astoflo plus service instructions

Service Instructions

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Stihler Electronic GmbH 70597 Stuttgart Germany

Page - 2 - Rev. 4 09/2009

Service Instructions ASTOFLO PLUS (AFP)

Manufacturer: STIHLER ELECTRONIC GmbH Julius-Hoelder-Strasse 36 70597 Stuttgart Germany Tel. +49 (0) 711-720670 Fax +49 (0) 711-7206757 www.stihlerelectronic.de E-Mail: [email protected]

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List of contents 1 General ........................................................................................................................... 4

1.1 Technical Service and Ordering Spare Parts ................................................. 4 1.2 Guarantee repairs .......................................................................................... 4 1.3 Liability ........................................................................................................... 4 1.4 Important instructions..................................................................................... 5

2 Description of the warmer............................................................................................. 5 2.1 Introduction .................................................................................................... 5 2.2 Technical description ..................................................................................... 5 2.3 Warmer components...................................................................................... 6 2.4 Control panel components ............................................................................. 6 2.4 Control panel components ............................................................................. 7 2.5 Technical Specifications................................................................................. 8 2.6 Safety features and alarm systems................................................................ 9 2.7 Description of electronic components .......................................................... 10

3 Cleaning and disinfection ........................................................................................... 12 4 Troubleshooting .......................................................................................................... 13

Part I: When putting the warmer into use................................................................ 13 Part II: During operation.......................................................................................... 15 Part III: During the safety and operation check....................................................... 16

5 Repairing/replacing parts and components .............................................................. 21 5.1 Opening the control unit ............................................................................... 22 5.2 Disassembling the front housing section...................................................... 22 5.3 Assembling the front housing section .......................................................... 24 5.4 Disassembling the rear housing section....................................................... 26 5.5 Assembling the rear housing section ........................................................... 28 5.6 Assembling the control unit .......................................................................... 31

Appendix ......................................................................................................................... 33 A Spare parts list .....A1 B Testing instructions (safety and function checks) .....B1 C Test before putting into service .....C1

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1 General 1.1 Technical Service and Ordering Spare Parts STIHLER ELECTRONIC GmbH Tel: +49 (0) 711-720670 Julius-Hoelder-Str. 36 Fax: +49 (0) 711-7206757 70597 Stuttgart www.stihlerelectronic.de Germany E-mail: [email protected]

When making requests or ordering spare parts, please state the reference and serial number of the device in question. You can find them on the device rating plate:

Fig. 1 Information on the rating plate

1.2 Guarantee repairs

A 12-month guarantee is granted. During the guarantee period, the manufacturer will remedy all defects due to material or manufacturing faults free of charge either by repair or replacement. This guarantee does not cover any other damage. Damage due to misuse or improper handling, excessive force or regular wear is not covered by this guarantee. This also applies to interventions by persons other than those authorised by the manufacturer or if the original condition is changed. If damage occurs during the guarantee period, please clean the device and send it to a sales location near you or directly to STIHLER ELECTRONIC. The costs of transport and packaging are for the sender's account.

1.3 Liability

The manufacturer shall only be liable for the safety, reliability and performance of the device if all operating, maintenance and testing procedures comply with the procedures communicated by the manufacturer and are carried out by properly trained and qualified personnel; if -when necessary- only original spare parts are used to replace components; if assembly and repairs are only carried out by authorised personnel or an authorised service centre; if the electrical systems comply with the locally applicable instructions and regulations and the IEC requirements and if the device is used in keeping with the instructions of use for the intended purpose and at a suitable location.

CAUTION

The fact that technical documents or spare parts are made available does not imply any authorisation on the part of the manufacturer to open or repair the device.

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1.4 Important instructions All tests must be carried out by properly qualified staff, i.e. staff who have the relevant

expert professional training, knowledge and experience and are familiar with the relevant technologies, standards and local rules and regulations. Personnel who have to assess safety must be able to recognise any consequences and dangers caused by devices which do not comply with the requirements.

