User Manual Part 1 System Hardware - usf.edu€¦ · User Manual – Part 1 – System Hardware page 9 / 45 2 About this manual 2.1 User manual: The user manual is intended for trained

User Manual – Part 1

System Hardware

Small animal scanner

inSight64, inVision128 and inVision256-TF

iThera Medical GmbH

Zielstattstrasse 13

81379 München

Germany

Small Animal Imaging System

MSOT inSight64, inVision128 and inVision256-TF

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MSOT inVision Series

User Manual – Part 1 – System Hardware

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Table of Contents

1 Warning Symbols .............................................................................................. 5

1.1 Legend of symbols: ................................................................................................. 5

1.1.1 Warning signs .......................................................................................... 5

1.1.2 Signs advising of necessary activities ..................................................... 6

1.1.3 Safety Labels ........................................................................................... 6

1.1.3.1 Location of labels .............................................................................. 6

1.1.3.2 Label types ........................................................................................ 8

2 About this manual ............................................................................................. 9

2.1 User manual: ........................................................................................................... 9

2.2 Declaration of Conformity: ....................................................................................... 9

2.3 Operation and expert staff: ...................................................................................... 9

2.4 Product liability: ....................................................................................................... 9

2.5 General guidelines: ............................................................................................... 10

2.6 Harmonized regulations and standards ................................................................. 11

2.7 Marking of the listed harmonized standards and rules ........................................... 11

2.8 Revision ................................................................................................................ 11

3 Product description ........................................................................................ 12

3.1 Intended use: ........................................................................................................ 12

3.2 Reasonably foreseeable misuse: ........................................................................... 12

4 Safety instructions .......................................................................................... 14

4.1 General: ................................................................................................................ 14

4.2 Grounding ............................................................................................................. 15

4.3 Fuse requirements and current protection ............................................................. 15

4.4 Overvoltage protection .......................................................................................... 15

4.5 Laser Safety .......................................................................................................... 15

4.6 Leakage Current.................................................................................................... 17

4.7 Liquids ................................................................................................................... 17



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4.8 Desinfection / Cleaning.......................................................................................... 17

4.9 Supply Voltage ...................................................................................................... 17

4.10 Ventilation requirements ................................................................................. 18

4.11 Requirements for special services, for example, air, cooling liquid .................. 18

4.12 Air filter mat ..................................................................................................... 18

4.13 Mechanical Hazard ......................................................................................... 19

4.14 Interlock .......................................................................................................... 19

4.15 Anesthesia Supply .......................................................................................... 19

4.16 Heating ........................................................................................................... 20

5 Technical data ................................................................................................. 21

5.1 Dimensions ........................................................................................................... 21

5.2 Power Supply ........................................................................................................ 21

5.3 Laser ..................................................................................................................... 21

5.4 Anesthesia Supply ................................................................................................. 21

5.5 Environmental Conditions ...................................................................................... 22

6 Transport and Application .............................................................................. 23

6.1 Transport ............................................................................................................... 23

6.2 Assembly............................................................................................................... 25

6.2.1 Assembly of parts .................................................................................. 25

6.2.2 Final assembly ...................................................................................... 25

6.3 Safety checking ..................................................................................................... 25

6.4 Commissioning ...................................................................................................... 26

6.4.1 Power Supply ........................................................................................ 26

6.4.2 USB und Ethernet Connections ............................................................. 26

6.4.3 Oxygen and anesthesia ......................................................................... 27

7 Equipment operation ...................................................................................... 29

7.1 Principle of Operation ............................................................................................ 29

7.2 Starting the Device ................................................................................................ 29

7.3 Placing the Animal ................................................................................................. 30



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7.4 Performing Measurements .................................................................................... 33

7.5 Shutting down ....................................................................................................... 34

8 Service and Maintenance ............................................................................... 35

8.1 Contacts for Technical Support ............................................................................. 35

8.2 Change of Water ................................................................................................... 35

