KARl100

The PET Revolution

TECHNICAL SPECIFICATIONS
ENG_Rev.14
 KARl100 TECHNICAL SPECIFICATIONS_ENG_Rev_14 Date

This publication cancels and replaces any previous edition and

10-02-2022
revision

NAME ROLE SIGNATURE

Redactor

Luigi Bolognini Product Specialist

Approved by

U.T.E
Marco Guardigli
Responsible

Quality Assurance
Antonio Brancaleoni
Manager

Revision N° Type of Revision Date

00 - 10 Emission - Updates 03/11/2011 - 16/07/2019
11 Software update 07/06/2021
12 Update 10/06/2021
13 Update 21/06/2021
14 Wall Mount Stand added 10/02/2022

KARL100_TS_EN_Rev_14 2
 TABLE OF CONTENTS

1. INTENDED USE .......................................................................................................................................... 4

2. DIMENSIONS AND WEIGHT ...................................................................................................................... 6
3. SHIELDING ................................................................................................................................................. 7
4. INTERNATIONAL STANDARDS ................................................................................................................... 8
5. COMPLIANCES........................................................................................................................................... 9
6. CHARACTERISTICS ................................................................................................................................... 10
7. OPERATION LOGIC .................................................................................................................................. 11
7.1 REMOTE INJECTION – UNIQUE FEATURE................................................................................................ 11
7.2 DIRECT INJECTION ................................................................................................................................... 11
8. MAIN COMPONENTS .............................................................................................................................. 13
9. MAIN WORKING AREA ............................................................................................................................ 14
9.1 RAD-INJECT HOUSING ............................................................................................................................. 15
9.2 PIERCING AREA ....................................................................................................................................... 16
10. VENTILATION .......................................................................................................................................... 17
11. ELECTRIC - ELECTRONIC CHARACTERISTICS ............................................................................................ 18
12. BATTERY .................................................................................................................................................. 19
13. MOTORIZATION ...................................................................................................................................... 20
14. RADIATION MONITOR............................................................................................................................. 21
15. RAD-INJECT AUTOMATIC INJECTOR........................................................................................................ 22
15.1 RAD-INJECT - DIMENSIONS AND WEIGHT .............................................................................................. 24
15.2 RAD-INJECT STAND ................................................................................................................................. 25
15.3 RAD-INJECT STAND – DIMENSIONS ........................................................................................................ 26
15.4 RAD-INJECT STAND - MAIN COMPONENTS ............................................................................................ 27
15.5 RAD-INJECT WALL MOUNT STAND ......................................................................................................... 28
15.6 RAD-INJECT WALL MOUNT STAND – DIMENSIONS ................................................................................ 29
15.7 RAD-INJECT - COMPONENTS DETAILS: INJECTION PUMP ...................................................................... 30
15.8 RAD-INJECT - COMPONENTS DETAILS: SYRINGE SHIELD ........................................................................ 31
15.9 RAD-INJECT - CONTROL PANEL ............................................................................................................... 32
16. DISPOSABLE KIT ...................................................................................................................................... 33
16.1 DAILY KIT ................................................................................................................................................. 33
16.2 SYRINGE KIT ............................................................................................................................................ 34
16.3 INFUSION KIT .......................................................................................................................................... 35
16.4 DISPOSABLE KIT FEATURES ..................................................................................................................... 36
17. SOFTWARE .............................................................................................................................................. 37
17.1 DISPENSING............................................................................................................................................. 38
17.2 DOSE CALIBRATOR .................................................................................................................................. 39
17.3 VIAL LOADING ......................................................................................................................................... 40
17.4 MANUAL MODE ...................................................................................................................................... 43
17.5 SETUP ...................................................................................................................................................... 43
17.6 ARCHIVE .................................................................................................................................................. 43
18. LABEL PRINTER ........................................................................................................................................ 44
19. CONTROL AND VALIDATION TESTS: FAT – SAT – IQ – OQ - PQ............................................................... 45
20. INSTALLATION REQUIREMENTS .............................................................................................................. 46
20.1 TECHNICAL SUMMARY – KARL100.......................................................................................................... 46
20.2 TECHNICAL SUMMARY – RAD-INJECT ..................................................................................................... 47

KARL100_TS_EN_Rev_14 3
 1. INTENDED USE

The KARl100 System is a mobile unit designed to handle both the dispensing and injections of FDG
and other PET Radiopharmaceuticals, using syringes and our unique automatic injection RAD-
INJECT.

KARl100 is a CE0476 Certified Medical Device composed of:

- KARl100: dose dispensing system, Class 1m Medical Device

- RAD-INJECT: automatic injector, Class 2b Medical Device
- STAND for RAD-INJECT

(It is possible to download the Medical Device Certifications from our website:
https://www.temasinergie.com/company/quality-and-certifications/)

Image 1 - KARl100 Image 2 – RAD-INJECT Image 3 – STAND for RAD-INJECT

KARL100_TS_EN_Rev_14 4
 There are four good reasons to choose the KARl100.

Patient Safety
Keep Radiopharmaceuticals Sterile
Incoming activity from bulk vial is filtered through an in-line 0.22 µm filter. The single dose
injector, the RAD-INJECT, is automatically connected to the main disposable kit within an isolated
vented box with a HEPA filtered atmosphere. The patient is never connected to the multi dose
mother vial: there is no risk of patient-to-patient contamination.
No Risk of an Overdose
The use of single dose injectors avoids any possibility of an accidental dangerous overdose.

Operator Safety
No Hazardous Manual Operations
The lead pot, containing the bulk vial, is automatically uncapped by the system, ensuring full
radioprotection to the operator during the mother vial loading. Moreover, KARl100 is also provided
with a built-in G.M. tube, for continuous on-line dosimetry monitoring.

