Blood Warmer

Type PF2-265
PRISMAFLEX System
Accessory Device

Operator’s Manual

Distributed by: Manufactured by:

GAMBRO LUNDIA AB STIHLER ELECTRONIC GmbH
Magistratsvägen 16 Julius-Hoelder-Strasse 36
SE-220 10 Lund 70597 Stuttgart
Sweden GERMANY
Tel. +49 (0) 711-720670
Fax +49 (0) 711-7206757
www.stihlerelectronic.de
E-Mail: info@stihlerelectronic.de

Date: 2009/01 PN 0690.7210.12NA

Rev. A3
Questions or comments about this publication can be directed to your local representative or to:
GAMBRO Lundia AB, System Support, Box 10101, SE-220 10 Lund, Sweden.

2
CONTENTS
1. Introduction......................................................................................................... 4
Indications .......................................................................................................... 4
Contraindications................................................................................................ 4
Shipping Carton Contents .................................................................................. 4
Warnings ............................................................................................................ 5
Precautions......................................................................................................... 6
Symbols.............................................................................................................. 7
International Standards and Classification ......................................................... 8
Disclaimer........................................................................................................... 8
Warranty ............................................................................................................. 8
Service Information............................................................................................. 9
Device Disposal.................................................................................................. 9
Return of Used Product ...................................................................................... 9
2. Product Description ......................................................................................... 10
Introduction....................................................................................................... 10
Technical Description ....................................................................................... 10
Blood Warmer Components ............................................................................. 11
Control Panel Components .............................................................................. 12
3. Installation......................................................................................................... 13
Install the PRISMAFLO II Blood Warmer to the Holder.................................... 13
Position the Warmer ......................................................................................... 15
4. Operation........................................................................................................... 16
Introduction....................................................................................................... 16
Using PRISMAFLO II Blood Warmer................................................................ 17
Installation - Patient at the Right Side of the PRISMAFLEX ............................ 18
Installation - Patient at the Left Side of the PRISMAFLEX ............................... 18
End Procedures................................................................................................ 18
5. Alarm Systems and Troubleshooting ............................................................. 19
Excessive Temperature Alarms........................................................................ 19
Low Temperature Alarm ................................................................................... 19
Auto Restart after Power Supply Interruption ................................................... 19
Troubleshooting................................................................................................ 20
6. Maintenance and Periodic Safety Inspection................................................. 21
Preventive Maintenance ................................................................................... 21
Cleaning and Disinfecting................................................................................. 21
Periodic Safety Inspection ................................................................................ 22
7. Technical Data .................................................................................................. 23
8. Prismaflo II Ordering Information ................................................................... 24

3
1. Introduction
The PRISMAFLO II Blood Warmer is used to warm the return blood flow in order to
replace heat lost to the atmosphere and effluent flow 1 during treatment with the
PRISMAFLEX system.
The PRISMAFLO II Blood Warmer is designed for use with all models of the
PRISMAFLEX System, and the appropriate PRISMAFLEX Set for the therapy in use.
PRISMAFLEX System is manufactured by GAMBRO. PRISMA System's indications
are continuous solute and/or fluid removal in patients with acute renal failure or fluid
overload.

Indications
The PRISMAFLO II warmer is used for warming returning blood flow.

Contraindications
There are no known contraindications to warming the return blood flow during a
treatment on the PRISMAFLEX system.

Shipping Carton Contents

The shipping carton contains the following items:
• PRISMAFLO II Blood Warmer with attached power cord
• Pluggable High Flow Heating Profile (PF2-WP2618)
• PRISMAFLO II Blood Warmer Operator´s Manual (CD-ROM)
• Support for Heating Profile right incl. screws
Support for Heating Profile left incl. screws

You must read the Operator's Manual before using this

product!

