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Fluido®Compact

Blood and Fluid Warming SystemUser manual

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Table of Contents1 General information 5

1.1 About this manual 51.2 Intended use 51.3 Contact address 51.4 Warranty 51.5 Authorisation of personnel 51.6 Warning, caution and note 61.7 Disclaimer 7

2 Safety 82.1 General safety precautions 8

2.1.1 Warnings 82.1.2 Cautions 92.1.3 Literature 9

2.2 Safety symbols 10

3 Description 163.1 Overview of the device 163.2 Overview of the control module 173.3 Overview of the warming module 183.4 Overview of the disposable set 193.5 Overview of the control panel 203.6 LED indicator behavior 21

3.6.1 Set point indicator 223.6.2 Repair required 223.6.3 Overtemperature indicator 22

4 Installation 234.1 Transport and storage 234.2 Install the cables 23

4.2.1 Remove the hatch 234.2.2 Install the interface cable 234.2.3 Install the power supply cord 244.2.4 Place the hatch 25

4.3 Change the rotation of the universal clamps (optional) 254.4 Attach the device 26

Table of Contents

3

5 Operation 275.1 Safety instructions before operation 275.2 Preparation before operation 28

5.2.1 Turn the device on 285.2.2 Install the disposable set 295.2.3 Prime the system 30

5.3 Operate the device 315.4 Stop the device 32

6 Maintenance 356.1 Cleaning 36

6.1.1 General cleaning procedure 366.1.2 Cleaning of the warming module 376.1.3 Cleaning of the control module 376.1.4 After cleaning 37

7 Test the device 387.1 Electrical safety test 38

7.1.1 Necessary items 387.1.2 Preparation 387.1.3 Procedure 38

7.2 System operation test 397.2.1 Necessary items 397.2.2 Preparation 397.2.3 Procedure 39

7.3 Overtemperature alarm test 407.3.1 Necessary items 407.3.2 Preparation 407.3.3 Procedure 40

8 Specifications 418.1 Specifications of the device 418.2 Specifications of the disposable set 42

9 Electromagnetic compatibility 439.1 Electromagnetic immunity 439.2 Electromagnetic emissions 479.3 Recommended separation distances 48

Table of Contents

4

1 General information

1.1 About this manualIn this manual, you can find important information about how to operate theFluido® Compact System (hereafter referred to as ‘the device’).The manual helps you with the operation and the maintenance of the device, in asafe and responsible manner.Read this manual carefully. Complete all the procedures. Do the procedures inthe given sequence. Always keep the manual near the device.

1.2 Intended useThe device is developed to supply warm fluids to a patient.The Fluido Compact Standard Set is developed for adults.Use the device for warming:

• crystalloid• colloid IV-fluids• anti-coagulated blood• plasma

Do not use the device for any other use.Use the FluidoAirGuard System if high flow is requested or more than one bag ofblood is administered.

1.3 Contact addressThe 37CompanyBeeldschermweg 6FNL-3821 AH AmersfoortThe Netherlands

1.4 WarrantyFor the warranty provisions, refer to the website: www.the37company.com

1.5 Authorisation of personnelMake sure that only authorised personnel use the device.

General information

Fluido®Compact INT/R683-EN/0-08/14 5

1.6 Warning, caution and noteThis manual gives more information about dangerous situations.

WARNING!A "warning" tells you that there is a risk of personal injury ordeath.

CAUTION!A "caution" tells you that:

• there is a risk of damage to the device, and/or• there is a risk of damage to other equipment.

NOTE!A "note" gives more information.

General information

6 INT/R683-EN/0-08/14 Fluido®Compact

1.7 DisclaimerThe manufacturer reserves all rights. No part of this document may bereproduced or published, electronically, mechanically, in print, photographic print,on microfilm or by any other means whatsoever, without the explicit consent ofmanufacturer.The content of this document has been compiled with the greatest possible careand this information can be regarded as reliable. Nevertheless, the manufacturerreserves the right to make alterations and improvements to the device. Thesemay not yet have been described in the instructions. The manufacturer cannot beheld liable for the final outcome of the patients’ treatment.This document contains proprietary information that may not be disclosed to thirdparties. This document may not be used without the explicit written consent ofthe manufacturer.These instructions are intended for personnel authorised to work with and/orservice the medical device described in this manual.

