Instructions for Use

DE - Edition 02 / 2007

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C&H Instructions for Use

IMPORTANT:
These instructions are an essential part of the device. They must therefore be
kept in a suitable place near the device and should accompany the device if it
is transferred to other users.
For proper and safe use of this device it is essential that the following
warnings and safety instructions, as well as the instructions for use are read
and carefully observed by all users before first using the device.
It is the responsibility of those using the device to fully acquaint themselves
with its proper use and operation.
If a malfunction is suspected, the device is to be taken out of service
immediately and suitable warning signs should be attached to the device to
ensure that it cannot be used before necessary service and repair work has
been carried out.

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Instructions for Use

Table of contents
1 WARNINGS AND SAFETY INSTRUCTIONS.............................................. 5
2 DESCRIPTION............................................................................................. 7
2.1 GENERAL DESCRIPTION....................................................................... 7
2.2 SCOPE OF DELIVERY............................................................................ 7
2.3 CONSUMABLE MATERIALS................................................................... 8
3 INITIAL OPERATION.................................................................................. 9
3.1 INITIAL OPERATION OF THE DEVICE................................................... 9
3.2 ALARMS................................................................................................ 12
3.3 SHUTTING DOWN THE DEVICE.......................................................... 12
4 MAINTENANCE......................................................................................... 12
5 CLEANING AND DISINFECTION............................................................. 13
6 PERIODIC INSPECTIONS......................................................................... 14
7 MANUFACTURER LIABILITY................................................................... 16
8 WARRANTY CONDITIONS....................................................................... 16
9 RETURN OF DEVICES.............................................................................. 17
10 ELECTROMAGNETIC COMPLIANCE.................................................... 18
11 MANUFACTURER'S DECLARATION..................................................... 21
12 SYMBOLS............................................................................................... 22
13 OPERATING AND STORAGE CONDITIONS......................................... 23
14 TECHNICAL DATA.................................................................................. 23
15 MANUFACTURER................................................................................... 24

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1 WARNINGS AND SAFETY INSTRUCTIONS

• In the event of any suspected malfunction while in operation, the device
should be immediately removed from service and not used for infusions
or transfusions until appropriate investigations have demonstrated that
there has been no impairment.
• If the high temperature alarm is triggered the supply of liquid to the
patient must be immediately stopped by disconnecting the connection
tube to the patient. The medium being used in the device must no longer
be administered to the patient.
• The device may only be fastened to infusion stands, tripods or equipment
rails which are suitable due to their stability and load capacity.
• Only sterile consumables prescribed by C & H may be used in
conjunction with the CH-EIW-02.
• The device must only be used in areas in which the electrical installations
are in accordance with the standards and regulations in force.
• Safe disconnection from the mains power supply can only be achieved
by unplugging the mains plug.
• The device may not be used in rooms subject to explosion hazard.
• Repairs and modifications to the device may only be carried out by
persons or service centres authorised by C & H.
• The device must not be immersed in liquids or sterilised with steam or by
thermochemical methods.
• All extraneous influences, such as electromagnetic waves or high
temperatures are to be kept to a minimum.
• The system may malfunction due to the effect of strong electromagnetic
fields (e.g. by HF therapy or surgical devices). The warmer works
perfectly within the limit values of the Standard EN 60601-1-2. The
system can be affected by limit values that do not comply with the
Standard EN 60601-1-2.
• Avoid exerting force on the device or its accessories.
• If the device is dropped, damaged by force or if it shows a function
deviating from the instructions for use, stop using the device immediately
and return it to the service centre.
• The periodic technical safety inspections must be carried out (see
section: “Periodic inspections”)

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Supplementary safety instructions for the accessory tube warmer C & H

Tubeflow CH-EIW-02:

• The C & H Tubeflow may only be clamped to the C & H blood

warmer CH -EIW -02 with the fixing clamp according to the diagram in the
chapter "Initial operation".
• Do not kink, cover , warm or cool the C & H Tubeflow . Do not cover
the Tubeflow with cloths or dressing material. Do not lead under blankets ,
warm air blankets , etc. Do not expose to direct sunlight or heat radiation .
Lead the Tubeflow through the air unencumbered . Do not lead into or
through incubators . Overwarming of the warmed liquid or burns to the
patient cannot to be excluded in the case of non-compliance.
• Do not shorten or damage the C & H Tubeflow.