The measuring equipment must comply with the relevant standards. All repair activities, all tests carried out and their results must be recorded. The pattern approval is invalidated if the device is no longer in its original state. You

must therefore use only original spare parts. Due to the safety risks, electronic PWBs must only be repaired by the manufacturer. If

they are faulty they must always be replaced in their entirety.

2 Description of the warmer 2.1 Introduction

ASTOFLO PLUS enables fluids which are supplied to patients to be heated, to avoid and/or minimise hypothermia or to increase the patient's wellbeing. The technical design of the heating profile is such that, as a rule, no extra disposables are necessary.

2.2 Technical description

The warmer consists of a control unit with electronics and a removable (=plug-in) flexible heating profile. Control unit Contains the electronics including temperature control and monitoring, control and display elements for temperature selection and attachment device. Heating profile Heating profiles of different lengths (180 & 240 cm) and groove diameters (4-5 & 6-7 mm) are available. Strict tolerances are observed to enable these heating profiles to be mutually interchangeable and to be operated with any control unit. The heating profile has been extruded from high-quality silicone material. Heat conductors and a total of 3 temperature sensors (NTCs) run through a total of 6 channels. The outside has thermal insulation with silicone foam. In addition to safety, a long service life had the main priority when designing and manufacturing the heating profile. All functions (heating, temperature monitoring) are permanently monitored for cable breaks.

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2.3 Warmer components

Fig. 2 Warmer components

Power supply cord Supplies electricity from the mains outlet to the warmer Heating profile supply line

Connection between the device and the plug-in heating profile

Heating profile Transfers the heat from the heat conductor to the medium to be heated via the infusion line which has been introduced into the heating profile.

Control panel control buttons and LEDs

Control unit Contains power supply, operation, control and monitoring units for the heating profile

Heating profile socket

Plug

Attachment device Is used to attach the ASTOFLO PLUS to infusion stands or medical equipment rails.

Clip for heating profile secures the infusion line and the heating profile together

Test socket or alternatively connector for potential equalizationfor measuring the protective earth resistance

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2.4 Control panel components

Fig. 3 Control panel components

1 Stand-by LED lights up orange when the device is in STAND-BY.

2 Key - STAND-BY

Toggle between "Stand-by" and "Device on" modes. The following takes place in the "Device on" mode: The temperature display is activated The red alarm LED (9) flashes The green Power LED (4) flashes The acoustic alarm is activated

3 Key - START

Start of the heating process. The following takes place: The green Power LED (4) is constantly on The acoustic alarm is off The red alarm LED (9) goes off as soon as 33C (low temperature

alarm limit) is reached

4 Power LED flashes green when the device has been switched on, but the heating process has not started yet. Is permanently green when the START key has been pressed.

5 Temperature up key

6 Temperature down key

Arrow keys to select the required temperature setting. Raise or lower the heating profile temperature (from 33 C to 43 C) in 0.5C steps. In addition: Alarm test functions 1, 2 and 3, see chapter 5.1 Note: After selecting a temperature you have to confirm it by pressing the START key

within approx. 5 seconds. The power LED will flash during this time. If the temperature is not confirmed, the warmer will heat to the preset temperature.

7 "SET" temperature display

Shows the temperature selected by the operator.

8 Actual temperature display

Shows the current temperature of the heating profile. Note: "L" is shown at T< 20 C and "H" at T > 50 C.

9 Alarm LED Flashes red if there is an alarm condition or an error. If an excessive temperature occurs, the internal heating element is switched off and the acoustic alarm is activated at the same time.