1
4
Effluent flow includes ultrafiltration and/or spent dialysate.
Warnings
1. DANGER - Risk of explosion! Do not use the PRISMAFLO II Blood Warmer in
an environment at risk of explosion or in the present of flammable anaesthetics.
2. Before operating this device, carefully read this PRISMAFLO II Blood Warmer
Operator’s Manual. You should also be thoroughly familiar with the PRISMAFLEX
System Operator’s Manual and the PRISMAFLEX Set Instruction’s For Use.
3. The use of procedures other than those published in this manual can result in
patient injury or death. Operate and maintain this device only in accordance with
the procedures given in this PRISMAFLO II Operator’s Manual. The
manufacturer will not be responsible for patient safety if procedures other than
those published are used.
4. All electrical installations must comply with both the electrical standards
applicable in each case and the specifications quoted by the manufacturer.
5. Persons who operate and maintain this device must be appropriately trained and
qualified.
6. WARNING: No modification of the MEDICAL ELECTRICAL EQUIPMENT is
allowed.
7. CAUTION - To reduce the risk of electric shock, this equipment must only be
connected to a mains supply with protective earth. Do not remove the rear part of
the PRISMAFLO II housing.
8. If a High Temperature Alarm (red alarm light, audible beep) occurs, do the
following:
• Verify the PRISMAFLO II safety system has disabled the heater and
temperature is dropping below 43 °C. If temperature is not dropping, stop
the PRISMAFLEX blood pump to prevent blood from returning to the
patient. Remove the applicable tubing immediately from the heating
profile. Further evaluation should be carried out by qualified medical
personnel, such as a physician, before blood in the line can be re-
infused.
• Evaluate possible causes for the alarm. See the Alarm System and Trouble-
shooting chapter for more information. If necessary, discontinue use of
the blood warmer.
9. The power cord must be removed from the electrical wall outlet to completely
disconnect electrical power to the device.
10. The manufacturer will not be liable for user/patient safety if measures other than
those specified by the manufacturer are applied in use, servicing and safety
checks. Persons performing such measures must be appropriately qualified and
trained.
11. Highest PRISMAFLO II set point (43°C) shall be used with care when operating
the PRISMAFLEX system at low Effluent flow rates (below 500 ml/h) with patients
below 30 kg. Global positive heat balance and net patient warming may be
present is such circumstances.
12. In the case of several devices being combined and connected (e.g. at multiple
sockets), the sum of the leak currents must not exceed the permissible limit value
(see national provisions in each case).
13. The position of the heating profile shall not interfere with the PRISMAFLEX
scales.

5
 14. Do not use any clamps or sharp instruments on the heating
profile as damage to the profile itself or the line inside may occur.
15. The PRISMAFLO II Blood Warmer is not to be used on the replacement or
infusion line of the PRISMAFLEX Set.
16. The heating profile may not be covered during use.

Precautions
1. Procedures using the PRISMAFLO II Blood Warmer must be performed under the
responsibility of a physician.
2. If for any reason the PRISMAFLO II Blood Warmer must be returned to the local
distributor, it is the responsibility of the health care institution to adequately prepare
and identify the product for return shipment.
3. The PRISMAFLO II Blood Warmer contains no user-serviceable parts. Do not
attempt to repair the PRISMAFLO II Blood Warmer yourself. Contact the local
distributor for service or technical information. See “Service Information” in this
chapter.
4. To reduce the risk of patient or operator injury, do not use the PRISMAFLO II
Blood Warmer if any of the following conditions exist:
• Damaged or worn-out power cord, plug, or receptacle
• Damaged housing or control panel
• Warmer has been dropped or had liquid spilled on its internal electronics
• Warmer is not heating correctly as indicated by visible or audible alarms
• Red alarm light and/or audible alarm beep fail to activate when the button
STAND-BY (on the control panel) is pressed
• Damaged heating profile
5. When plugging in the warmer be sure the power cord and the heating profile do not
touch the scale hook or fluid bags on the PRISMAFLEX Control Unit. Contact with
the scales or bags during treatment can cause nuisance alarms.
6. Secure attachment of return line/heating profile in respect to heating profile weight.
7. When fluids are warmed up, it is possible that gas may evolve (bubble form).
8. Extreme care should always be taken to ensure that a bolus of air does not pass to
the patient
9. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a
physician.

6
Symbols
Where these symbols are applicable, they appear at the relevant point on the device, the
packaging, the rating plate or in the accompanying paperwork.

This symbol states that this device is a Type CF applied part to standards
IEC 60601-1.
This symbol states that this device is protected from drips under the
IPX1 specified operating conditions in accordance to IEC 60529.

You must read the instructions for use before using this product.

This symbol means that precise knowledge of the accompanying

paperwork is a prerequisite for safe operation of the device.

Indicates an alarm condition if the associated lamp is red.