The CH-EIW-02 may not be used if:

• the housing is damaged or one of the front film layers becomes detached.
• the device has been exposed to a hard physical shock (e.g. dropped, hit or
shaken)
• the device has been immersed in water
• the device has triggered a high temperature alarm that was not caused by
external factors.
• the mains power cord or plug is damaged
• the device has given somebody an electric shock
• the fixing clamps are damaged and no longer assure safe clamping to the
infusion stand.

Should a malfunction be evident, suitable warning signs should be attached

to the device to ensure that it cannot be used before necessary service and
repair work has been carried out.

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2 DESCRIPTION
2.1 GENERAL DESCRIPTION

The C & H CH-EIW-02 is a warmer for infusions or transfusions and operates on

the basis of a continuous flow warmer , where the heat from the heat exchanger
is transferred via the extension tubing to the liquid flowing within it.

The patented groove design enables several extension tubes to be used,

provided that each of the tubes placed in position can be warmed sufficiently.

The design of the housing allows rapid and simple fitting to all suitable
infusion stands and equipment rails. The temperature of the warmer element
can be set between 37°C and 40°C in steps of 0.1°C and is clearly displayed.

The preset temperature after switching on the CH-EIW-02 is 38.5°C. The alarm
and self -test functions for high and low temperature that are incorporated into
the device assure safe operation.

Optional : The accessory tube warmer C & H Tubeflow is available as a

warming system for transfusions and infusions between CH-EIW-02 and the
patient . The system can be used in all cases in which warming of the
transfusion or infusion is necessary up to the patient.

2.2 SCOPE OF DELIVERY

Blood and infusion warmer CH-EIW-02 and instructions for use

Optional accessory for CH-EIW-02:

Tube warmer C & H Tubeflow Order no 12000

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2.3 CONSUMABLE MATERIALS

Various consumable materials are available according to requirements.

For use with CH-EIW-02 without tube warmer:

Extension set 3.5 m Order no 35000

Extension set 4.6 m Order no 45000
Extension set with bubble trap 4.6 m Order no 25000

For use with CH-EIW-02 with tube warmer:

Extension set 5.3 m Order no 16000

Extension set with bubble trap 5.3 m Order no 15000

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3 INITIAL OPERATION

Observe the instructions for use! Users must familiarise themselves

in detail with the contents of these instructions for use before putting
the system into operation.
3.1 INITIAL OPERATION OF THE DEVICE

Fix the CH -EIW -02 firmly to the infusion stand using the clamps at the back
(Diag .1/8). Only use infusion stands , tripods or equipment rails that are
sufficiently stable.

Connection of the optional tube warmer C & H Tubeflow (to the CH-EIW-02):
The tube warmer C & H Tubeflow must be inserted with light pressure as
indicated in diagram 3 into the intended fixture (Diag. 3/4) on the CH-EIW-02.
Remove the dust cap from the CH-EIW-02 and attach the connector of the
Tubeflow to the female connector on the CH-EIW-02.

Connect the power cable to the power supply. Before connecting to the
mains power supply, check the voltage specified on the device label. The
device emits a short beep and the standby light (Diag.1/4) lights up.

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If a temperature other than 38.5°C is desired, it can be preset in the Standby

mode by using the controls and (Diag.1/5 and Diag.1/6). If an
adjustment control is pressed, the visual display indicates the existing preset
temperature. By repeated operation of the control or , the temperature
can be reset. Resetting of the temperature can only be performed in the
Standby mode.