8.3 Changing the filters ............................................................................................... 37

8.4 Cleaning and Disinfection ...................................................................................... 38

8.4.1 Recommended disinfectants/detergents ............................................... 38

8.4.2 Cleaning and disinfection of the exterior of the device .......................... 39

8.4.3 Cleaning and disinfection of imaging chamber and internal tubing ........ 39

8.5 Notes on Replacing Components .......................................................................... 39

8.6 Preventative Cleaning and Maintenance Routines ................................................ 40

8.7 Spare Parts and consumables ............................................................................... 40

9 Waste of Electrical and Electronic Equipment (WEEE) ............................... 42

10 Trouble Shooting ....................................................................................... 43

11 Warranty ..................................................................................................... 44

12 EG Declaration of Conformity .................................................................. 45



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1 Warning Symbols

1.1 Legend of symbols:

1.1.1 Warning signs

Warning!

Warning! Risk of electric shock.

Caution, hot surfaces!

Warning! Hazardous laser radiation.

Caution, mechanical hazard.



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1.1.2 Signs advising of necessary activities

Read all safety and operating instructions

carefully before operating this equipment.

Unplug the device from main power supply

before opening.

1.1.3 Safety Labels

1.1.3.1 Location of labels

A

B

D

E C



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E

F

G



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1.1.3.2 Label types

Label A

Label B

Label C

Label D

Label E

Label F

Label G



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2 About this manual

2.1 User manual:

The user manual is intended for trained operation staff as well as qualified service and maintenance staff.

Before commissioning and first use the user manual has to be read in its entirety!

2.2 Declaration of Conformity:

Changes of animal scanner components result in expiration of the Declaration of

Conformity.

Therefore, changes are only allowed according to an agreement with the manufacturer.

The EG Declaration of Conformity is attached as the last page of this user manual.

2.3 Operation and expert staff:

The operation staff has to be introduced to the modes of operation of the animal scanner

before use. Of particular note is the identification of possible risks. The safety instructions

must therefore be noted.

The animal scanner is only allowed to be serviced by iThera Medical GmbH or its

distributors’ trained staff.

Maintenance is only allowed by qualified, permitted staff.

Personnel not previously qualified by iThera Medical

GmbH is not allowed to open any sealed enclosure.

2.4 Product liability:

iThera Medical is only responsible for personal injury or material damage which occurred

during intended use as described by iThera Medical and if all safety installations are fully

functional and the user manuals of the manufactures of the individual components as well

as all safety instructions have been observed.



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iThera’s liability shall be limited to acts of willful misconduct or gross negligence by its

staff and limited to claims for the injury of life, body or health of a person. Any liability

pursuant to the Act on Product Liability (‘Produkthaftungsgesetz’) shall remain unaffected.

Notwithstanding the aforementioned, iThera shall not be liable for any incurred indirect or

consequential damages, including but not limited to lost profits, lost business or lost

revenue.

Unless, and then only to the extent that, the applicable law requires differently, the

aggregated liability from or in relation to this Agreement shall be limited to the contract

value.

The above limitation of liability shall also apply to the iThera’s employees, representatives

and vicarious agents. The customer has to immediately notify iThera in writing of any

incident of liability or expected liability under this Agreement to enable the concerted

mitigation of damages.

2.5 General guidelines:

The safety instructions in the user manual and the user manuals of the manufacturers of

the individual components give information to the user which ensures a safe und

functional working of the animal scanner.

If such details are neglected this could lead to errors,

damages or disturbances of the intended operating

procedure. Failure to comply with the safety instructions

could potentially lead to injury of employees in the

workplace.



