3M Ranger 245 Blood/Fluid Warming System Ohjekirja

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Ranger 245 Blood/Fluid Warming System
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3M RANGER MODEL 245 BLOOD/FLUID WARMING SYSTEM
OPERATOR’S MANUAL
DOCUMENT TYPE: REFERENCE TOOL
C-0506-14-60343 Published Date: 21-Aug-2019
Page 1 of 1 Review Date: 21-Aug-2022
This is a controlled document for BCCH& BCW internal use. Refer to online version. Print copy may not be current. See Disclaimer at the end of the document.
Document Owner:
Transfusion Medicine
Purpose of Document(s):
Operator’s Manual
Applicability
BC Children’s Hospital & BC Women’s Hospital + Health Centre
Version History
DATE
DOCUMENT NUMBER and TITLE
ACTION TAKEN
13-Aug-2019
C-0506-14-60343 3M Ranger Model 245 Blood/Fluid
Warming System Operator’s Manual
Approved at: Transfusion Safety
Disclaimer
This document is intended for use within BC Children’s and BC Women’s Hospitals only. Any other use or reliance is at
your sole risk. The content does not constitute and is not in substitution of professional medical advice. Provincial Health
Services Authority (PHSA) assumes no liability arising from use or reliance on this document. This document is protected
by copyright and may only be reprinted in whole or in part as per the Terms of Use on the website.
Ranger
Blood/Fluid
Warming System
Model 245
Operator's Manual
1 Ranger™ Blood/Fluid Warming System Model 245 • Operator’s Manual
2 Unité de réchauement de sang/soluté 3M™ Ranger™ modèle 245 • Manuel d'utilisation
3 Ranger™ Blut‑ und Infusionswärmesystem Modell 245 • Bedienungsanleitung
4 Sistema per il riscaldamento di sangue/uidi Ranger™ modello 245 • Manuale dell'operatore
5 Sistema de calentamiento de sangre/uidos Ranger™ Modelo 245 • Manual del operador
6 Ranger™ bloed‑/vloeistofverwarmingssysteem model 245 • Bedieningshandleiding
7 Ranger™ blod‑ och vätskevärmesystem, modell 245 • Användarhandbok
8 Ranger™ blod‑/væskevarmesystem, Model 245 • Betjeningsvejledning
9 Ranger™ varmesystem for blod/væske, modell 245 • Brukerhåndbok
0 Ranger™‑veren‑/nesteenlämmitysjärjestelmä, malli 245 • Käyttöopas
- Sistema de Aquecimento de Sangue/Fluidos Ranger™ Modelo 245 • Manual do Utilizador
= Ranger™ Σύστημα Θέρμανσης Αίματος/Υγρών Μοντέλο 245Εγχειρίδιο χειριστή
H System Ranger™ do podgrzewania krwi/płynów model 245 • Instrukcja obsługi
J Ranger™ vér‑ és folyadékmelegítő rendszer, 245‑ös modell • Felhasználói kézikönyv
F Ohřívací systém pro krev/tekutiny Ranger™ model 245 • Návod k obsluze
Q 245modelio Ranger™ kraujo / skysčių šildymo sistema • Naudotojo vadovas
M Система подогрева крови и жидкостей Ranger™, модель 245Руководство по эксплуатации
d Ranger™ Kan/Sıvı Isıtma Sistemi Model 245 • Kullanım Kılavuzu
I Ranger™输血/输液升温系统 245 操作指南
MECHANICAL ART
DESC: 3M™ Ranger™ - Bluid/Fluid Warming System - Insert
Printed Colors-Cover:1
K
Item Spec. #:
34-8719-2502-9
Supersedes#:
Structure#:
Reference:
245
Requesters:
Frank Boeshart
DIE #:
8.5" x 11"
DATE CHANGES INT.
