GERATHERM UniqueTemp User manual

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UniqueTemp°
Instruction manual | PatientWarmingSystem
More than hot air
Medical Warming Systems

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UniqueTemp°
The Geratherm Patient Warming System
Before using the Patient Warming System, please
read through the operating instructions carefully!
Thank you for choosing a
Geratherm Patient Warming System.
The benefits of Geratherm UniqueTemp° are:
Active warming from above•
Semiconductor-coated textiles•
Warming with individual blankets•
Microprocessor-controlled•
Monitoring of the core body temperature with trend•
graph display
Thin, cosy warming blankets•
Noiseless, no distribution of germs through air•
disturbance
Simple to use:•
Plug in – Switch on – Feel the warmth
Display and temporary recording of the patient’s body•
temperature
Geratherm UniqueTemp° has been developed for the
prevention of hypothermia in the operating theatre. It is
suitable for pre-, intra- and post-operative use.

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Contents
page
1Identification 4
2Purpose 5
3 Safety precautions 6
4Description 9
4.1 Overview of individual components and of
manual control elements
9
4.2 Safety features 12
5 Starting up and operation 13
5.1 Assembly and installation 13
5.2 Connecting the blankets 14
5.3 Connecting the temperature sensor 15
5.4 Positioning the blankets 15
5.5 Starting up 16
5.6 Switching off the warming blankets 17
5.7 Preselection of temperatures for individual
blankets
17
5.8 Switching off individual warming blankets 18
5.9 Adding and removing warming blankets 18
5.10 Starting up the body temperature sensor 19
6 Shutting down 20
6.1 Shutting down individual blankets 20
6.2 Shutting down the Geratherm UniqueTemp° 20
7 Message and faults 21
page
8 Preparation and hygiene measures 24
8.1 Cleaning and disinfecting 24
8.2 Checks after processing 25
8.3 Replacement of consumables 25
9 Maintenance 26
9.1 Servicing 26
9.2 Service menu 26
10 Disposal 27
11 Warranty 27
12 Technical data 28
12.1 Control unit 28
12.2 Arm/shoulder blanket 29
12.3 Torso blanket 29
12.4 Leg blankets 29
12.5 Connecting cable 30
12.6 Reusable cover for arm/shoulder blanket 30
12.7 Reusable cover for leg blankets 30
12.8 Reusable cover for torso blanket 30
12.9 Holding claw 30
12.10 Mains cable 30
12.11 Body temperature sensor 30
12.12 Scope of delivery 31
12.13 Symbols used 32
Annex 33

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Geratherm UniqueTemp° can be identified as follows:
Manufacturer’s designation:
Geratherm Medical AG
Fahrenheitstrasse 1
98716 Geschwenda
Model:
Geratherm UniqueTemp° Patient Warming System
Device/software version:
Version 1.80
Serial number:
The serial number of the control unit is to be found on the
back of the casing, on the commercial invoice and in the
attached documentation.
MPG classification:
Geratherm UniqueTemp° has been categorised as a Class
IIb device.
Geratherm UniqueTemp° meets the requirements of Coun-
cil Directive 93/42 EEC of 14.06.93 on Medical Devices
and of the standard DIN EN 60601-1 (Medical electrical
equipment, Part 1: General requirements for safety), DIN
EN 60601-1-2 (Medical electrical equipment Part 1-2: Ge-
neral requirements for safety – Collateral standard: Elec-
tromagnetic compatibility – Requirements and Tests), DIN
EN 12470-4 and DIN EN 60601-2-35 (Medical electrical
equipment, Part 2: Particular requirements for the safety
of blankets, pads and mattresses intended for the warming
of patients in medical use). A DIN EN ISO 13485 certified
quality management system ensures that these require-
ments are met and entitles the manufacturer to use the CE
0118 label.
1 Identification

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Geratherm UniqueTemp° has been developed for the pre-
vention of hypothermia. The warming blankets are light-
weight, cosy and warm the patient from above.
The Geratherm warming blankets can be used for covering
the patient in various ways without restricting the surgery
area and for actively warming the patient.
All the blankets can be freely combined. The flexibility of
the blankets makes it possible to warm the patient even
if complicated positioning on the operating table is re-
quired.
After being placed over the patient, Geratherm Unique
Temp° can be covered over with surgery drapes.
Geratherm UniqueTemp° is suitable for use with adult pa-
tients of all sizes.
The blankets should not be used for children. Geratherm
UniqueTemp° shall only be operated under the supervision
of the user.
2 Purpose

