3M 247 Crib Toy User Manual

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Ranger™ Irrigation
Fluid Warming
System
Model 247
Operator’s Manual
1 Irrigation fluid warming system
Operator's manual
= Εγχειρίδιο χρήσης συστήματος θέρμανσης υγρών
καταιόνησης
2 Manuel de l’utilisateur du système de
réchauffement pour liquide d’irrigation
H Instrukcja obsługi systemu do podgrzewania
płynów stosowanych przy irygacji
3 Spülflüssigkeitserwärmungssystem
Benutzerhandbuch
J Irrigációsfolyadék-melegítő rendszer
Kezelői kézikönyv
4 Manuale per l'operatore del sistema di
riscaldamento dei fluidi di irrigazione
F Ohřívací systém pro irigační tekutiny –
Návod k obsluze
5 Sistema de calentamiento
de fluidos de irrigación
Manual del operador
Q Irigacinio skysčio šildymo sistema
Operatoriaus vadovas
6 Gebruikershandleiding verwarmingssysteem
voor irrigatievloeistoffen
7 Användarhandbok för
spolvätskeuppvärmningssystem
8 Varmesystem til udskylningsvæske
Brugervejledning
9 Oppvarmingssystem for irrigasjonsvæske
brukerveiledning
0 Huuhtelunesteen lämmitysjärjestelmä
Käyttöopas
- Manual do utilizador do Sistema de
aquecimento de fluidos de irrigação
M Руководство по эксплуатации системы для
подогрева промывочной жидкости
: İrigasyon sıvısı ısıtma sistemi
Kullanım kılavuzu
E イリゲーション液加温システム取扱説明書
I 灌注液体升温系统操作指南
U Check the 3M TM RangerTM system website to ensure you have the most recent version of this document.
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3
Ranger™ Irrigation Fluid
Warming System
Model 247
Operator’s Manual
English1
Français15
Deutsch33
Italiano49
Español
65
Nederland
81
Svenska
97
Dansk113
Norsk129
Suomi145
Português161
Ελληνικά177
Polski195
Magyar
211
Česky227
Lietuvių Kalba
243
Русский259
Türkçe275
日本語291
英语
307
‫العربية‬
‫اللغة‬
323
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English
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Table of Contents
Technical Service and Order Placement������������������������������������������������������������������������3
In-warranty Repair and Exchange�������������������������������������������������������������������������������3
When You Call for Technical Support������������������������������������������������������������������������3
Introduction������������������������������������������������������������������������������������������������������������������4
Indications for Use���������������������������������������������������������������������������������������������������������4
Definition of Symbols����������������������������������������������������������������������������������������������������4
Explanation of Signal Word Consequences�������������������������������������������������������������������5
Warning:������������������������������������������������������������������������������������������������������������������������6
Caution:�������������������������������������������������������������������������������������������������������������������������6
Notice:���������������������������������������������������������������������������������������������������������������������������6
Product Description������������������������������������������������������������������������������������������������������7
Ranger Irrigation Fluid Warming Unit�����������������������������������������������������������������������7
Ranger Irrigation Fluid Warming Disposable Set��������������������������������������������������������7
Model 247 Product Safety Features�������������������������������������������������������������������������������8
Instructions For Use������������������������������������������������������������������������������������������������������9
Preparation and Setup of the Ranger Irrigation Fluid Warming Unit �������������������������9
Removing the Irrigation Fluid Warming Set from the Ranger Irrigation Fluid
Warming Unit�������������������������������������������������������������������������������������������������������������9
Troubleshooting����������������������������������������������������������������������������������������������������������10
Maintenance and Storage��������������������������������������������������������������������������������������������12
Specifications���������������������������������������������������������������������������������������������������������������14
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3MTM RangerTM Irrigation Fluid Warming System
English
Technical Service and Order Placement
Technical Service
usa
TEL:+1-952-947-1200
+1-800-733-7775
FAX:+1-952-947-1400
Outside of the USA
Contact your local 3M Patient Warming representative.
In-warranty Repair and Exchange
To return a device to 3M Patient Warming for service, first 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. We will service and ship your device
within five (5) working days of our receipt. Call your local supplier or sales representative to inquire about a loaner
device 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.
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3MTM RangerTM Irrigation Fluid Warming System
English
Introduction
The 3MTM RangerTM irrigation fluid warming system is designed to warm irrigation fluids and deliver these at
flow rates under gravity up to 867 mL/min when the bag is hung 100 cm above the scope. At these flow rates, the
device maintains fluid output temperatures ranging from 33°C to 41°C (Note: This is for room temperature fluids
only). It takes less than 2 minutes to warm up to the 41°C set point temperature. The alert points on the Model
247 are 48°C and 50°C.
The fluid warming disposable set is sterile, latex-free, single-use-only and is designed to be used with the
reusable Model 247 warming unit. For additional information on Ranger disposable sets visit us online at
rangerfluidwarming.com. This manual includes operating instructions and unit specifications for the Model
247 irrigation fluid warming system. For information about using Ranger irrigation fluid warming disposable
sets with the Model 247 irrigation fluid warming unit, refer to the “Instructions for Use” included with each
disposable component. The Ranger irrigation fluid warming system should only be used in healthcare facilities by
trained medical professionals.
Indications for Use
The Ranger irrigation fluid warming system is intended to warm irrigation fluids.
Definition of Symbols
ON
4
OFF
Fuse
CAUTION
Type B 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 6060-1; 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.
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3MTM RangerTM Irrigation Fluid Warming System
Protective earth ground
Consult 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.
Manufacturer
Follow instructions for use
Date of manufacture
Sterile, ethylene oxide
Store at room temperature
English
DEHP-free
Quantity
Single use
Latex free
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.
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3MTM RangerTM Irrigation Fluid Warming System
English
WARNING:
1. To reduce the risks associated with hazardous voltage and fire and thermal energy hazards:
• Do not substitute other devices (i.e. Model 245) for the Ranger irrigation fluid warming unit or Ranger
irrigation disposable 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 fluid flow and discard the disposable
set. Have the warming unit tested by a biomedical technician or call 3M Patient Warming technical
service.
2. To reduce the risks associated with hazardous voltage and fire:
• Do not modify or service this device, and do not open the warming unit case- there are no userserviceable parts in the Ranger warming unit.
• Connect power cord to receptacles marked “Hospital Only,” “Hospital Grade,” or a reliably grounded
outlet.
• Use only the power cord specified for this product and certified for the country of use.
• Do not allow the power cord to get wet.
• Do not use the Ranger warming system when it appears the warming unit, power cord, or disposable
is damaged. Use only 3M specified 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.
3. To reduce the risks associated with air embolism:
• Never use fluids if air bubbles are present in the fluid line.
CAUTION:
1.
2.
3.
4.
Not for I.V. use.
To reduce the risks associated with cross-contamination:
• The cleaning tool provides only superficial cleaning, it does not disinfect or sterilize the interior of the
unit.
To reduce the risks associated with impact and facility medical device damage:
• Clamp the Ranger irrigation fluid 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).
To reduce the risks associated with environmental contamination:
• Follow applicable regulations when disposing of this device or any of its electronic components.
NOTICE:
1. Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional.
2. To avoid device damage:
• Do not clean the warming unit with solvents. Damage to the case, label, and internal components may
result.
• Do not immerse the warming unit in cleaning or sterilizing solutions. The unit is not liquid proof.
• 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 difficult to clean the unit.
3. The Ranger irrigation fluid warming unit meets medical electronic interference requirements. If radio
frequency interference with other equipment should occur, connect the unit to a different power source.
6
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3MTM RangerTM Irrigation Fluid Warming System
English
Product Description
The Ranger irrigation fluid warming system consists of a Model 247 warming unit and a sterile disposable fluid
warming set.
Alert
indicator
light
I.V. pole clamp
ALE RT
Power
switch
Alphanumeric
display
Slot for warming
cassette
Ranger Irrigation Fluid Warming Unit
The warming unit is a compact, lightweight, liquid-resistant device with a clamp located on the side
for attachment to an I.V. pole. When mounted to the I.V. pole, the unit fits easily above the 3MTM
Bair HuggerTM 500 or 700 series warming unit. A carrying handle on the top of the unit makes it easy to transport.
Located on the front panel you will find:
• Alphanumeric display that indicates the heater temperature during normal operation. In an over temperature
condition, the display alternately flashes a temperature of 48°C or higher and the word “HI.” An audible alert
also sounds. In an under-temperature condition, the display alternately flashes 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 Irrigation Fluid Warming Disposable Set
Irrigation fluid warming sets1 include a
cassette, tubing, connectors, flow chamber and
clamps.
Cassette
Fluid source
Inlet tube
Blue clamp
Irrigation set
White clamp
Outlet tube
Exit
Flow Rate
Priming Volume
Patient Line Length
0-867 mL/min2
308 mL
213 cm
1. Refer to the instructions provided with each disposable set for information on use.
2. With the bag hung 100 cm above the scope under gravity flow.
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3MTM RangerTM Irrigation Fluid Warming System
Model 247 Product Safety Features
The following chart describes the safety alarm features of the Ranger irrigation fluid warming unit.
Alert Type
Set-Point
Indication
Description
Primary over-temperature
alert system
48°C
LED alternately displays
“HI” and temperature,
alert sounds, alert
light flashes.
Primary Alert: Alert sounds,
controller cuts power to the
heaters until temperature falls
below 48°C. When heater
temperature drops below 48°C,
audible and visual alerts stop.
Independent back-up
over-temperature alert
system (cut-off).
50°C
LED displays the
temperature or has gone
dark, alert sounds.
Primary failure. Temperature
will rise to 50°C within a few
seconds. The safety backup
system is activated at 50°C
and power is immediately
shut off to the heating plates.
Under-temperature alert
33°C
LED displays “LO” and
temperature, alert sounds,
alert light flashes.
Heater temperature has fallen
to 33°C. Alerts will stop
when temperature rises above
33°C. Continue use of unit.
NOTE:
The difference in over-temperature alert system cut-off points does not indicate any difference in safety and is simply a result of
tighter controller tolerances.
The Ranger irrigation fluid warming system is designed with very tight controls to regulate its temperature to the 41°C set-point.
The microprocessor controller measures the temperature at the fluid pathway inside the warming plate four times every second,
making it very responsive to changes in flow rate.
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English
Instructions For Use
Preparation and Setup of the Ranger Irrigation Fluid Warming Unit
1. Attach the Ranger irrigation fluid warming unit to the I.V. pole. Tighten the pole clamp securely.
CAUTION:
To prevent tipping, clamp the Ranger irrigation fluid 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). Failure
to do so may result in damage to the product (see Figure 1).
Figure 1
2. Slide the irrigation cassette into the slot in the warming
unit. The cassette can only fit into the device one way
(see Figure 2).
3. Prime the warming set. For more information about
priming the set, refer to instructions provided with the
warming sets.
4. Plug the power cord into an appropriate outlet. Turn the
unit ON. In a few seconds the alpha-numeric display
will illuminate. It takes less than 2 minutes to warm up
to the 41°C set point temperature.
5. Begin flow. When flow is completed, remove the
warming set and discard according to institutional
protocol.
44"
(112 cm)
14" (35.6 cm)
Removing the Irrigation Fluid Warming Set from
the Ranger Irrigation Fluid Warming Unit
1. Close the inlet clamp proximal to the fluid warming
cassette and open all clamps distal to the cassette.
2. Disconnect the warming set from the fluid source, if
applicable.
3. Allow a small amount of fluid to drain from the end of
the patient line to reduce pressure in the cassette.
4. Remove the warming set from the warming unit and
discard according to institutional protocol.
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Figure 2
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3MTM RangerTM Irrigation Fluid Warming System
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.
• Call 3M Patient Warming
technical support.
Condition
Cause
Solution
Alert indicator illuminates and
alert sounds, alpha-numeric display
alternately flashes a temperature of
48°C or higher and the word “HI.”
Temporary over-temperature
condition because:
• An extreme change in flow
rates occurred (e.g., from
500 ml/min to stop flow).
• Open flow to reduce temperature.
Alerts will stop when the
temperature drops below 48°C.
The unit is ready to use.
• Unit was turned on and reached
set point temperature before
warming cassette was inserted.
• Alerts will stop when the
temperature drops below 48°C.
The unit is ready to use.
• Fluids were prewarmed to
above 42°C before being run
through the warming unit.
• Turn off unit and unplug it.
Discontinue infusion of fluids.
Do not warm fluids before
infusing them through the Ranger
irrigation fluid warming unit.
Condition
Cause
Solution
Alert sounds, alpha-numeric display
and alert indicator light go dark.
Primary controller failure.
Unit will no longer operate.
Power to heating plates will shut off
if temperature rises to 50°C. Turn
unit off and unplug it. Discontinue
use of unit. Discard disposable set.
Alert will continue to sound if you
do not unplug unit. Call 3M Patient
Warming technical support.
