3M Ranger 245 User manual
A Blood/Fluid Warming Unit, Model 245 Operator’s Manual 01
b Manuel de l’utilisateur de l’unité de réchauement pour sang/liquide, modèle 245 10
c Erwärmungseinheit für Blut/Flüssigkeit, Modell 245, Bedienungsanleitung 20
d Manuale d’uso dell’Unità riscaldante per sangue/uidi, modello 245 30
e Manual del operario de la unidad de calentamiento de sangre/uidos (Modelo245) 40
f Bedieningshandleiding verwarmingsunit bloed/vloeistof, model245 50
g Blod-/vätskevärmeenhet, modell 245 Bruksanvisning 60
h Varmeenhed til blod/væske, model 245, betjeningsmanual 70
i Varmeenhet for blod/væske, modell 245 Brukerhåndbok 80
j Veren/nesteen lämmitysyksikkö malli 245 Käyttöopas 90
k Manual do Operador da Unidade de Aquecimento de Fluidos/Sangue, Modelo 245 100
l Μονάδα Θέρμανσης Αίματος/Υγρών, Μοντέλο 245 Εγχειρίδιο Χειριστή 110
m Urządzenie do podgrzewania, model 245 — instrukcja obsługi 121
n Vér-/folyadékmelegítő egység, 245-ös modell, Kezelői kézikönyv 131
o Návod kobsluze ohřívací jednotky pro krev/tekutiny, model 245 141
p Používateľská príručka jednotky na ohrev krvi/tekutín, model 245 151
q Enota za ogrevanje krvi/tekočin, model 245 Uporabniški priročnik 161
r Vere/vedeliku soojendussüsteemi mudeli 245 kasutusjuhend 171
s Asins/šķidruma sildītājs, modelis 245– lietotāja rokasgrāmata 181
t Kraujo / skysčio šildymo įrenginio (245 modelio) naudotojo vadovas 191
u Unitate de încălzire a sângelui/uidului, Model 245 Manualul operatorului 201
v Инструкция по эксплуатации устройства для подогрева крови/растворов, модель245 211
X Grijalica krvi/tekućina, model 245, operaterov priručnik 222
y Ръководство за оператора на устройство за затопляне на кръв/течност, модел 245 232
1 Kan/Sıvı Isıtma Ünitesi, Model 245 Kullanım Kılavuzu 244
4 245 型输血/输液加温器操作手册 254
7 245 264
1
Table of Contents
Section 1: Technical Service and Order Placement .................................................................. 2
Technical Service and Order Placement ................................................................................ 2
USA....................................................................................................................... 2
Outside of the USA. ...................................................................................................... 2
In-warranty repair and exchange ........................................................................................ 2
When you call for technical support ..................................................................................... 2
Section 2: Introduction............................................................................................... 2
Product Description...................................................................................................... 2
Indications for use........................................................................................................ 2
Patient Population and Settings.......................................................................................... 2
Explanation of Signal Word Consequences ............................................................................. 2
WARNING: ............................................................................................................... 2
CAUTION:................................................................................................................ 3
NOTICE:.................................................................................................................. 3
Overview and Operation................................................................................................. 3
Ranger blood/uid warming set example ............................................................................... 3
Model 245 Product safety features...................................................................................... 4
Section 3: Instructions for Use ....................................................................................... 4
Preparation and setup of the Ranger blood/uid warming unit ......................................................... 4
Removing the warming set from the Ranger blood/uid warming unit ................................................. 4
Transferring the warming set from one Ranger warming unit to another ............................................... 4
Section 4: Troubleshooting .......................................................................................... 5
Section 5: General Maintenance and Storage ....................................................................... 5
Cleaning Instructions .................................................................................................... 5
To clean the exterior of the warming unit: ............................................................................... 5
To clean the heating plates: ............................................................................................. 6
To clean resistant, dried-on uids: ....................................................................................... 6
Storage ................................................................................................................... 6
Servicing ................................................................................................................. 6
Symbol Glossary ......................................................................................................... 6
Section 6: Specications............................................................................................. 7
Physical Characteristics.................................................................................................. 9
Classications............................................................................................................ 9
Leakage Current ......................................................................................................... 9
Environmental Conditions ............................................................................................... 9
A
2
USA: TEL: 1-800-228-3957 (USA Only)
Outside of the USA: Contact your local 3M representative.
3M assumes no responsibility for the reliability, performance, or safety of the temperature warming unit if the following events occur:
• Modications or repairs are not performed by a qualied, medical equipment service technician who is familiar with good practice for medical device repair.
• The unit is used in a manner other than that described in the Operator’s or Preventive Maintenance Manual.
• The unit is installed in an environment that does not provide grounded electrical outlets.
• The warming unit is not maintained in accordance with the procedures described in the Preventive Maintenance Manual.
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
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.
Section 2: Introduction
The Ranger blood/uid warming system consists of a Model 245 warming unit and a sterile disposable uid warming set.
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.
This manual includes operating instructions and unit specications 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 warmer is intended to warm blood, blood products, and liquids.
Adult and pediatric patients being treated in operating rooms, emergency trauma settings, or other areas where blood/uids are infused.
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.
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.
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 specied for this product and certied 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 specied
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 conguration in which it will be used.
3
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 supercial 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.
4. 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.
5. Follow the AABB Guidelines for the use of blood warming devices which caution against warming when administering platelets, cryoprecipitate, or
granulocyte suspensions.
6. 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.
NOTICE:
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 dicult to clean the unit.
2. 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 dierent power source.
Overview and Operation
The 3MTM RangerTM blood/uid warming system consists
of a Model 245 warming unit and a sterile disposable uid
warming set.
The 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.
The Ranger blood/uid warming system consists of a
Model 245 warming unit and sterile warming set.
Alert indicator light
Slot for cassette
Alphanumeric display Power switch Bubble trap holder
I.V. pole clamp
Figure 1
A. Inlet line
B. Blue inlet pinch clamp
C. Fluid warming cassette
D. Bubble trap
E. Roller Clamp
F. Patient line
G. Injection port
H. White outlet pinch clamp
I. Patient connection
Refer to the instructions provided with each warming set for
information on use.
4
The following chart describes the safety alert features of the Ranger blood/uid warming unit.
Alert Type What To Look For 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.
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.
* 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 What To Look For 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 off 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
Section 3: Instructions for Use
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, #1).
3. Prime the warming set. For more information about priming the set, refer to
instructions provided with the warming sets (see Figure 4, #2).
4. Place the bubble trap in the holder.
5. Plug the power cord into an appropriate outlet. Turn the unit ON (see Figure 4, #3). 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.
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.
44"
(112 CM)
14"
(35.6 CM)
Figure 3 Figure 4
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.
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.
5
Section 4: 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.
Alert indicator illuminates and alert sounds,
alpha-numeric display alternately ashes a
temperature of 43°C or higher and the word
“HI.”
Temporary over-temperature 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 off unit and unplug it. Discontinue infusion of uids.
Do not warm uids before infusing them through the
Ranger warming unit.
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.
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 off and unplug it. Call 3M.
Alert sounds but unit has been turned o. Independent backup safety system has been
activated.
Unplug unit. Call 3M.
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.
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.
Alphanumeric display reads “Er 4” or “Open.” Open wire on temperature sensor. Do not use unit. Call 3M.
Alphanumeric display reads “Er 5” or “Open.” Electrical interference. Remove the unit. Refer to biomedical technician or call 3M
Section 5: General Maintenance and Storage
Cleaning Instructions
1. Disconnect the warming unit from the power source before cleaning.
2. Cleaning should be performed in accordance with hospital practices for cleaning OR equipment. After every use; wipe the warming unit and any
other surfaces that may have been touched. Use a damp, soft cloth and a hospital approved mild detergent, germicidal disposable wipes, disinfecting
towelettes, or antimicrobial spray. The following active ingredients are acceptable for use in cleaning the warming unit:
• Oxidizers (e.g. 10% Bleach)
• Quaternary Ammonium Compounds (e.g. 3MTM Quat Disinfectant Cleaner)
• Phenolics (e.g. 3M™ Phenolic Disinfectant Cleaner)
• Alcohols (e.g. 70% Isopropyl Alcohol)
3. Let air dry.
CAUTION
To reduce the risks associated with cross-contamination:
• The cleaning tool provides only supercial cleaning, it does not disinfect or sterilize the interior of the unit.
6
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.
1. Unplug the irrigation uid warming unit.
2. Unfold the cleaning tool. Wet the foam pads with a nonabrasive
solution. The following active ingredients are acceptable for use
with the cleaning tool:
• Oxidizers (e.g. 10% Bleach)
• Quaternary Ammonium Compounds (e.g. 3MTM Quat
Disinfectant Cleaner)
• Phenolics (e.g. 3M™ Phenolic Disinfectant Cleaner)
• Alcohols (e.g. 70% Isopropyl Alcohol)
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. Discard the tool
according to institutional protocol.
5. Wipe o the unit to remove excess uid.
Figure 5
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.
NOTICE
1. To avoid device damage:
• Do not immerse the Ranger unit or accessories in any liquid or subject them to any sterilization process.
• 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 dicult to clean the unit.
NOTE: You may use a nonmetal instrument, such as a cotton swab, to clean the upper channels. If you are unable to adequately clean the unit, call 3M
technical service.
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. In the
USA, call 3M at 1-800-228-3957 for service information. Outside of the USA contact your local 3M representative.
Please report a serious incident occurring in relation to the device to 3M and the local competent authority (EU) or local regulatory authority.
The following symbols may appear on the product’s labeling or exteriorpackaging.
"OFF" (power) To indicate disconnection from the mains, at least for main switches, or their positions, and all those
cases where safety is involved. Source: IEC 60417-5008
"ON" (power) To indicate connection to the mains, at least for mains switches, or their positions, and all those cases
where safety is involved. Source: IEC 60417-5007
Authorized Representative
in European Community /
European Union
Indicates the authorized representative in the European Community / European Union. Source: ISO
15223, 5.1.2, 2014/35/EU, and/or 2014/30/EU
Catalogue number Indicates the manufacturer's catalogue number so that the medical device can be identied. Source: ISO
15223, 5.1.6
Caution Indicates that caution is necessary when operating the device or control close to where the symbol
is placed, or that the current situation needs operator awareness or operator action in order to avoid
undesirable consequences. Source: ISO 15223, 5.4.4
CE Mark 2797 Indicates conformity to all applicable European Union Regulations and Directives with notied body
involvement.
Date of manufacture Indicates the date when the medical device was manufactured. Source: ISO 15223, 5.1.3
7
Type BF applied part To identify a type BF applied part complying with IEC 60601-1. Source: IEC 60417-5333
Equipotentiality To identify the terminals which, when connected together, bring the various parts of an equipment or of a
system to the same potential, not necessarily being the earth (ground) potential. Source: IEC 60417-5021
Refer to instruction manual/
booklet
To signify that the instruction manual/booklet must be read. Source: ISO 7010-M002
Fuse Indicates a replaceable fuse
Importer Indicates the entity importing the medical device into the locale. Source: ISO 15223, 5.1.8
Keep dry Indicates a medical device that needs to be protected from moisture. Source: ISO 15223, 5.3.4
Manufacturer Indicates the medical device manufacturer. Source: ISO 15223, 5.1.1
Medical Device Indicates the item is a medical device. Source: ISO 15223, 5.7.7
Protective earth (ground) To identify any terminal which is intended for connection to an external conductor for protection against
electric shock in case of a fault, or the terminal of a protective earth (ground) electrode. Source: IEC
60417, 5019
Recycle electronic
equipment
DO NOT throw this unit into a municipal trash bin when this unit has reached the end of its lifetime.
Please recycle. Source: Directive 2012/19/EC on waste electrical and electronic equipment (WEEE)
Rx Only Indicates that U.S. Federal Law restricts this device to sale by or on the order of physician. 21 Code of
Federal Regulations (CFR) sec. 801.109(b)(1)
Serial number Indicates the manufacturer's serial number so that a specic medical device can be identied. Source:
ISO 15223, 5.1.7
UL Classied Indicates product was evaluated and Listed by UL for the USA and Canada.
Unique device identier Indicates a carrier that contains Unique Device Identier information. Source: ISO 15223, 5.7.10
For more information see HCBGregulatory.3M.com
Section 6: Specifications
The model 245 is intended for use in the electromagnetic environment specied below. The customer or the user of the model 245 should assure that it is
used in such an environment.
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
The model 245 is intended for use in the electromagnetic environment specied below. The customer or the user of the model 245 should assure that it is
used in such an environment.
IEC 60601 test level
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 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.
8
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% UT
(>95% dip in UT)
for 0,5 cycle
40% UT
(60% dip in UT)
for 6 cycles
70% UT
(30% dip in UT)
for 30 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 0,5 cycle
40% UT
(60% dip in UT)
for 6 cycles
70% UT
(30% dip in UT)
for 30 cycles
<5% UT
(>95% dip in UT)
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 UT is the a.c. mains voltage prior to application of the test level.
The model 245 is intended for use in the electromagnetic environment specied below. The customer or the user of the model 245 should assure that it is
used in such an environment.
IEC 60601 test level
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.
d = 1.2√P
d = 1.2√P80 MHz to 800 MHz
d = 2.3√P800 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).
electromagnetic site surveya, should be less than the compliance level
in each frequency rangeb. 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 aected by absorption and reection from structures, objects and people.
aField 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.
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.
W
m
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800MHz
d = 1.2√P
800 MHz to 2,5 GHz
d = 2.3√P
0,01 0.12 0.12 0.23
0,1 0.37 0.37 0.74
11.17 1.17 2.30
10 3.69 3.69 7.37
100 11.67 11.6 7 23.30
9
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 aected by absorption and reection from structures, objects and people.
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)
• Protection against electric shock: Class I Medical Electrical Equipment with Type BF applied part.
• Protection against ingress of water: IPX0 (Ordinary Equipment).
• Mode of operation: Continuous operation.
Electrical Characteristics
100-120 VAC, 50/60 Hz
220-240 VAC, 50/60 Hz
41° ± 1.5°C
900 W
43° +3/-2°C
Fues
2 x T10A-H (250V) for 100-120 VAC
2 x T6.3A-H (250V) for 220-240 VAC
33° ± 2°C
Fuse Type
Time delay, high breaking
46° +3/-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 IEC 60601-1.
15° to 40°C (59° to 104°F)
-20° to 45°C (-4° to 113°F)
: 10 to 85% RH, noncondensing
50 kPa to 106 kPa
10
Section 1 : Assistance technique et commandes ....................................................................11
Assistance technique et commandes.................................................................................... 11
États-Unis ................................................................................................................ 11
En dehors des États-Unis................................................................................................. 11
Réparation et échange dans le cadre de la garantie..................................................................... 11
Demande d’assistance technique........................................................................................ 11
Section 2 : Introduction ..............................................................................................11
Description du produit ................................................................................................... 11
Indications................................................................................................................ 11
Patients et services....................................................................................................... 11
Explication des conséquences correspondant aux mentions d’avertissement.......................................... 11
AVERTISSEMENT :....................................................................................................... 11
MISE EN GARDE :........................................................................................................12
AVIS : .....................................................................................................................12
Présentation et fonctionnement .........................................................................................13
Exemple de set de réchauement pour sang/liquide Ranger ...........................................................13
Caractéristiques de sécurité du modèle 245 ............................................................................13
Section 3 : Instructions d’utilisation ................................................................................ 14
Préparation et installation de l’unité de réchauement pour sang/liquide Ranger .....................................14
Retrait du set de réchauement de l’unité de réchauement pour sang/uide Ranger................................14
Transfert du set de réchauement d’une unité de réchauement Ranger à une autre .................................14
Section 4 : Dépannage .............................................................................................. 14
Section 5 : Maintenance générale et stockage ..................................................................... 15
Instructions de nettoyage................................................................................................15
Pour nettoyer l’extérieur de l’unité de réchauement : .................................................................15
Pour nettoyer les plaques de réchauffement : ..........................................................................16
Pour nettoyer des liquides séchés, résistants : ..........................................................................16
Stockage .................................................................................................................16
Entretien..................................................................................................................16
Glossaire des symboles ..................................................................................................16
Section 6 : Caractéristiques ........................................................................................ 17
Caractéristiques physiques ..............................................................................................19
Classications............................................................................................................19
Courant de fuite..........................................................................................................19
Conditions environnementales ..........................................................................................19
b
11
États-Unis : TÉL. : 1-800-228-3957 (États-Unis uniquement)
En dehors des États-Unis : contactez votre représentant 3M local.
•
pratiques de réparation des dispositifs médicaux.
•
•
•
Réparation et échange dans le cadre de la garantie
jetable stérile.
établissements de santé et par des professionnels de santé formés.
Indications
AVERTISSEMENT :
AVIS :
1.
•
•
biomédical ou appelez 3M.
2.
•
•
•
•
12
•
•
•
•
3.
•
•
4.
provoquer une embolie gazeuse.
5.
1.
•
2.
•
3.
•
4.
veineux central (CVC), veillez à ce que la pointe du cathéter ne soit pas en contact direct avec le cœur et veillez à ce que tous les dispositifs électriques
5.
suspensions de granulocytes.
•
directives et dans la déclaration du fabricant.
•
1.
•
internes.
•
•
•
•
2.
13
3MTM RangerTM
jetable stérile.
potence I.V. (voir la Figure 1). Une poignée sur le dessus
Vous trouverez sur le panneau avant :
• Écran alphanumérique indiquant la température
alternativement une température de 43 °C ou plus et
alternativement une température de 33 °C ou moins et
•
élevée ou trop basse.
Fente pour cassette
Écran alphanumérique
Clamp pour potence I.V.
Figure 1
C. Cassette de réchauffement de liquide
D.
Clamp à roulette
F. Tubulure patient
G.
H. Clamp de sortie blanc
I. Raccordement au patient
Action
température
excessive - 43 °C
une température de 43 °C ou supérieure et les
La température du
à cause de conditions
transitoires.*
température ne retombe pas à 41 °C (cela peut
température trop
basse - 33 °C
une température de 33 °C ou inférieure et les
La température du
à 33 °C.
température ne dépasse pas 33 °C, débranchez
•
•
•
Action
indépendante -
44 °C
une température de 43 °C ou supérieure et
La température du
14
1.
le clamp de la potence (voir la Figure 3).
•
2.
entrer dans le dispositif que dans un sens (voir la Figure 4, n° 1).
3.
n° 2).
4.
5.
quelques secondes. Il faut moins de deux minutes pour atteindre le point de consigne
de température de 41 °C.
Commencez la perfusion. Une fois la perfusion terminée, retirez le set de
1.
2.
3.
44"
(112 CM)
14"
(35,6 CM)
Figure 3 Figure 4
4.
5.
1.
2.
3.
4.
5. Ouvrez les clamps et continuez la perfusion.
État Cause Solution
une prise adéquate.
alternativement une température de 43°C ou
Condition de température excessive provisoire
car :
Le débit a changé brutalement (par exemple de
le point de consigne de température avant
15
État Cause Solution
plus fonctionner.
coupée si la température atteint 44 °C (unités de
cette alerte apparaisse).
mise sous tension pour que cela se produise).
ou absente.
a été activé.
La cassette est trop pleine, des liquides sont
proximal de la cassette.
de retirer la cassette, que les liquides ne sont plus
pression excessive.
alternativement une température de 33 °C ou
Condition de température trop basse due à un
Fil ouvert sur le capteur de température.
Interférence électrique.
appelez 3M
Instructions de nettoyage
1.
2.
• Oxydants (ex : eau de javel à 10 %)
• TM)
•
•
3.
•
16
1.
2.
avec une solution non abrasive. Les ingrédients actifs suivants
• Oxydants (ex : eau de javel à 10 %)
•
quaternaire 3MTM)
•
•
3.
4.
5.
Figure 5
1.
2.
AVIS
1.
•
•
•
•
•
Stockage
Entretien
dehors des États-Unis, contactez votre représentant 3M local.
Indique une déconnexion du secteur, au moins pour les interrupteurs secteur, ou leurs positions, et tous
Indique la connexion au secteur, au moins pour les interrupteurs secteur, ou leurs positions, et tous les
Représentant autorisé pour la
Numéro de référence
Date de fabrication
17
Équipotentialité
Fusible
Importateur
Conserver au sec
Fabricant
Dispositif médical
Mise à la terre (masse)
Recycler les équipements
électroniques
Rx Only Indique que conformément aux lois fédérales en vigueur aux États-Unis, ce dispositif ne peut
801.109(b)(1)
Numéro de série
Indique que le produit a été évalué et répertorié par UL pour les États-Unis et le Canada.
dispositifs
Émissions RF
Groupe 1
voisin.
Émissions RF
Émissions harmoniques
Conforme
18
CEI 60601
Décharge
Contact ±8 kV
Contact ±8 kV
moins 30 %.
Transitoire électrique
2+ kV pour les lignes
2+ kV pour les lignes
commercial ou médical type.
1± kV de ligne à ligne
2± kV de ligne à masse
1± kV de ligne à ligne
2± kV de ligne à masse
commercial ou médical type.
Creux de tension,
interruptions courtes et
variations de tension sur
<5 % UT
(creux >95 % de UT)
pour 0,5 cycle
40 % UT
UT)
70 % UT
(creux de 30 % de UT)
pour 30 cycles
<5 % UT
(creux >95 % de UT)
pendant 5 secondes
<5 % UT
(creux >95 % de UT)
pour 0,5 cycle
40 % UT
UT)
70 % UT
(creux de 30 % de UT)
pour 30 cycles
<5 % UT
(creux >95 % de UT)
pendant 5 secondes
Champ magnétique de
standard.
UT
CEI 60601
Niveau de
RF conduite
Émissions RF par rayonnement
3 Vrms
De 150 kHz à 80 MHz
De 80 MHz à 2,5 GHz
3 Vrms
Les équipements de communications RF portables et mobiles ne doivent
câbles, mais à une distance de séparation recommandée calculée sur la
d = 1,2P
d = 1,2P 80 MHz à 800 MHz
d = 2,3P 800 MHz à 2,5 GHz
P
d est la
a, déterminées par
au niveau de conformité pour chaque gamme de fréquenceb. Des
symbole suivant :
Other manuals for Ranger 245
6
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