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•Toensuresafeuse,itisnecessarytoreadalltheway
through the operating instructions.
•Like all medical devices, Geratherm Patient Warming
Systems require special care with regard to EMC. The
safety precautions described in these operating instruc-
tions (e.g. avoiding placing the device on EEG equip-
ment) must be strictly adhered to.
•Warning!Toavoidtheriskofanelectricshock,thisde-
vice shall only be connected to an earthed power supply
system.
•ItshouldbenotedthatportableandmobileHFcommu-
nication equipment could affect medical devices.
•IfHFsurgicalinstrumentsorendocardialcathetersare
used at the same time as the warming system, attention
must be paid to equipotential bonding.
•Onlythecomponentsbelongingtothesystemshallbe
used for operation of the Patient Warming System. The
use of other components could lead to increased emissi-
ons or to lower interference immunity of the device. The
use of several connecting cables can also cause distur-
bances. If good thermal conductors, such as water, gel
and other substances, are used, the body temperature
of the patient may fall when the warming equipment is
switched off.
•Forfasteningthecontrolunit,onlytheGerathermhol-
dingclawprovidedshallbeused!Ifyoudonotusethe
holding claw, ensure that the control unit is positioned
firmlyandsecurely!
•System components of Geratherm UniqueTemp° shall
never be connected to or operated with equipment
produced by other manufacturers. Connection to other
equipment may lead to serious personal injury or mate-
rial damage.
•Thecompatibilityofsystemcomponentsaddedonlater
mustbeapprovedbythemanufacturer!
• Geratherm UniqueTemp° warming blankets must
not be cleaned in a washing machine or autoclave!
•Donotoperatethecontrolunitinareassubjecttoexplo-
sion hazard or in the presence of explosive anaesthetic
gases!
•Donotuse GerathermUniqueTemp°warmingblankets
together with other heat sources (e.g. radiation lamps,
incubatorsorhotwaterbottles)!Thiscouldbedetrimen-
tal to the patient’s health.
•DonotplacethecontrolunitdirectlyontopofECGor
EEG equipment. Otherwise, faults may arise, e.g. the de-
vicesmayproducefalsereadings!
3 Safety precautions

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• Before each use, check the surface of the warming
blankets for any visible damage! Discontinue use
of any damaged blankets immediately!
•PuttheGerathermUniqueTemp°warmingblanketscom-
pletely on the patient. To prevent overheating, do not un-
deranycircumstancesfoldtheequipment!
•Donotplaceanyobjectsontopofthewarmingblankets
to avoid any localised overheating or heat accumulati-
on.
•It must be checked whether any fixture is required to
keep the patient in place. If so, the same must be positi-
oned underneath the warming blankets.
•The temperature setting is the responsibility of the
anaesthetist.
•Do not use Geratherm UniqueTemp° on patients
with impaired circulation! The manufacturer is not
aware of any other contra-indications.
•Wheneverheattreatmentisapplied,thecorebodytem-
perature of the patient must be monitored at regular in-
tervals. The length of the intervals shall be determined
by the medical staff.
If HF surgical instruments or endocardial catheters are
used at the same time as the patient warming system,
equipotential bonding must be ensured.
•Geratherm UniqueTemp° shall only be used under the
supervision of the anaesthetist.
• Do not apply adhesive tape to the warming blan-
kets. This will lead to permanent soiling of the sur-
face.
•Onlyusedrywarmingsystemsonthepatient.
•When using the body temperature sensor, it is abso-
lutely necessary to observe the prescribed connecting
sequence. (Before the temperature sensor is connected
to the patient, the plug on the sensor must be inserted
into the control unit.)
• Warning!
All transducer units connected to the patient by conduc-
ting wires are subject to a certain risk of faulty readings,
localised overheating and possible damage due to in-
tensive HF radiation. Electrosurgical equipment is such
a source, since capacitively coupled currents may flow
to earthing through the probe cables of unconnected
devices. This can lead to the patient suffering burns.
Whenever possible, remove the probe from the patient
completely before activating the surgical equipment or
other HF source. If the probes have to be used simulta-
neously with electrosurgical equipment, the devices to
which the probes are connected should be checked for
adequate protective earthing with high frequencies. The

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potential hazard can be reduced by selecting a tempera-
ture measuring point, which is located far away from the
expected course of the HF current flow to earthing.
•Theuseofadaptercablesforthetemperaturesensoris
prohibited.