General information


2 Safety

2.1 General safety precautionsRefer to chapter 6.1 Cleaning for specific safety precautions.

2.1.1 Warnings

Materials

• Use blood products that comply to EU and/or US standards.• Do not mix fresh frozen plasma or red blood cells with drugs. See 2.1.3

Literature: 3 and 4.• Use saline (0.9% Sodium Chloride) to dilute red blood cells to lower the

viscosity. See 2.1.3 Literature: 1 and 2.• Obey the following conditions to use the device to warm fresh frozen plasma:

• Make sure that the fresh frozen plasma is completely melted and keep itat a temperature of 22°C. See 2.1.3 Literature: 1, 3 and 4.

• Make sure that no cryoprecipitate is present.• Monitor the flow if fresh frozen plasma is administered simultaneously

with blood.• Check the cassette of the disposable set if the flow is not correct.

• Do not mix dextrose solution (5%) with blood components. This can causehaemolysis. See 2.1.3 Literature: 4 and 5.

• Do not use the device for warming platelets, cryo-precipitates or granulocytesuspense.

Before operation

• The Fluido Compact Warming module is to be used only with the FluidoCompact Control module and Fluido Compact disposable sets.

• Do not use the device if the warming surface is damaged (e.g. dents,cracks). Take the device out of service.

• Do not use the device in any of the following cases. Clean and dry thewarming surface if:- the warming surface is wet (e.g. leaked IV fluids/blood, cleaning agents).- the warming surface is dirty (e.g. coagulated blood).

• Use a new hospital administration set for every application. (See 2.1.3 Literature: 4).

• Use disposable sets. Use each disposable set for only one patient. Do notuse a disposable set if the expiration date has passed.

• Follow the standard IV line protocols for priming the complete infusion setand the disposable set before connecting to a patient. Take care to ensurethere is no air in the lines to cause an air embolism.

• Do not use the device outside the environmental specification. See alsochapter 8.

Safety


Operation

• Do not position the warming module close to the head of the patient if inhalertherapy is used.

• If fluid leakage is observed, stop the fluid flow, and open the slider todisengage the device from operating.

• Warming IV fluids/blood could result in outgassing. Regularly check thedisposable set on accumulated gas bubbles. These can cause air embolism.

• If the IV line runs dry, disconnect it from the patient. Re-prime the systemand ensure that all air is removed and reconnect it to the patient.

• The disposable set should not be used for longer than 24 hours.

After operation

• The heating surface of the warming module and the cassette of thedisposable set can get quite warm when heating cold IV fluids/blood at highflow rates. Wait a few seconds after stopping the IV fluid/blood flow beforeremoving the cassette of the disposable set.

• After applying blood products, clean the hospital administration set using onepriming volume of saline.

• This device may be a potential biohazard during and after use. Handle anddispose in accordance with acceptable medical practice and applicableregulations.

Other

• No modification of this equipment is allowed.

2.1.2 Cautions

• Obey local regulations.• Use the FluidoAirGuard System if high flow or a large volume is requested.• Take care that the device is not dropped, to reduce the risk of damage.

2.1.3 Literature

1. Reserved operations Blood transfusion, Jacques, M.B., DirectorateEducation & Training, 2008, Leids Universitair Medisch Centrum; Reader,2009-04-06.

2. Guidelines for the use of blood warming devices, AABB, 2002.3. Handbook of Transfusion Medicine, DBLL McClelland, UK blood service 4th

Edition, ISBN 0-11-322677-2.4. Blood and Transplant, NHS, December 2009 version 1.5. Fantl and Morris, Thorax (1965),20,372, Influence of dextrose on heparinized

blood.

Safety


2.2 Safety symbols

IPX1Protected against falling water Equivalent to 3-5 mmrainfall per minute for a duration of 10 minutes. Unit isplaced in its normal operating position (according to IEC60529).