6 Key - Temperature up

5 Key - Temperature down

3 Key - START

2 Key - STAND-BY

1 Stand-by LED

9 Alarm LED 8 Display - actual temperature

7 Display - temperature setting

4 Power LED

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2.5 Technical Specifications

ASTOFLO PLUS AFP EU/CH/CN/DK/TH

AFP UK/AU

AFP NA

AFP JA

Electr. connection 230VAC 10% 50-60Hz

240VAC 10% 50-60Hz

115VAC 10% 50-60Hz

100VAC 10%

50-60Hz Power consumption max. 90 W Protection class (IEC 60601) I Protective earth resistance 0.2 Equipment leakage current 0.2 mA Applied part (IEC 60601-1) Applied part of type BF (up to control unit SN 1999)

or CF (from control unit SN 2001) is supplied with 22 VAC by the device

Applied part leakage current BF (mains voltage on the applied part) < 5 mA

Applied part leakage current CF (mains voltage on the applied part) < 0.05 mA

Primary fuses (F3, F4) T1.25H 250 V (5 x 20 mm) T2H 250 V (5 x 20 mm) Secondary fuse (F1) T4H 250 V (5 x 20 mm) IP (IEC 60529) IPX1 Classification acc. to appendix IX IIb (rule 9)

Dimensions Height (without heating profile) Width Depth (with universal attachment)

280 mm 120 mm 175 mm

Weight 3 kg Operating mode Continuous operation Perm. ambient conditions during operation during storage

Relative humidity 10 % to 75 % 10 % to 75 % non-condensating

Temperature +16 C to +32 C - 20 C to +60 C

Air pressure 700 hPa to 1060 hPa 500 hPa to 1060 hPa

Temperature of the heating profile 33.0C to 43.0C ( 1 C) can be selected by the user in 0.5C steps

1st excessive temperature cut-off 2nd excessive temperature cut-off 3rd excessive temperature cut-off

45.0 C ( 1 C) 45.0 C ( 1 C) 45.0 C ( 1 C)

Low temperature alarm 33.0 C ( 1 C) The device is not intended for use in potentially explosive

atmospheres.

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2.6 Safety features and alarm systems Excessive temperature alarms To prevent the risk of overheating due to the temperature control being down, the ASTOFLO PLUS has a total of 3 excessive temperature cut-offs, 2 of which are fully independent of each other (see "Safety" circuit diagram). In the event of an excessive temperature, the heating is switched off and the alarm indication (red alarm LED and acoustic warning signal) is activated. An excessive temperature alarm is triggered if the temperature of the heating profile exceeds 45 C 1 C. If the alarm has been triggered, the device can only be started again (and the alarm status deactivated) if the temperature has fallen to below the alarm limit. Note: Excessive temperature alarms can also be triggered by exterior circumstances (external source of heat

such as sunlight or radiators). Low temperature alarm If the temperature of the heating profile drops to below 33C 1 C, "Low temperature" is indicated (red alarm LED flashing and the acoustic warning signal is activated for 15 seconds every 3 minutes). The heating is not switched off for this alarm.

Auto restart after power supply interruption After short mains power interruptions (up to 5 seconds) the warmer will continue to heat at the preset temperature as soon as the power returns. Note: The warmer cannot distinguish between actual power downs and intentional deactivation quickly

followed by reactivation. In the latter case, the warmer will restart automatically (without the START key having been pushed). To avoid this effect you must wait for approx. 30 seconds before switching the device on again.

Test facilities Pressing the START key triggers a test to check that relays K1 and K2 will safely cut the current in the event of a fault. Both safety cut-offs (ABS11/12 and ABS2) are sent fault signals in turn. The relays react to this with audible clicks. If the test is successful, the electronic system will switch on the heating. A double function of the "Temperature up" and "Temperature down" keys enables the operation of the 3 hardware cut-outs to be tested at all times.

Applied part (= heating profile) The applied part is a type "BF" or CF (see rating plate control unit), i.e. the electrical conductors in the heating profile have been insulated from the other parts of the medical device to such an extent that no higher current than the permissible patient leakage current flows when an undesired voltage from an external source comes into contact with the patient and is effective between the applied part and the earth circuit as a result. To simplify the measurement of patient leakage current, the secondary side of the control unit will be connected directly.

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2.7 Description of electronic components

Fig. 4 "Functional" circuit diagram

Mains supply PWB The mains supply PWB serves to enable flexible and easy adjustment of the device to different mains voltages (100-115-230-240 VAC). To achieve this, the relevant tap of the primary winding of the toroidal core transformer is connected to the power supply cord input by means of flat connectors.

