GERATHERM UniqueResc+ User manual

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Instruction manual | PatientWarmingSystem
Medical Warming Systems
UniqueResc+
Warmth that saves lives

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UniqueResc+
Thank you for choosing a Geratherm Patient Warming System.
Before using the Patient Warming System, please
read through the operating instructions carefully!
The benefits of Geratherm UniqueResc+are:
•Activewarmingfromabove
•Duetosemiconductor-coatedtextilesrespectivelycar-
bonfibresasheatingmaterialaconsistentandplane
heatingisensured
•Microprocessor-controlled
•Thin,cosywarmingblanketsbyapplicationofmodern
insulatingmaterial
•Noiseless,nodistributionofgermsthroughairdistur-
bance
•Simpletouse:
 Plugin–forthwithwarming
•Highlydurableandeasytocleanastheoutermaterial
ismadeupofweldedPUfabrics
•DuetospecialGerathermlineadapter,asanoptional
feature,itisadaptabletoallalternatingcurrentnet-
worksfrom90Vuntil230V(50Hz/60Hz)
Geratherm UniqueResc+has been developed for the
prevention of hypothermia at the rescue scene, for
instance is the system by application of a lithium-ion
battery over a longer period of time independent of
supply systems.

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Contents
page
1 Identification 4
2 Purpose 5
3 Safety precautions 6
4 Description 8
4.1 Overview of the components and
manual control elements 8
4.1.1 Type R130 8
4.1.2 Type R150 10
4.2 Safety features 12
5 Starting up and operation 13
5.1 Assembly and installation 13
5.2 Positioning the blankets 13
5.3 Starting up 14
5.4 Switching off the warming blankets 15
6 Shutting down 16
6.1 Shutting down after use 16
6.2 Shutting down in order to storage
for a certain length of time 16
7 Messages and faults 17
page
8 Preparation and hygiene measures 18
8.1 Cleaning and disinfecting 18
8.2 Checks after processing 19
8.3 Replacement of consumables 19
9 Maintenance 20
10 Disposal 20
11 Warranty 21
12 Technical data 22
12.1 Type R130 22
12.2 Type R150 22
12.3 Geratherm power adapter 23
12.4 Scope of delivery 23
12.5 Symbols used 24
Annex 25

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The Geratherm UniqueResc+can be identified as
follows:
Manufacturer’s designation:
Model:
Geratherm UniqueResc+Rescue Warming System
Type: R130
R150
Device/ software version:
Version: 1. and 2. digit of the serial number
Serial number:
The serial number is to be found under the transparent
window of the control cover plate, on the commercial
invoice and in the attached documentation.
MPG classification:
Geratherm UniqueResc+has been categorised as a
Class IIb device.
Geratherm UniqueResc+meets the requirements of
Council Directive 93/42 EEC of 14.06.93 on Medical
Devices and of the standard DIN EN 60601-1 (Medi-
cal electrical equipment, Part 1: General requirements
for safety), DIN EN 60601-1-2 (Medical electrical
equipment Part 1-2: General requirements for safety
– Collateral standard: Electromagnetic compatibility
– Requirements and Tests), and DIN EN 60601-2-35
(Medical electrical equipment, Part 2: Particular re-
quirements for the safety of blankets, pads and mat-
tresses intended for the warming of patients in medical
use).
A DIN EN ISO 13485 certified quality management sy-
stem ensures that these requirements are met and en-
titles the manufacturer to use the CE 0118 label.
1 Identification

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Geratherm UniqueResc+has been developed for the
prevention of hypothermia. The warming blankets are
light-weight, cosy and warm the patient from above.
The use of several blankets per patient is possible. The
flexibility of the blankets makes it possible to warm
the patient even during complicated rescue operating
terms.
Geratherm UniqueResc+is suitable for use with adult
patients of all sizes.
Geratherm UniqueResc+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
instructions (e.g. avoiding placing the device on EEG
equipment) must be strictly adhered to.
• Note: In order to avoid hazards, the unit should
be only used at direct current low voltage power
sources (12V up to 28V), as e.g. by on-board po-
wer supply systems of rescue vehicles or by the
optional Geratherm power adapter. As well the
use of suitable batteries is possible.
• It should be noted that portable and mobile HF
communication equipment could affect medical
devices.
• Theuseofextensioncablescancausedysfunctions.
In areas around thermally conductive materials as
water, snow and similar substances the patient’s
body temperature could cool down as long as the
device is disconnected.
• All of the Geratherm UniqueResc+must not be
operated on DC or AC power out of the indicated
range (12 – 28V). Connections to other power
supplies respectively the operation on not approved
adapters can result in serious personal injury and
material damage. Only special Geratherm adapters
are allowed to be used.
• IftheGerathermpoweradapterisapplieditshould
be only connected to one warming blanket!
• Geratherm UniqueResc+warming blankets must
not be cleaned in a washing machine or autoclave!
• 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
instructions (e.g. avoiding placing the device on EEG
equipment) must be strictly adhered to.
3 Safety precautions