IPX4Protected against splashing water - Water spraying at allangles at 10 liters/min at a pressure of 80-100kN/m2 for 5min. (according to IEC 60529).

Do not use the device if the package is damaged.

Caution: Federal US law restricts this device to sale by oron order of a physician.

As to electrical shock, fire and mechanical hazards only inaccordance with ANSI/AAMI ES60601-1 (2005) + AMD 1(2012), CAN/CSA-C22.2 No. 60601-1 (2014), IEC60601-1-6 (2010) + A1 (2013).

Caution: risk of electrical shock.

Serial number

Safety


Catalogue / article number

Quantity

Sterile, method of sterilisation ethylene oxide

Batch code / lot number

Manufacturer

Transport and storage ambient temperature range

Transport and storage relative humidity range

Safety


Transport and storage atmospheric pressure limitation

Keep away from sunlight.

Keep away from rain.

AC voltage

Type BF applied parts (according to IEC 60601-1)

Expiry date, year/month

For single patient use only. Do not re-use.

Safety


LATEX

Does not contain natural latex components.

Does not contain DEHP.

Fuse

Read the user manual.

Check the instructions for use.

CE marking of conformity (XXXX = identification numberof Notified Body).

Dispose according to European Community Directive2002/96/EC (WEEE).

Safety


Caution. Check the instructions for use for importantcautionary.

Repair is required.

Check the device and the power cords for damage. Do notuse the device if it is damaged.

Do not use a damaged disposable set to prevent damageto the device.

Do not immerse the device. Clean the appliance withstandard cleaning agents. See 6.1 Cleaning.

Attach the device to a pole before you use the device.

De-aerate the disposable set before you use the device.

Safety


>300mmHg

Make sure that the pressure does not exceed 300 mmHg.Do not use a (manually) operated pressure device withouta pressure indicator.

151413121110987

MOD RECORD

654321

Modification update, example = MOD 6

Plug the device into an earthed mains socket.

Do not move the device on a drip stand during use.Remove the device from the drip stand before you moveit.

Safety


3 Description

3.1 Overview of the device

C

B

A

A. Control moduleB. Warming module

C. Disposable set

Description


3.2 Overview of the control module

D

A

B

C

E

A. Control panelB. Universal clampC. Drip chamber holder (optional)

D. Warming module holderE. Power supply cord

Description


3.3 Overview of the warming module

A

B

C

D

A. SliderB. Warming interface

C. Status LEDD. Interface cable

Description


3.4 Overview of the disposable set

A B

D

C

A. Luer-Lock (male)B. Clamp

C. Patient lineD. Cassette

Description


3.5 Overview of the control panel

A

B C D E

A. Standby/on buttonB. Standby/on indicatorC. Set point indicator

D. Repair requiredE. Overtemperature indicator

Description


3.6 LED indicator behaviorControl panel LEDs

LED Behavior Meaning

Standby/on indicator Off The device is notpowered.

Orange continuous The device is in standbymode.

Green continuous The device isoperational.

Set point indicator Green continuous The derived fluidtemperature at the outletof the disposablecassette is within range(39 ± 2°C).See 3.6.1

Green flashing The derived fluidtemperature at the outletof the disposablecassette is out ofsetpoint range.

Repair required Yellow continuous An error is detected. Thedevice cannot be used.When the system iswarming an audiblealarm (repeating beep) isalso active.See 3.6.2

Overtemperatureindicator

Yellow continuous The safety circuit of thedevice has measured atoo high temperature.See 3.6.3

Description


Warming module LED

LED Behavior Meaning

Status Orange continuous No disposable set isinstalled or thedisposable set isinstalled incorrectly.

Green continuous The disposable set isinstalled correctly, thesystem is warming.

3.6.1 Set point indicator

The set point indicator indicates if the derived fluid temperature at the outlet ofthe disposable cassette is within range (39 ± 2°C) or not.The temperature at the end of the patient line depends on the fluid flow rate andenvironmental conditions. If the fluid inlet temperature and environmentaltemperature are 20°C, the temperature at the end of the patient line is 39±2°C atflow rates from 5 to 100 ml/min.