01.13.16 Pick up file 34-8714-4406-2 from Job 4045890 and update with new GB translations. kmh
01.20.16 Alt per marked up PDF kmh
08.26.16 Pickup English file from 4264747, convert to 3M Circular and add 18 language translations kmh
09.07.16 Copy edits per proof report & Final release. DJ
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04
9300 WINNETKA AVE N, BROOKLYN PARK, MN 55445, 763.488.5700
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Deutsch�������������������������35
Italiano��������������������������53
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Nederlands����������������������89
Svenska������������������������107
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Português ����������������������179
Ελληνικά ......................197
Polski �������������������������� 217
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Česky��������������������������255
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Ranger
Blood/Fluid
Warming System
Model 245
Operator's Manual
English 34-8719-2502-9
Ranger™ Blood/Fluid Warming System Model 245 English 1
TABLE OF CONTENTS
Technical Service and Order Placement ���������������������������������������������������������������������������������������������� 2
Introduction ������������������������������������������������������������������������������������������������������������������������������������������������ 3
Indications for use������������������������������������������������������������������������������������������������������������������������������������� 3
Definition of Symbols �������������������������������������������������������������������������������������������������������������������������������3
Explanation of Signal Word Consequences �����������������������������������������������������������������������������������������4
WARNING:��������������������������������������������������������������������������������������������������������������������������������������� 5
CAUTION: ���������������������������������������������������������������������������������������������������������������������������������������� 5
NOTICE: ��������������������������������������������������������������������������������������������������������������������������������������������6
Product Description ����������������������������������������������������������������������������������������������������������������������������������6
The Ranger blood/fluid warming unit�����������������������������������������������������������������������������������������6
Ranger blood/fluid warming set ��������������������������������������������������������������������������������������������������6
Product safety features �����������������������������������������������������������������������������������������������������������������6
Instructions for Use ����������������������������������������������������������������������������������������������������������������������������������� 8
Preparation and setup of the Ranger blood/fluid warming unit �������������������������������������������8
Removing the warming set from the Ranger blood/fluid warming unit ������������������������������ 8
Transferring the warming set from one Ranger warming unit to another ���������������������������8
Troubleshooting �����������������������������������������������������������������������������������������������������������������������������������������9
Maintenance and Storage ������������������������������������������������������������������������������������������������������������������������11
Cleaning the Ranger blood/fluid warming unit ������������������������������������������������������������������������11
Specifications��������������������������������������������������������������������������������������������������������������������������������������������12
Physical Characteristics ���������������������������������������������������������������������������������������������������������������14
2 English Ranger™ Blood/Fluid Warming System Model 245
Technical Service and Order Placement
USA
TEL: 1‑800‑228‑3957
Outside of the USA
Contact your local 3M representative�
In‑warranty repair and exchange
To return a device to 3M for service, rst obtain a Return Authorization (RA) number from a
customer service representative� Please use the (RA) number on all correspondence when
returning a device for service� A shipping carton will be delivered to you at no charge, if needed�
Call your local supplier or sales representative to inquire about loaner devices while your device is
being serviced�
When you call for technical support
Remember, we will need to know the serial number of your unit when you call us� The serial
number label is located on the bottom of the warming unit�
English 34-8719-2502-9
Ranger™ Blood/Fluid Warming System Model 245 English 3
Introduction
The 3M™ Ranger™ blood/uid warming system includes a warming unit and a disposable
warming set� The Ranger blood/uid warming system is designed to warm blood, blood
products, and liquids and deliver these at ow rates from KVO to 500mL/min� At these ow
rates, the device maintains uid output temperatures ranging from 33°C to 41°C (Note: Output
temperatures are dependent on input uid temperatures and ow rate)� It takes less than
2minutes to warm up to the 41°C set point temperature� The alert points on the Model 245are
43° and 44° C�
Disposable blood/uid warming sets are available in: pediatric ow, standard ow, and high ow
applications� Warming sets are sterile, not made with natural rubber latex, single‑use‑only items
and are designed to be used with the warming unit�
The Ranger blood/uid warming unit is designed to be mounted to an I�V� pole� A handle located
on the top of the unit makes transport easy� When mounted to the I�V� pole, the unit ts easily
above the 3M™ Bair Hugger™ warming unit� For additional information on the Ranger blood/uid
warming sets visit us online at rangeruidwarming�com�
This manual includes operating instructions and unit specications for the Ranger blood/uid
warming system� For information about using Ranger blood/uid warming sets with the Ranger
blood/uid warming unit, Model 245, refer to the “Instructions for Use” included with each
warming set� The Ranger blood/uid warming system should only be used in healthcare facilities
by trained medical professionals�
Indications for use
The Ranger blood/uid warming system is intended to warm blood, blood products, and liquids�
Denition of Symbols
ON
OFF
Fuse
CAUTION
Type BF Applied Part
Voltage, Alternating Current (AC)
An equipotentiality plug (grounded) conductor other than a protective earth
conductor or a neutral conductor, providing a direct connection between
electrical equipment and the potential equalization busbar of the electrical
installation� Please consult IEC 60601‑1; 2005for requirements�
This system is subject to European WEEE Directive 2002/96/EC� This product
contains electrical and electronic components and must not be disposed of
using standard refuse collection� Please consult local directives for disposal of
electrical and electronic equipment�
Protective earth ground
4 English Ranger™ Blood/Fluid Warming System Model 245
Consult instructions for use
Follow instructions for use
Recycle to avoid environmental contamination� This product contains recyclable
parts� For information on recycling ‑ please contact your nearest 3M Service
Center for advice�
Date of manufacture
Manufacturer
Sterile, ethylene oxide
Store at room temperature
Container quantity
Do not reuse
Not made with natural rubber latex
Keep dry
Temperature limits
Explanation of Signal Word Consequences
WARNING:
Indicates a hazardous situation which, if not avoided, could result in death or serious injury
CAUTION:
Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury
NOTICE:
Indicates a situation which, if not avoided, could result in property damage only
CONTRAINDICATIONS:
None�
English 34-8719-2502-9
Ranger™ Blood/Fluid Warming System Model 245 English 5
WARNING:
1� To reduce the risks associated with hazardous voltage and re and thermal energy hazards:
Do not substitute other devices (i�e� Model 247) for the Ranger blood/uid warming unit
or Ranger blood/uid warming sets�
Do not continue use of the unit if the over‑temperature alert continues to sound and the
temperature does not return to the set point temperature� Immediately stop uid ow
and discard the warming set� Have the blood/uid warming unit tested by a biomedical
technician or call 3M Patient Warming technical service�
2� To reduce the risks associated with hazardous voltage and re:
Do not modify or service this device, and do not open the warming unit case as there are
no user‑serviceable parts in the unit�
Connect power cord to receptacles marked “Hospital Only,” “Hospital Grade,” or a
reliably grounded outlet�
Use only the power cord specied for this product and certied for the country of use�
Do not allow the power cord to get wet�
Do not use the Ranger blood/uid warming system when it appears the unit power cord,
or warming set is damaged� Use only 3M specied replacement parts�
Keep power cord visible and accessible at all times� The plug on the power cord serves
as the disconnect device� The wall socket outlet shall be as close as practical and shall be
easily accessible�
Do not use with a multiple socket outlet or extension cord�
Do not use this equipment adjacent to, stacked with or in combination with other
equipment without verifying that the total leakage current from the combined equipment
does not exceed the safety limits for Type BF equipment and to assure normal operation
in the conguration in which it will be used�
3� To reduce the risks associated with air embolism and incorrect routing of uids:
Never infuse uids if air bubbles are present in the uid line
Ensure all luer connections are tightened�
4� Do not mount the Ranger blood uid warming system higher than patient level during
infusion, as air embolism may result�
5� To reduce the risks associated with potential blood loss, do not use in combination with an
extracorporeal circuit�
CAUTION:
1� To reduce the risks associated with cross‑contamination:
The cleaning tool provides only supercial cleaning, it does not disinfect or sterilize the
interior of the unit�
2� To reduce the risks associated with impact and facility medical device damage:
Clamp the Ranger blood/uid warming unit to an IV� pole with a minimum 14” (35�6cm)
radius wheelbase and at a height no higher than 44” (112cm)�
3� To reduce the risks associated with environmental contamination:
Follow applicable regulations when disposing of this device or any of its
electroniccomponents�
Do not use for direct cardiac application� When using the Ranger blood/uid warming
system with a central venous catheter (CVC), ensure that the catheter tip does not have
direct contact with the heart and ensure that all electrical devices connected to or near
the patient have an appropriate leakage current rating for the application� If a CVC tip
is found to be in direct contact with a patient’s heart, the blood/uid warming unit,
Model 245should be immediately disconnected from the CVC until the CVC is safely
repositioned� Failure to follow these precautions may cause cardiac disturbance and/or
patient injury
4� Follow the AABB Guidelines for the use of blood warming devices which caution against
warming when administering platelets, cryoprecipitate, or granulocyte suspensions�
5� The 3M Ranger blood/uid warming system has been tested to be resistant to both
electromagnetic elds (EMI) and electrostatic discharge (ESD)� To reduce the risk associated
with EMI due to portable and mobile RF communications equipment:
Install and put into service the 3M Ranger blood/uid warming system according to the
EMC information provided in the Guidance and Manufacturer's Declaration�
Should interference occur move away from the portable or mobile RF
communicationsequipment�
6 English Ranger™ Blood/Fluid Warming System Model 245
NOTICE:
1� Federal law (USA) restricts this device to sale by or on the order of a licensed
healthcareprofessional�
1� To avoid device damage:
Do not clean the blood/uid warming unit with solvents� Damage to the case, label, and
internal components may result�
Do not immerse the blood/uid warming unit in cleaning or sterilizing solutions� The unit
is not liquid proof
Do not insert metallic instruments in the blood/uid warming unit�
Do not use abrasive materials or solutions to clean the heater plates�
Do not allow spills to dry inside the unit, as this may make it more dicult to clean
theunit�
The Ranger blood/uid warming unit meets medical electronic interference
requirements� If radio frequency interference with other equipment should occur,
connect the unit to a dierent power source�
Product Description
The Ranger blood/uid warming system consists of a Model 245 warming unit and a sterile
warming set�
The Ranger blood/uid
warming unit
The blood/uid warming unit is a
compact, lightweight, liquid‑resistant
device with a clamp located on the
side for attachment to an I�V� pole (see
Figure 1)� A carrying handle on the top
of the unit makes it easy to transport�
Located on the front panel you will nd:
Alphanumeric display that
indicates the heater temperature
during normal operation� In an
over‑temperature condition,
the display alternately ashes
a temperature of 43°C or higher and the word “HI” An audible alert also sounds� In an