Flexibility
Continue to Use Your Standard Shielded Containers
KARl100 can handle and automatically uncap any lead pot and vials brands/models on the market:
there is no need for your Radiopharmacy to change their standard mode of operation.
No Limits for Supplied Activity Concentrations
KARl100 is capable of drawing all of the bulk vial activity up to the last drop! And, KARl100 performs
an automatic dilution of the main activity, assuring precise dispensing even for an extremely high
incoming activity concentration.
In case of patients with fragile veins, it is always possible to perform the injection in totally safe
conditions thanks to the manual plunger provided with the RAD-INJECT. The operator can, in any
time, use the manual plunger instead of the RAD-INJECT pump.

Multi-Friendly
Carry Only 1Kg injectors!
There is no need to drive the full equipment each time you inject a dose: the operator may carry
only the light and portable injector, the RAD-INJECT, to each injection room (user-friendly),
allowing the preparation of the next dose with a second RAD-INJECT (optional) while injecting the
previous one (time-friendly) and reducing patient anxiety during dose administration by using only
these very compact individual injectors (patient-friendly).

KARL100_TS_EN_Rev_14 5
 KARl100 is designed to distribute, dispense, and inject from vials containing PET Isotopes in totally
safe conditions, as per the following dosimetry:

Incoming PET Activity in Surface 5 cm from 10 cm from 30 cm

radiopharmaceutical Gbq surface surface from
activity in mCi surface
700 mCi 25,90 Gbq 12,00 uSv/h 7,11 uSv/h 4,72 uSv/h 1,0 uSv/h
750 mCi 27,75 Gbq 12,78 uSv/h 7,62 uSv/h 5,06 uSv/h 1,07 uSv/h
800 mCi 29,60 Gbq 13,63 uSv/h 8,13 uSv/h 5,40 uSv/h 1,14 uSv/h
1 Ci 37,00 Gbq 16,00 uSv/h 8,5 uSv/h 6,47 uSv/h 1,5 uSv/h
1,5 Ci 55,50 Gbq 25,5 uSv/h 15,20 uSv/h 10,12 uSv/h 3,33 uSv/h
2,0 Ci 74,00 Gbq 34,70 uSv/h 20,03 uSv/h 13,49 uSv/h 4,44 uSv/h
Table 1

KARl100 provides the highest achievable level of safety for both personnel and patients.

2. DIMENSIONS AND WEIGHT

KARl100
mm 540 (w) x 1.160 (d) x 1.070 (h)
External dimensions
inch 21 (w) x 45 (d) x 42 (h)
kg 445
Weight
lb 981
RAD-INJECT
mm 163 (h)
External dimensions
inch 6,4
kg 1,1
Weight
lb 2,4
STAND for RAD-INJECT
mm 2.100
Maximum height
inch 82,6
mm 375
Supporting base radius
inch 14,7
kg 24
Weight
lb 52
Table 2 - Reading Key: w = wide d = depth h = height

KARL100_TS_EN_Rev_14 6
 3. SHIELDING

The lead sheets and the tungsten parts are designed and positioned to minimize the total weight
of the unit, optimizing radioprotection during all phases of the working cycle. In this way any
possible radiation leakage through the shielding structure is eliminated. Shielding thicknesses vary
for the different components:

1 2 3

6 5 4

Image 4

Pos. Area description Shielding

1 Transferring 20 mm Pb
2 Dose calibrator 30 mm Pb
3 External Lead Pot 15 mm Pb lateral and top
compartment 20 mm Pb bottom
10 mm W (*) filter sides
4 RAD-INJECT housing 15 mm W (*)
5 Dispensing 10 mm Pb
6 Mother Vial 60 mm Pb
7 RAD-INJECT 8,45 mm W (*) RAD-INJECT γ
8,45 mm Plexiglas RAD-INJECT β
8 STAND 20 mm W (*) with RAD-INJECT γ
20 mm Stainless steel AISI 304 with RAD-INJECT β
Table 3 – (*) W: Wolfram, tungsten

Please note: the RAD-INJECT injector is provided with its own shielding to grant the
radioprotection from the filling phase up to the injection. See Chapter 15 RAD-INJECT AUTOMATIC
INJECTOR.

KARL100_TS_EN_Rev_14 7
 4. INTERNATIONAL STANDARDS

The KARl100 has been designed and built according to the following international standards:
Normative Description
ISO 15223-1.2 Medical devices – symbols to be used with medical device labels,
labelling and information to be supplied – part 1: general requirements
UNI CEI EN ISO 14971 Medical Devices - Application of risk management to medical devices
CEI EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
CEI EN 60601-1-2 Medical electrical equipment. Part 1. General requirements for safety.
Section 2: Collateral normative: Electromagnetic compatibility.
Requirements and tests. – Ed. 07.2003.
CEI EN 60601-1-8 Medical electrical equipment - Part 1: General requirements for safety -
Collateral Standard: Alarm systems - General requirements, tests and
guidance for alarm systems used in electrical equipment and systems.
CEI EN 62304-10 Medical device software - cycle processes of software life
UNI 9106 Determination of activities of radionuclides contained in
radiopharmaceuticals.
Procedures for the determination of known activity of radionuclides
present in radiopharmaceuticals used in nuclear medicine, using a dose
calibrator ionization chamber with an accuracy within 10% contained.
EN 60601-2-24 Medical electrical equipment - Part 2: Particular requirement for the
Only for the RAD safety of infusion pump and controllers
INJECT infusion pump
Directive and Law Description
D.Lgs. 24 Feb 1997 n. Implementation of Directive 93/42/EEC concerning medical devices
46 + revisions
MDR 2017/745, 5 Regulation (EU) 2017/745 of the European Parliament and of the
April 2017 Council of 5 April 2017 on medical devices, amending Directive
2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
(Text with EEA relevance. )
D.Lgs. 25 Jul 2005 n. Implementation of Directives 2002/95/EC, 2002/96/EC and
151 2003/108/EC on the reduction of the use of hazardous substances in
electrical and electronic equipment and waste disposal
Dir. 2006/42EC On machinery, and amending Directive 95/16/EC (recast)
Dir. Laying down basic safety standards for protection against the dangers
2013/59/EURATOM arising from exposure to ionising radiation, and repealing Directives
89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom
and 2003/122/Euratom
Table 4