3.6.2 Repair required

Do the following steps when the "Repair required" indicator is active.

• Check if the interface cable of the warming module is correctly attached tothe control module.

• To reset the device disconnect the power supply cord, wait a few secondsand reconnect the power supply cord.

If the problem persists the system needs to be replaced.

3.6.3 Overtemperature indicator

Do the following steps when the overtemperature indicator is active.

• Check the disposable cassette for air or air bubbles. If air or air bubbles arepresent, prime the set again (see 5.2.3 Prime the system).

• Check if the warming surface of the warming module is wet or contaminated.If wet or contaminated, clean and dry the surface (see 6.1 Cleaning).

• To reset the device, disconnect the power supply cord, wait a few secondsand reconnect the power supply cord.

If the problem persists the system needs to be replaced.

Description


4 Installation

4.1 Transport and storageStore the device and accessories according to the transport and storagerecommendations. See chapter 8 Specifications.

4.2 Install the cables

4.2.1 Remove the hatch

1 Remove the bolt (A) from the hatch (B),using a 2mm hex key.The used bolt is: M3X8 A2-70 DIN7984

2 Remove the hatch (B).

hex key 2mm

B

A

4.2.2 Install the interface cable

1 Turn the connector ring on the interfacecable (A) to the open position.

2 Connect the interface cable.

A

12

Installation


3 Turn the connector ring on the interfacecable (A) to the locked position.

A

4.2.3 Install the power supply cord

1 Connect the power supply cord (A).

A

Installation


4.2.4 Place the hatch

1 Place the lower parts of hatch (A).2 Rotate the hatch upwards until it is

closed.3 Fasten the bolt in the hatch.

hex key 2mm

A

3

1

2

4.3 Change the rotation of the universal clamps (optional)Turn the universal clamp 90° if you want to install the universal clamp to a bedrail:1 Turn the knob (A) until the universal

clamp (B) is fully open.2 Loosen the bolts (C), using a 3mm hex

key.The used bolts are: M5X12 A2-70DIN7984

hex key 3mm

BC A

Installation


3 Turn the universal clamp (A) 90°.4 Fasten the bolts (B).

hex key 3mmAB

4.4 Attach the device

NOTE!When installing the device, make sure that the operator can readthe control panel from his normal working position.

1 Open the universal clamp (A).2 Position the control module such that

universal clamp encloses the IV pole(B) or bed rail.

3 Close the universal clamp.4 Put the warming module in the warming

module holder (C).

A

BC

Installation


5 Operation

5.1 Safety instructions before operation

WARNING!

• Do not add calcium rich supplements (such as Hartmann’ssolution or Ringers lactate) as priming solution to blood toprevent blood clots.

• Do not use blood stored below 2°C to prevent blood clots.The device is tested with blood stored at 4-6°C.

• Do not use a leukocyte reduction filter in combination withthe disposable set.

• Do a check on the device after a temporary interruption ofthe mains supply. The device does not have an isolatingswitch. After an interruption of the supply mains, the deviceis in standby mode.

• Make sure that there is a physician order for switching on thedevice and for continued use.

• Make sure that the power supply cord can be disconnectedeasily in case of an emergency.

• To remove all power, disconnect the power supply cord.• Check the patient’s condition and temperature at least every

15 minutes.• Do not maintain the device while it is in use with a patient.• Make sure that only authorised personnel use the device.

CAUTION!

• Obey this procedure if there is interference with randomdevices:• Stop random devices one by one to isolate the offending

device.• Put the other receiving device to a different location.• Put the device that interferes further away from the

device or use a different socket.• Contact your local dealer if you need help.• Use only specified power supply cords to prevent

increased emission or decreased immunity of the unit.

The device is approved for electromagnetic interferenceaccording to IEC 60601-1-2. Details on electromagneticcompatibility can be found in 9 Electromagnetic compatibility

Operation


5.2 Preparation before operationBefore you prepare the device, ensure that the device is installed correctly (referto 4 Installation).