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4 Description
4.1 Overview of individual components and of manual control elements
Control unit: front
1 Housing
2 Handle
3 TFT display
4 Slider (sensitive slide control)
5 OK button (to confirm input)
6 Infrared interface
2
1
3
4
5
6

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Control unit: back
1 Blanket connector socket 1
2 BF type applied part
3 Blanket connector socket 2
4 Equipotential bonding pin
5 Temperature sensor socket
6 Serial number of the device
7 Mains cable socket
8 Power switch
9 Read operating instructions
10 Safety class
11 Do not dispose of in household waste
1
3
4
5
8
2
6
7
9 10 11

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Holding claw for
control unit UniqueTemp°
2 Leg blankets Torso blanket Arm/shoulder blanket

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Geratherm UniqueTemp° has an optical and acoustic alarm
system, which indicates all faults.
A short tone after the unit is switched on indicates that the
alarm system and the independent safety device have been
automatically checked and are operational. The control unit
will not switch on if the safety device is faulty.
The functioning of the warming system can be checked by
means of the following test:
After removal of a warming blanket that is in operation, the
removed blanket should light up on the TFT display and an
acoustic alarm should be heard.
4.2 Safety features

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Prior to starting up, Geratherm UniqueTemp° must be as-
sembled in such a way that it is safe to operate.
Assembly variants
The holding claw (Fig.
2) can be used to fas-
ten the control unit to
IV poles (Fig. 1-a) or to
suitable rails on equip-
ment. The unit can also
be placed on an equip-
ment rack (Fig. 1-b). The control unit must be positioned
on a non-slip surface.
Holding claw
The holding claw fits all
IV poles with round po-
les ranging in diame-ter
from 15 mm to 25 mm.
The holding claw can be used to attach the control unit at
variable heights and angles (see Fig. 3).
Attachment
Attach the
holding claw
to the pole of
the IV poles as
shown in Fig.
3 and fix the
position using
the adjusting
screw (Fig. 2-
B). Push the
control unit by
means of the
handle onto
the attachment on the holding claw (Fig. 2-C) and secure it
using the knurled-head screw (Fig. 2-D), (Fig. 3-2). Once
the control unit is securely placed in the attachment, its an-
gle can be adjusted as required (Fig. 3-3) and fixed using
the knurled-head screw (Fig. 2-E).
5 Starting up and operation
5.1 Assembly and installation

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5.2 Connecting the blankets
Up to 4 warming blankets can be used simultaneously.
When several blankets are used together, they must first
be connected to each other and then connected to one of
the two sockets (marked A and B) on the back of the control
unit.
If 2 blankets are used, it is also possible to connect each
blanket separately to one of the sockets. Both sockets are
interconnected in the bus system.
The operating theatre system is
designed for use with one pati-
ent. The warming blankets must
be used as designated. For the
function and designation of the
individual blankets, please see
Technical Data (Point 12 of these
operating instructions).
Rear view of control unit
The coloured markings on the plug (black anti-kink sleeve)
and on the socket/coupling (grey anti-kink sleeve) facilitate
connection. When connecting the
blankets , always begin by
inserting the plug of one warming
blanket into the control
unit. The plug of the next
blanket should then be connected to
the coupling of the
blanket that is already connected, i.e. the
black anti-kink sleeve is always in the direction of the control
unit and the grey anti-kink sleeve is always in the direction of
the next warming
blanket . When the plugs are inserted they
audibly click into place. The warming
blankets can be con-
nected with each other or with the control unit as desired.
The control unit automatically recognises each connected
warming
blanket .
In order to ensure that the diagram shown on the control unit
display accords with the actual position of the
blankets , we
recommend the following arrangement:

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The Geratherm UniqueTemp° war-
ming
blankets must be laid on
the patient in such a way that they
cover as large a proportion of the
patient’s body surface as possible.
Using the different
blankets in combination makes it possible
to cover the body in an optimum way. The warming blankets
can then be covered with surgical drapes.
5.3 Connecting the temperature
sensor
If a special case requires that the body temperature of the
patient be monitored and/or recorded, it is possible to con-
nect a MET 400 type body temperature sensor to the socket
provided for this purpose on the back of the control unit.
When connecting it, care must be taken to perform the fol-
lowing steps in the correct order:
1. Insert the sensor plug into the device.
2. Connect the sensor to the patient.
5.4 Positioning of the blankets
• Do not lay the patient on top of the Geratherm
UniqueTemp°warmingblankets!
• Put the warming blankets on the patient in such a way
that the dark orange side is facing the patient and
the light orange or two-tone side is facing upwards. The
warming blankets can be put directly on the patient;
strongly insulating layers placed in between will inhibit
the transfer of heat to the patient.
• Please note! If the warming blankets are placed on the
patient with the light orange or two-tone side facing the
patient, the patient will not be warmed, i.e. Geratherm
UniqueTemp°willnothaveanyeffect!

