Sacci 111521 User manual

Infusion Thermo Bag
USER MANUAL
ARTNO 111521

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User manual - Infusion Thermo Bag User manual - Infusion Thermo Bag
CONTENTS General information
General information
3Purpose
3Safety – regulations and warnings
4Markings and symbols
5Certicates and markings
5Technical lifespan
6Recycling
6Manufacturer
Instruction manual
7Unpacking
7Usage
8Cleaning and maintenance
8Safety function
9Trouble shooting
Product description
11 Functional description
13 Technical data
Accessories and spare parts
14 Content Installation kit (article number 009122)
14 Mounting instructions for Installation kit
15 Operational control
PURPOSE
This manual is intended to provide necessary information to
users to ensure proper and safe use of the product.
SAFETY  REGULATIONS AND WARNINGS
Read the entire user manual and follow the instructions
before using the product for the rst time. The user manual
has been written to ensure that you can handle the product in
a safe and correct manner.
»The product may only be used by authorised personnel with
relevant competence to operate the product.
»The product is not intended for outdoor use and therefore
not designed for use in such an environment.
»The product must be installed by qualied personnel accor-
ding to the instructions in the user manual.
»Never use the product near a mobile phone, CB radio or any
other form of radio communications and/or electromagnetic
eld as this can aect the product’s function.
»The product is not intended for storage of blood/plasma or
heat-sensitive infusion solutions.
»When removing the infusion solution from the bag, the user
must keep the heated bag against the skin as extra safety

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User manual - Infusion Thermo Bag User manual - Infusion Thermo Bag
check to ensure body temperature as a nal test that the
temperature of the infusion solution is correct.
»If the display gives o a red light, do not remove the infusion
solution bag for use.
»If the display does not illuminate, the bag should be taken
out of service and troubleshooting be initiated.
»The user is responsible for following the regulations for
storage, heating, durability and handling provided by the
manufacturer of the infusion solutions.
MARKINGS AND SYMBOLS
Explanation of markings and symbols on the product:
Manufacturer
Direct current
Car battery
Serial number
Manufacture date
The product is CE marked according to the medical
device directive (MDD) 93/42/EEC in class IIa
Warning, read attached documentation
Not intended for outdoor use
The product must not be disposed of in the refuse
but must be recycled. Used bag is to be deposited
in accordance with WEEE Directive 2002/96/EC for
disassembly and recycling.
CERTIFICATES AND MARKINGS
The product is tested by Intertek in accordance with IEC
60601-1. CE marked according to the medical device directive
(MDD) Annex V 93/42/EEC in class IIa.
TECHNICAL LIFESPAN
This product has a technical lifespan, which is determined

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User manual - Infusion Thermo Bag User manual - Infusion Thermo Bag
by Sacci Ryggsäckar AB to be 2 years. Like all products, the
infusion thermo bag from Sacci Ryggsäckar AB is subjected to
wear and ageing, and even if the product is maintained and
service is performed regularly, the function cannot be guaran-
teed after the specied lifespan. Service, spare parts, et cetera
that are provided by the manufacturer after the expiry of the
specied lifespan does not extend the lifespan.
RECYCLING
Used bag is to be deposited in accordance with WEEE
Directive 2002/96/EC for disassembly and recycling.
THIS PRODUCT IS MANUFACTURED, MARKETED AND
DISTRIBUTED BY:
Sacci Ryggsäckar AB
Gamla Tunavägen 8
SE-784 36 BORLÄNGE
SWEDEN
Phone [phone]
Fax [phone]
Email [email protected]
www.sacci.se
Instruction manual
UNPACKING
1. Unpack and inspect the product upon delivery. Contact your
local distributor immediately if you nd any damage to the
product.
2. If you need to change the adapter, follow the instructions
under the heading Electrical connection.
3. Connect the product to a power source.
USAGE
1. Place three 1 L infusion solution bags on top of each other
(stacked) and then close the bag.
2. Wait until the display lights green before the infusion solu-
tion bag can be removed to ensure that the temperature is
37 °C ± 2 °C. Filled infusion thermo bag has a heating time of
about 2 hours.
3. When the display lights green, the infusion solution bag can
be removed from the lower opening of the infusion thermo
bag by opening the zipper.
4. Check the removed infusion solution bag temperature by
holding a hand to it to ensure that the content is at body
temperature before administering the infusion solution to
the patient.

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User manual - Infusion Thermo Bag User manual - Infusion Thermo Bag
5. New unheated infusion solution bags are placed inside the
product from above. Follow local routines for labelling,
storage, handling and disposal of infusion solution bags.
CLEANING AND MAINTENANCE
In case of blood or vomiting on/in the product, rst rinse with
water and then scrub/wipe with disinfectant.
In order to wash the fabric part of the product, rst the metal
insert with associated electronics needs to be removed by
technical personnel. The outer bag in fabric may be washed in
a washing machine at 40 °C, but they must not be centrifuged
or tumble-dried. Instead, let the bag drip dry.
SAFETY FUNCTION
The product has a built-in overheat protection that shuts o
the product in case the temperature control stops working
properly. In the event of a triggered overheating protection,
the product must be taken out of operation and undergo
an operational control. For details, read under the heading
Operational control. In case the operational control does not
give the desired outcome, the product must be sent to Sacci
Ryggsäckar AB for repair.
Display does
not light up.
Red or green
display
without colour
change despite
changed tem-
perature.
Overheat protec-
tion triggered.
Cord between
control board
and display
disconnected.
Faulty display.
Take the product out of
service and perform an
operational control. In
the event of non-
approved operational
control, the product
must be sent to Sacci
Ryggsäckar AB for repair.
Check to make sure
the cord is properly
attached.
Take the product out
of service and send to
Sacci Ryggsäckar AB for
repair.
TROUBLE SHOOTING
Symptom Possible causes Action