5.2.1 Turn the device on

1 Connect the power supply cord to thesocket.The LED on the control module is noworange.

2 Push the standby/on button (A).• You will hear a single beep.• The LEDs on the control module

flash one time.• The standby/on LED stays green.• The LED on the warming module is

now orange.

A

Operation


5.2.2 Install the disposable set

1 Unpack and inspect the disposable set.2 Connect the hospital administration set

(A) to the disposable set (B).

B

A

3 Take the warming module out of thewarming module holder.

4 Open the slider (A) of the warmingmodule.

5 Put the disposable set (B) in thewarming module. The disposable setfits in only one way.

6 Close the slider.The LED on the warming module isnow green, to indicate that thedisposable set is detected andpositioned correctly.

B

A

Operation


NOTE!When the LED on thewarming module staysorange the detection ofthe disposable setfailed.• Remove the set

(see 5.4).• Check the heating

surface fordamages andcontamination.

• Check the cassetteof the disposableset for damagesand contamination.

• Prime thedisposable set (see5.2.3).

• Install thedisposable setagain.

7 Wait until the set point indicator LED onthe control module stays green.The LED flashes green until therequired temperature is reached.

8 Put the warming module (A) in thewarming module holder (B) with theinterface cable (C) downwards.

9 Make sure that the clamp (D) is open.

B

A

C

D

5.2.3 Prime the system

Prime the hospital administration set and the disposable set.

Operation


1 Hold the disposable set in the uprightposition.Make sure that the clamp (A) of thedisposable set and the roller clamp (B)of the hospital administration set areopen.Make sure that there is no air left in thesystem.Close the roller clamp (B).

B

A

WARNING!If fluid leakage is observed, stop the fluid flow, and open theslider to disengage the device from operating.

5.3 Operate the deviceBefore you operate the device, prepare the device (refer to 5.2).1 Put the warming module near the

patient.

WARNING!Do not position thewarming module closeto the head of thepatient if inhalertherapy is used.

NOTE!The position of thewarming moduledepends on theposition of the IVcatheter.

2 Connect the patient line (A) to the IVcatheter.

A

Operation


3 Open the roller clamp.

5.4 Stop the device1 Push the standby/on button (A).

NOTE!The LED of thewarming module is noworange.

A

2 Close the roller clamp of the hospitaladministration set.

Operation


3 Close the clamp of the patient line.

4 Disconnect the patient line (A) from theIV catheter.

A

5 Open the slider.

Operation


6 Remove the disposable set from thewarming module.

WARNING!If it is necessary, cleanthe warming module,according to hospitalguidelines. See 6.1 Cleaning.

7 Close the slider.

B

A

8 Put the warming module (A) in thewarming module holder (B).

9 Dispose the disposable set.

B

A

Operation


6 MaintenanceFor the device, maintenance is not necessary, the device has no user-maintainable parts. The heating element of the warming module cannot bechanged.If you contact the hospital service department or the local supplier for technicalsupport, make sure that you have the serial number of the warming module orcontrol module depending on which device support is needed.You can find the serial number of the control module on the back, just above theuniversal clamp. The serial number of the warming module is on the slider.

NOTE!If the device indicates 'Repair required', contact your localdistributor.

WARNING!The device should be tested at least once a year, see chapter 7 Test the device.The essential performance of the device is to warm fluids withinthe safe temperature and time limits according to ASTM F2172-2. Testing is required to validate if the device still complieswith its essential performance.

Maintenance


6.1 Cleaning

6.1.1 General cleaning procedure

WARNING!Before you clean the device, disconnect the power supply cord.

CAUTION!

• Do not use dripping wet cloths.• Do not use ketones (MEK, acetone, etc) or abrasive

cleaners.• Do not use steam sterilization (autoclave) or dry heat to

sterilize the device.• Make sure that water cannot come in the electrical areas of

the device.• Clean the device from too much detergent or disinfectant.• Let the device air dry.• To clean the outer surface of the device, use a soft cloth

lightly dampened with a solution of hand warm water and amild detergent or a non-staining hospital disinfectant.