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5.5. Starting up
After connecting the control unit
to the power supply and attaching
the required warming blankets, the
control unit can be switched on
using the power switch.
Procedure after switching on the control unit:
•Theinitialdisplayshownbesides
appears. Whilst the initial dis-
play is visible, all the necessary
checks of the warming system
are carried out automatically.
•Atthesametimeashortacou-
stic signal is heard. This is to
test the functioning of the acou-
stic alarm.
•Afterthat,thedisplayshowsthe
outline of the patient (in white)
with all the warming blankets currently connected (in blue),
and the preset starting temperature of 36°C in all blankets.
Now the control unit is ready for operation.
Slider and “OK” button
By touching the “OK” button on
the front of the control unit the
heating process in the warming
blankets is activated. As the tem-
perature rises, the graphical repre-
sentations of the warming blankets
gradually turn orange.
When the graphical representa-
tions of the blankets are completely orange, the preset tem-
perature has been reached. With an ambient temperature of
20°C, the time required for heating up to 37°C is approx.
8 minutes. Using the slider located above the “OK” button
the temperature can be increased to up to 42°C.
It is also possible to reduce the temperature to 30 °C, as
long as the preset temperature is higher than the ambient
temperature. Any changes must be confirmed by touching
the “OK” button. If this is not done within 5 seconds, the
preset temperature will remain operative.

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5.6 Switching off the warming
blankets
Using the slider, the blanket temperature on the control unit
is set at less than 30.0°C. Then the blankets on the display
appear in blue and lines appear instead of the number indi-
cating the temperature setting for the blankets. Confirm by
touching the “OK” button.
•Please note: The time required for raising the tempe-
rature of the warming blankets from 20 °C to 37 °C is
approx. 8 minutes.
After a power cut, the above temperature setting pro-
cedures need to be carried out again.
5.7 Preselection of temperatures for
individual blankets
After the control unit is switched on
and the testing of the safety sys-
tems has been carried out, all the
blankets are switched off (depicted
in blue). The warming blankets are
switched on by touching the “OK”
button. If you would like to set dif-
ferent temperatures in the various warming blankets, press
the “select” button area in the bottom right-hand corner
of the display.
In this mode, each blanket is ac-
tivated separately as follows:
1. Touch the graphical representa-
tion of the temperature.
2. Set the temperature by means
of the slider or “+” and “-“ .
3. Confirm the selected temperature
by touching the “OK” button.
If the “OK” button is not touched, after 5 seconds the con-
trol unit will restore the settings that existed prior to the
change.

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5.8 Switching off individual warming
blankets
In the “select” mode, the desired
blanket or the area of the tempe-
rature display is touched, the tem-
perature is set at less than 30°C
using the slider and confirmed by
touching “OK”.
5.9 Adding and removing warming
blankets
Warming blankets shall only be removed or added when
the control unit is switched off or after all the blankets have
been deactivated (all blankets are shown in blue).
The control system will recognise any changes automati-
cally and will correct the graphical representation within a
few seconds.
If warming blankets are removed while switched on, an
acoustic signal will be heard and a failure message will
appear for a short time. The warming blankets are activa-
ted and the temperatures are set as described in Point 5.5.
Care must be taken that all the blankets still required are
connected to each other again.
• Important! When pulling out the blanket plug, pull only
ontheplugitself!Neverpullontheconnectingcable!
• Please note! Removing blankets that are switched on
causes the control unit to switch off and a failure mes-
sage to appear.

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5.10 Starting up the body
temperature sensor
• Warning! Only sensors that correspond to the MET 400
basicsetpointseriesshallbeused!
• The control unit is not designed for operation with sen-
sors of the MET 700 basic setpoint series.
• The use of adapter cables is prohibited.
• Before the temperature sensor is attached to the patient,
the connecting plug of the sensor must be inserted into
the control unit.
• The body temperature can only be measured correctly
if the sensor is positioned at the prescribed measuring
points. In the case of the sensor provided, these points
are the rectum and the oesophagus.
• The temperature is displayed and recorded automatical-
ly when the sensor is connected.
• The current body temperature is shown on the TFT dis-
play in the top right-hand corner. Touching this display
causes a diagram to appear, which shows the progres-
sion of the body temperature. To return to the represen-
tation of the blankets temperature, touch the “back”
button. The symbols “-->” and “<--” can be used for
scrolling.

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6 Shutting down
6.1 Shutting down blankets
On this subject see: 5.6 Switching of the warming
blankets, 5.8 Switching off individual warming blan-
kets and 5.9 Adeling and removing warming blan-
kets
6.2 Shutting down the
Geratherm UniqueTemp°
In order to shut down Geratherm UniqueTemp°, it is neces-
sary to switch off the control unit at the power switch. A brief
confirmation tone will be heard. All the indicator lamps will
go out and the illuminated TFT display will go dark. When
the control unit is switched off, the settings (pre-set blan-
ket temperatures) and the recorded body temperatures are
deleted.
• Warning! Before the temperature sensor plug is taken out
of the control unit, it is very important that the probe be remo-
ved from the patient’s body.No particular measures are re-
quired if the unit is to be out of service for a lengthy period.