Condition
Cause
Solution
Unit alerts 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 Patient
Warming technical support.
Heater temperature rises to 50°C and
unit shuts down soon after plugging
it in (unit does not have to be turned
on for this condition to occur).
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3MTM RangerTM Irrigation Fluid Warming System
Condition
Cause
Solution
Alert sounds but warming
unit has been turned off.
Independent backup safety
system has been activated.
Unplug unit. Call 3M Patient
Warming technical support.
Condition
Cause
Solution
Cannot remove cassette from unit.
•Cassette is too full, fluids
are still being infused, or
clamp is open proximal to
the warming cassette.
• Make sure fluid is drained from
warming cassette before sliding
out the cassette, that fluids
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
Alerts indicator light illuminates and
alert sounds, alpha-numeric display
alternately flashes a temperature of
33°C or below and the word “LO.”
Under temperature condition caused
by very high flow using very cold
fluid, or defective heater/relay.
Alerts should stop when temperature
rises above 33°C. If alerts continue,
turn off unit, unplug unit, and
discontinue use. Call 3M Patient
Warming technical support.
Condition
Cause
Solution
Alpha-numeric display
reads “Er 4” or “Open.”
Open wire on temperature sensor.
Do not use unit. Call 3M Patient
Warming technical support.
Condition
Cause
Solution
Alpha-numeric display
reads “Er 5” or “Open.”
Electrical interference.
Remove the unit. Refer to biomedical
technician or call 3M Patient
Warming technical support.
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3MTM RangerTM Irrigation Fluid Warming System
English
Maintenance and Storage
Cleaning the Ranger Irrigation Fluid Warming Unit
Clean the Ranger irrigation fluid warming unit on an as-needed basis.
CAUTION
1.
To reduce the risks associated with cross-contamination:
• The cleaning tool provides only superficial cleaning, it does not disinfect or sterilize the interior of the
unit.
NOTICE
1. 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 difficult to clean the unit.
to clean the exterior of the warming unit:
1. Disconnect the Ranger irrigation fluid 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.
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3MTM RangerTM Irrigation Fluid Warming System
English
method
1. Unplug the irrigation fluid warming unit.
2. Unfold the cleaning tool. Wet the foam pads
with a nonabrasive solution, such as AlconoxTM
brand detergent.
3. Insert the tool from the back of the unit and
pull the tool all the way out from the front.
4. Rinse the tool with water and repeat 3 times. Discard the tool according to institutional protocol.
5. Wipe off the unit to remove excess fluid.
to clean resistant, dried-on fluids:
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: 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 Patient Warming 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 irrigation fluid warming unit. All service must be performed by
3M Patient Warming or an authorized service technician.
Call 3M Patient Warming technical service at 800-733-7775 or 952-947-1200 for service information.
Alconox is a trademark of Alconox, Inc.
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3MTM RangerTM Irrigation Fluid Warming System
Specifications
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; 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
Classified under IEC 60601-1 Guidelines (and other national versions of the Guidelines) as Class I, Type B,
Ordinary equipment, Continuous operation. Classified by Underwriters Laboratories Inc. with respect to electric
shock, fire and mechanical hazards only, in accordance with IEC/EN 60601-1 and in accordance with Canadian/
CSA C22.2, No. 601.1. Classified under the Medical Device Directive as a Class IIb device.
Electrical characteristics
Temperature characteristics
input voltageset point temperature
100-120 or 220-240 VAC
operating frequency
100-120 VAC, 50/60 Hz
220-240 VAC, 50/60 Hz
maximum heating power
900 W
fuse 2 x T10A-H (250V) for 100-120 VAC
2 x T6.3A-H (250V) for 220-240 VAC
41°C
over-temperature alert
48°C
under-temperature alert
33°C
over-temperature cutoff
50°C
fuse type
Time delay, high breaking
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 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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3M is a trademark of 3M Company. RANGER, BAIR HUGGER and the BAIR HUGGER logo are trademarks of
Arizant Healthcare Inc., used under license in Canada. ©2013 Arizant Healthcare Inc. a 3M company. All rights reserved.
3M Deutschland GmbH, Health Care Business
Carl-Schurz-Str. 1, 41453 Neuss, Germany
3M Health Care, 2510 Conway Ave., St. Paul, MN 55144 USA
TEL 800-228-3957 | www.rangerfluidwarming.com
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