KARL100_TS_EN_Rev_14 8
 5. COMPLIANCES

The KARl100 meets all requirements in order to be compliant with:

GMP Good manufacturing practice

• Volume 4 of “The rules governing medicinal products
in the European Union”
• Annex 1 Manufacture of Sterile Medicinal Products
• Annex 2 Manufacture of Biological Medical Products
for Human Use
• Annex 3 Manufacture of RadioPharmaceuticals
• Annex 11 Computerised Systems

FDA Food and drug Administration (USA)

• CFR21 part 11 (Software)

KARL100_TS_EN_Rev_14 9
 6. CHARACTERISTICS

Tema Sinergie’s long experience in the field of hot cells and dispensers has made it possible to
reach the highest level of performance and reliability for:

• STERILITY
Sterility of the entire process is achieved using the 0.22 µm filter in the bulk vial loading line. The
HEPA 14 filter grants the Class A (ISO 5) grade of the air flushing in the filling area. The filling
station, equipped with automatic connection/disconnection system, eliminates the possibility of
contamination from patient to patient. The disposable kits are conceived as “enclosed system”:
there is no possible way in for the potentially dirty external air.

• RADIOPROTECTION
This is provided by high purity lead sheets and tungsten. The lead sheets are positioned to ensure
the continuity of radioprotection in all directions. This eliminates any possible radiation leakage
through the shielding structure.

• SAFETY
KARl100 automatically performs the uncapping of the lead pot and perforation of the bulk vial
septum, as well as the dose drawing from the vial, within the fully shielded compartment for a full
operator protection throughout the whole working cycle. KARl100 is also equipped with a built-in
G.M. tube for a real-time online dosimetry monitoring.
Using the RAD-INJECT, the remote injection allows the operator to take distance from the patient
during the injection phase, reducing the exposure to radiations coming from the injected patient.
Top cover lock system: the system is provided with a mechanical lock of the top cover.
However, an acoustic and visual alarm is given when the top cover is accidentally opened once the
production cycle has been started.

• ERGONOMICS
The locations of all working items are easily accessible by the operator during all working phases.

• GMP DATA TRACEABILITY

The KARl100 software allows the saving of an Audit Trail (chronological list of operations) and Alarm
Log File (chronological list of alarms) as incorruptible files.

• MULTI-TRACER COMPATIBLE
KARl100 system is compatible with multiple radio isotopes. For the complete list please see Chapter
20.1 TECHNICAL SUMMARY – KARL100.

• MRI COMPATIBLE
With KARl100 it is possible to dispense a syringe within an optional non-magnetic tungsten
shielding. The operator can bring this dispensed syringe into the PET MRI room in safe conditions
and perform a manual injection in the patience already laying on the PET MRI couch.

KARL100_TS_EN_Rev_14 10
 7. OPERATION LOGIC

KARl100 provides a brand-new way of solving your problems for PET distribution, dispensing, and
patient-safe injections, granting the safest process according to GMP.
KARl100 can operate according to two different approaches of patients’ injection:
- Remote injection
- Direct injection

7.1 REMOTE INJECTION – UNIQUE FEATURE

This modality allows preparing individual doses inside the 10 ml syringe of the RAD-INJECT,
bringing it to the injection room where the radiopharmaceutical administration takes place and
leaving the KARl100 in its dispensing room.

The benefits of the remote injection are:

- saving time and faster workflow, when one dose is ready it is possible to start preparing
the next one by placing a second RAD-INJECT (optional) in the KARl100, while the first is
carried in the injection room
- reducing the dose received by the operator who can step back at the moment of the
injection, being the whole phase taken care by the RAD-INJECT which produces an acoustic
10 second countdown before starting the injection and a final acoustic signal at the end
- reducing the visual impact on the patient by bringing only the RAD-INJECT in the injection
room and not the KARl100 main unit

KARl100 is the one and only dose administration system on the market which allows the Remote
Injection.

7.2 DIRECT INJECTION

With the Direct Injection modality, the KARl100 main unit can be directly connected to the patient
for the administration of the dose. The operator must carry the KARl100 main unit to every single
patience room to perform the injection.
Note that the Direct Injection is actually chosen by less than 1% of the KARl100 users.

In both cases the patient is NEVER connected to the mother vial, and the cycle is fully aseptic.

KARL100_TS_EN_Rev_14 11
 REMOTE INJECTION

Image 5 – Remote injection, the operator brings the RAD-INJECT inside its shielding container to the patience room
for the injection.

DIRECT INJECTION

Image 6 – Direct Injection, the operator must carry the KARl100 main unit to every patient room to perform the
injection.

KARL100_TS_EN_Rev_14 12
 8. MAIN COMPONENTS

1
11 12

9
10

8 2

6
7 Image 7

1 External cover 7 Motorized electric wheel

2 Shielded cover for transferring area 8 Label printer area
3 Shield area for dose calibrator 9 RAD-INJECT automatic injector
4 Piercing area for bulk vial 10 Touch screen PC
5 Lead pot area 11 Filling area
6 Directional wheels 12 Shielded area for mother vial
Table 5

KARL100_TS_EN_Rev_14 13
 9. MAIN WORKING AREA

The working area is made of anodized aluminium. The work level is at about 106 cm from the
floor, and it has raised edges all around to prevent any leakage of accidentally spilled liquid.
The disposable kit is installed in cold conditions, and slides within its shielded guides.
The top cover, made of Polyurethane HD, guarantees compactness, and protects the operator
from accidental contact during working operation. The cover includes a 10 mm Pb shielding for the
dispensing area.