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• Donotoperatethecontrolunitinareassubjectto
explosion hazard!
• DonotuseGerathermUniqueResc+warming blan-
kets together with other heat sources (e.g. radiation
lamps, incubators or hot water bottles)! This could
be detrimental 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 devices may produce false readings!
• Beforeeachuse, check the surfaceof thewar-
ming blankets for any visible damage! Disconti-
nue use of any damaged blankets immediately!
• PuttheGerathermUniqueResc+warming blankets
completely on the patient. To prevent overheating,
do not under any circumstances fold the equip-
ment!
• Do not place any objects on top of the warming
blankets to avoid any localised overheating or heat
accumulation.
• Itmustbecheckedwhetheranyfixtureisrequired
to keep the patient in place. If so, the same must be
positioned underneath the warming blankets.
• Thetemperaturesetting(onlybymodeltypeR130)
is the responsibility of the physician.
• DonotuseGerathermUniqueResc+on patients
with impaired circulation! The manufacturer is
not aware of any other contra-indications.
• Wheneverheattreatmentisapplied,thecorebody
temperature of the patient must be monitored at re-
gular intervals. The length of the intervals shall be
determined by the medical staff.
• Geratherm UniqueResc+shall only be used under
the supervision of the medical staff.
•Do not apply adhesive tape to the warming blan-
kets. This will lead to permanent soiling of the
surface.

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Complete warming blanket
example of application
4 Description
4.1 Overview of the components and manual control elements
4.1.1 Type R130

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control unit
1 Device description and type
2 LED display HEATING (display flashes
during heating-up)
3 LED display POWER (display lights up
during operating)
4 LED display ERROR (lights up if a fault
occurs)
5 Display of the selected set temperature
6 SELECT button for switching-over the
set temperature
7 Safety class
8 Do not dispose of in household waste
9 BF type applied part
10 Read operating instructions
11 Serial number of the device
2
1
4
3
5
6
7
9
8
10
11

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4.1.2 Type R150
example of application
Complete warming blanket

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control unit
1 Device description and type
2 LED display HEATING (display flashes
during heating-up)
3 LED display POWER (display lights up
duringoperating)
4 LED display ERROR (lights up if a
fault occurs)
5 Safety class
6 Do not dispose of in household waste
7 BF type applied part
8 Read operating instructions
9 Serial number of the device
1
2
4
3
5
7
6
8
9

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Geratherm UniqueResc+has an optical and acoustic
alarm system, which indicates all faults.
The system possesses monitoring installation of hard-
ware as well as software.
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.
4.2 Safety features

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5.1 Assembly and installation
Geratherm UniqueResc+warmingblanketsmustbelaidon
thepatientinsuchawaythattheycoveraslargeapropor-
tionofthepatient‘sbodysurfaceaspossible.
Therangeofdifferentwarmingblanketsenablesanopti-
mumcoveringofthemostfrequentlycaseofoperations
possible.
5.2 Positioning the blankets
• Do not lay the patient on top of the Geratherm
UniqueResc+warming blankets!
• Putthewarmingblanketsonthepatientin such a
way that the control unit´s window side is facing
away the patient.
The warming blankets can be put directly on the pa-
tient; strongly insulating layers placed in between
will inhibit the transfer of heat to the patient.
• Note:
If the warming blankets are placed on the
patient with the side on which the control unit is
positioned facing the patient, the patient will not
be warmed, i.e. Geratherm UniqueResc+will not
have any effect!
5 Starting up and operation

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5.3 Starting up
After connecting the warming blanket to the supply
voltage the heating process in the warming blanket is
immediately after short self test activated.
In case of using the Geratherm power adapter it will be
ready for use approx. two seconds after connecting to
theACvoltage(showedbyagreenLED).
• Warning:If the Geratherm power adapter is applied it
should be only connected to one warming blanket!
Procedure after switching on the
control unit:
• Allofthe3LED’slightupbriefly.Allrequiredheating
system equipment checks are performed automati-
cally in this period of time.
•At the same time, a short tone signal announces the
test of the acoustic alarm function.
• Then,theredERRORLEDhasgoneoutnowthatthe
green HEATING LED flashes consistently until the
pre-selected blanket temperature is reached.
•If needed, type R130 now allows changing the final
temperature from 41 °C to 37 °C by pressing three
times the temperature selection button (SELECT
button).
•Due to high sensitivity of the sensors, the ERROR
LEDcouldprobablyflashbriefly(ca.2–3seconds)
during the heating process. This is no system error
and it is reset autonomously.