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2.6 Harmonized regulations and standards

Document Edition Title

2006/95/EC 2006-12-12 (Low voltage directive) Directive of the councilor for

approximation of laws of Member States which regards

electrical production equipment for use within certain

voltage limits

2004/108/EC 2004-12-15 (Electromagnetic compatibility) Directive of the councilor

for approximation of laws of Member States about the

electromagnetic compatibility

2.7 Marking of the listed harmonized standards and rules

EN 61010-1 2010 Safety requirements for electrical equipment for

measurement, control and laboratory use – Part : General

requirements

IEC 61326-1 2006 Electrical equipment for measurement, control and

laboratory use - EMC requirements - Part 1: General

requirements

IEC 60825-1 2007 Safety of laser products –

Part 1: Equipment classification and requirements

2.8 Revision

Revision 3, December 11, 2014

Editors: Josef Konradl, iThera Medical GmbH, Harry Reichert, SGS Germany GmbH



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3 Product description

3.1 Intended use:

The inSight / inVision series of preclinical small animal scanners are intended for

anatomical, functional and molecular imaging of mice and small rats.

Biological processes and the effect of pharmacological substances can be observed in

vivo and in real time, in high resolution, on a cellular and molecular level.

The product is allowed only to be used in a laboratory environment with restricted access

only. No public use is intended.

The use of the product is only allowed according to the description in this user manual.

All other use is not permitted.

3.2 Reasonably foreseeable misuse:

The device is not intended for clinical use

Do not put flammable materials into the imaging chamber

Place the imaging specimen only in accordance with the

instructions in Chapter 7.3 - Placing the Animal

To achieve quantitative results, the device has to be

calibrated with a phantom before performing

measurements

Use only deionized water for measurements



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Use only with the delivered plug: Mennekes, 16A, 200-250

V, IP 44, TYP 148A

Caution – Use of controls or adjustments or performance of

procedures other than those specified in this user manual

may result in hazardous radiation exposure



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4 Safety instructions

4.1 General:

The corresponding occupational safety regulation, the accident prevention regulation and

the user manuals of the manufacturers of individual components are valid for the

commissioning of the animal scanner.

The animal scanner is built according to the general accredited technical rules. It

conforms to the standards of LVD directive 2006/95/EG.

Risks for persons and material can come from the components of the animal scanner if

the safety instructions are ignored, if the animal scanner is unconventionally operated or

if the handling of the individual components is faulty.

Examples for unconventional handling, which can impair the safety of the device:

Disregard of warning signs and indication lights

Unauthorized maintenance

Read all safety and operating instructions carefully before

operating this equipment.

If the device is not operated in a way described in this

manual, safety may be impaired.

If it is assumed that a safe operation is no longer

possible, immediately inform the manufacturer,

especially in the case of visible damage or malfunction.

Opening any sealed enclosure of the animal scanner is

strictly forbidden by non-authorized personnel. Do not try

to repair the device by yourself. This could result in

equipment damage, malfunction, electric shock, fire or

serious injury.



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The unit is equipped with safety interlocks to prevent the

emission of hazardous laser radiation. Manipulations can

lead to serious eye damage. Refrain from any attempt to

override or to shortcut the safety interlock.

4.2 Grounding

The unit must have adequate PE-connection to avoid

electric shock in case of a single fault.

4.3 Fuse requirements and current protection

A building fuse with rating 230V/16A is required.

There are no user replacable fuses inside the product.

4.4 Overvoltage protection

For overvoltage protection a blocktrap is used of type BT-1S-230AC/A, Phoenix Contact.

4.5 Laser Safety

The small animal, when put in place, receives laser radiation from two circular arranged

rows of five fiber optic arrays each. Both circles are placed axially apart. The fiber optic

arrays emit the laser radiation towards the centres of the circles onto the small animal.

The laser radiation is emitted in very short bursts of laser energy, 8 ns duration, 10 mJ

radiant energy per fiber optic array at a rate of ten bursts per second. The wavelength is

set by the user within the range from 680 nm (red, visible) to 980 nm (infrared, invisible).