Toroidal core transformer The toroidal core transformer has been designed with the different mains voltages (100-115-230-240 VAC) in mind so that different taps of the primary winding always lead to an output voltage of 22 VAC with the mains voltage referred to. In addition, statically insulated copper foil has been integrated as screen. This screen is purely a static screen to dampen mains interruptions and voltage peaks in the high-frequency band (EMC); it is connected to the protective earth conductor.

Power PWB In principle, the power PWB serves to supply the power for or switch off the heating of the heating profile. The power PWB can be divided into several function blocks:

Generation of 5V DC for the processor Zero crossing detection Heating power switch (on/off via MOS FET) Power down logic to restart the device after a short power failure Two relays for the two independent safety circuits to switch off the secondary voltage (heating)

Heating profile

Toroidal core Power PWB Mains supply PWB Display PWB

Test socket

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Display PWB The display PWB serves as an information display for the user, a control unit and as an electronics control. It can be subdivided as follows: Indication of the current temperature of the heating profile, as well as the preselected target temperature. Two independent hardware cut-outs to switch off the heating in the event of excessive temperature on one of the 3 NTCs or a cable break in the NTC wires. Device control keys Controller with program Preparation of the analogue temperature measurement signal (NTC temperature sensors)

Fig. 5 "Electronic/thermal safety" circuit diagram

Power PWB

Display PWB

Heating profile

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3 Cleaning and disinfection CAUTION

When handling detergents and disinfectants observe your own safety and use the relevant personal safety equipment. To prevent damaging the warmer, do not immerse the warmer or the heating profile in any fluids. do not disinfect the warmer with steam (i.e. in an autoclave), hot air or

thermo-chemical cleaning solutions, only disinfect the heating profile with a disinfectant based on alcohol, if using a ready-to-use disinfectant only use an alcohol-based disinfectant

with a low aldehyde content (< 0.2 %).

Clean and disinfect the warmer as required or when it gets dirty, as follows: 1. Pull the mains plug from the power outlet. 2. Clean all surfaces, including the groove in the flexible heating profile,

with a soft cloth/cotton buds and a mild soap solution. 3. Either disinfect the housing of the control unit with a 1/4% solution of bleaching agent

(sodium hypochlorite) or one of the recommended disinfectant. 4. Only disinfect the heating profile with an alcohol-based disinfectant or with one of the

recommended disinfectants.

Disinfectant Manufacturer Disinfectant Manufacturer ClearSurf Fresenius

Medical Care Mikrozid AF Liquid Schlke &

Mayr GmbH Meliseptol B. Braun

Melsungen AG Bacillol plus

Biguamed Perfekt N Desomed Dr. Trippen GmbH

Mikrobac forte Bode Chemie GmbH

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4 Troubleshooting Part I: When putting the warmer into use Action If you

Correct device reaction Does the following take place?

Incorrect device reaction Possible cause(s) Remedy

1.1.1 Faulty power outlet Select another power outlet

1.1.2 Faulty power supply cord

Replace the power supply cord

1.1.3 Faulty primary fuse Replace the primary fuse

1.1.4 Faulty toroidal core transformer

Replace the toroidal core transformer

1 connect the warmer to the power outlet and observe the control panel

The orange stand-by LED lights up if the warmer was disconnected from the mains for 30 seconds or more*.

1.1 no reaction

1.1.5 Faulty power PWB Replace the power PWB

2.1.1 Key was pressed too briefly

Press and hold the stand-by key for at least 1 second (this is a built-in safety function to prevent unintentional activation)

2.1 no reaction

2.1.2 Electronic defect Replace the electronic PWBs

2 press the stand-by key

the orange stand-by LED goes out temperature display or "L" is

displayed red alarm LED and green power

LED flash acoustic alarm is activated

2.2 Temperature display is incomplete, distorted or not visible at all

2.2.1 Temporary display control failure

Switch off the warmer with the stand-by key again and switch it on again

*otherwise the warmer may immediately switch to operating mode (also see chapter 2.6 ->Auto restart after power supply interruption)