Image 8 – Karl100 with top cover, lead pot area and dispensing area open

KARL100_TS_EN_Rev_14 14
 9.1 RAD-INJECT HOUSING
This part of the machine performs the automatic connection and disconnection between the RAD-
INJECT and the daily disposable kit in a GMP Class A sterile area (See Chapter 10 VENTILATION).

Image 9 – RAD-INJECT housing on the working area.

3
2

4
1

Image 10 – RAD-INJECT housing and automatic connection/disconnection components.

1 Daily kit coupling support 3 RAD-INJECT housing

Patient infusion kit coupling support (used only for
2 Syringe kit coupling support 4
the Direct Injection)
Table 6

KARL100_TS_EN_Rev_14 15
 9.2 PIERCING AREA
On the top working area of the machine there is the needle insertion device. A special housing
holds the 0,22 μm filter and the needle in position for the correct perforation of vials.

Image 11 - 0,22μm filter and needle housing open

Image 12 –0,22μm filter and needle housing close

KARL100_TS_EN_Rev_14 16
 10. VENTILATION

KARl100 is equipped with a ventilation system dedicated to the filling area (RAD-INJECT housing)
where the components of the automatic connection/disconnection and filling systems operate.
The air is conveyed in this area through the HEPA 14 filter. The effect of this ventilation is the
achievement of clean air Grade A in correspondence to critical areas. This area is provided with
pressure seals.

KARl100 is the one and only dose administration system on the market which performs the filling
of the syringe in a GMP Class A (ISO 5) environment.

An additional feature is the possibility to perform the particle counting at any time, thanks to the
predisposition for the isokinetic probe inside the area.

Image 13 – Filling area

VENTILATION SYSTEM CHARACTERISTICS

Extraction fan Capacity 8 m3/hour
Air Speed Electronically Controlled 0,45 m/s ±20%
Inlet filter Absolute Filter Type HEPA H14 - Ei > 99,995%
Working pressure Positive
Grade of the air GMP Class A - (ISO 5)
Table 7

KARL100_TS_EN_Rev_14 17
 11. ELECTRIC - ELECTRONIC CHARACTERISTICS

A sophisticated electronic control system for the n. 2 peristaltic pumps grants both a high
volumetric precision and fast dose distribution. Pump features and the disposable kit materials
ensure extremely high reliability for this system.
The system dynamically measures the characteristics of each disposable kit when it is installed, by
calibrating the pump to match that particular tube sets mechanical response.
Moreover, it automatically detects if the disposable kit has any defects that compromise its use
and ask to replace it.

Image 14 – Peristaltic pump

KARl100 includes:
• N. 2 bubble sensors for checking the presence of air inside the tubes
• N. 1 pressure sensor for checking each disposable kit installed (tubes and syringes)
• N. 1 electronical system for checking the right positioning of the needle at the bottom of
the vial in the external lead pot

KARL100_TS_EN_Rev_14 18
 12. BATTERY

KARl100 is equipped with high efficiency Lithium batteries. The batteries grant 8 hours of working
time with 100% recharging in approximately 2 hours.
The battery level is displayed on the software on the touch screen PC, but there is also a battery
level status LED indicator placed in the label printer area.

Image 15 – Battery level status LED indicator

KARL100_TS_EN_Rev_14 19
 13. MOTORIZATION

KARl100 is provided with a motorized system that allows the operator to easily move the main unit
using the buttons placed next to the touch screen PC. The electrical motor is supplied with a
combination of extremely high efficiency batteries. The motorized wheel also works as brake, and
feeds power back to the battery.

1 2

3
5 4

Image 16 – View of the touch screen PC and buttons

1 Emergency stop button 4 Touch screen PC

2 Motion speed button 5 Ready to go button
3 Forward/backward button
Table 8

Image 17 – Directional and motorized electric wheels.

KARL100_TS_EN_Rev_14 20
 14. RADIATION MONITOR

KARl100 is provided with G.M. tube internally mounted. This on-board G.M. tube is located just
below the touch screen PC, where the operator stands the majority of the time. The G.M.
monitors continuously the dose rate corresponding to the operator location.

Image 18 – The G.M. tube is positioned just below the touch screen PC.

KARL100_TS_EN_Rev_14 21
 15. RAD-INJECT AUTOMATIC INJECTOR

The injection is one of the most dangerous phases for dose rate of the hands, due to the
combination of long time and short distance between the operator’s hands and the
radiopharmaceutical contained in the syringe.
RAD-INJECT is the answer to the operator’s need of radioprotection during the
radiopharmaceutical injection phase.
RAD-INJECT is the last ring of the radioprotection chain.
It is a unique radiopharmaceutical injector for size, versatility and certifications.

RAD-INJECT is a medical device Class 2b CE 0476

Its STAND is classified a medical device Class I, according to 93/42/EEC Directive, Annex VII.

RAD-INJECT is available in n. 2 different models:

• RAD-INJECT γ, specific for γ emitters
• RAD-INJECT β, specific for β emitters

They work with the same logic, with different shielding and injector parameters, to meet the
injector requirements for diagnostic imaging or therapy protocols.

Image 19 – RAD-INJECT automatic injector with tungsten shielding for γ emitters

Image 20 - RAD-INJECT automatic injector with Plexiglass shielding for β emitters

Thanks to a very high level of the electronic support, the RAD-INJECT is able to inject a 10 ml
syringe in less than 60 seconds. No waste of radiopharmaceutical is allowed thanks to the
automatic rinsing after injection, with 2 cycles of 3 ml of saline solution (as per factory settings).
The number of rinsing cycles, as well as the volume of the saline, are customizable.