under‑temperature condition, the display alternately ashes a temperature of 33°C or lower
and the word “LO
Alert indicator light that comes on when either an over‑ or under‑temperature
conditionoccurs�
Ranger blood/uid warming set
Blood/uid warming sets include a cassette, tubing and connectors compatible
with hospital standard I�V� blood/uid administration sets and a bubble trap�
Flow rate Priming volume Patient line length
Standard Flow Set 150 mL/min 39‑44 mL 76 cm
152 cm (76 cm patient line
plus 76 cm extension)
High Flow Set 100‑500 mL/min 65‑150 mL 152 cm (76 cm patient line
plus 76 cm extension)
Pediatric/Neonate 100 mL/min 20 mL 46 cm
Refer to the instructions provided with each warming set for information on use�
Slot for cassette
Alphanumeric
display
Bubble trap holder
Power switch
I.V. pole
clamp
Alert indicator light
Figure 1
Figure 2
Warming Set
English 34-8719-2502-9
Ranger™ Blood/Fluid Warming System Model 245 English 7
Product safety features
The following chart describes the safety alert features of the Ranger blood/uid warming unit�
alert tyPe whattolookFor DescriPtion/
cause
action
Over
temperature
alert ‑ 43°C
Alert indicator light
illuminates and alert
sounds, alphanumeric
display alternately ashes
a temperature of 43°C or
higher and the word “HI
Heater
temperature
rose to 43°C
because of
transient
conditions�*
Observe alphanumeric display
If temperature does not drop to
41°C (may take a few minutes),
discontinue use of unit� Call 3M
customer service�
Under
temperature
alert ‑ 33°C
Alert indicator light
illuminates and alert
sounds, alphanumeric
display alternately ashes
a temperature of 33°C or
lower and the word “LO
Heater
temperature
has fallen to
33°C�
Alerts stop when temperature
rises above 33°C� Continue use
of unit� If the temperature does
not rise above 33°C, unplug
the unit and call 3M customer
service�
* Transient conditions may cause an over‑temperature alert condition� These
conditionsinclude:
There was an extreme change in ow rates (e�g�, from 500mL/min to stop ow)�
The unit was turned on and reached the set point temperature of 41°C before the
warming cassette was inserted in the device�
Fluids were prewarmed to above 42°C before being infused�
alert tyPe whattolookFor DescriPtion/
cause
action
Independent
back‑up safety alert
‑ 44°C
Alert indicator light
illuminates and alert
sounds, alphanumeric
display alternately
ashes a temperature of
43°C or higher and the
word“HI
Alphanumeric display
is dark, alert sounds
(backup safety alert still
works even if display
isdark)�
Heater
temperature
rose to 44°C�
Safety backup
system is
activated at
44°C and
unit shuts
o power to
the heating
plates�
TURN OFF THE UNIT AND
UNPLUG IT� Do not use the
blood/uid warming unit�
Discard the disposable set�
Call 3M customer service�
8 English Ranger™ Blood/Fluid Warming System Model 245
Instructions for Use
Preparation and setup of the Ranger
blood/uid warming unit
1� Attach the Ranger blood/uid warming unit to the I�V
pole� Tighten the pole clamp securely (see Figure 3)�
CAUTION:
To reduce the risks associated with impact and facility medical
device damage:
Clamp the Ranger blood/uid warming unit to an IV
pole with a minimum 14” (35�6cm) radius wheelbase
and at a height no higher than 44” (112cm)�
2� Slide the cassette into the slot in the warming unit�
Thecassette can only t into the device one way
(seeFigure 4)�
3� Prime the warming set� For more information about
priming the set, refer to instructions provided with the
warming sets�
4� Place the bubble trap in the holder
5� Plug the power cord into an appropriate outlet� Turn the
unit ON� In a few seconds the alphanumeric display will
illuminate� It takes less than two minutes to warm up to the
41°C set point temperature�
6� Begin infusion� When infusion is completed,
remove the warming set and discard according to
institutionalprotocol�
Removing the warming set from the Ranger blood/uid
warming unit
1� Close the inlet clamp proximal to the cassette and open all clamps distal to thecassette�
2� Disconnect the warming set from the uid source, ifapplicable�
3� Allow uid to ow to the patient (this may take 2‑3seconds)� Close a distalclamp�
4� Remove the cassette from the warming unit and discard according to institutionalprotocol�
5� Reconnect the patient I�V� line to the uid source to continue the infusion withoutwarming�
Transferring the warming set from one Ranger warming unit
to another