Change between stand-by mode and operating mode. When the

associated orange lamp comes on, the device is in stand-by mode.
Switches on the heating element. The heating element is switched on
when the associated lamp is green.

▲ Increases the temperature setting in 0.5 °C steps.

▼ Decreases the temperature setting in 0.5 °C steps.

Energy output for pluggable heating profile.

Energy input at pluggable heating profile.
Appears before the 4-digit year of manufacture.

Indicates the manufacturer.

Do not cover heating profile.

Flow direction of the fluid to the patient.

Press button to separate heating profile.

Classified by UNDERWRITERS LABORATORIES INC. with respect to

electric shock, fire and mechanical hazards only in accordance with UL
MEDICAL ELECTRICAL 60601-1 and CAN/CSA C22.2 No. 601-1-M90.
EQUIPMENT
UL 60601-1 AND CAN/CSA UL control number: 75JA.
C22.2 601.1 75JA

7
International Standards and Classification
UL 60601-1 (2003)
Medical Electrical Equipment, Part 1: General Requirements for Safety
CAN/CSA-C22.2 No. 601-1-M90
Medical Electrical Equipment - Part 1: General Requirements for Safety –
1. Collateral Standard: Safety Requirements for Medical Electrical Systems
ASTM F 2172-02
Standard Specification for Blood/Intravenous Fluid/Irrigation Warmers

Disclaimer
The manufacturer and/or subsidiaries accepts responsibility for the safety, reliability,
and performance of this equipment only if the operating, maintenance, and calibration
procedures are those specified by the manufacturer; the persons performing the
procedures are appropriately trained and qualified; genuine parts are used when
replacement of spare and component parts is required; assembly operations,
extensions, adjustments, modifications, or repairs are carried out by persons or
service centers authorized by the manufacturer; all electrical installations comply with
the applicable local electrical codes and IEC requirements; and if the equipment is
used in accordance with the published instructions for use (this document), for the
purpose intended, and in the appropriate environment.

Warranty
The warranty period is 12 months. During the warranty period, defects in materials or
workmanship will be corrected by either repair or replacement of the device at no cost
to the customer.
Other damages are not covered by this warranty. No claims for warranty will be
recognized in cases of abuse or misuse, use of force, or damages due to normal wear
and tear. No claims for warranty will be recognized for modifications or other actions
by persons not authorized by the manufacturer.
In case of claims under this warranty, return the device to the nearest local distributor.
(See “Service Information” below.) Packaging and shipping costs are the
responsibility of the customer.

8
Service Information
The PRISMAFLO II Blood Warmer contains no user serviceable
parts. Do not attempt to repair the PRISMAFLO II Blood Warmer
yourself. Contact the local distributer for service or technical
information.

For service or technical assistance contact your local representative or:

Gambro Lundia AB, System Support Box 10101 SE-220 10 Lund Sweden.

Device Disposal
Please follow regional regulations on the disposal of old devices or send the old
cleaned and disinfected device to STIHLER ELECTRONIC GmbH or to your local
distributor with an explanatory note. So it is ensure your old device will be disposed
cheaply and properly.

Return of Used Product

It is the responsibility of the health care institution to adequately

prepare and identify the product for return shipment.

If for any reason this product must be returned to the local distributor, a returned
goods authorization may be required before shipping. Contact the local distributor
before returning any used product.
If the product has been in contact with blood or body fluids, it must be thoroughly
cleaned and disinfected before packing. (See “Cleaning and Disinfection” in the
Maintenance and Periodic Safety Inspection chapter.) The product should be shipped
in the original or an equivalent carton to prevent damage during shipment.

9
2. Product Description
Introduction
The PRISMAFLO II Blood Warmer is an accessory device for use with the
PRISMAFLEX* control unit and appropriate PRISMAFLEX set for the therapy in use.
The PRISMAFLO II Blood Warmer heats the return blood flow during a PRISMAFLEX
system treatment in order to replace heat lost to the atmosphere and effluent flow.
The warmer may be used during delivery of any PRISMAFLEX therapy.

