modification of the equipment is allowed
No part of this medical accessory is to be serviced or maintained wihile in use
Laser aperture as shown below.

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7000494 Rev C, USA
Environmental and Handling Conditions
Laser Leveler
Operation Temperature range
+10 to +40°C
Operation
Air humidity
15 –90%
Operation
Ambient pressure
70 –106 kPa
Storage and transport
Temperature range
+2 to +50 °C
Storage and transport
Air humidity
15 –90%
Storage and transport
Ambient pressure
50 –106 kPa
IP Rating
IP22
Power Source
3.6V Battery
Do not place the device near heating equipment nor expose to direct
sunlight. Elevated temperatures can result in shortened battery life and
degrade performance.
Installation Procedure
• The IRRAflow Laser Leveler device is provided with a mounting
screw for use with the The IRRAflow CNS control unit.
•Contraindication: This device is not designed to be
installed or used other than indicated.
• Clean and disinfect device per section 10.
• Remove black cap from the head of the shoulder screw. Insert
shoulder screw into the device as shown.

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7000494 Rev C, USA
• Using the provided allen wrench, tighten the shoulder screw
into the side of the IRRAflow Control Unit. The device should
swing freely with no looseness along the shoulder screw. You
should not be able to see screw thread.
• Replace the black cap over the head of the shoulder screw.
Instructions for Use
• The recommended workflow begins with verifying the patient is
in a resting position and the laser leveler is attached to the
control unit. The treatment normally occurs at the bedside but
anywhere with direct line of sight to the patient’s head may
work.
• Rotate the body of the device towards desired target location
(away from eyes).
• Push button to activate laser. A red mark shall appear on or
near the patient.
Note: Do not hold down the button.
• Adjust the body of the device as need.
• With the device hanging freely, adjust height of the IRRAflow
Control Unit as necessary. Note: Do not hold onto the device
during height positioning.
• Laser automatically turns off after approximately 20 seconds.
Disposal
Do not throw in trash. Recycle per your facility’s electronic waste procedure
and local regulations.

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7000494 Rev C, USA
Cleaning and Disinfection
The Laser Leveler shall be cleaned and disinfected after each treatment.
If fluids spill onto the Laser Leveler during treatment, pause or stop treatment
and wipe off the spillage immediately.
The recommended method for cleaning is to wipe the parts with a soft cloth
dampened with soapy water until all foreign material has been removed.
The recommended method for surface disinfectant is to wipe the parts with
a soft cloth dampened with the following intermediate level disinfectant
agents or an intermediate level disinfectant wipe.
Only the following intermediate level disinfectant liquid may be used with a
minimum dwell time of one minute exposure:
70% Isopropyl alcohol or 70% ethyl alcohol solution
No liquid may be allowed to be directly poured or sprayed onto the Laser
Leveler during cleaning or disinfecting as this may damage the equipment.
No liquid may be allowed to dispel from the cloth during cleaning, as this
may damage the equipment.
Never use any type of tools or brush when cleaning, as this may damage the
equipment.
Device is supplied non sterile. No components, parts or accessories to the
IRRAflow Laser Leveler may be sterilized.
IRRAS AB does not make any claims for or representation as to the
performance characteristics of this product if it is used in conjunction with
other accessories or other than intended. If there are doubts about how to
install or clean the Laser Leveler, the effect of cleaning, the functions and/or
safety of the unit, then the unit should be withdrawn from service and the
distributor and/or manufacturer consulted (see section 11 for contact
information).

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7000494 Rev C, USA
Appendix
10.1. Laser Technical Specifications
Wavelength
630-680 nm
Divergence
1.6 mrad
Pulse Pattern
Square
Max Output
< 1 mW
Class
Class 2
10.2. Electromagnetic Compatibility
Electromagnetic compatibility tests have been performed with a 2.5 m power
cable.
Guidance and manufacturer’s declaration –electromagnetic emissions
The IRRAflow Control Unit, and IRRAflow Tube Set is intended for use in the
electromagnetic environment specified below. The customer or the user of the
IRRAflow CNS system should assure that it is used in such an environment.
Standard
Description
IEC 60601-1-2 4th ed
Cispr 11/EN55011
RF Emissions
Group 1, Class B
IEC61000-4-2
ESD
8 kV contact, 15 kV air
IEC61000-4-3
Radiated RF
Immunity
80-2700MHz :3 V/m ordinary, 10V/m home
healthcare, 80% AM, 1 kHz
385MHz :27 V/m, PM,18Hz
450MHz :28 V/m, FM+/-5kHz dev, 1 kHz sine
710, 745, 780MHz :9 V/m, PM, 217 Hz
810, 870, 930MHz :28 V/m, PM, 18Hz
1720, 1845, 1970MHz :28 V/m, PM, 217 Hz
2450MHz :28 V/m, PM, 217 Hz
5240, 5500, 5785MHz :9 V/m, PM, 217 Hz
IEC61000-4-8
Magnetic Immunity
30 A/m, 50 Hz
Table B-1 Electromagnetic compatibility

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7000494 Rev C, USA
10.3. Laser Levelers and Manual
Please contact your local distributor if you wish to order Laser Levelers or a
replacement manual.
• IRRAflow Laser Leveler (Ref no. ICLS 010)
• Laser Leveler User manual, English edition (catalogue no. IFS-
0119)

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7000494 Rev C, USA
Contact
Manufactured By:
Address:
IRRAS USA, Inc.
11975 El Camino Real, Suite 304
San Diego, CA 92130
USA
URL: http://www.IRRAs.com
E-mail address: US.customerservi[email protected]
Phone: [phone]
EC Representative:
Address:
Europe
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands