USER MANUAL

Rev.27. Date 29th May 2020

USER MANUAL
CONVECTIVE AIR SYSTEM FOR
PREVENTION OF PERIOPERATIVE
HYPOTHERMIA OF THE PATIENT

CALIMA

CELSIUS MEDICAL, S.L.

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CONTENTS
1. INTRODUCTION _____________________________________________________ 3
2 INDICATIONS FOR USE __________________________________________ 4
3 WARNINGS AND PRECAUTIONS __________________________________ 4
4 DESCRIPTION OF THE CALIMA™ THERMAL REGULATING SYSTEMS 7
5 INSTALLATION ________________________________________________ 10
6 MODES OF USE AND OPERATION ________________________________ 10
6.1 OPERATOR BUTTONS ___________________________________________ 10
6.2 NOTE ON OPERATING MODES AND ALARMS _____________________ 11
7 CLEANING AND INSTRUCTIONS _________________________________ 12
7.1 CLEANING _____________________________________________________ 12
8 SPECIFICATIONS _______________________________________________ 13
9 GUIDE TO POSSIBLE PROBLEMS AND SOLUTIONS ________________ 16
10 WARRANTY ___________________________________________________ 18
11 MANUFACTURER AND TECHNICAL SERVICE _____________________ 18
12 SYMBOL USED DEFINITION _____________________________________ 19

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1. INTRODUCTION
1.1 DEFINITION OF HYPOTHERMIA
Normal body temperature is around 37ºC, small variations cause small perspiration,
vasodilatation or vasoconstriction and shivering.
Central core body temperatures equal or less than 35ºC is considered hypothermia.
Temperatures up to 32ºC indicate moderate hypothermia or a safe hypothermic zone, in which
the heat conservation and heat production mechanisms such as peripheral vasoconstriction
and shivering are, generally, observed.
In temperatures between 32ºC and 24ºC there is a transition zone characterized by the
progressive depression of the tissue metabolism, appearance of a maximum vasoconstriction
and disappearing of shivering. Under 24ºC is very dangerous and is where hypothermia
occurs, in which a human being behaves like a poikilothermic entity, which means it adopts
the temperature of the environment around them. With care provided during the normal
preoperative stage, approximately half of the patient’s central temperature falls below 36ºC.
Of these approximately a third, their temperature falls below 35ºC during surgery.
1.2 REASONS FOR HYPOTHERMIA
Among the main reasons for hypothermia are:
1. Operating room temperature, around 21ºC.
2. Anaesthesia effect of the body temperature regulating system
3. Supply of cold intravenous fluids.
4. Open body cavities during surgical procedure.
5. Exposure to low temperatures.
6. Spinal injury trauma.
1.3 ACTIVE WARMING SYSTEMS
Active heating systems are undoubtedly the most effective in maintaining normothermia. The
heat transfer is proportional to the surface area being treated.
The CALIMA™ warmer is a "convective warm air" machine: The main characteristics of
these machines are that they allow heat to be directed onto the skin area, increasing the
transfer of heat by convection. The warm air reduces heat losses due to radiation by protecting
the body surface area in contact with the warming blanket. It maintains normothermia, and
decreases the adrenergic response, the incidence of shivering and increases thermal well-
being, which is why it is one of the most efficient systems for preventing hypothermia. It must
always be used with the appropriate disposable blanket to obtain the correct distribution of
heat is supplied to avoid possible injuries. Heating of the skin is more effective in the
presence of vasodilatation, which is why it is easier to maintain intra-operative normothermia
when patients are vasodilatated than to warm them up again in the postoperative phase when
hypothermic patients are vasoconstricted. The prevention of intra-operative hypothermia
should start with preheating at least 30-60 minutes before the anaesthetic is administered
because it is necessary to transfer substantial amounts of heat through the skin area to
decrease hypothermia as a result of redistribution.

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2 INDICATIONS FOR USE

CELSIUS MEDICAL S.L. CALIMA™ Thermal Regulating System is intended to prevent
and treat hypothermia and provide warmth to cold or shivering patients. In addition, the
CELSIUS MEDICAL CALIMA™ Thermal Regulating System should be used whenever
conditions exist that could cause hypothermia.
The device must be used with Celsius Medical’s blanket, and it should be used with patient
lying down to maintain effective operation.
3 WARNINGS AND PRECAUTIONS
WARNINGS:
• IMPORTANT .DO NOT BLOCK THE EQUIPMENT AIR VENTS
• Danger of electrical discharge. Do not open the machine.
• Be sure that hose is connected both to the blower air outlet and to the blanket prior to
starting to run the CALIMA™ blower.
• In the event of permanent and continuous activation of the excess temperature alarm,
do not continue with the therapy. Turn off the machine and inform the technical
service department.
• The Calima System should only be used by qualified and trained medical
professionals. Before use, carefully read the product-specific instructions for use. The
user will have to be located to one meter in front of the control panel.
WARNING: When an audible alarm indicator beeps, the user must go immediately to
the above mentioned position.
• Equipment must be used only by capable personnel trained in its use after carefully
reading the current user manual.
• Only use blankets manufactured by CELSIUS MEDICAL S.L.
• The machine does not ensure the patient's temperature, and only helps to maintain it.
Checking the patient's temperature and the correct connection of hose connector
to the blanket every 15 or 20 minutes is recommended.
• Do not use power supply cable other than the ones provided with the equipment, in
cases where a different power supply cable is going to be used, please contact the
manufacturer.
• In cases where use of the equipment takes place in close proximity or placed under
other equipment, make sure there are no operational disturbances between any of the
equipment due to their electromagnetic fields
• Before installing the device, check the information at the end of the manual regarding
to EMC risk.
• The device has electronic components; any manipulation of these components must be
taken under ESD protection.

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• This unit can suffer alterations during its normal usage, or when put into standby mode
operation, with the use of EFT above 1 kV (highly unlikely). In case that this event
occurs, the equipment should not be used until removal of the disturbance.
• The equipment is Class I, with reinforced insulation, so you need to be connected to a
mains socket outlet with grounding protection.
• In case of any malfunction due to interferences, it must be verified that the outcoming
air temperature in the nozzle does not exceed 54 ° C in any case
• The presence of portable and mobile RF communications equipment can affect the
operation of the equipment. It is recommended not to position the Calima near this
type of equipment or at least at an adequate distance (minimum 30 cm)
• Calima is classified as Class A suitable only for use in hospitals. The equipment is not
designed for use in a residential environment.
• The equipment may be affected by electromagnetic interference. To guarantee the
useful life of the equipment, it is necessary to comply with the warnings and
precautions defined in this manual.
• Any modification on the equipment is not permitted, and potentially dangerous, and
all modifications must be approved by the manufacturer. If the device is modified it
must be return to the manufacturer.
• Position the equipment in a way that it will be easy to remove the mains plug if
required.
• Caution should be taken when using this equipment in conjunction with patient fluid
irrigation, so that the hose and fluid lines do not come into contact, as this may cause
burning to the patient.
• Before using the unit, please confirm no mechanical damage to the heating unit
• The use of materials, such as water, gel or similar substances, between blanket and
patient, can reduce the effectiveness of the equipment and the patient's body
temperature.
• When using equipment, be aware the patient body or limbs can block airway pathways
and reduce the effectiveness of the heating device.
• The use of transcutaneous treatments (patches) can increase the drug supply with
potential patient harm.
• To disconnect the device, unplug the main power cable.
CAUTION
• Danger of explosion. Do not use the equipment in the presence of flammable gas.
• Do not submerge the unit under water or other cleaning products. Clean with a clean
and slightly damp cloth.
• Do not cover the equipment with cloths or other objects that can block the equipment’s
air vents or internal ventilation ducts. This can lead to deterioration of the equipment
due to overheating of its internal components.

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• Store in a dry location with a room temperature between -5 ºC and 70ºC

• The use of the unit with an unattached hose is prohibited. The hose should never be
used directly on the patient.
• Thermal injury may occur if convective warming therapy is applied to an ischemic
limbs.
• In case of alarm of overtemperature, remove the blanket from the patient, to insure the
patient never reaches 48 ºC for more than 10 minutes.
• The maximun temperature of the blanket is ±1ºC in normal use conditions, and in the
first failure conditions the maximun temperature at the machine’s exit will be 54ºC.
• Federal (USA) law restricts the sale of this device by or on the order of a licensed
healthcare practitioner
• Pay attention to the way the hose is placed on the hose placement clip:

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4 DESCRIPTION OF THE CALIMA™ THERMAL REGULATING SYSTEMS

DEVICE DESCRIPTION

1. Handle.
2. Display panel.
3. Hose exit.
4. Fuses.
5. IV pole connection.
6. Switch ON/OFF.
7. Plug inlet for power cable.
8. Additional ground connection.
9. Hose placement clip.

5
6
7
8

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DISPLAY PANEL DESCRIPTION

1. On/off (standby)
2. AMB – Ambient room temperature
3. 38ºC - Low temperature
9
4. 43ºC – Medium temperature
5. 45ºC – High temperature.(This is a boost
setting than runs for 45 minutes before 5 8
dropping back down automatically to 43ºC
6. Low Fan Speed – 9 m/s 4 7
3 6
7. Medium Fan Speed – 13m/s 2
1
8. High Fan Speed – 16 m/s
9. Display messages
4.1 OPERATING PRINCIPLE
The machine is based on the propulsion of air by single high performance turbine and the air
is heated by Joule effect through wound electric resistances. The circulating air is heated
when it passes through a wound resistance just before the turbine and supplied to the blanket
through a 1.8 m long tube.
The machine incorporates an electronic control of temperature, so that it is capable of
maintaining a stable temperature of the selected value within a variance of±1ºC.
The machine warms up to set temperature in around 5 minutes. This time is necessary in order
for the machine to reach a stable temperature.
The machine is designed to be placed on a stable, flat and smooth surface (floor, tables,
worktops), on a bed support or clamped to an I.V. pole. The use of the specific support stand
with wheels for the Calima system is recommended.
Only the blanket will be in contact with the patient for the intended use. The user will be in
contact with the device for installation and use, but no part of the device will be at any risk
from electrical shock or high temperature.
The device achieves thermal stability with a blanket within 5 minutes, based on an ambient
temperature between 18-20 ° C. If the ambient temperature is lower, the stabilization time
may be greater.
The equipment does not require any calibration by the operator. It will only carry out the
temperature calibration by the Technical Service, in cases in which the temperature test fails
during the annual maintenance, if during normal use of the equipment a temperature error
occurs or after performing some repair to it
4.2 OPERATING MODES
The equipment has four temperature settings: ambient, 38º C, 43º C and 45º C (the 45º C
option is a boost selection, the machine maintains this temperature for 45 minutes then returns
automatically to 43º C if the 45º C key is pressed again immediately the equipment will go
into boost operation indefinitely unless the safety system of the equipment detects the need to
lower it to 43º C. The user has the option of selecting one of these four configurations

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4.3 DESCRIPTION OF THE CALIMA™ THERMAL REGULATING SYSTEM

• A thread resistance heater of approx. 1200 w and housed in the casing of the machine.
• A turbine electronic motor has no dynamo brushes.
• An exchangeable air inlet filter. This is housed in the casing and can be accessed by a
panel that opens with the removal of a number of screws.
• Electronic Control System by microprocessor.
• Certified medical grade, switched power supply.
• Electronic temperature safety sensor.
• Acoustic insulation.
• Working Interface with intuitive control buttons.
• Alphanumeric 16-character display, showing the working temperature and the current
state of the machine.
• Main power switch, with 2 power supply fuses.
• Luminous LEDs integrated in the buttons to show the mode of operation of the
machine.
• Exchangeable supports for I.V. pole and standard operating table equipment.
4.4 ELECTRONICS CONTROL SYSTEM
The machine is controlled by different electronic controls modules including:
• Motor speed control.
• Air output temperature control.
4.5 SAFETY SYSTEMS
The machine is equipped with safety systems, which in the event of a fault or incorrect use,
prevents an uncontrolled rise of temperature in the machine.
The primary safety system consists of 4 electronic temperature sensors, which manages the
thermostat of the system. These are placed at the exit of the turbine and the exit of the hose by
the connector. In each location there are 2 sensors, one acting as the primary sensor and the
second checking there is no significant variance from the other. If the temperature at the end
of the hose exceeds 54°C the control will turn off the warming resistor.
The system of secondary and redundant safety include electronic temperature sensor, which
acts independently of the microprocessor control.
As a third safety system the equipment incorporates a mechanical safety sensor that measures
the temperature near the heating element and if this mechanical sensor temperature exceeds a
defined temperature, the circuit is shorted, opening the circuit and removing any current to the
resistors.

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5 INSTALLATION
1. -Check that the machines voltage rating found on the identification label corresponds to the
country where it is to be used.
2. -Connect the machine to the electricity supply at the rear of the equipment and use the
power cable supplied.
3. -Connect the hose to the blanket ensuring it is pushed in all the way to the neck of the
connector. Please see the directions for use supplied on the label of the blanket supplied by
the manufacturer with the blanket.
4. - Turn on the mains power supply switch so the green indicator lights up.
At this point the blue background screen will come on.
5. - Press the on/off (standby) key on the machine display panel(the key in the centre of the
display panel).
The turbines will start to run and the machine will begin the heating process, until it reaches
the selected temperature and fan speed on the panel. Both settings are shown in the display at
all time.
When the difference between the set temperature and average temperature at the tip of the
tube is above 3ºC, the thermometer symbol of the display flashes while the system is working,
and stops when it is below 1ºC

6 MODES OF USE AND OPERATION

6.1 OPERATOR BUTTONS

1. On/off (standby)
2. AMB – Ambient room temperature
3. 38ºC - Low temperature
4. 43ºC – Medium temperature 9
5. 45ºC – 45ºC – (This is a boost setting than
runs for 45 minutes before dropping back
down automatically to 43 ºC.)
6. Low fan speed ≥ 9 m/s (*) 5 8
7. Medium fan speed ≥ 13 m/s (*) 4 7
8. High fan speed ≥ 16 m/s (*) 3 6
9. Display messages 2
1

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To operate the equipment, once the internal tests have been performed and the display
remains off, press the on/off button (1) located in the center of the keyboard, the machine will
switch to standby showing in the display "STAND BY".
NOTICE: When the computer is in "Stand by" status, the display LED is off, showing with a
slight but visible lighting the "Stand By" status.
Select the desired working temperature by pressing one of the 4 keys located on the front left
hand side of the display panel:
• Ambient
• Low: 38ºC
• High: 43ºC
• High/Boost: 45 ºC
Select the desired fan speed by pressing one of the 3 keys located on the front right hand side
of the display panel:
• Low speed
• Medium speed
• High speed
The recommended operating speed for each model of blankets is specified in the
corresponding instruction manuals.
To stop the machine, press the on/off key (1) (located at the centre of the display panel), so
that the machine switches to STANDBY mode, the screen will display STANDBY visible
with a slight but lighting.
NOTE: the machine will continue to blow ambient air for 10 or 20 seconds (depending on
software version) to ensure all the heat is dissipated from the machine.
To disconnect the machine completely, press the rear switch, turning the green light off.
6.2 NOTE ON OPERATING MODES AND ALARMS
The functioning of the machine does not depend on the type of blanket connected to it, as the
machine automatically controls the turbines to produce a constant and uniform air flow into
the blanket.
The temperature can be checked at any time by a temperature probe connected to the end of
the hose, temperatures measured at that point must equal the display temperature select with a
tolerance of± 1 °C
The user will have to be located to one meter in front of the control panel.

WARNING: When an audible alarm indicator beeps, the user must go immediately to the
above mentioned position.

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ALARMS

At start-up, the device performs an automatic auto-check sequence to verify the correct
operation of the audible alarms as well as the screen displays the safe device mode. See
Annex I and point 9 for the device alarms description

7 CLEANING AND INSTRUCTIONS

Warning
Do not immerse the machine in cleaning liquids. The machine is not designed for cleaning by
immersion.
Do not clean the machine with solvents, as these can damage the machine's casing, labelling
and internal components.
The working life of the product will depend to a large extent on the correct performance of
cleaning and maintenance tasks, therefore, special attention should be paid to these.
7.1 CLEANING
1. Disconnect the machine from the power supply.
2. Wipe the outside of the machine with a non-abrasive damp cloth. Use a quaternary, phenol
or alcohol based cleanser. Do not use abrasive products, such as solvents or bleaches.
3. Wipe the outside of the machine with a soft dry cloth.

FIn the event of a liquids leaking inside the machine, do not attempt to dismantle the machine.
NOTE
Notify the technical service.

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8 SPECIFICATIONS
Physical characteristics

External dimensions of the machine

• High 285 mm
• Wide 280 mm
• Deep 290 mm Plus 75 mm (Aluminium Piece)

HEPA FILTER
• Particulate removal tested to 99.5% at 0.15 μ-0.2 μ MPPS according to EN1822-1
• Rated airflow capacity: 300 m3/h
• High efficiency classification H13 as per EN 1822
(It is mandatory to change filter every 1,000 hours of use, by Technical Service or qualified
personnel).
Weight of the machine
• Weight. 5.7 Kg IV Pole Bracket 0.265 Kg
Equipment life span
The equipment has a useful life of 10 years from the date of manufacture. Once accomplished,
the device should be treated as electrical waste.
Hose Blanket disposable connection specifications
• Length of the tube: 1800 mm
• Inner diameter of the tube: 55 mm
(Use only with CELSIUS MEDICAL’s blanket.)

Operational mode
Working temperature ranges at hose end attached to blanket
• Room temperature: Ambient
• Low temperature: 38°C ± 1°C
• Medium temperature: 43°C ± 1°C
• High/Boost temperature: 45°C± 1°C (for 45 minutes before dropping back
to 43 °C)
Working Fan Speeds
• Low: ≥ 9m/s
• Medium: ≥ 13m/s
• High: ≥ 16m/s

Speed values are minimum ones. The value for each one is according to the rule: Low fan
speed < Medium fan speed < High fan speed

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Maximum temperature at the end of the hose in normal condition

• 45 ºC± 1 °C
Maximum temperature at the end of the hose in first failure condition
• 48 ºC
Electric specifications

Device rating
• Supply voltage 100-120 Vac ≈ 220-240 Vac ≈
• Frequency 50/60 Hz 50/60 Hz
• Power Consumption Peak 1250 W 1250 W
• Power Consumption Average 1200W 1200W
• 2 retarded fuses 16 A 6A

Power cord:
• Calima 220-240 V:
o Connector C19 - 16 A-220V
o Plug Type F - 16 A - 220 V
o Cord: 14 AWG x 3, (1.5 mm x 3), length: 4 m
IMPORTANT: For connections from 220V to 240V and at 50 Hz, a supply network with
a maximum impedance Z max ≤ | 0.34 | Ω

• Calima 100 -120 V:

o Connector C19 - 16 A-120 V
o Plug Type B - 16 A - 120 V
o Cord 12 AWG x 3, (2.5 mm x 3), length: 4 m.
o It is necessary that they be medical grade for Canada / USA and Japan
Temperature control
• Microprocessor control.
Heating Element
• Two block of heater resistors 600W + 600 W
Leakage current
• Meet UL 60601-1 and IEC 60601-1
Environment condition

Environment operating use conditions

• Temperature: 10 ºC -35ºC (Recommended Temperature: 18 ºC -25 ºC)
• Humidity: 35 - 75%
• Pressure: 100 - 70 Kpa

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Storage and transport conditions

• Temperature: -5 ºC - 70 ºC
• Humidity: 0% -90%
• Pressure: 100-10 kPa
Environment requirements
• Compliance with directive 2011/65/UE(RoHS2)
• Compliance with directive 2012/19/EU(WEE)
Applicable parts
• Contact to patient is through disposable blankets

Safety system

Thermostat
• Two sensors in parallel control the temperature at the end of the hose, with an
accuracy ±1ºC
Electronic Alarm System
• If the temperature is above 48 ºC and below 54 ºC.During this time the system tries
to regulate the temperature to the set temperature.
• If the temperature is above 48 ºC and below 54 ºC for more than 1 minute, the
buzzer alarms continuously and then power is cut to both the turbine and heat
resistances after 3 minutes. The device then needs the power switch turning off
manually at the back of system.
• If the temperature is above 54 ºC at any time, the buzzer alarms and the power is
cut to both the turbine and heat resistances. The device then needs the power
switch turning off manually at the back of system.
Analogical Safety system
• Thermo fuse over temperature 93ºC on the heater block.
Sound pressure levels of alarms:
• High Priority Alarms: 80.5 dBA.
• Medium Priority Alarms: 78.5 dBA.
Over current protection
• Dual input fused lined
Electric risk classification
• Class I, Type BF
Fluid IngressProtection
• IPX2
Function Mode
• Device continuous mode

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Certification
• UL 60601-1; IEC 60601-1; IEC 60601-2; EN 55011; CAN/CSA-C22.2
Routine maintenance
• Filter must be replaced every 1000 operating hours. This change must be done by
the technical service or qualified personnel.

• Periodic inspections/checks of the equipment must be carried out at a minimum

every 12 months by the technical service or qualified personnel.
9 GUIDE TO POSSIBLE PROBLEMS AND SOLUTIONS

STATE OF THE POSSIBLE CAUSE POSSIBLE SOLUTION

MACHINE

The machine is not turned on, the
cable is not plugged into the machine
or the AC outlet is not switched on or
faulty. The wrong plug may have
been used.
Ensure that the correct type of mains cable is
properly connected to the ACinput module
’ machine, or use a new cable.

The switch light located at the back Press the switch located at the back of the
‘of the device is not ON device‘to turn it ON, and it will light up
green.
The display does
not turn on. The switch light still not turning ON Check the fuseson the back and replace
when pressed. them with new ones.

The switch light is ON but the device Press the ON/OFF buttonΠlocated on the
still does not work front display panel of the case

After pressing the ON/OFFΠInternal failure. Inform the technical service.
Button, the device still does not
work.

If the temperature of the heater Verify that the air grill located at the bottom
module exceeds the maximum of the device or the hose are not blocked.
temperature selected, the audible
excess temperature alarm is activated,
and the display light flashes.
High temperature
alarm The device does not regulate to the Internal failure. Inform the technical service.
set temperature and keeps alarming.

The excess temperature alarm persists The device goes from normal mode to
and the safety system activates. overtemp mode. Switch it off and unplug the
device. Inform the technical service.

After the filter’s life has come to an Replace the filter as described in the manual.
Filter change alarm end, message displayed on screen
“Replace Filter” .

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STATE OF THE POSSIBLE CAUSE POSSIBLE SOLUTION

MACHINE

After the filter has been replaced, the Internal failure. Turn off and unplug the
problem persists device. Inform the technical service.

Audible intermittent alarm with the
“no filter” message on the display.
No filter alarm
If the problem persists there may be
an internal fault in the machine.
Check the filter is installed and close the
door correctly.
Turn off and unplug the machine. Inform
technical service

The Calima System does not warm

up, regardless of any of the available
Turn off and restart the device. If the
temperature ranges, or it stops
problem persists, contact the technical
warming while operating. The
service.
acoustic intermittent alarm sounds
Resistance failure
and the screen displays the message
alarm
“Heat. Resist. Fail”
The problem persists (Check that
equipment air vents are not blocked). Internal failure. Turn off and unplug the
Internal failure in the resistance device. Contact technical service.
heaters
The turbine stops working or runs too
slowly (under the minimum speed).
Turbine Failure The acoustic intermittent alarm Internal failure. Turn off and unplug the
alarm sounds and the screen displays the device. Inform the technical service.
message “Turbine Fail”. The device
does not start up or it stops working.

The device does not start up and the

screen displays the message “Sensor
Fail”; or under normal operation the
Internal failure in temperature sensors which
device stops working (displaying the
Sensors Failure control de device. Turn off and unplug the
same message). The acoustic
alarm device. Inform the technical service.
intermittent alarm sounds and the
screen displays the message “Sensor
Fail”. The device does not start up or
it stops working.

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10 WARRANTY
The machine is under warranty for 2 years. Users will not be charged for replacement parts
during this period.
Damage to the machine due to misuse or incorrect maintenance, are excluded from this
warranty. The accessories or consumables for the machine are excluded from this warranty.
The warranty is voided if:
• Has been manipulated inside.
• The malfunction was due to negligence in use by users.
• The device has been open
• Shock suffered by the unit
• The identification label has been damaged or tampered with.
All failures should be notified to the manufacturer to repair
NOTE F Before is sent to the manufacturer for repair, all devices must meet the following
requirements:
• Be properly disinfected.
• They must be accompanied by a return merchandise authorization (RMA) number
which must appear on the box along with the manufactures serial number.
• Be packaged properly
In case of any adverse reaction or incident contact Celsius Medical S.L. info@celsius-
medical.com
Telephone:+34 91 887 42 20
Fax:+34 91 887 44 44

11 MANUFACTURER AND TECHNICAL SERVICE

The machine can only be repaired by an Authorised Official Technical Service. Users should
not attempt to repair any fault themselves.
CELSIUS MEDICAL SL shall provide technical documents upon customer request, including
circuit diagrams, parts list, descriptions, calibration instructions, or other information to help
service personnel to repair these parts of equipment that are designated by the manufacturer.
Servicing and repair must be carried out by trained and authorised technician.
CELSIUS MEDICAL SL
Ctra. Torrejon-Ajalvir, Km. 5,200
28864Ajalvir, Madrid España.
http://www.celsius-medical.com
Phone:+34 91 887 4220

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12 SYMBOL USED DEFINITION

SYMBOL DESCRIPTIONS

TURNING THE MACHINE OFF

TURNING THE MACHINE ON

PROTECTION FUSES

WARNING. CONSULT ACCOMPANYING DOCUMENT

DANGEROUS VOLTAGE

ALTERNATE CURRENT
Vac
IMPORTANT WARNING TO THE USER FOR SAFE USE OF
NOTE F THE MACHINE

THE EQUIPMENT SHOULD NOT BE DISPOSED OF A

DOMESTIC WASTE. THE EQUIPMENT SHOULD BE
CONSIDERED AS ELECTRICAL WASTE WHEN
CONSIDERING DISPOSAL OR RECYCLING, DIRECTIVE
2012/19/EU

PROTECTIVE EARTHING

PROHIBITED USE WITH FREE HOSE

PART APPLICABLE , Device Class I

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Table C.7
Recommended separation distances between portable and mobile RF communications devices.
For MACHINES AND SYSTEMS that are not for ESSENTIAL CARE

Recommended separation distances between portable and mobile RF communications

devices
The CALIMA™ air warmer is designed for use in an electromagnetic environment in which disturbances
broadcast by RF are controlled. The client or user of the CALIMA air warmer can help prevent
electromagnetic interference by maintaining a minimum distance between the machine and the portable
and mobile communications RG device (transmitters) and the CALIMA as recommended below, in
accordance with the maximum output power.
Maximum output Separation distance according to transmitter frequency
power assigned to the M
transmitter 150KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

W d= 1.17√P d= 1.17√P d= 2.33√P

0.01 0.12 0.12 0.23

0.1 1.23 1.23 2.44
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
For transmitters assigned with a maximum output power not listed above, the recommended separation distance d in metres (m) can
be determined using the equation applicable to the transmitter frequency, where P is the maximum output power assigned in (W)
according to the manufacturer of the transmitter.

N.B. - At 80MHz, the separation distance for the highest frequency range is applied.
NOTE 2 - These guidelines cannot be applied in all situations. Electromagnetic propagation is subject to absorption and reflection by
structures, objects and people.

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Table C.8
Guide and manufacturer's declaration – electromagnetic emissions - for all MACHINES AND
SYSTEMS

Guide and manufacturer's declaration – electromagnetic emissions.

The CALIMA™ air warming machine is designed for use in an electromagnetic environment such as the one specified
below. The client or user of the CALIMA warm air machine should make sure that they are used in this environment.

Emissions Test COMPLIANCE Electromagnetic Environment

The CALIMA air machine only uses

RF Emissions RF energy for its internal operations.
As a result, the RF emissions are very
Group 1
low and they are unlikely to cause any
CISPR Standard 11 interference in nearby electronic
machines.

RF Emissions
Class S
CISPR Standard 11

The CALIMA air machine is suitable

Harmonic emissions for use in all establishments, including
domestic establishments and those
Class A
connected directly to the public supply
IEC Standard 61000-3-2
network at low voltage supplying
housing buildings.

Fluctuations Voltage/flickers
Complies
IEC Standard 61000-3-3

The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If used in a residential environment (for which CISPR 11
Class B is normally required), this equipment may not offer adequate protection for radio
frequency communication services. The user may need to take mitigation measures, such as
relocating or reorienting the equipment.

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Table C.4
Guide and manufacturer's declaration –electromagnetic immunity - for all MACHINES AND
SYSTEMS

Guide and manufacturer's declaration – Electromagnetic immunity.

The CALIMA™ air warming machine is designed for use in an electromagnetic environment such as the one specified below. The
client or user of the CALIMA warm air machine should make sure that they are used in this environment.

IEC 60601 standard test Electromagnetic environment.

Immunity test Level of compliance
level Guide.
The floors should be wooden,
± 8 kV por contacto ± 8 kV por contacto
concrete or ceramic tiles. If the
Electrostatic discharge (ESD) floors are covered with
IEC Standard 61000-4-2 ± 2 kV, ± 4 kV,± 8 kV, ± 2 kV, ± 4 kV,± 8 kV, ± synthetic material, the relative
humidity should be at least
± 15 kV por aire 15 kV por aire
30%.

± 2 kV ± 2 kV The quality of the supply

Temporary / Fast Flashes network should be that of a
IEC Standard 61000-4-4 100 kHz repetition 100 kHz repetition typical commercial environment
frequency frequency or of a hospital.
The quality of the supply
Shock wave network should be that of a
± 1 kV ± 1 kV typical commercial environment
IEC Standard 61000-4-5
or of a hospital.
0 % Ut; 0,5 cycle 0 % Ut; 0,5 cycle
At At The quality of the supply
network should be that of a
0º,45º,90º,135º,,180º,22 0º,45º,90º,135º,,180º,225 typical commercial environment
Falls in voltage, 5º,270º and 315 º º,270º and 315 º or of a hospital. If the user of
Interruptions and variations in the CALIMA air machine
voltage in power supply lines requires continuous operation
0 % Ut; 1 cycle 0 % Ut; 1 cycle
during interruptions in the
And And power supply we recommend
IEC Standard 61000-4-11
70 % Ut; 25/30 cycles 70 % Ut; 25/30 cycles that the CALIMA air warmer is
powered by a power supply or a
Single phase: at 0º Single phase: at 0º battery without stopping.

Interrupcion voltage Interruption voltage

0 % Ut; 250/300 cycle 0 % Ut; 250/300 cycle
IEC Standard 61000-4-11 IEC Standard 61000-4-11
Magnetic field at network The magnetic fields at network
frequency (50/60 Hz) frequency should be at levels
30 A/m 30 A/m that are normal in a standard
location in a typical commercial
IEC Standard 61000-4-8 environment or a hospital.
Note - U r is the alternating current supply voltage before application of the test level.

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Table C.8
Guide and manufacturer's declaration –electromagnetic immunity - for all MACHINES AND
SYSTEMS
Guide and manufacturer's declaration – Electromagnetic immunity.

The CALIMA™ air warming machine is designed for use in an electromagnetic environment such as the one specified below.
The client or user of the CALIMA warm air machine should make sure that they are used in this environment.

IEC 60601 standard Level of

Immunity test Electromagnetic. Guide.
test level compliance
Mobile and portable RF communications devices
should not be used nearer to any part of the
CALIMA air warmer, including the cables, than the
recommended separation distance for the transmitter
frequency.

Recommended separation distance

Conducted RF 3V 3V
IEC Standard 61000- 0,15- MHz-80 MHz 0,15- MHz-
d = 1’17 p
4-6 6 V in ISM bands 80 MHz
between 0,15 MHZ 6 V in ISM
and 80 MHZ bands
80% AM at 1 kHz between 0,15
MHZ and 80 d = 1’17 p 80 MHz a 800 MHz
MHZ
80% AM at 1 d = 2’33 p 800 MHz a 2,5 GHz
kHz
Where P is the maximum output power assigned to
3 V/m 3 V/m the transmitter in watts (W) according to the
Broadcast RF 80 MHz a 2,7 GHz 80 MHz a 2,7 manufacturer of the transmitter and k is the
IEC Standard 61000- 80 % AMD at 1 kHz GHz recommended separation distance in metres (m).
4-3
80 % a 1GHz
The field intensities from the fixed RF transmitter, as
determined by an electromagnetic site study, should
be less than the compliance level in each frequency
range b.

Interference can occur in the vicinity of any machine

marked with the following symbol:

Note 1 - At 80 MHz and 800 MHz, the highest frequency range is applied.
NOTE 2 - These guidelines cannot be applied in all situations. Electromagnetic propagation is subject to absorption and
reflection by structures, objects and people.

a.) The field intensities of fixed transmitters, such as base stations for radio telephones (cell / cable free) and mobile
terrestrial radio stations, amateur radio stations, AM/FM radio broadcasts and TV broadcasts cannot theoretically be
predicted with any precision. To assess an electromagnetic environment due to fixed RF transmitters, an electromagnetic
study should be considered. If the measurement of the field intensity in the area in which the CALIMA air machine is being
used exceeds the applicable RF compliance level above, the CALIMA air machine should be watched to confirm normal
operation. If abnormal operation is observed, additional measures may be necessary, such as reorientation or relocation of the
table.
b) The field intensity should be less than 3 V/m on the frequency range of 150 KHz to 80 MHz.

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