1� Follow steps 1‑3above, then remove the warming set from the rst warmingunit�
2� During transport, keep the clamps closed and do not infuse uids while the cassette is
outside of the warmingunit�
3� Slide the cassette into the second warmingunit�
4� Ensure that air is removed from thetubing�
5� Open the clamps and continue theinfusion�
Figure 4
Figure 3
44"
(112 cm)
14"
(35.6 cm)
English 34-8719-2502-9
Ranger™ Blood/Fluid Warming System Model 245 English 9
Troubleshooting
conDition cause solution
Nothing illuminates on the
warming unit panel�
Unit is not turned on,
plugged in, or power cord
is not plugged into an
appropriate outlet�
Turn unit on� Make sure the
power cord is plugged into
the power entry module
of the warming unit� Make
sure the warming unit is
plugged into a properly
groundedoutlet�
Unit failure� Check panel fuses
Call 3M technical service�
conDition cause solution
Alert indicator illuminates
and alert sounds,
alpha‑numeric display
alternately ashes a
temperature of 43°C or
higher and the word “ HI
Temporary overtemperature
condition because:
An extreme change in
ow rates occurred (e�g�,
from 500 mL/min to
stopow)�
Unit was turned on
and reached set point
temperature before
cassette was inserted�
Fluids were prewarmed
to above 42°C before
being run through the
warmingunit�
Open ow to reduce
temperature� Alerts will stop
when the display reads 41°C
The unit is ready to use�
Alerts will stop when the
display reads 41°C� The unit
is ready to use�
Turn o unit and unplug it�
Discontinue infusion of uids�
Do not warm uids before
infusing them through the
Ranger warming unit�
conDition cause solution
Alert sounds,
alphanumeric display
and alert indicator light
godark�
Primary controller failure�
Unitwill no longer operate�
Power to heating plates will shut
o if temperature rises to 44°C
(warming unit Rev N and newer)
or 46°C (warming units Rev A to
M)� Turn unit o and unplug it�
Discontinue use of unit� Discard
disposable set� Alert will continue
to sound if you do not unplug
unit� Call 3M technical service�
10 English Ranger™ Blood/Fluid Warming System Model 245
conDition cause solution
Unit alerts soon after plugging
it in (unit does not have to be
turned on for this condition
tooccur)�
Heater temperature rises to
44°C (warming units Rev N
and newer) or 46°C (warming
units Rev A to M) and unit
shuts down soon after
plugging it in (unit does not
have to be turned on for this
condition to occur)�
Test screw on bottom of unit
is loose or missing�
Make sure test screw is
completely tightened� If
it is missing, turn unit o
and unplug it� Call 3M
technicalservice�
conDition cause solution
Alert sounds but unit has
been turned o
Independent backup safety
system has been activated�
Unplug unit�
Call3Mtechnicalservice�
conDition cause solution
Cannot remove cassette
fromunit
Cassette is too full, uids
are still being infused, or
clamp is open proximal to
the cassette�
Make sure uid is drained
from cassette before
sliding out the cassette,
that uids are no longer
infusing, and that clamp
is closed proximal to the
warmingcassette�
Warming unit is below
patient level, creating
excessive back pressure�
Raise unit above
patientlevel�
conDition cause solution
Alert indicator light
illuminates and alert
sounds, alphanumeric
display alternately ashes a
temperature of 33°C or below
and the word “LO
Under temperature condition
caused by very high ow
using very cold uid, or
defective heater/relay
Alert should stop when
temperature rises above
33°C� If alert continues, turn
unit o, unplug unit and
discontinue use� Call 3M
technicalservice�
conDition cause solution
Alphanumeric display reads
“Er 4” or “Open�
Open wire on
temperaturesensor
Do not use unit�
Call3Mtechnicalservice�
conDition cause solution
Alphanumeric display reads
“Er 5” or “Open�
Electrical interference� Remove the unit� Refer to
biomedical technician or call
3M technicalservice�
English 34-8719-2502-9
Ranger™ Blood/Fluid Warming System Model 245 English 11
MAINTENANCE ANDSTORAGE
CLEANING THE RANGER BLOOD/FLUID WARMINGUNIT
Clean the Ranger warming unit on an as‑neededbasis�
CAUTION
To reduce the risks associated withcross‑contamination:
The cleaning tool provides only supercial cleaning, it does not disinfect or sterilize the
interior of theunit�
NOTICE
To avoid devicedamage:
Do not immerse the warming unit in cleaning or sterilizing solutions� The unit is not
liquidproof
Do not clean the warming unit with solvents� Damage to the case, label, and internal