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Display lights
up but no heat
is supplied.
No power to
the system.
Green display
lights, but
temperature
of infusion
solution bags
exceeds 40 °C.
Faulty control unit
or heating circuit.
Cable/cable
installation failure.
Software error or
short circuit on the
circuit board.
Take the product out
of service and send to
Sacci Ryggsäckar AB for
repair.
Check the installation
of cable/voltage drop.
Alternatively send to
Sacci Ryggsäckar AB for
repair.
Take the product out
of service and send to
Sacci Ryggsäckar AB for
repair.
Symptom Possible causes Action Product description
FUNCTIONAL DESCRIPTION
The product is a heat-regulated bag that holds three pieces of
1 L infusion solution bags and is intended for heating infusion
solution to body temperature. The product is intended for
installation in ambulance vehicles to provide body temperature
infusion solution.
The product is an insulated bag with room for three 1 L infu-
sion solutions. The product has a metal insert with a built-in
temperature-controlling microcontroller which ensures that
the temperature stays at 37 °C ± 2° C, where correct tempe-
rature specication gives green colour to the built-in display
while red colour means that the temperature is outside the
specication. The product also has a safety function in the
form of mechanical overheating protection which shuts o
the product if the temperature of the metal insert of the bag
exceeds 60 °C, see gure 1.
During the heating phase, the metal insert will be warmer
than 37 °C ± 2 °C to accelerate the heating of the infusion
solution bags. When the infusion solution bags reach the desi-
red temperature after about 2 hours, the product and the infusion
solution bag will maintain the temperature of 37 °C ± 2 °C.

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User manual - Infusion Thermo Bag User manual - Infusion Thermo Bag
Figure 1. Placement of display, microcontroller and overheating
protection.
Display
Microcontroller and
overheating protection
Width
Height
Depth
Weight of empty bag
Weight of full bag (3 × 1L infusion solution bags)
Material
Voltage
Power (20 °C)
Electric current
Electrical resistance
320 mm
230 mm
100 mm
980 grams
3780 grams
Acrylic coated polyamide fabric
12 V
75 W
6.25 A
1.94 Ω ± 10%
TECHNICAL DATA

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User manual - Infusion Thermo Bag User manual - Infusion Thermo Bag
Accessories and spare parts
CONTENT INSTALLATION KIT ARTICLE NUMBER 009122
Installation kit is supplied as an accessory and includes:
»Contact for wall mounting
»Switches for wall mounting
»Fuse holder with fuses
»Cables
MOUNTING INSTRUCTION FOR INSTALLATION KIT
See gure 2 for mounting instruction.
Preparation
1. Mount the customised aluminium rail (article number 112012)
with a chassis knob in a suitable/desired location in the
ambulance. No more than 1.4 metres from the power source
which is limited by the cable length of 1.5 metres.
2. At a distance of max 60 cm from the bag, drill two round
holes with a diameter of 26 mm and 23 mm respectively in
the wall.
3. In the holes, the SELV contact and the switch included in the
Installation kit are mounted.
Electrical connection
1. From the switch, which is mounted in the smaller of the
pre-drilled holes, a separate supply cable with a cross-
sectional area of 2.5 mm2(attached cable) – with the pro-
duct as sole user – is drawn to the ambulance fuse holder
or directly to the battery in the engine compartment.
2. If the ambulance has a special battery for healthcare
equipment, the supply cable is drawn to this battery.
The connection must be made with good quality 6.3 mm
insulated cable shoe. For cars with 24 V DC, high quality
converters must be installed. The cable length in the bag
is 1.5 metres.
3. Connection must not be made to the car’s cigarette lighter
socket, as these usually cause large voltage drops after a
period of use.
OPERATIONAL CONTROL
When the unit is connected to the socket, the display should
be lit in red and the unit should start to heat up the infusion
solution. When the desired temperature of 37 ˚C ± 2 ˚C has
been reached, the display should light green.
If an external heat source is supplied and the temperature
of the liquid becomes warmer than specied, the display will
light in red. When the temperature drops, it will light green
again.

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User manual - Infusion Thermo Bag User manual - Infusion Thermo Bag
Check the unit so that the heater becomes warm when con-
nected. Apply a thermometer and read o so that the display
shows green at the right interval. If the unit is out of order
and the heater becomes too hot, an overheating protection
will break the current.
In case of non-approved operational control, the product must
be returned to Sacci Ryggsäckar AB for repair.

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User manual - Infusion Thermo Bag User manual - Infusion Thermo Bag
Figure 2. Mounting instructions for installation kit
Switch with black casing and
green lit spot (type 9).
Red L – 4,000, cut to appropriate length.
Black grounded in point without voltage drop. Red
Black
Red +
Packed blue 6,3 cable shoe is pressed on the
cable and mounted in the fuse holder.
Connected to the
battery+ or connection
point without voltage
drop.
Round cable shoe ø8,2
Red
Marking placed on
fuse holder
51301
Year Week
Placed in appropriate
accessible place
Fuse holder
Fuse 15A
SELV outlet
12V DC 16A
To be mounted in wall
Cable tie
Cable
1 + out
2 + in
3
1
2
3
+ in
+ out
Mounting frame, hole ø22
Power switch (possible hole 19,4x13)
Mounting: First press the frame in the hole,
followed by the switch