KARL100_TS_EN_Rev_14 22
 The RAD-INJECT works with a highly efficient Lithium battery. The battery is simply replaced
without any loss of data thanks to an internal memory.

Once the syringe is filled by the main unit of the KARl100, the line is washed with saline solution
(NaCl) and air. This is an important feature, because the part of the syringe kit out of the shielding
is cold when the RAD-INJECT is moved and connected to the infusion kit of the patient.

Image 21

Another main feature is the wide range of the injection time the RAD-INJECT can manage: the
operator, depending on the radiopharmaceutical to be injected and the patient conditions, can
simply set the injection time from 1 up to 240 minutes.

KARL100_TS_EN_Rev_14 23
 15.1 RAD-INJECT - DIMENSIONS AND WEIGHT
The synthesis of high technology and innovative design provides a product with very compact
dimension and high performances:

Image 22 - The dimensions are expressed in mm

Model Weight
kg 1,1
RAD-INJECT γ
lb 2,4
kg 0,28
RAD-INJECT β
lb 0,6

KARL100_TS_EN_Rev_14 24
 15.2 RAD-INJECT STAND
The RAD-INJECT stand is classified as medical device Class I, according to 93/42/EEC Directive,
Annex VII.

The RAD-INJECT STAND is similar to a standard infusion

stand but with some differences.
The supporting base is star shaped, with a 375 mm radius
which is been equipped with 5 rotating wheels giving the
system an easy and smooth sliding movement.

The height of the stand, with the stud at its maximum

extended position, is 2.100 mm from floor. The stud, in
stainless steel, is equipped with a hook to hold the
physiological bottle container. The height of the hook is
adjustable.

The stand shield holder is about at 1.350 mm from the

floor. This circular structure holds the stand shield. This
shield is a circular shielding, 20 mm thickness, with a
circular slot in the centre, designed to house the RAD-
INJECT shielded. The shielding material is made in
tungsten for RAD-INJECT γ and stainless steel AISI 304 for
RAD-INJECT β.
The connection between the two shielding is done through
an easy plug-in movement.

The stand is equipped with a tray designed to support

different materials. The operator uses the tray to place the
different equipment needed for the operations. The tray
has raised edges in order to avoid that any material fall out.
Image 23 – RAD-INJECT stand

N. 2 independent rotation pivots are present in the lower part of the stand: one is for the tray and
the other is for upper part. These rotations represent a great help for the operator who can, at any
time, rotate, with a finger pressure, the tray or the stand shield holder, in order to place them at
the best.

Model Shielding material Thickness

RAD-INJECT γ Tungsten 20 mm
RAD-INJECT β Stainless steel AISI 304 20 mm
Table 9

KARL100_TS_EN_Rev_14 25
 15.3 RAD-INJECT STAND – DIMENSIONS

Image 24 - All dimensions are in mm

KARL100_TS_EN_Rev_14 26
 15.4 RAD-INJECT STAND - MAIN COMPONENTS

A
B

D
C

E
F
H I
G

Image 25

Stud hook for saline solution (NaCl)

A F Star shaped supporting base
support
B Stand stud (height adjustable) G Rotating wheels
Tray for material support (rotating on
C H Stand shield holder
pivot)
n.2 rotating pivots: one for Tray and one Syringe shield for RAD-INJECT (inside
D I
for the upper part stand shield)
E Saline solution collection vessel for priming
Table 10

KARL100_TS_EN_Rev_14 27
 15.5 RAD-INJECT WALL MOUNT STAND
Alternatively, or to be used together with the RAD-
INJECT Stand, Tema Sinergie can also provide a Wall
Mount Stand, designed and built to support the RAD-
INJECT and protect from exposure to radiations
during injection of the radiopharmaceutical.

This type of stand could be a suitable solution where

there is not enough space in the injection/patient A
room to bring the mobile RAD-INJECT stand.

The RAD-INJECT WALL MOUNT STAND is a Class I

medical device in accordance with Regulation (Eu)
2017/745 (UE) on Medical Device.

The Wall Mount Stand includes a steel bracket

anchored to the wall, with a polycarbonate plate in-
between used to isolate the product from any free
current, a height-adjustable arm with hook for B
holding the saline solution, a housing for the E
Tungsten shielding for the RAD-INJECT and a built-in
shelf. C

A Stand stud (height adjustable) with hook for

saline solution (NaCl) support
B Isolating plate
C Wall bracket
D Saline solution collection vessel for priming
E Syringe shield for RAD-INJECT
Table 11
D
Image 26 – Wall Mount Stand

KARL100_TS_EN_Rev_14 28
 15.6 RAD-INJECT WALL MOUNT STAND – DIMENSIONS

Image 27 - All dimensions are in mm

KARL100_TS_EN_Rev_14 29
 15.7 RAD-INJECT - COMPONENTS DETAILS: INJECTION PUMP

The injection pump is a portable device dedicated to the controlled injection of

radiopharmaceuticals.

A B

F D C
E

G
Image 28

A Liquid crystal display

B Connection system to coupling flange
C Control push buttons
D Plunger stroke
E Battery slot
F Syringe plunger
G Manual plunger
Table 12

KARL100_TS_EN_Rev_14 30
 15.8 RAD-INJECT - COMPONENTS DETAILS: SYRINGE SHIELD

L A

I
C

H D
G F E
Image 29 – γ Shield

A Shielding cap
B Syringe shield configuration for injection phase
C Plunger body
D Plunger head
E Spring pressure button for flange disconnecting
F Connexion flange
G Sphere spring for flange pressure block
H Syringe shield position holder inside stand shield
I Syringe tungsten shield
L Syringe shielding for dispensing phase “RI-SSG” shielding
Table 13- Please note: β Shielding differs only for plexiglass shield instead of tungsten shield (point B)

The syringe shield (I) houses the 10 ml syringe, without plunger. The connexion flange (F) holds the
injection pump tight to the shield: this coupling creates a continuous shielding around the
radioactive source of 8,45 mm thickness of tungsten or equivalent shielding: when the plunger
body (C) or the shielding cap (A) are connected.