• Use one of the following cleaning solutions:• 90% (or 70%) isopropyl alcohol• mild detergent solution• diluted chlorine bleach (30 ml/l water)• ammonia based cleaners• glutaraldehyde-based cleaners 2.4%• hydrogen peroxide 3%

Maintenance


6.1.2 Cleaning of the warming module

CAUTION!To clean the warming module:

• Use solutions with less than 2.4% glutaraldehyde.• Obey the manufacturer's recommendations, see 6.1.1.

CAUTION!Make sure that you do not damage the interface of the warmingmodule. If the interface is wet, still dirty or damaged, do not usethe device and replace the warming module.

6.1.3 Cleaning of the control module

CAUTION!To clean the control module:

• Use solutions with less than 2.4% glutaraldehyde.• Obey the manufacturer's recommendations, see 6.1.1.

CAUTION!

• Make sure that fluids cannot come in the control module.• Make sure that the control module is dry before you use it

again.

6.1.4 After cleaning

WARNING!Do not use the device in any of the following cases.

• the warming surface is damaged (e.g. dents, cracks),• the warming surface is wet (e.g. leaked IV fluids/blood,

cleaning agents)• the warming surface is dirty (e.g. coagulated blood)

Clean or dry the surface or take the device out of service ifnecessary.

Maintenance


7 Test the device

CAUTION!Do not open or repair the device to prevent damage to the unit.

Do the following tests once per year.

• Electrical safety test, see 7.1 Electrical safety test• System operation test, see 7.2 System operation test• Overtemperature alarm test, see 7.3 Overtemperature alarm test

7.1 Electrical safety test

7.1.1 Necessary items

• the device• IV pole (optional)• saline or other crystalloid fluids• disposable set• syringe or hospital administration set• medical electrical safety tester (refer to IEC 60601-1)• metal catheter

7.1.2 Preparation

1 Connect a metal catheter to the end of the patient line.2 Open the clamps on the hospital administration set and the patient line.3 Make sure that the complete disposable set and the catheter are free of air.4 Close the clamps of the hospital administration set.5 Connect the metal part of the catheter to the safety tester. This is an applied

part on the terminal of the safety tester.

7.1.3 Procedure

1 Do the electrical safety test, refer to IEC 60601-1, for a class II, BodyFloating Device.

Test the device


7.2 System operation test


• the device• IV pole (optional)• saline or other crystalloid fluids 21 ± 3°C• disposable set• hospital administration set• measuring cup and timing device to measure the flow rate• thermometer to measure the outlet temperature• syringe with male Luer-Lock

7.2.2 Preparation

1 Put the warming module in a horizontal position.2 Make sure that the output of the patient line is a minimum of 130 millimeter

higher than the device to simulate a venous pressure.3 Put the end of the patient line in the measuring cup.4 Adjust the height of the bag that contains IV fluid so the vertical distance

between the bottom of the bag is 1 meter higher than the end of the patientline.

5 Make sure that the environmental temperature is 21 ± 3°C and draft-free.

7.2.3 Procedure

1 Push the standby/on button to start warming.2 Adjust the roller clamp of the hospital administration set until the flow is

correct.3 Measure the actual flow rate by measuring the increase in volume (milliliter)

of IV fluid in the measuring cup over a period of time.4 Make sure that the IV fluid temperature at the end of the patient line (40

centimeter) is between 37-41°C after temperature stabilisation for the flowrate range of 5-100 milliliter/minute.

Test the device


7.3 Overtemperature alarm test

WARNING!Be careful when you use hot water.


• the device• IV pole (optional)• water at 49-55°C• disposable set• hospital administration set• syringe with male Luer-Lock

7.3.2 Preparation

1 Push the standby/on button to put the device in standby mode.2 Prime/flush the disposable set.3 Close the roller clamp and the clamp on the patient line.4 Disconnect the hospital administration set from the disposable set.5 Fill a syringe with male Luer-Lock with water at 49-55°C.6 Connect the syringe to the disposable set.7 Open the clamp on the patient line.