The warmer of the CH-EIW -02 can be started by pressing the

control (Diag.1/3). A self-test of safety relevant device functions is carried
out, which is terminated by a short acoustic signal . The CH-EIW -02 attains the
set target temperature within 1 minute . The actual temperature (+/- 0.5°C) is
indicated on the display.

Select suitable consumable materials. See the section "Consumable

materials".

Prepare infusion or transfusion. Important: The length of the tube between

the CH-EIW-02 and the patient must be at least 40 cm and the tube must not be
stretched.

Diag. 2
Position of the tube in the groove of the heat
exchanger

Beginning at the back of the heat exchanger, gently pull the extension tube
and coil it in a counter-clockwise direction towards the front. It is advisable
that the distance between the CH -EIW -02 and the patient does not exceed
much more than 80 cm.

Important: The tube must be completely inserted into the groove (Diag. 2)
The flow direction specified in diagram 1 must be complied with.

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Optional accessory tube warmer C & H Tubeflow for CH-EIW-02:

The connector as per diagram 3/2 must be connected to the CH-EIW-02

before starting the optional tube warmer.
Insert the transfusion or infusion tube into the
groove of the tube warmer. Insert the tube over
the complete length of the C & H Tubeflow.

Important: Overwarming can result, if the full

length of the tube warmer is not utilised, thereby
possibly harming the medium or patient, since
the reference temperature sensor is located at
the distal end.

Diag.3

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The Tubeflow is also activated when the CH-EIW-02 is turned on; this
is indicated by a green control light on the Tubeflow.

3.2 ALARMS

The CH-EIW-02 can trigger two types of temperature alarm:

The low temperature alarm is activated when the temperature of the heat
exchanger drops below 36 °C. The audio low temperature alarm is
deactivated during the first 60 seconds after switching on.

The high temperature alarm is activated when the temperature of the heat
exchanger exceeds 42.0°C. In this event visual and audio alarm signals are
given and the heating is switched off. To reset the device or switch off the
alarm, disconnect the device from the power supply.

Important: The temperature alarm can also be set off externally e.g. by
exposure to sunlight.

3.3 SHUTTING DOWN THE DEVICE

After being used for treatment, the device is shut down as follows:
Switch the device into Standby mode using control (Diag.1/3).
Release pressure from the system by switching off possibly used pressure
cuffs or infusion pumps. Empty and disconnect the system as far as possible.
Remove the consumable materials from the heat exchanger (Diag.1/1) and, if
used, also from the optional tube warmer and dispose of in accordance with
the applicable local regulations
Disconnect the device from the power supply and clean and disinfect
according to the section "Cleaning and disinfection".

4 MAINTENANCE
The CH-EIW-02 is designed as a low-maintenance device. To preserve the
quality and functional safety, please comply with the following points:

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• Always keep the device clean (see the section: "Cleaning and
disinfection").
• The periodic technical safety inspections must be carried out (see the
section "Periodic inspections")

5 CLEANING AND DISINFECTION

The CH-EIW-02 and the optional tube warmer Tubeflow may only be cleaned
using a soft cloth with a water -soluble , non -aggressive cleaning agent or a
special cleaning agent for plastics.
For the purposes of disinfection, ready-made alcohol-based spray
disinfectants can be used.
Important: Before cleaning or disinfecting, the device must always be
disconnected from the mains power supply by pulling the plug.

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Do not disinfect the device with steam (i.e. in autoclaves), hot air or
thermochemical cleaning solutions.

6 PERIODIC INSPECTIONS
The periodic technical safety inspections (according to the local standards in
force – e.g.. in Austria ÖVE /ÖNORM E 8751 -1) must be carried out on the
CH -EIW -02 at least every 12 months by persons able to carry out such
technical safety inspections based on their training , knowledge and experience
gained by practical activities.

