3M Ranger 245 Blood/Fluid Warming System Руководство пользователя

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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 245 • Εγχειρίδιο 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 245 • Руководство по эксплуатации

d Ranger™ Kan/Sıvı Isıtma Sistemi Model 245 • Kullanım Kılavuzu

I Ranger™输血/输液升温系统 245 型 • 操作指南

MECHANICAL ART

DESC: 3M™ Ranger™ - Bluid/Fluid Warming System - Insert

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Item Spec. #:

34-8719-2502-9

Supersedes#:

Structure#:

Reference:

245

Requesters:

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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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9300 WINNETKA AVE N, BROOKLYN PARK, MN 55445, 763.488.5700

English��1

Français��17

Deutsch��35

Italiano��53

Español ��71

Nederlands��89

Svenska��107

Dansk��125

Norsk��143

Suomi��161

Português ��179

Ελληνικά ......................197

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中文��331

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 I�V� 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 I�V�

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 manuFacturer’sDeclaration–electromagnetic 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 manuFacturer’sDeclaration–electromagnetic 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 manuFacturer’sDeclaration–electromagnetic 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 7�37

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

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