components mayresult�
Do not insert metallic instruments in the warmingunit�
Do not use abrasive materials or solutions to clean the heaterplates�
Do not allow spills to dry inside the unit, as this may make it more dicult to clean
theunit�
To clean the exterior of the warmingunit:
1� Disconnect the Ranger warming unit from the powersource�
2� Wipe the outside of the unit with warm, soapy water, nonabrasive cleaning solutions, dilute
bleach, or cold sterilants� Do not use abrasivematerials�
3� Wipe with a dry, softcloth�
To clean the heating plates:
The Ranger hardware cleaning tool is intended to clean both heating plates of the warming unit� It
is not necessary to disassemble the warming unit to use thetool�
Method
1� Unplug the warmingunit�
2� Unfold the cleaning tool� Wet the foam pads with a nonabrasive
solution, such as Alconox™* branddetergent�
3� Insert the tool from the back of the unit and pull the tool all the
way out from the front (see Figure5)�
4� Rinse the tool with water and repeat 3times�
5� Wipe o the unit to remove excessuid�
To clean resistant, dried‑on uids:
1� Spray a nonabrasive solution inside the slot of the warming unit
and let sit for 15‑20minutes�
2� Clean the unit by using the cleaningtool�
Note: If the cleaning tool cannot be inserted through the slot of the
warming unit because of excess dried‑on uids, send the unit to a
biomedicaltechnician�
Storage
Store all components in a cool, dry place when not inuse�
Servicing
There are no user‑serviceable parts in the Ranger blood/uid warming unit� All service
must be performed by 3M or an authorized service technician� Call 3M Technical Serviceat
1‑800‑228‑3957for service information� Outside of the USA contact your local 3M Patient
Warmingrepresentative�
*Alconox is a trademark of Alconox,Inc�
Figure 5
12 English Ranger™ Blood/Fluid Warming System Model 245
SPECIFICATIONS
guiDance anD manuFacturersDeclarationelectromagnetic emissions
The model 245is intended for use in the electromagnetic environment specied below The
customer or the user of the model 245should assure that it is used in such anenvironment�
emissions test comPliance electromagnetic environment - guiDance
RF emissions
CISPR 11
Group 1 The model 245uses RF energy only for its internal
function� Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronicequipment�
RF emissions
CISPR 11
Class B The model 245is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low‑voltage power
supply network that supplies buildings used for
domesticpurposes�
Harmonic emissions
IEC 61000‑3‑2
Class A
Voltage uctuations/
Flicker emissions
IEC 61000‑3‑3
Complies
guiDance anD manuFacturersDeclarationelectromagnetic immunity
The model 245is intended for use in the electromagnetic environment specied below The
customer or the user of the model 245should assure that it is used in such anenvironment�
immunity test
iec 60601
test level
comPliance
level
electromagnetic
environment - guiDance
Electrostatic
discharge (ESD)
IEC 61000‑4‑2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile� If oors are covered
with synthetic material, the relative
humidity should be at least30%�
Electrical fast
transient/burst
IEC 61000‑4‑4
±2 kV power lines ±2 kV power
lines
Mains power quality should be
that of a typical commercial or
hospitalenvironment�
Surge
IEC 61000‑4‑5
±1 kV line to line
±2 kV line to gnd
±1 kV line to line
±2 kV line to
gnd
Mains power quality should be
that of a typical commercial or
hospitalenvironment�
Voltage
dips, short
interruptions and
voltage variations
on power supply
inputlines
IEC 61000‑4‑11
<5% U
T
(>95% dip in U
T
)
for 0,5 cycle
40% U
T
(60% dip in U
T
)
for 6 cycles
70% U
T
(30% dip in U
T
)
for 30 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
<5% U
T
(>95% dip in U
T
)
for 0,5 cycle
40% U
T
(60% dip in U
T
)
for 6 cycles
70% U
T
(30% dip in U
T
)
for 30 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
Mains power quality should be
that of a typical commercial or
hospital environment� If the user of
the model 245requires continued
operation during power mains
interruptions, it is recommended
that the model 245be powered
from an uninterruptible power
supply or abattery
Power frequency
(50/60 Hz)
magneticeld
IEC 61000‑4‑8
3 A/m 3 A/m Power frequency magnetic
elds should be at levels
characteristic of a typical location
in a typical commercial or
hospitalenvironment�
NOTE U
T
is the a�c� mains voltage prior to application of the test level�
English 34-8719-2502-9