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5.4 Switching off the warming
blankets
The switching off of the warming blanket is achieved by
disconnecting it from the voltage source.
 • Note:
The heating phase of the warming blanket
from 20 °C to 37 °C is approx. 5 minutes.
When executing R130 and the power supply is inter-
rupted, the temperature is re-set independently from
the eventually preselected temperature to 41 °C. If ano-
ther temperature is required, the pre-selection of tem-
perature has to be activated anew as shown in chapter
5.3.
 • Note:
To get the blanket unplugged, only pull the
plug, never pull the cable!

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6 Shutting down
6.1 Shutting down between the
operations
Seechapter:
5.4Switchingoffthewarmingblankets
6.2 Long-termed shutting down of
the Geratherm UniqueResc+
Prior to storing UniqueResc+no maintenance is re-
quired.
The system may only be deposited dryly.
If ring connectors are often used, it is recommended to
lightly grease (Vaseline) the contacts of the ring con-
nectors to avoid oxidation.

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The control unit is equipped with a program which re-
cognizes errors autonomically and displays them by
theredERRORLED.
The type of disorder of devices with infrared module
can be read-out additionally with an infrared adapter by
the service technician.
Duetohighsensitivityofthesensors,theERRORLED
could probably flash briefly (ca. 2 – 3 seconds) during
the heating process. This is no system error and it is
reset autonomously.
If another error occurs, the warming blanket must be
put out of operation immediately. Our customer service
department is glad to can be at your disposal.
If you return the system for repairs, please send only
disinfected warming blankets.
7 Messages and faults

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8.1 Cleaning and disinfecting
The Geratherm UniqueResc+warming blankets can be
wished off and wiped with disinfectant. For this pur-
pose, please use only commercially available alcohol-
based colourless disinfectants in accordance with the
instructions of the manufacturers of the disinfectant.
Users should not employ any cleaning or decontamina-
ting procedures other than those recommended by the
manufacturer without first checking with the manufac-
turer whether the proposed procedures could damage
the device.
When disinfectant is used, its compatibility with the
materials must first be tested on a test area. Upon re-
quest, Geratherm will be pleased to provide samples
of the materials for such tests. A suitable product is,
for example, Incidur-Spray manufactured by Ecolab
GmbH,P.O.Box130406,D-40554Düsseldorf.
If you wish to use other cleaning agents or procedures,
you must consult the manufacturer first. Otherwise the-
re is a risk that the warming system will be damaged.
•Warning!
Insufficiently disinfected blankets constitute an
infection hazard.
Do not clean or sterilise the warming blankets in a
washing machine or autoclave.
•Warning!
Care must be taken to ensure that the blankets
are completely dry after cleaning and prior to
storing respectively before stowing into the
transportation containers.
8 Preparation and hygiene
measures

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8.2 Checks after processing
Check the warming blankets and connecting cables re-
gularly for any damage.
Any damage to the surface coating due to long-term
intensive use or strong mechanical forces necessitates
replacement by the manufacturer.
Damaged blankets shall not be used again.
8.3 Replacement of consumables
Therearenoconsumables!

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9 Maintenance
Servicing and safety checks must be carried out in com-
pliancewithEN60601-1andMPBetreibV(inGermany
only) using the Geratherm Service Manual of Rescue
Warming Systems UniqueResc+and the checks for
medical electrical equipments are instructed every 24
months. The warming systems must be subjected to
technical inspections, including safety-related checks,
by the manufacturer or an authorised person every 24
months. Checking the calibration of the systems is only
required after the replacement of assembly modules
and as part of the safety-related checks.
The Service Manual can be obtained free of charge
from the manufacturer upon request.
• Warning!
Alterations to the UniqueResc+are not permitted
without the consent of the manufacturer.
10 Disposal
The device must be disposed of in accordance with the
WEEE Recycling Directive, not as household waste.
Disposal does not entail any particular hazards.