From this data the radiant power can be calculated. It is 1.25 Megawatt. This very high

level of radiant power is needed to generate the ultrasound signal in the target. However,

it is also very dangerous to the eye for two reasons. One is the eye’s ability to produce

an image of the small fiberoptic laser source. Hence the eye focuses the light, which

penetrates the pupil, onto its retina. The other is the very short laser pulse with the

duration of nanoseconds to which the eye is very vulnerable.



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Assuming the worst case, i.e. the access panel being kept open (interlocks defeated), a

fiberoptic array being viewed and the laser emitting, then the viewer’s eyes will almost

inevitably be injured. The accepted maximum permissible exposure (“MPE”), which is still

considered safe, is exceeded at least by two orders of magnitude (>100 x MPE).

Laser equipment is usually classified, from class 1 (safe) to class 4 (very dangerous),

according to the level of radiation which is accessible to humans. The accessible radiation

of this equipment, when the access panel is open and the laser is emitting, is that of laser

class 4. This would need a set of safety requirements being met by the user, including

the use of eye protecting laser safety glasses or -goggles. Since the access panel of this

equipment is safety-interlocked, there is no hazardous laser radiation accessible to

humans. The laser equipment is therefore classified and labelled as a laser class 1

although the laser source is class 4. Similar laser systems are called “embedded class 4

lasers”.

This means that the laser radiation safety of this equipment primarily depends on the

integrity of the safety interlocks and their wiring. The design of the safety interlocks is

redundant, i.e. the two interlocks cause the laser to stop emission via two separate

circuits.

The user should be aware of the fact that any attempt to defeat the interlocks would

put him/her and other nearby persons into a very hazardous situation.

The laser radiation is generated in a unit which comprises a frequency doubled flashlamp

pumped Nd:YAG laser (1064/532 nm). Its radiation is coupled into an OPO (optical

parametrical oscillator) which produces the desired wavelengths. The output is guided via

glass fiber bundles to the target. The level of radiation within this unit is dangerous. This

unit is separately housed, thus preventing leakage of hazardous laser radiation to the

space within the equipment housing, except at the apertures where the fiberoptic cables

are attached. Both, the laser unit and the fiberoptic cables are safely contained within the

protective housing of the equipment.

The user should be aware of the fact that any attempt to open the protective

housing would present a serious hazardous situation to him or her.

Maintenance procedures, as described in this user manual neither require defeating the

safety interlocks of the access panel, nor require the user to remove part of the protective

housing. Service procedures which would include adjustments within the laser unit

including the fiberoptics are prohibited to be performed on the user level, unless training

and certification is provided by the manufacturer.



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4.6 Leakage Current

Warning! No extensive high leakage current expected if

device is suitably connected to supply mains.

4.7 Liquids

Please refer to chapter 8.

4.8 Desinfection / Cleaning

For details see chapter 8.4.

4.9 Supply Voltage

Please refer to chapter 6.4.1.



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4.10 Ventilation requirements

Keep at least 50 cm space between wall and side vents. On the back and the top of the device no space for ventilation is required.

For stable operation the room temperature has to be in the range of 15°C to 25°C.

4.11 Requirements for special services, for example, air, cooling liquid

Once a year, the internal laser cooling system has to be maintained by an iThera service

technician.

4.12 Air filter mat

The air filter mat has to be checked yearly and if necessary replaced by an iThera service

technician.

min. 50 cm min. 50 cm



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4.13 Mechanical Hazard

The positioning stages are calibrated while entering the acquisition mode. Do not put a

finger or other parts into the gap between the positioning stage and the imaging chamber.

4.14 Interlock

The access panel is equipped with safety interlocks to prevent the emission of hazardous

laser radiation. It is not allowed to defeat or override the safety interlocks.

For additional information see 4.5 (Laser Safety).

4.15 Anesthesia Supply

The device is equipped with internal tubing and connectors for anesthesia supply and

exhaust.

If oxygen is used parallel to anesthesia, the accumulation of excess or exhaled oxygen

together with the presence of any combustible material poses a severe risk of fire.

