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

IRRAflow Laser Leveler User Manual 3
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.

IRRAflow Laser Leveler User Manual 5
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

8IRRAflow Laser Leveler User Manual
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.