Technical Description
The PRISMAFLO II Blood Warmer operates independently of the PRISMAFLEX
control unit. There is no electronic interconnection between the two devices.
During operation of the Warmer, heat is transferred from the internal heating wire to
the heating profile.
The heating profile is designed so that the blood return line of the PRISMAFLEX set
in use can simply be inserted in the flexible groove. The heat from the heating profile
is transferred to the fluid to be warmed.
The temperature of the heating profile is monitored by a temperature control system
and by independent alarm systems which draw the operator’s attention to alarm
reactions and switch off the heating process automatically in the event of excessive
temperature.
During operation, the control panel shows the internal temperature of the heating
profile (not equal to the temperature of the fluid to be warmed). This means that the
PRISMAFLO II does not regulate the actual temperature of the medium to be warmed
nor does it monitor this. This temperature is dependent on a variety of additional
factors (room temperature, outlet temperature of the fluid to be warmed, flow rate).

Typical in vitro warming performance:

measured with HF (high flow) heating profile (temperature set 43°C)
Inlet Temperature Blood Flow Outlet Temperature
35°C 300 ml/min 35.6°C
35°C 400 ml/min 35.4°C

measured with LF (low flow) heating profile (temperature set 43°C)

Inlet Temperature Blood Flow Outlet Temperature
20°C 30 ml/min 30°C
31°C 30 ml/min 36°C
31°C 100 ml/min 33°C

*The PRISMAFLEX Control Unit is manufactured by GAMBRO

10
Blood Warmer Components
1 Control Panel Provides buttons and an LCD display by which the operator controls the
PRISMAFLO II Blood Warmer. See "Control Panel Components" in this
chapter for more information.
2 Pluggable Heating Transfers heat from the heating wire to the medium to be warmed via the
Profile inserted blood return line.
3 Attachment Attaches the PRISMAFLO II Blood Warmer to the holder which is
Device mounted on the backside of the PRISMAFLEX control unit.
4 Power Supply Conveys electricity from the wall power supply to the blood warmer.
Cord
5 Cable for Heating Connection between PRISMAFLO II and pluggable heating profile
Profile
(pluggable)

3 Attachment
Device

2 Pluggable
Heating Profile

1 Control
Panel

4 Power Supply
Cord
5 Cable for
Heating Profile
(pluggable)

Fig. 1 PRISMAFLO II Blood Warmer

11
 Control Panel Components

1 Stand-by Lamp When the orange lamp comes on, the device is in stand-by mode.
Change between the states "Stand-by" and "Device switched on". In the
"Device switched on" state, the following occurs:
Button • temperature display is activated
2
STAND-BY • alarm lamp (9) flashes red
• operating lamp (4) flashes green
• acoustic alarm is activated
Start of the heating-up process. The following occurs:
Button • operating lamp (4) is continuously green
3
START • red alarm lamp (9) goes out
• acoustic alarm falls silent
flashes green when the device is switched on but heating has not yet started,
4 Operating Lamp
or is continuously green when the button START is pressed.
Button Arrow buttons to choose the desired temperature. Increases or decreases the
5 Increase temperature of the heating profile (between 33 °C and 43 °C) with 0.5 °C
Temperature steps.
Note: After choosing a temperature you have to confirm it by pushing the START button within
Button
5 seconds. During this time the operating lamp is flashing. Otherwise the warmer
6 Decrease
chooses the previous temperature.
Temperature
Display
7 Indicates the selected temperature choosen by the operator.
Temperature Set
Display Actual Indicates the actual temperature of the heating profile.
8
Temperature Note: Below 20 °C display shows “L”, above 50 °C display shows “H”
Alarm lamp flashes red if an alarm condition or a fault exists. If an
9 Alarm Lamp overtemperature is reached the internal heating element is simultaneously
switched off and the acoustic alarm is activated.

9 Alarm Lamp
5 Button Increase
8 Actual Temperature
Temperature
6 Button Decrease
Temperature

7 Set Temperature 3 Button

START

4 Operating Lamp 2 Button

STAND-BY

1 Stand-by
Lamp
Fig. 2 Control Panel

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3. Installation
Read these Installation Instructions and the PRISMAFLO II Blood
Warmer Operator’s Manual before starting installation.
Electrical installations must comply with all applicable local
electrical codes and the manufacturer’s specifications (see
Chapter "Technical Data").

Install the PRISMAFLO II Blood Warmer to the Holder

Note: PRISMAFLO II is mounted by means of a special warmer holder to the PRISMAFLEX. This
holder has to be ordered separately. The holder shipping carton contains all installation parts,
tools and instructions for the installation of the holder to the PRISMAFLEX.