The results of the periodic inspection are to be documented, together with the
date and the inspecting agency.
Important: Should a malfunction be evident, suitable warning signs should be
attached to the device to ensure that it cannot be used before necessary
service and repair work has been carried out.

CHECKING THE WARM-UP PERIOD

This is the time taken by the CH -EIW -02 to heat up to 38 .5°C from room
temperature . The device is malfunctioning if it takes much longer than one
minute.

CHECKING THE CONTROL TEMPERATURE

The control temperature is checked on the groove bed of the heat exchanger.
The sensor of a suitable contact thermometer (tolerance +/- 0.15°C) is fixed
to this position, e.g. by using a piece of infusion tubing. The examination is
performed at a temperature setting of 38.5°C.
The measured value is read after it has stabilised. The difference must not
exceed +/- 0.5°C. There is a malfunction if a difference from the control
temperature of greater than +/- 0.5°C is obtained.

CHECKING THE LOW TEMPERATURE ALARM

Preheat the device to 38.5°C, then disconnect the mains plug. Hold down the
control and reconnect the mains power plug. After the beep has ceased,
release the control . Press the switch . The device is now in an
operational state where all the alarms are active, but the heating is switched
off. The CH -EIW -02 now slowly cools down . When the temperature drops
below the 36°C threshold, the low temperature alarm should trigger.

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For reasons of safety, short beeping sounds are given at intervals of a

second in this operational mode and the STANDBY indicator (Diag.1/4)
flashes. There is a malfunction if the low temperature alarm is not triggered.

CHECKING THE HIGH TEMPERATURE ALARM

Preheat the device to 41°C and wait for the temperature to stabilise, then
disconnect the mains plug. Hold down the control and reconnect the
mains power plug. After the beep has ceased, release the control . Press
the switch . The device now slowly heats up to a target temperature of
42°C. Observe the temperature display carefully. The high temperature alarm
should be triggered at a temperature of 41.5°C.
For reasons of safety, short beeping sounds are given at intervals of a
second in this operational mode and the STANDBY indicator (Diag.1/4)
flashes. There is a malfunction if the high temperature alarm is not triggered.

VISUAL CHECK OF GENERAL CONDITION

The device should be checked for mechanical damage (general condition)
and for the completeness of the sticker information, particularly the device
label on the reverse. There is a malfunction if mechanical damage to the
device is evident which could be harmful or impair the functional operation of
the device.

ELECTRICAL SAFETY
All relevant electrical safety data should be checked, particularly the earth
conductor resistance (Target: < 0.3 Ohm) and leakage current (Target: < 0.75
mA). There is a malfunction if there is a measured value outside the
tolerances.

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7 MANUFACTURER LIABILITY
The manufacturer and the supplier of the device reject all liability if:
• the device is not used in accordance with the instructions for use
• the user is not sufficiently informed about the functioning of the device on
the basis of the instructions for use and the safety instructions
• repairs are not performed exclusively by the manufacturer or by persons
and service centres expressly authorised by the manufacturer
• the device is used in places in which the electrical installations do not
comply with the applicable national standards, or if power supply during
the period of use of the device is not guaranteed
• original spare parts material are not used or the maintenance interval
is not complied with.

• disposal of the device and its accessories is not carried out in

accordance with the applicable local regulations.

8 WARRANTY CONDITIONS
The manufacturer guarantees that all flaws of material and workmanship
which arise within 24 months from the date of purchase will be repaired free
of charge.
Claims are only accepted under the following terms:
• The manufacturer and/or supplier is informed immediately of the fault for
which the warranty claim is being made.
• The instructions of the manufacturer and/or supplier on storage or return
of the device are complied with.
• Presentation of a legible copy of the invoice for the device concerned,
showing the date of purchase.
• An exact description of the defects or malfunctions identified by the
customer.