KARL100_TS_EN_Rev_14 31
 15.9 RAD-INJECT - CONTROL PANEL
The control panel is very compact and easy to use with the main operation function written on the
push button side. The control panel manages:
• the injection cycle
• the operating signals
• the alarm signals
• the parameters control

The RAD-INJECT is equipped with a pressure sensor which, in case the infusion line to the patient
gets partially or totally blocked, decreases the pressure or stops the injection cycle.

The RAD-INJECT is equipped with acoustic alarm for the following operations:
• 10 seconds acoustic alarm count down before injection start, in order to let the
operator step back and take some distance
• injection cycle end acoustic alarm, to inform the operator the injection was
processed
• procedure error acoustic alarm, to inform the operator the operation procedure is
not following the correct steps

A
B

D C
Image 30

Liquid crystal display visualizes the status of the RAD-INJECT and the different phases of the
A
operations

B + push button starts the injection cycle

- push button, used together with the P button, starts the mechanical plunger disconnection
C
movement
P push button, used together with the – button, starts the mechanical plunger disconnection
D
movement
Table 14

KARL100_TS_EN_Rev_14 32
 16. DISPOSABLE KIT

For the correct functioning of the KARl100, it is necessary to use:

- the daily sterile mono-use disposable kit for injector filling (code: KA-DAY / AF-D060)
- the syringe kit (code: KA-SYK / AF-D062)
- the infusion kit (code: RI-INK / AF-D056)

16.1 DAILY KIT

The daily kit is installed by the operator on the KARl100 at the beginning of the working day prior
the arrival of the external lead pot containing the radioactive radiopharmaceutical.

The daily kit is composed by:

- tubes
- containers
- 3-way directional valves
- spike for saline solution (NaCl) bag
- needle for bulk vial piercing
- 0.22 µm filter for bulk vial loading line

The installation of the daily kit on the KARl100 is simple and very easily and can be performed in a
short time. With dedicated guides for the tubes and valves, the installation is fast, safe and with no
possible error, because of a unique mounting design. Incorrect installation is not possible thanks
to the step-by-step guide displayed on the KARl100 touch screen PC.

KARL100_TS_EN_Rev_14 33
 16.2 SYRINGE KIT
The syringe kit is composed by a 10 ml capacity syringe with plunger, luer-lock cap and extension
tube, which the operator needs to place inside the RAD-INJECT before each dispensing/injection.
The operator needs to perform the manual pumping test to check the correct functioning of the
syringe to be dispensed. After this check, the plunger can be unscrewed and removed, it is not
needed anymore since the RAD-INJECT has its own mechanical plunger (See Chapter 15.5 RAD-
INJECT , details B and D)

The extension tube (C) is supplied with n.2 luer-lock:

- female for the connexion to the syringe (male)
- male for the connexion to the infusion kit (female)
The scope of the extension is to give the operator the possibility to perform the luer-lock
screwing-unscrewing operations outside the radiation beam.

A B C D

G F E
Image 31

A Vented cap with membrane

B Male luer-lock stopper
C Extension tube equipped with female and male luer-locks
D Syringe manual plunger
E Syringe central body, 10ml capacity
F Plunger gasket
G Female luer-lock stopper
Table 15

KARL100_TS_EN_Rev_14 34
 16.3 INFUSION KIT
The infusion kit is designed to be installed on the RAD-INJECT stand to perform the injection once
connected to the RAD-INJECT. On one end it allows the connection of saline solution (NaCl)
bottle/bag for intravenous supply of such solution into the patient arm during
radiopharmaceutical injection by the RAD-INJECT. The kit is provided with check valves and air
filter to guarantee the patient safety during the automatic injection.

Image 32

A (*) Saline solution (NaCl)

B Vented spike
C Infusion chamber
D Roller clamp
E Self-ejecting rotating male luer lock
F (*) Butterfly (composed by: needle + tubing + connector)
G Vented filter
H One-way check valve
I Needle free “Y” connector
L Luer lock one-way check valve
M Luer lock connector (from syringe extension tube: see syringe kit pos. I)
N One-way check valve
(*) pos. A and F are not included in the Infusion kit supply
Table 16

KARL100_TS_EN_Rev_14 35
 The infusion kit is composed by all item listed from A to N (A and F are not included in the infusion
kit supply because present in every clinical centre). Compared to standard infusion kit, the RAD-
INJECT infusion kit has the following special equipment:
• N: one-way check valve before the needle free Y connector
• I: one-way check valve after the needle free Y connector
• L: luer lock one-way check valve
• G: vented filter for eventual air bubbles elimination
The valves and the filter avoid any possible air injection.

16.4 DISPOSABLE KIT FEATURES

• Packaging: the products are individually packed and supplied as sterile and pyrogen-free.
The Daily kit and the Syringe kit are supplied in double sterile bags. The Infusion kit is
supplied in a simple sterile bag.

• Sterilization: is carried out using a CO2 / ethylene oxide mixture, in compliance with EN
550 standards.

• Sterility: is guaranteed for 5 years. The product cannot be re-sterilized.

• Components control: each component undergoes, upon receipt and before sterilization, a
size and visual check to verify conformance with appropriate internal quality control
standards. In addition, before being sterilized, the kits undergo checks for physical integrity
as well as tightness tests, glue tests, and welding tests according to internal quality control
procedures (IC01: visual and size controls; IC02: tightness and permeability test; IC03:
welding test; IC04: glue test). The sterilized finished devices are inspected for package
integrity. All sampling procedures comply with UNI ISO 2859-1 standards. The sterilized
finished devices and components undergo sterility tests as well as chemical toxicity and
ethylene oxide residue tests according to F. Eu. IV ed. and ISO 10993-7 monograph and
biocompatibility tests according to ISO 10993.