Therefore, it is important that the user takes care of appropriate precautions.

Only use anesthesia devices which are intended for small

animals and which are in accordance with the

specifications given in chapter 5.4.



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For commissioning of the anesthesia system please refer to chapter 6.4.3.

4.16 Heating

A constant temperature of the water inside the imaging chamber is maintained through

heating mats on the outside of the chamber and temperature sensors (image).

Make sure that these sensors are immersed in water during operation.

Caution, metallic chamber surfaces can get hot!

Always use a suitable exhaust and absorption filters to

avoid any accumulation of anesthesia gas or oxygen

inside the device.

Make sure the room is sufficiently ventilated.



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5 Technical data

5.1 Dimensions

Height (including wheels):................................................................. 1650 mm (65.0 in)

Height of Workbench (approx.): .......................................................... 915 mm (36.0 in)

Width (including hinges): .................................................................... 895 mm (35.2 in)

Depth: ............................................................................................... 1041 mm (41.0 in)

Weight (approx.): ................................................................................................ 500 kg

5.2 Power Supply

Input: .................................................................................. 230V, 50/60 Hz, 16 A max.

Fuses ..................................................................................... no user replacable fuses.

Appliance Class ................................................................................................. Class 1

Protection Rating ................................................................................................... IP20

Battery ........................................... 2 AA and 2 AAA batteries for mouse and keyboard

5.3 Laser

Laser Class .................................................... Class 1, embedded Class 4 laser device

Wavelength range: ............................................... 680nm – 980 nm, 532 nm, 1064 nm

Pulse frequency: .................................................................................................. 10 Hz

Pulse length: ........................................................................................................... 8 ns

Pump energy (@ 1064 nm): .................................................................... 800 mJ, max.

OPO energy (@ 740 nm) ......................................................................... 120 mJ, max.

5.4 Anesthesia Supply

Agents ........................................Oxygen / Air / N2O mixture with up to 5% Isoflourane

Operating Flow Range: .............................................................. up to 1 litre per minute



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Operating Pressure Range: .......................................................................... up to 5kPa

5.5 Environmental Conditions

Usage: ............................................................................................ For indoor use only

Altitude:..................................................................................................... up to 2000 m

Storage temperature: ................................................................................... 5°C – 40°C

Operation temperature: ............................................................................. 15°C – 25°C

Relative humidity: .......................................................................................... max. 80%

Voltage fluctuations: ........................................................ up to 10% of nominal voltage



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6 Transport and Application

6.1 Transport

Considering the dimensions and the weight the device can only be lifted and transported

with suitable load pick up instruments (e.g. with forklift truck or pallet jack).

For safe operation the forklift should be moved underneath the device from the back into

the space between the wheels.



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Make sure that the forks are long enough to support the

whole device.

Do not access with the forklift from left or right side

underneath the device, as this can result in severe

damage.

Unit components have to be secured from atmospheric

influence during transport.

Mobile and loose parts as well as external wires have to

be secured before transport.

For movement inside a building the device is equipped with wheels and handles.

All wheels have integrated brakes, which have to be loosened before transportation and

fixed afterwards.



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The wheels are designed for plane floor inside buildings

Do not attempt to use stairs or steps while rolling the

scanner

6.2 Assembly

6.2.1 Assembly of parts

The animal scanner must be installed according to an installation plan on a level plane

with enough bearing strength of the floor.

Individual parts must be cleaned before assembly.

Where applicable, transport locks must be removed from animal scanner.

All loose or individual transported components must be reinstalled.

6.2.2 Final assembly

Assembly and first commissioning is only allowed to be done by trained expert staff of the

manufacturer or its distributors.

6.3 Safety checking

Check the animal scanner components through a visual check for mechanical

damages!

Check the cables and wiring for insulation damages!

Check the safety installations (e.g. interlock) for secure function!

Check the whole working area for cleanliness and accessibility!