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The manufacturer's warranty will be void if it is found that the maintenance,

disinfection and inspection instructions have not been followed according to
the instructions for use, the device has been damaged by force or operating
error or has been used in any way contrary to the instructions for use and
safety instructions . The warranty will also be void if original C&H materials
were not used as replacement parts, or measures for repair were undertaken
by persons not authorised by the manufacturer or supplier.

If the manufacturer is required to meet a warranty claim in accordance with

these terms, the customer shall bear the costs and risks of transport of the
device from and to the place of use.

The manufacturer and/or supplier shall under no circumstances assume

liability for slight negligence. The compensation for lost earnings and profits is
likewise excluded.

9 RETURN OF DEVICES
Devices must be carefully cleaned and disinfected before being placed in the
original packaging for returning.

If the original packaging is no longer available, the product has to be suitably

packaged for the method of dispatch.

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10 ELECTROMAGNETIC COMPLIANCE
Table 201

Guidelines and manufacturer's declaration – electromagnetic emission

The CH-EIW-02 is intended for use in the environment specified below. The customer or the user of the CH-EIW-02
should assure that it is used in such an environment.

Interference Complian Electromagnetic environment - guidelines

emission ce
measurements

RF emissions acc. Group 1 The CH-EIW-02 uses RF energy only for its internal function. Therefore, its RF
to CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic
equipment.

RF emissions acc. Class B The CH-EIW-02 is suitable for use in all establishments, including domestic
to CISPR 11 establishments and those directly connected to the public power supply network
that also supplies buildings used for domestic purposes.

Emission of Class A
harmonics acc. to
IEC 61000-3-2

Emission of Complies
harmonics acc. to
IEC 61000-3-3

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Table 202

Guidelines and manufacturer's declaration – electromagnetic interference resistance

The CH-EIW-02 is intended for use in the electromagnetic environment specified below. The customer or the user of the
CH -EIW-02 should assure that it is used in such an environment.

Interference IEC 60601- Compliance level Electromagnetic environment - guideline

resistance test test level

Electrostatic discharge ± 6 kV contact ± 6 kV contact discharge Floors should be wood, concrete or ceramic
(ESD) acc. to discharge ± 8 kV air discharge tile. If floors are covered with synthetic
IEC 61000-4-2 ± 8 kV air discharge material, the relative humidity should be at
least 30%.

Fast transient ± 2 kV for power ± 2 kV for power supply The mains power supply quality should be that
/electrical bursts acc. supply lines lines of a typical commercial or hospital
to IEC 61000-4-4 ± 1 kV for environment.
input/output lines

Surge voltages ± 1 kV differential ± 1 kV normal mode voltage The mains power supply quality should be that
(surges) acc. to mode ± 2 kV common mode of a typical commercial or hospital
IEC 61000-4-5 ± 2 kV common voltage environment.
mode

Voltage dips, short < 5% UT (> 95% dip < 5% UT (> 95% dip in UT) The mains power supply quality should be that
interruptions and in UT) for ½ cycle of a typical commercial or hospital
voltage variations of for ½ cycle environment.
the supply voltage 40% UT (60% dip in UT) If the use of the CH-EIW-02 requires
acc. to 40% UT (60% dip in for 5 cycles continued operation during power mains
IEC 61000-4-11 UT) interruptions, it is recommended that the
for 5 cycles 70% UT (30% dip in UT) BW 685 be powered from an uninterruptible
for 25 cycles power supply or a battery.
70% UT (30% dip in
UT) < 5% UT (> 95% dip in UT)
for 25 cycles for 5 s

< 5% UT (> 95% dip

in UT)
for 5 s

Power frequency (50 3 A/m 3 A/m Power frequency magnetic fields should be at
Hz/60 Hz) magnetic levels characteristic of a typical location in a
field acc. to IEC typical commercial or hospital environment.
61000-4-8

Note UT is the AC mains voltage prior to application of the test level.

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Table 204

Guidelines and manufacturer's declaration – electromagnetic interference resistance to

The CH-EIW-02 is intended for use in the electromagnetic environment specified below. The customer or the user of the CH
-EIW-02 should assure that it is used in such an environment.