• Manufacture and conformance: the device meets the requirements of the 93/42/EEC and
MDR 2017/45, and it is biocompatible according to ISO 10993. The materials are of
pharmaceutical grade and the components comply with ISO 594/1-2, F. Eu. IV ed.

• Classification: Medical device class IIa, EC marked according to the 93/42/EEC.

• Disposal: unused devices must be disposed as waste in compliance with local waste
regulations. Used devices must be considered as radioactive waste and disposed according
to appropriate regulations.

KARL100_TS_EN_Rev_14 36
 17. SOFTWARE

A complete, simple, and direct management software allows the dispensing of FDG inside syringes
with a simple finger touch.

The KARl100 software has the following features:

• simple and direct touch screen interface
• incorruptible data with traceability and flexible software access, daily printed reports
• our “Fibre Calibration” technology (developed by Tema Sinergie) makes the system
dynamically correct for the characteristics of each installed disposable kit, by calibrating
the pump to match the tubes mechanical response

KARl100 can be interfaced with the hospital data information system: the software is DICOM
compliant for data exchange with centralized hospital data management software, in order to
import patients database directly in the PC device and send data back after dose preparation.
Please refer to our Technical Department for further details.

At the end of each syringe dispensing / injection operation the system provides the precise values
to the hospital database, which updates the patient’s history with all the data that it can supply.
The software is highly configurable, in order to customize the unit and the distribution logic
according to the operator that uses it. Simple and clear graphics helps the operator to avoid any
possible errors, distractions, or incorrect operations.

The software is installed on a tiles-based touch screen PC running Windows 10 IOT.

Image 33

KARL100_TS_EN_Rev_14 37
 17.1 DISPENSING
The dispensing module is the heart of the application where the operator can manage the
distribution of the radiopharmaceuticals in syringes.

Image 34

It consists of different area/touch buttons:

• start the production cycle
• all the commands needed to plan and prepare a production cycle
• the list of syringes of the production (both dispensed and to be done)
• the complete specification of a single dose selected in the list
• procedure for loading from an external vial

Image 35

KARL100_TS_EN_Rev_14 38
 The KARl100 is standardly provided with a Geiger Mueller probe installed in the operator’s position.
A dedicated touch button in the dispensing module allows the monitor for dose rate with relevant
graph (See Chapter 14 RADIATION MONITOR).

17.2 DOSE CALIBRATOR

Tema Sinergie has developed the dedicated software “Dose Calibrator Viewer”, to manage the
dose calibrator functions by the same software as the main unit. This gives the operator direct
access to all the needed functions by the same PC. The dose calibrator is an integral component to
support all KARl100 functions.
The KARl100 is supplied with a specific compact dose calibrator already configurated to manage F18
isotopes.

The KARl100 software allows:

1) The Background key calls upon the KARl100 software to carry out a base activity measuring
procedure.

2) The Stability Check is a procedure that allows the verification of the integrity of the dose
calibrator.

3) The Linearity Test has a double value: combined with the stability check, it allows a cross-check
to be carried out on the performance of the dose calibrator and, furthermore, to check the purity
of the radiopharmaceutical produced (from the decay analysis).

Image 36

KARL100_TS_EN_Rev_14 39
 17.3 VIAL LOADING
This section gives the operator the possibility to load the radiopharmaceutical from an external
vial. One of the most relevant features for the KARl100 is its capability of drawing all the source
vial activity up to the last drop, with no limits for supplied activity concentrations.

Image 37

The customer continues to use its standard shielded containers. The KARl100 can handle and
automatically uncap any major lead pot and vials brands/models: there is no need for the radio
pharmacy to change their standard mode of operation.

In addition to Tema Sinergie lead pot models, KARl100 is already configured to work with the
following brands models:

Tema Sinergie Tema Sinergie DAMAN VORTAL DAMAN VORTAL no pins

CT/A-30P CT/A-30 (Belgium) (Belgium)

KARL100_TS_EN_Rev_14 40
 COMECER CF18P COMECER CF18T CYCLOTRON VU VON GAHLEN 1727
(Italy) (Italy) (Holland) (Holland)

ONET-GRAVATOM MEDRAD BIODEX 001-706 BETA PLUS

(UK) (USA) (USA) (Belgium)

ECZACIBASI MONROL NTP RADIOISOTOPES BROENS MAP

(Romania) (South Africa) (Australia) (Finland)

CYCLOPHARMA CROFT PET 18F TECNIBUSA

(France) (UK) (Czech Republic) (Spain)

The process of piercing and loading of the radiopharmaceutical is made automatically: no

hazardous manual operation must be done. The right positioning of the needle at the bottom of
any vial is made automatically. The automatic washing cycles and transferring of the diluted
solution in the main vial avoids any loss of radiopharmaceutical.

KARL100_TS_EN_Rev_14 41
 Automatic uncapping of the lead pot and perforation of the bulk vial septum process:

1 2

1 – The operator opens the lead pot compartment 2 – The operator places the lead pot in its housing
and removes the handle

3 4

3 – The operator adjusts of the clamps on the lead 4 – KARl100 automatically uncaps the lead pot
pot cap and closes the lead pot compartment

5 6

5 – KARl100 automatically slides the cap 6 – The lead pot is lifted automatically

7 8

7 – The lead pot reaches the needle 8 – The needle perforates the vial and loads the
radiopharmaceutical

KARL100_TS_EN_Rev_14 42
 17.4 MANUAL MODE
The KARl100 manual module allows the operator to carry out individual operations manually, in
order to solve problems or critical situations. It also allows the operator to carry out a diagnostic
check of all the sensors installed on the machine, to check the status of the valves, pumps, and
optical fibres.