If you detect a defect during the checking do not commission the animal

scanner! Let the expert staff repair the animal scanner!

Make sure that environmental conditions are met as described in chapter 5.4.



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6.4 Commissioning

6.4.1 Power Supply

The main power supply connection is a plug of type IEC 60309. It is located on the right

side of the device. The main power connection plug is considered as a disconnection

device.

The animal scanner is designed for a mains voltage of 230V and a maximum current of

16A.

Access to the power plug must not be obstructed by

furniture or other objects in order to disconnect the device

from the mains in case of a hazard!

Only use the delivered power cord of type IEC 60309. Do

not use adapters or extensions. Suitable socket outlet must

be used.

6.4.2 USB und Ethernet Connections

Via the network RJ45 jack the device can be connected to a LAN network.

The USB ports on the front side allow optional connection to external backup media or a

variety of peripheral devices.



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6.4.3 Oxygen and anesthesia

The device can be connected to an anesthesia device and gas exhaust unit via the

connections on the right side of the device.

A suitable connector is delivered with the device. Replacement parts can be ordered from

iThera Medical. The tubing should have an inner diameter of 3mm.

The length of the USB cable must not exceed 3 m.

Both, LAN and USB cable must be kept within the

building.



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The recommended aneasthesia unit can be obtained separately from iThera Medical.



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7 Equipment operation

7.1 Principle of Operation

The inSight and inVision series are multispectral optoacoustic tomography scanners

intended for preclinical imaging of mice and small rats. Based on the photoacoustic effect,

intrinsic absorbers such as haemoglobin or melanin or exogenously administered

molecular probes can be visualized in vivo and in real time, allowing the spatial and

temporal quantification of optoacoustic signals.

7.2 Starting the Device

Before starting, fill the internal water tank until the marking with deionized water according

to the instructions in chapter 8.2.

After the system is started, the application “ViewMSOT” will start automatically.

By pressing “LoadHW” (please see Software Manual) the hardware system will be

initialized, water will be pumped from the water tank to the imaging chamber and the

water will be heated to a constant temperature.

To switch the system on, turn the key switch on the front

panel in clockwise direction.

A green indicator shows the actual status of the system.

If the system does not start, please switch the system off

for 10s and try again.



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7.3 Placing the Animal

1

Place the frame inside the

mounting station, and ensure that

the frame is clamped into the

base.

2

Pull the coupling membrane

carefully to the front of the

mounting station.

3

Place the animal holder into the

mounting station.

To prevent water from leaking into the animal holder during

acquisition, ensure the frame and the animal holder are dry

before putting them into place.

Drying can be carried out using absorbent paper.



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4

Cut the foil by pushing down on

the lid.

5

Fix the foil with magnetic stripes.

6

Place sample or mouse inside

holder

If placing a live animal make sure

to connect anesthesia first (7)

Close the frame by raising it to the

holder. Ensure that the frame

clicks into place.

7

The anesthesia can be

disconnected by pressing the

metal parts on the sides of the

connector.



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Once the holder has been placed into the imaging

chamber, the frame must not be opened and closed again

as this will compromise the water seal.

Once the frame has been opened, the user must

thoroughly dry the frame and holder and repeat mouse

placement starting from step 1.



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7.4 Performing Measurements

Ensuring first that the laser is not firing, open

the flap of the small imaging device and

place holder inside the device.

Connect anesthesia connector of the device

to the mouse holder and close the flap.

The MSOT measurement is controlled by software. For details please refer to the

software manual.



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7.5 Shutting down

After the measurement has been performned, turn off the laser and remove the mouse

holder from the system.

Press the button “Unload HW” and wait until the status popup disappears.

By closing the software tool “ViewMSOT” the water is pumped out of the imaging

chamber.

After the software has closed, please shut down the computer.

Only switch off the system after the screen turns black by turning the key switch

counterclockwise.

Make sure that the anesthesia supply valve is closed.