Interference IEC 60601- Compliance Electromagnetic environment - guidelines

resistance test test level level

Portable and mobile RF communications equipment should be

used no closer to any part of the CH-EIW-02, including cables ,
than the recommended protection distance calculated from the
equation applicable to the frequency of the transmitter:

Recommended protection distance:

Conducted RF 3 Veff
 V1 in V  3,5 
disturbance variables
acc. to IEC 61000-4-6
150 kHz to 80
MHz d = 
∗ P
 V1 

Emitted RF 3 V/m
 E1 in  3,5 
d = 
∗ P
disturbance variables 80 kHz to 2.5
V/m for 80 MHz to 800 MHz
acc. to GHz
IEC 61000-4-3  E1 

 7 
d = 
∗ P for 800 MHz to 2.5 GHz
 E1 
Where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer and d is
the recommended protection distance in metres (m).
Field strengths from fixed RF transmitters, as determined by
an 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 affected by
absorption and reflection from structures, objects and people.

a
Field strengths from stationary 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 stationary RF transmitters,
an electromagnetic site survey should be considered. If the measured field strength in the location in which
the CH-EIW-02 is used exceeds the applicable RF compliance level as specified above, the CH-EIW-02
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the CH-EIW-02.

b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

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Table 206

Recommended protection distances between

portable and mobile RF communications equipment and the CH-EIW-02

The CH-EIW-02 is intended for use in an electromagnetic environment in which radiated RF disturbance variables are
controlled. The customer or user of the CH-EIW-02 can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the CH-EIW-02 as recommended
below, according to the maximum output power of the communications equipment.

Protection distance according to transmitter frequency m

Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
output power of
transmitter W
 3,5   3,5   7 
d = 
∗ P d = 
∗ P d = 
∗ P
 V1   E1   E1 

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended distance can be determined 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 higher frequency range applies.

Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

11 MANUFACTURER'S DECLARATION
The blood and infusion warmer CH-EIW-02 is a medical product as defined
by Directive 93/42/EEC.

This is documented by attaching the CE mark.

Notified Body: TÜV Product-Service, Approval Number CE0123

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12 SYMBOLS
Certifies compliance with the Directive 93/42/EEC
0123
Observe the instructions for use!

Do not dispose of this product as unsorted municipal waste

Control for increasing the temperature setting

Control for decreasing the temperature setting

IPX 4 Humidity Classes

Degree of protection B

Control for switching On / Standby

- for optional tube warmer Tubeflow

I Operation Malfunction

Do not cover Do not wrap up

Do not expose to direct

sunlight Do not cut

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13 OPERATING AND STORAGE CONDITIONS

Permissible environmental conditions for transport and storage:
Temperature setting: 37 – 40°C (adjustable at rate of 0.1°C)
Relative humidity: 30 – 75%
Air pressure: 700 – 1060 hPa
Accuracy : ±0.5°C; High temperature cut -off : 41 °C/42 °C/50 ±5°C; Low
temperature alarm 36°C; Normal transfusion / infusion tubing can be used in
low flow rate;

14 TECHNICAL DATA
Device: Blood and infusion warmer

Voltage: 220V±10% / 50-60Hz

Power consumption: Max.320VA
Protection class: I
Degree of protection: B
Humidity protection: IPX4 splash proof
Control temperature: 37°C - 40°C adjustable in 0.1°C steps
Overtemperature shutdown: 41°C / 42°C / 50±5°C
Operational mode: Continuous operation
Dimensions: 145 x 135 x 225 mm
Weight: 2.30kg

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15 MANUFACTURER

C&H Medical (Guangzhou) Co., Ltd.

#809, 28th Jiwuduan Street, Yuexiu Distric,
Guangzhou 510400, China
Tel. +862085997993 Fax +862086503632
email: sales@ch-med.cn www.ch-med.cn

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