1. Be sure the warmer holder is installed according to its mounting instructions.

2. Position the holder so that it is at a 90 degree angle to the control unit. The spring
knob will snap into an index hole in the rotation arm.
3. Attach the PRISMAFLO II Blood Warmer by putting the black metal mount (rear of
device) on the end of the holder (Fig. 3-A).
4. Fix the Warmer to the holder by tightening the two screws (incl. washers) and
close the screw holes with included plastic caps (Fig. 3-B).
5. Fix the power supply cord with the clip which is attached to the holder (Fig. 3-C).
6. Store the PRISMAFLO II Blood Warmer in the Transport position until ready to
use. (See “Position the Blood Warmer", Fig. 4)
7. Install the supports for the heating profile on the left and right side of the
PRISMAFLEX system using a T20 Torxdriver (Fig. 3-D, 3-E).

13
 A B

D E

Fig. 3 Installing the PRISMAFLO II Blood Warmer and the Supports for
the Heating Profile to the PRISMAFLEX Control Unit

14
Position the Warmer
(See fig.4. Functional positions of the PRISMAFLO II Blood Warmer)
The Warmer should be positioned according to its present use. The Transport
Position while moving the PRISMAFLEX Control Unit with attached warmer to a new
location. The Operating Position is used while conducting patient treatment.
To move the PRISMAFLO II Blood Warmer into various positions, lift the spring knob
on the fixing arm with one hand and swivel the fixing arm with the other hand.
Then lift the spring knob on the rotation arm with one hand and swivel the rotation
arm with the other hand.

Operating Position Transport Position

Fig. 4 Functional Positions of the PRISMAFLO II Blood Warmer

15
4. Operation
Introduction
Do not use the warmer when mains cable, housing, control panel or heating profile is
defective. Make a visual inspection of these parts before each use.
The PRISMAFLO II should be switched on before use so that the heating profile can
heat up. The warming process takes about 3 minutes.
During operation, the PRISMAFLO II should be attached upright to the PRISMAFLEX
control unit in operating position (see Fig. 4).
1. Plug the mains plug of the PRISMAFLO II into a socket (orange lamp (1) comes
on to show that the warmer is in standby mode).
2. Switch on the PRISMAFLO II at the button STAND-BY (operating lamp (4) and
alarm lamp (9) flashes; the acoustic alarm sounds; temperature display (7 & 8)
appears).
Note: As long as the temperature of the heating profile is below 20 °C the display shows “L”.
3. Choose the desired temperature of the heating profile by using the buttons
temperature increase or decrease .
4. Press the button START to confirm the temperature selection and switching on
the heating element (the alarm indicators are deactivated and operating lamp (4)
is continuously green).

The position of the heating profile shall not interfere with the
PRISMAFLEX scales.
Do not use any clamps or sharp instruments on the heating profile
as damage to the profile itself or the line inside may occur.
The PRISMAFLO II is not to be used on the replacement or infusion
line of the PRISMAFLEX Set.
Do not cover the heating profile while using.
Do not kink the heating profile.
Secure attachment of return line/heating profile in respect to heating
profile weight.

16
Using PRISMAFLO II Blood Warmer
1. Follow the on-line instructions of PRISMAFLEX from the first screen through the
PREPARE AND CONNECT LINES until PRISMAFLEX Control units displays
SOLUTIONS screen.
2. Take the heating profile of the PRISMAFLO II then align the groove of the heating
profile in the upward position. Make sure that the profile is not twisted.
3. Place the end of the PRISMAFLEX Set blood return line (blue strip) to the end of
the heating profile approximately 4 to 6 cm from the blue Luer Lock connector
(Fig. 5-A).
4. With the thumb, insert the PRISMAFLEX Set blood return line up to the
PRISMAFLEX cabinet (Fig. 5-B).
5. Put the heating profile of the PRISMAFLO II into the support for the heating profile
allowing a kinking free inlet of the blood return line (Fig. 6 and 7).
6. Press CONTINUE on PRISMAFLEX screen and follow the instructions until the
patient is connected.