Ranger™ Blood/Fluid Warming System Model 245 English 13
guiDance anD manuFacturersDeclarationelectromagnetic immunity
The model 245is intended for use in the electromagnetic environment specied below The
customer or the user of the model 245should assure that it is used in such anenvironment�
immunity test
iec 60601
test level
comPliance
level
electromagnetic
environment
- guiDance
Conducted RF
IEC 61000‑4‑6
Radiated RF
IEC 61000‑4‑3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of
the model 245, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of
thetransmitter
Recommended separation distance
d = 1�2
P
d = 1�2
P 80 MHz to 800 MHz
d = 2�3
P 800 MHz to 2,5 GHz
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (m)�
Field strengths from xed RF
transmitters, as determined by an
electromagnetic site survey,
a
should
be less than the compliance level in
each frequency range�
b
Interference may occur in the vicinity
of equipment marked with the
followingsymbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies�
NOTE 2 These guidelines may not apply in all situations� Electromagnetic propagation is
aected by absorption and reection from structures, objects and people�
a
Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy� To assess the electromagnetic
environment due to xed RF transmitters, an electromagnetic site survey should be
considered� If the measured eld strength in the location in which the model 245 is used
exceeds the applicable RF compliance level above, the model 245 should be observed to
verify normal operation� If abnormal performance is observed, additional measures may be
necessary, such as re‑orienting or relocating the model 245�
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m�
14 English Ranger™ Blood/Fluid Warming System Model 245
recommenDeD seParation Distances between Portable anD mobile rF communications equiPment anD
the moDel 245
The model 245is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled� The customer or the user of the model 245can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the model 245as recommended below,
according to the maximum output power of the communicationsequipment�
rateD maximum
outPut Power oF
transmitter
w
seParation Distance accorDing to Frequency oF transmitter
m
150 khzto
80 mhz
d =1.2
P
80 mhzto
800 mh
z
d=1.2
P
800 mhzto2,5 ghz
d=2.3
P
0,01 0�12 0�12 0�23
0,1 0�37 0�37 0�74
1 1�17 1�17 2�30
10 3�69 3�69 737
100 11�67 11�67 23�30
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmittermanufacturer
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency
rangeapplies�
NOTE 2 These guidelines may not apply in all situations� Electromagnetic propagation is
aected by absorption and reection from structures, objects and people�
PHYSICAL CHARACTERISTICS
WARMINGUNIT
4�5in� (11cm) high x 7�5in� (19cm) wide x 10in� (25cm) long; wt�: 7lb� 7oz� (3�4kg)
CERTIFICATIONS
IEC/EN 60601‑1; IEC/EN 60601‑1‑2; CAN/CSA‑C22�2,No�601�1
CLASSIFICATION
MEDICAL — GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601‑1; CAN/ CSA‑C22.2,
No.601.1; ANSI/AAMI ES60601‑1:2005CSA‑C22.2No. 60601‑1:08; ControlNo.4HZ8
Classied under IEC 60601‑1Guidelines (and other national versions of the guidelines) as Class
I, Type BF, Ordinary equipment, Continuous operation� Not suitable for use in the presence of
ammable anesthetic mixtures with air or with oxygen or nitrous oxide� Classied by Underwriters
Laboratories Inc� with respect to electrical shock, re and mechanical hazards only, in accordance
with IEC/EN 60601‑1and Canadian/CSA C22�2, No� 601�1Classied under the Medical Device
Directive as a Class IIbdevice�
English 34-8719-2502-9
Ranger™ Blood/Fluid Warming System Model 245 English 15
Electrical characteristics Temperature and
accuracy characteristics
DEVICE RATING
100‑120 VAC, 50/60 Hz
220‑240 VAC, 50/60 Hz
SET POINT TEMPERATURE
41° ± 1° C
MAXIMUM HEATING POWER
900 W
OVER-TEMPERATURE ALERT
43° +3/‑2° C
FUSE
2 x T10A‑H (250V) for 100‑120 VAC
2 x T6�3A‑H (250V) for 220‑240 VAC
UNDER-TEMPERATURE ALERT
33° ± 2° C
FUSE TYPE
Time delay, high breaking
OVER-TEMPERATURE CUTOFF
44° ± 2° C (warming units Rev N
and newer) 46° ± 2° C (warming
units Rev A to M)
LEAKAGE CURRENT
Meets leakage current requirements in accordance with UL/IEC60601‑1�
ENVIRONMENTAL CONDITIONS
OPERATING TEMPERATURE RANGE
15° to 40°C (59° to 104°F)
STORAGE AND TRANSPORT TEMPERATURERANGE
20° to 45°C (‑4° to113°F)
OPERATING HUMIDITY
10to 85% RH,noncondensing
ATMOSPHERIC PRESSURE RANGE
50kPa to 106kPa
/