7.3.3 Procedure

1 Push the standby/on button to put the device in on mode.2 Open the slider a few millimeters until the set point indicator LED is off.3 Flush the hot water into the disposable set.4 Make sure that the over temperature alarm starts.5 Close the clamps.

Test the device


8 Specifications

8.1 Specifications of the deviceGeneral specifications

Part No. Fluido® Compact 650000

Part No. control module 650100

Part No. warming module 650200

Fuse control module 2x T3.15AH 250V

Voltage 100 – 240V~ (50/60 Hz)

Maximum power 160 W

Dimensions control module H: 285 mmW: 120 mmD: 195 mm

Dimensions warming module H: 165 mmW: 75 mmD: 50 mm

Weight control module < 1700 g

Weight warming module < 450 g

Class (IEC 60529) control module IPX1

Class (IEC 60529) warming module IPX4

Class IEC 60601-1 Class II, Body FloatingThe third conductor in the powersupply cord is only a functional earth.

Class (MDD93/42/EEC) Class II b

Flow range (39 ± 2°C) 5 – 100 ml/min at Tin = 20°C & Tenv =20°C

Input temperature range 5 – 30°C

High temperature limit Within safe range according to ASTMF2172-02 (2011)

Environmental specifications

Ambient temperature 15ºC to 30ºC

Relative humidity 30% to 75%

Atmospheric pressure 70 kPa to 106 kPa

Specifications


Transport and storage specifications

Ambient temperature -40ºC to 70ºC

Relative humidity 10% to 90% (non-condensing)


8.2 Specifications of the disposable set

Part. No. 672000

Maximum pressure 300 mmHg

Priming volume 3 ml

Free flow (300mmHg, no catheterattached)

≥400 ml/min

Transport specifications

Ambient temperature -20ºC to 40ºC



Storage specifications

Store in a dry and dark place under warehouse conditions, preferable between2ºC and 30ºC.



Specifications


9 Electromagnetic compatibility

9.1 Electromagnetic immunityGuidance and manufacturer’s declaration - electromagnetic immunityThe device is intended to use in de electromagnetic environment specifiedbelow. The customer or the user of the device should assure that it is used insuch an environment.

Electromagnetic compatibility


Immunity test IEC60601 testlevel

Compliancelevel

Electromagneticenvironmentguidance

Electromagneticdischarge (ESD)IEC 61000-4-2

±6 kV contact±8 kV air

±6 kV contact±8 kV air

Floors should bewood, concrete orceramic tile. Iffloors are coveredwith syntheticmaterial, therelative humidityshould be at least30%

Electrical fasttransient / burstIEC 61000-4-4

±2 kV for powersupply lines±1kV for input/output lines

±2 kV for powersupply lines±1kV for input/output lines

Mains powerquality should bethat of a typicalcommercial orhospitalenvironment.

SurgeIEC61000-4-5

±1 kV differentialmode±2 kV commonmode

±1 kV differentialmode±2 kV commonmode

Mains powerquality should bethat of a typicalcommercial orhospitalenvironment.

Voltage dips,short interruptionsand voltagevariations onpower supplyinput linesIEC 61000-4-11

<5 % UT (>95 %dip in UT ) for 0.5cycle40 % UT (60 %dip in UT ) for 5cycles70 % UT (30 %dip in UT ) for 25cycles<5 % UT (>95 %dip in UT ) for 5sec

<5 % UT (>95 %dip in UT ) for 0.5cycle40 % UT (60 %dip in UT ) for 5cycles70 % UT (30 %dip in UT ) for 25cycles<5 % UT (>95 %dip in UT ) for 5sec

Mains powerquality should bethat of a typicalcommercial orhospitalenvironment. Ifthe user of thedevice requirescontinuedoperations duringpower mainsinterruptions, it isrecommendedthat the device ispowered from anuninterruptiblepower supply or abackup batterysystem.