17.5 SETUP
The setup module is divided into different menus that allow the configuration of the settings and
parameters that define the functioning mode of the system:
• all the parameters of the machine
• user’s access configuration module with list of users and their level of access
• measurement unit (Ci, mCi, MBq, etc.) and the number of decimal points to be visualized
for activity and volume

17.6 ARCHIVE
This is the section where the user can consult archives containing data concerning all the cycles
carried out.

It consists of four sections:

1) Batches - the operator can use the search filter to find the cycle or set of cycles to be analysed
2) Item - this allows the selection of viewing of data for an individual single syringe produced
3) Audit trail - the list of all the events happened saved in an uncorruptible file
4) Production Report - the report of the productions, with all the information necessary to
validate the process

KARL100_TS_EN_Rev_14 43
 18. LABEL PRINTER

The DYMO LabelWriter 450 Turbo is the standard KARl100 printer, it is placed under the touch
screen PC. With printing at a speed of 55 labels per minute, this is the fastest printer in its class in
the world.

It also offers superior quality label. This printer’s flexibility, together with KARl100 software, allows
certain configurability of the labels, such as the different selections for the information to be
included, and inclusion of the bar code. The labels can be prepared and changed directly by the
operator (under password control). The labels can be printed in double or triple copies for: syringe
shield, shielded carrier, and patient record documents.

Its main characteristics are:

• 300 dpi for super quality labels
• Up to 60mm (2.36 inch) labels
• USB connection

Image 38

KARL100_TS_EN_Rev_14 44
 19. CONTROL AND VALIDATION TESTS: FAT – SAT – IQ – OQ - PQ

Tema Sinergie s.r.l. is a ISO9001 certified company since year 2000. According to ISO9001 (Quality
Management Systems – Requirements) all products undergo strict control check prior to
equipment shipment to customer.
All tests are performed by high qualified internal personnel by means of calibrated instruments
that satisfy all international standards.

Tema Sinergie products are tested at the factory, before shipment, to meet:

A) ISO 14644-1 Cleanrooms and associated controlled environments - Part 1: Classification of air
cleanliness
B) ISO 10648-2 Cleanrooms and associated controlled environments - Part 2: Specification for test
and monitoring to prove continued compliance with ISO 14644-1
C) ISO 14644-3 Cleanrooms and associated controlled environments - Part 3: Test methods
D) ISO 14644-7 Cleanrooms and associated controlled environments - Part 7: Separative devices
(clean air hoods, gloveboxes, isolators and mini-environments)
E) ISO 10648-1 Containment enclosures - Part 1: Design principles
F) ISO 10648-2 Containment enclosures - Part 2: Classification according to leak tightness and
associated checking methods
G) EEC – GMP
H) FS 209E standards.

For detailed information of the validation test please check the file:

Qualification and Acceptance Tests FAT-SAT-IQ-OQ-PQ

If this file is not attached, please require it to your contact person.

KARL100_TS_EN_Rev_14 45
 20. INSTALLATION REQUIREMENTS

Electrical Power Supply VAC 100 - 240

amp 15
Electrical socket Type Schuko Standard
(USA/Canada available)
Table 17

20.1 TECHNICAL SUMMARY – KARL100

Dimensions (w) x (d) x (h) mm 540 x 1.160 x 1.070
Weight Kg 445
Shielding See Chapter 3 SHIELDING
Maximum bulk activity Ci 2
GBq 74
Maximum bulk vial volume ml 50
Maximum volume saline solution (NaCl) ml 500
Maximum patient dose MBq 1000
Maximum dose volume ml 10
Minimum dose volume ml 0,5
Accuracy (Dose Dispensing Precision)
calculated as Requested Dose / Dispensed % ±2
Dose
Maximum injection rate ml/min 12
Minimum injection rate ml/min 0,04
External dose rate See Table 1
Maximum pharmaceutical loss ml 0
Radio isotopes compatibility 18F, 64Cu, 123I, 99Tc, 68Ga,
177Lu, 90Y, 223Ra, 131I, 89Zr,
11C (possible addition of

other isotopes)
Surface material Type Polyurethane HD
Working area material Type Anodized aluminium
Power consumption Va 350
Frequency Hz 50/60
Dose Repeatability % 1
Disposable kit sterilisation Gas EtOH (validated process)
Disposable kit components Grade Medical
Disposable kit components standards Type European Pharmacopeia
and/or ISO 10993
Table 18

KARL100_TS_EN_Rev_14 46
 20.2 TECHNICAL SUMMARY – RAD-INJECT
RAD-INJECT dimension
Please note: stand excluded
Syringe Tungsten Shielding mm 8,45
Length mm 163
Large mm 48
Weights for gamma and beta versions gr 1.100 (γ) - 280 (β)
STAND dimension
Stand Tungsten Shielding mm 20
Height (maximum – adjustable) mm 2100
Large (support base radius on wheels) mm 375
Weight kg 24
Syringe
Syringe volume capacity ml 10
Injection cycle time (FACTORY SETTINGS):
Can be set:
- for 7 ml volume of radiopharmaceutical
Time from 1 minute
- including 5 seconds for operators stepping back
to 240 minutes
- including 2 rinsing cycles of 3 ml volume saline (NaCl) each
Maximum injection volume ml 10
Power supply
Battery (camera type) Lithium CR123A 3V
Voltage V 3
Table 19

Please note: the images of this document must be considered as an example, merely illustrative.
In keeping with our continuous research and development, Tema Sinergie reserves the right to
modify dimensions, specifications, and equipment without prior notice.

KARL100_TS_EN_Rev_14 47
 This page is left blank on purpose.

KARL100_TS_EN_Rev_14 48