Note: If you desire to install the warmer after patient connection, follow step 2, 3, 4 and 5.
Note: During operating you can change the temperature of the heating profile at any time. Every
change of the temperature selection must be confirmed within 5 seconds by pushing the
START button, otherwise the warmer chooses the previous temperature. If the actual
temperature of the heating profile is below 33 °C the red lamp is flashing.
Note: To facilitate insertion of the return line, the heating profile can be dusted with commercial
talcum powder (from the pharmacy, for example).

A B

Fig. 5 Inserting the Blood Return Line

17
Installation - Patient at the Right Side of the PRISMAFLEX
If the patient is positioned at the right side of the PRISMAFLEX then guide the
heating profile directly from the right support of the heating profile back to the patient
(see Fig. 6).

Fig. 6 Using the Right Support

for the Heating Profile

Installation - Patient at the Left Side of the PRISMAFLEX

If the patient is positioned at the left side of the PRISMAFLEX then the heating profile
is guided infront of the PRISMAFLEX from the right support of the heating profile to
the left support and then back to the patient (Fig. 7-A, 7-B).

A B

Fig. 7 Using the Left Support for the Heating Profile

Be careful that the heating profile shall not touch the scales or fall in
front of the scales disturbing the usage (open-closure of the scales
and error on reading).

End Procedures
1. Press the button STAND-BY to switch off the PRISMAFLO II (all indicators go out,
stand-by lamp comes on).
2. Simply pull out the blood return line of the PRISMAFLO II heating profile.
3. Follow the instructions on the PRISMAFLEX Remove Set screen.
Note: To disconnect PRISMAFLO II from the mains completely, pull out the plug if necessary.
Note: Press button to disconnect the heating profile.
Do not twist the plug!

18
5. Alarm Systems and Troubleshooting
Excessive Temperature Alarms
In order to prevent potential overheating due to the temperature control system failing,
the PRISMAFLO II is fitted with three excessive temperature cut-off. Two of them are
independent from each other. In the event of excessive temperature, the heater is
switched off and the alarm indicator (red alarm lamp and acoustic warning signal) is
activated.
An excessive temperature alarm is triggered when the temperature of heating profile
rises to 45 °C ± 1 °C.
If the alarm is triggered, the device cannot be restarted (and alarm status deactivated)
until the temperature has dropped below the alarm limit.
Note: Excessive temperature alarms can also be triggered by external circumstances (external heat
sources like sunlight or radiators).

Low Temperature Alarm

If the temperature of the heating profile drops below 33 °C ± 1 °C, “Low temperature”
is indicated (red alarm lamp is flashing and after 3 minutes the acoustic warning
signal is activated). In this case the heating element is not switched off.

Auto Restart after Power Supply Interruption

In the event of short power supply interruption (up to 5 seconds) the warmer restarts
(with the before setted temperature) automatically on restauration of the power
supply.

19
 Troubleshooting
Symptom
Indicators do not come on -
device cannot be started up.
Stand-by lamp is on, but
device cannot be switched on.
Heating profile does not warm
up.
Stand-by lamp comes on,
device can be switched on but
does not start.
If temperature drops below the
alarm trigger temperature, the
device can usually be restarted.
Alarm state during use.
20
Possible cause(s)
1. Incorrect power supply - or
none at all.
2. Mains cable of warmer is not
plugged in.
3. Warmer is defective.
1. Warmer is defective.
1. Warmer is defective.
Alarm state triggered by:
1. Effect of external heat source.
2. Heating profile is not plugged
in.
3. Warmer / Heating profile
defective.
1. Effect of external heat source
or ambient temperature too
high.
2. Warmer / Heating profile
defective.
Remedy
1. Check plug/fuse, compare mains
voltage with rating plate.
2. Connect warmer to a functioning
socket. Press the button
STAND-BY, then button START
to start the heating-up process.
3. Return warmer to local sales
office.
1. Return warmer to local sales
office.
1. Return warmer to local sales
office.
1. Eliminate heat source or select
cooler location.
2. Plug in heating profile and start
warmer again
3. Return warmer / Heating profile
to local sales office.
1. Eliminate heat source or select
cooler location.
2. Return warmer / Heating profile
to local sales office.
6. Maintenance and Periodic Safety Inspection
Preventive Maintenance
PRISMAFLO II needs no preventive maintenance.