20.4

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Action If you



3.1.1 No heating profile connected

Connect the heating profile and start the warmer again

3.1.2 Cable break in heating profile (NTC/heating)

Replace the heating profile

3.1.3 Cable break in the plug-and-socket connection/supply line to the heating profile

Replace the heating profile supply line

3 press the Start key

the automatic relay test generates an audible click

green power LED is lit permanently the acoustic alarm goes off the red alarm LED shows the "Low

temperature alarm" below 33C and then goes out

temperature display slowly goes up until the "SET" temperature is reached

3.1 Warmer stays in the alarm status (acoustic alarm and red alarm LED)

3.1.4 Electronic defect Replace the electronic PWBs

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Part II: During operation Action If you

Device reaction and the following happens?

Possible cause(s) Remedy

4.1 Heating profile too hot due to external heat source (sun, radiator).

Eliminate the influence of the external heat source and let the heating profile cool down to below 45C until the warmer can be restarted.

4.2 Heating profile too hot because the temperature of the fluid to be heated is too high.

Let the fluid and the heating profile cool down until the warmer can be restarted.

4 use the warmer and the acoustic alarm suddenly sounds

Excessive temperature alarm the red alarm LED flashes the green power LED flashes the temperature display alternates

4.3 Electronic defect Replace the electronic PWBs

5.1 The input temperature of the fluid to be heated is too low or the flow rate is too high.

Lower the flow rate or pre-heat the fluid in another way

5 use the warmer and the acoustic alarm sounds every 3 minutes

Low temperature alarm the red alarm LED flashes the acoustic alarm is sounded for

15 seconds every 3 minutes

5.2 The room temperature or the heating profile temperature is far below the permissible ambient temperature

Find a suitable environment for the application

45.8

32.8

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Action If you

Device reaction and the following happens?

Possible cause(s) Remedy

6.1 Defective heating profile (NTC or heating broken)


6.2 Faulty plug-and-socket connection/supply line to heating profile

Replace the heating profile supply line

6 use the warmer and the acoustic alarm suddenly sounds

Cable break alarm the red alarm LED flashes the green power LED flashes the display shows an "L" 6.3 Electronic defect Replace the electronic PWBs

Part III: During the safety and operation check Action If you



7.1.1 Test box defective Check the test box and have it repaired/adjusted if there is a deviation.

7 check the accuracy of the temperature display

See testing instructions chapter 3.3 display accuracy

7.1 The temperatures shown are outside the tolerance.

7.1.2 Electronic defect Replace the display PWB or have it repaired

44.0 41.5

L

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Action If you




8 check the temperature control

See testing instructions chapter 3.3 temperature control

8.1 The warmer cannot be started or fails to react with an alarm or fails to show "E26".

8.1.2 Electronic defect Replace the display PWB/power PWB or have it repaired


9

check the excessive temperature alarms

See testing instructions chapter 3.3 excessive temperature alarms

9.1 Warmer does not react with an alarm or does not display "E16".


10 check the NTC cable break alarms

See testing instructions chapter 3.3 NTC cable break alarms

10.1 Warmer does not react with an alarm or does not display "E16".


t

T

t

T

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Action If you



test the excessive temperature cut-offs

See testing instructions chapter 5.1 operation of the excessive temperature cut-off 1 (H1)


11


11.1 The warmer does not react as described on the left


12.1 The warmer switches to the stand-by status:

12 test the auto restart after power supply interruption

See testing instructions chapter 5.2 function of auto restart after power supply interruption