Even if the system is switched off, the heating of the laser

will stay on to maintain a constant temperature of the

internal crystals.

Do not unplug the system!



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8 Service and Maintenance

To ensure safe operation the equipment must be regularly serviced by the manufacturer

once a year.

A description of the service tasks is documented in the inSight/inVision series service

manual.

Opening the side panels of the animal scanner is strictly

forbidden for non-authorized personnel. Do not try to

repair the device by yourself. This could result in

equipment damage, malfunction, electric shock, fire or

serious injury.

Except the parts explicitely described in chapter 8 the

device contains no parts that can be serviced by the user.

Should a malfunction occur, immediately stop operation

and contact the manufacturer.

8.1 Contacts for Technical Support

iThera Medical GmbH

Zielstattstrasse 13

81379 Muenchen

Germany

Phone: +49 (0) 89 7007 449 99

Fax: +49 (0) 89 7007 449 90

E-mail: [email protected]

8.2 Change of Water

In this device deionized water is used as a coupling medium. To ensure a smooth and

safe operation, this water must be changed daily.



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To disconnect the tubing on the red cap pull

the brass fitting downwards until it pops out

of place.

Open the second tubing (overflow) in the

same way.

Now take the water tank out of the device.

To exchange the water open the red cap.



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Install the water tank in reverse order.

Make sure to connect both tubings after the water tank

has been exchanged.

8.3 Changing the filters

The device is equipped with an antibacterial microfilter. This should be changed at least

once a month.

Proceed as follows:

Empty imaging chamber

Unscrew filter housing (transparent part) by turning it counterclockwise – be careful

there might still be water inside. It is recommended to use a small bucket or tissue

to absorb water, which might drip into the pump compartement

Remove filter cartridge from filter housing, empty remaining water from filter

housing

Clean filter housing with disinfectant

Insert new filter cartridge inside filter housing and screw it to the black holder, make

sure that the O-Ring is in place

Pump water into imaging chamber, start stirring pump and check if filter housing is

not leaking

Remark: For easy opening of the filter housing a filter wrench can be used. This wrench

is delivered with the system.



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Make sure, that no water is spilled, as this will be

detected by the internal leakage detector, all pumps will

be shut down and the system will show an error.

In case water was spilled and the leakage

detector (picture on the left) was activated

please carefully dry it with tissue or a blow-

drier.

8.4 Cleaning and Disinfection

8.4.1 Recommended disinfectants/detergents

For disinfection or cleaning the system the following substances are recommended:

Isopropanol 70%

Pursept FD (Merz Hygiene GmbH, Frankfurt am Main)

Deionized water with or without mild detergents



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8.4.2 Cleaning and disinfection of the exterior of the device

Use a cloth lightly damped with one of the recommended agents of chapter 8.4.1 to clean

the exterior surfaces of the device.

Make sure not to spill any liquid into the system.

8.4.3 Cleaning and disinfection of imaging chamber and internal tubing

Fill tank with one of the recommended agents of chapter 8.4.1.

For instructions regarding exchanging the water tank please refer to chapter 8.2.

Pump detergent/disinfectant into the imaging chamber

Let the solution circulate through the internal pump. Please observe the suggested

reaction time given by the manufacturer of the detergent/disinfectant

To achieve a better cleaning result repeatedly pump the cleaning agent into the

tank and into the chamber

After the reaction time pump the solution back into the tank, remove the tank from

the system and dispose its content.

Flush the water tank with clean deionized water.

To flush the imaging chamber insert water tank with clean deionized water into the

system, pump the water into the chamber and let it circulate for several minutes.

Afterwards pump it back into the water tank and dispose of the water

Repeat until there is no residue of the disinfecitant/detergent inside the imaging

chamber and water circulation system

It is recommended that the water filter is exchanged when the system is being disinfected.