NOTE: UT is the a.c. mains voltage prior to application of the test level.




Compliancelevel


Power frequency(50/60 Hz)magnetic field IEC61000-4-8

3 A/m 3 A/m Power frequencymagnetic fieldsshould be atlevelscharacteristic of atypical location ina typicalcommercial orhospitalenvironment.




Compliancelevel


Conducted RFIEC61000-4-6Radiated RFIEC61000-4-3

3 Vrms 150 kHzto 80 MHz3 V/m 80 MHz to2.5 GHz

3 Vrms3 V/m

Portable andmobile RFcommunicationsequipment shouldnot be used anycloser to any partof the device,including cables,than therecommendedseparationdistancecalculated fromthe equationapplicable to thefrequency of thetransmitter.(NOTE

1)

Field strengthsfrom fixed RFtransmitters, asdetermined by anelectromagneticsite survey(NOTE

3), should be lessthan thecompliance levelin each frequencyrange(NOTE 4).Interference mayoccur in thevicinity ofequipmentmarked with thefollowing symbol:




Compliancelevel


NOTE 1: Recommended separation distance:

• d = 1.2 √ P• d = 1.2 √ P (80 MHz to 800 MHz)• d = 2.3 √ P (800 MHz to 2.5 GHz)

where P is the maximum output power rating of the transmitter in watts (W)according to the transmitter manufacturer and d is the recommendedseparation distance in meters (m).At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagneticpropagation is affected by absorption and reflection from structures, objectsand people.NOTE 3: Field strengths from fixed transmitters, such as base stations for radio(cellular/cordless) telephones and land mobile radios, amateur radio, AM andFM radio broadcast and TV broadcast cannot be predicted theoretically withaccuracy. To assess the electromagnetic environment due to fixed RFtransmitters, an electromagnetic site survey should be considered. If themeasured filed strength in the location in which the device is used exceeds theapplicable RF compliance level above, the device should be observed to verifynormal operations. If abnormal performance is observed, additional measuresmay be necessary, such as reorienting or relocating the device.NOTE 4: Over the frequency range 150 kHz to 80 MHz, filed strengths shouldbe less than 3 V/m

9.2 Electromagnetic emissionsGuidance and manufacturer’s declaration – electromagnetic emissionsThe device is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the device should assure that it is used insuch an environment.



Emissions test Compliance Electromagneticenvironment –guidance

RF emissionsCISPR 11

Group 1 The device uses RFenergy only for itsinternal function.Therefore, its RFemissions are very lowand are not likely tocause any interferencein nearby electronicequipment.

RF emissionsCISPR 11

Class A The device is suitable foruse in all establishmentsother than domestic andthose directly connectedto the public low-voltagepower supply networkthat supplies buildingsused for domesticpurposes.

Harmonic emissionsIEC 61000-3-2

Not applicable

Voltage fluctuations/flicker emissionsIEC 61000-3-3

Not applicable

9.3 Recommended separation distancesRecommended separation distances between portable and mobile RFcommunications equipment and the deviceThe device is intended for use in an electromagnetic environment in whichradiated RF disturbances are controlled. The customer or the user of the devicecan help prevent electromagnetic interference by maintaining a minimumdistance between portable and mobile RF communications equipment(transmitters) and the device as recommended below, according to the maximumoutput power of the communications equipment.



Separation distance according to frequency of transmitterM

Rated maximumoutput power oftransmitter W

150 kHz to 80MHz

80 MHz to 800MHz

800 MHz to 2,5GHz

0.01 0.12 0.12 0.24

0.1 0.37 0.37 0.74

1 1.17 1.17 2.34

10 3.69 3.69 7.38

100 11.67 11.67 23.34For transmitters rated at a maximum output power not listed above, therecommended separation distance d in metres (m) can be estimated using theequation applicable to the frequency of the transmitter, where P is the maximumoutput power rating of the transmitter in watts (W) according to the transmittermanufacturer.NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higherfrequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagneticpropagation is affected by absorption and reflection from structures, objects andpeople.



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