Cleaning and Disinfecting

To avoid damage to the Warmer
• do not immerse the Warmer or the Heating Profile in fluid,
• do not disinfect the warmer with spray, steam (i.e. in an
autoclave), hot air or thermochemical cleaning solutions,
• disinfect the Heating profile only with alcohol-based agents,
• when using a ready-to-use disinfectant, use only alcohol-based
disinfectants with a low content of aldehydes (< 0.2 %).

Clean and wipe-disinfect the Warmer in accordance with the procedure below as
required or when dirt appears.

1. Disconnect the mains plug from the socket.

2. Clean all surfaces, including the groove in the pluggable heating profile with a soft
cloth/cotton swab and mild soap-and-water solution.
3. Disinfect the housing of the Warmer with either ¼ %-strength bleach solution
(sodium hypochlorite) or a ready-to-use disinfectant (see the Warning above).
4. Disinfect the Heating Profile only with alcohol-based disinfectant agents or ready-
to-use disinfectants (see the Warning above)

Note: To facilitate insertion of the return line, the heating profile can be dusted with commercial
talcum powder (from the pharmacy).

21
Periodic Safety Inspection
A safety inspection should be carried out on the PRISMAFLO II Blood Warmer at
least every 24 months. To do so, you can either purchase the necessary tools and
instructions from the manufacturer or ask the manufacturer or your local distributor to
test it for you.
Please ensure that all the applicable national directives for checking the safety of
medical equipment are observed.
Control unit
• Visual check
• Temperature check and display accuracy
• Alarm tests (excessive temperature and cable break)
• Auto restart after power supply interruption
• Electrical safety (according IEC62353)
(There is a test-socket (green/yellow) on the rear of the
housing (bottom) for testing the earth wire.)
- Earth wire resistance
- Insulation resistance
- Earth leakage current
- Patient leakage current

Heating profile
• Visual check
• Temperature sensors
• Resistance of heating wire

Test procedures and target values are given in the testing instructions
PRISMAFLO II.

Testing instructions order no. 0890.9610.12

PRISMAFLO II System Testbox order no. 0890.9500.00

22
7. Technical Data
PRISMAFLO II PF2-265 NA
Electrical connection 115 VAC ±10 %
50-60 Hz
Power supply cord Hospital Grade Plug
NEMA 5-15P
SJO, SJT
18/3
Power consumption max. 90 W
Protection class (IEC 60601-1) I
Insulation resistance > 2 MΩ
Earth wire resistance ≤ 0.2 Ω
Leakage current ≤ 0.2 mA
Regulatory Class as per FDA II
Applied part (IEC 60601-1) Type CF
supplied with 22 VAC by the control unit
Patient Leakage Current CF < 0.01 mA
< 0.05 mA (mains to applied part)
Fuses primary (F3, F4) T2H 250 V (5 x 20 mm)
Fuse secondary (F1) T4H 250 V (5 x 20 mm)
IP (IEC 60529) IPX1
Dimensions
Height (excl. heating profile) 280 mm
Width 120 mm
Depth (incl. attachment device) 165 mm
Weight 3 kg
Operating Mode continuous duty
Heating-Up Time (20 – 35°C) approx. 3 min.
Permissible Environmental Humidity Temperature Pressure
Conditions
in operation 10 % to 75 % +16 °C to +32 °C 700 hPa to 1060 hPa
in storage 10 % to 75 % -20 °C to +60 °C 500 hPa to 1060 hPa
not condensing
Temperature of the Heating Profile 33.0 °C to 43.0 °C (± 1 °C)
selectable by the user in steps of 0.5 °C
1. Saftey Temperature Cut-Off 45.0 °C (± 1 °C)
2. Saftey Temperature Cut-Off 45.0 °C (± 1 °C)
3. Saftey Temperature Cut-Off 45.0 °C (± 1 °C)
Low Temperature Alarm 33.0 °C (± 1 °C)
Do not use the PRISMAFLO II Warmer in an
environment at risk of explosion.

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8. Prismaflo II Ordering Information

PF2-265 NA Prismaflo II Warmer 115 VAC Version, Hospital Grade Plug

with attachment devices for system “PRISMAFLEX”

Necessary Operating Accessory:

Low Flow Heating Profile pluggable

for Blood Return Line Ø 4-5 mm:

PF2-WP2418 Length: 180 cm

or

High Flow Heating Profile pluggable

for Blood Return Line Ø 6-7 mm:

PF2-WP2618 Length: 180 cm

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