8.5 Notes on Replacing Components

Only use original spare parts and consumables supplied

by iThera Medical GmbH. Otherwise a reliable and safe

operation can not be guaranteed.



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8.6 Preventative Cleaning and Maintenance Routines

Task Ref. Maintenance

Interval

Performed by

Change of water, chamber 8.2 Daily User

Disinfection of chamber 8.4 As needed User

Change of water filter,

chamber 8.3 Monthly User

Change of laser flashlamp N/A 20 million shots iThera service

Change of deionizing

cartrigde, laser N/A Yearly iThera service

Change of water filter, laser N/A Yearly iThera service

Check (and if necessary

change) of filter mat N/A Yearly iThera service

Check (and if necessary

change) of interlocks N/A Yearly iThera service

Tasks which are marked with “iThera service” can only be

performed by an iThera service technician.

Do not attempt to carry out these tasks by yourself!

8.7 Spare Parts and consumables

Part number Description

ACC-AHM Animal Holder (Mouse - 120mm)

ACC-AHR Animal Holder (Rat - 180mm)

ACC-ANTH Anesthesia System



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ACC-MOUNT Mounting Station

ACC-PHANT Measurement Phantom

CBL-CLAMP Paw Clamps (4 pcs)

CBL-CONE Nose Cone (10 pcs)

CBL-DCART Deionizing Cartridge (Laser)

CBL-FILTL Water Filter (Laser)

CBL-FILTT Water Filter (Imaging Tank)

CBL-LAMP Laser Flashlamp

CBL-MEM10 Coupling Membrane (10x30m) - thin (10µm)

CBL-MEM20 Coupling Membrane (300m) - medium (20µm)

Spare parts and consumables can be obtained from iThera Medical GmbH.



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9 Waste of Electrical and Electronic Equipment (WEEE)

A safe and environmentally friendly disposal of working materials, auxiliary materials and

exchange parts must be arranged.

Mechanical exchange parts should be reworked and recycled.

Electrical exchange parts should be reworked and recycled.

The corresponding norms, also intra-company regulations, for the disposal of working

materials, auxiliary materials and exchange parts must be noted. The regulations of the

recycling management law must be acknowledged.



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10 Trouble Shooting

Issue Solution

System does not start, after

key switch was turned

1. Check if the system is connected to appropriate

mains supply

2. Switch off for at least 10s and try again

Critical Hardware Error 1. Water inside the lower compartment.

Leakage detector (green cylindrical part on the

right side) has to be dried.

Reload Hardware.

2. Imaging chamber overheated.

Fill water chamber and reload Hardware.

Critical Hardware error

persists after reloading

Hardware

Unplug system from mains, wait for approx. one

minute and replug the system.



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11 Warranty

The Seller warrants that the Product sold hereunder conforms to the written description

of the Product and will function in accordance with the specifications set out therein. In

case of more than minor defects the Seller shall be obliged to remediate the defect

through its on-site support staff during the warranty period.

Only if the Seller, or its support staff, determines that the defect cannot be remediated,

the Seller shall be obliged to deliver a replacement product. The assertion of further

claims by the Purchaser is excluded.

The warranty period shall be twelve (12) months from the date of provision of the product.



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12 EG Declaration of Conformity

iThera Medical GmbH

Ingolstaedter Landstraße 1 85764 Neuherberg / Muenchen

Germany

Phone: +49 (0) 89 3187-3973 Fax: +49 (0) 89 3187 4170

E-mail: [email protected]

CE – Declaration of Conformity for

Small Animal Scanner

inSight64, inVision128, inVision256-TF

We, iThera Medical, hereby declare, that the above mentioned product is in accordance with the following EU Directives:

Low Voltage Directive (2006/95/EG)

Electromagnetic Compatibility (EMC) Directive (2004/108/EG)

and their applied harmonized Standards:

EN 61010-1:2010

EN 61326-1:2006

EN 60825-1:2008

This document was signed under responsibility of:

_______________

Date: signature:

Company stamp

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