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Action If you



13.1.1 Measurement not sufficiently accurate due to varying environmental conditions or an inaccurate room thermometer.

Provide better measuring conditions and repeat the measurement

13 check the temperature sensors of the heating profile

See testing instructions chapter 4.2 measuring the temperature sensors

13.1 The difference between the highest and the lowest resistance values is more than 200 Ohm

13.1.2 Temperature sensor(s) faulty


14.1.1 There is an interruption in the power supply cord or in the warmer interior

Find the interruption and replace the faulty part

14.1.2 The protective earthed contactor contacts in the mains plug are dirty/corroded

Clean the contacts or replace the power supply cord

14 measure the resistance of the protective earthed conductor RSL

See testing instructions chapter 3.2.1 protective earth resistance

14.1 The measured value is higher than the indicated limit value or fluctuates when the power supply cord is moved

14.1.3 The test socket on the warmer is dirty

Clean or replace the test socket

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Action If you



15.1 The measured value is higher than the limit value

15.1.1 Faulty insulation of the mains plug or the power supply cord or mains supply PWB or toroidal core transformer

15

measure the equipment leakage current IEL

See testing instructions chapter 3.2.2 Equipment leakage current

15.2 The measured value is approximately 0.0 A

15.2.1 Faulty electrical connection between screen and protective earthed conductor or defective power supply cord

Replace/renew the fault part

16.1.1 Faulty screen in toroidal core transformer

Replace the toroidal core transformer 16 measure the applied part leakage current IAL

See testing instructions chapter 3.2.3 Applied part leakage current

16.1 The measured value is higher than the limit value

16.1.2 Faulty electrical connection between screen and protective earthed conductor or defective power supply cord

Correct the electrical connection

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5 Repairing/replacing parts and components

WARNING

If the housing is opened the sealing label will break. This will invalidate all guarantee claims.

Take the proper ESD prevention measures before touching electronic PWBs (e.g. ESD bracelet).

Immediately store removed electronic PWBs in ESD-safe containers or bags. Only use original spare parts (see the spare parts list in the appendix). Using

other parts invalidates the pattern approval. To enable traceability, the serial numbers of electronic PWBs which have

been replaced must be recorded. Lay the cables in accordance with the applicable instructions and regulations;

this is an integral element of the safety of the device. Repairs must only be carried out by trained technical staff, observing these

service instructions. Always carry out the safety and operating tests after making repairs and

before using the device on patients. All tests must be passed! If any errors are found, the warmer must be

repaired before using it on patients. Failure to detect or remedy errors can lead to death, serious injury, damage to the device or faulty operation.

Clean surfaces for adhesive labels with isopropanol (100 %). The heating profile does not contain any parts which can be repaired. If any

defects occur, it has to be repaired/replaced by the manufacturer.

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5.1 Opening the control unit Necessary tool 0.8 x 4 mm screwdriver

1. Pull the mains plug from the power outlet. 2. Loosen the 4 screws on the rear.

3. Separate the two housing halves and

4. lay the front housing half on the left of the rear housing half.

5.2 Disassembling the front housing section a) Removing the insulation sheet Necessary tool:

-

1. Carefully lift the insulation sheet holding it by its underside near the distance pins.

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b) Removing the connecting cable Necessary tool: Tx 10 torx screwdriver

1. Disconnect the connectors from the display and power PWBs and

remove the cable clip* by loosening the screw. Remove the black plastic block with the connecting cable from the housing.

*not fitted on all warmers

2. Disconnect the transformer connectors from the power PWB

c) Removing the PWBs Necessary tool: Tx 10 torx screwdriver

1. Loosen the fixing screws, 2. hold the PWBs in the housing with one hand and turn the unit

upside down.

3. Lift the housing away from the PWBs.

Careful: the LCD display is only connected to the PWB by the connecting cable. Do not subject this connection to a load!

4. Secure the LCD display to the PWB by means of an elastic band for transport and storage purposes.

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d) Removing the display frame Necessary tool: -

1. Take the display frame out of the housing from the top of the housing.

5.3 Assembling the front housing section a) Installing the display frame Necessary tool: -

1. Lay the display frame in the housing with the correct side up.

b) Installing the PWBs Necessary tool: Tx 10 torx screwdriver

1. Hold the housing and the PWB in a vertical position and move

them together. Slightly tilt the display PWB towards the housing, so that the display locates in the holes in the display frame. Make sure that the expanded rubber underlay which has to press the display against the housing is still located on the PWB.

2. Slowly insert the PWB and check that it is located correctly: if you move the PWB carefully it must always rest on the plastic supports in the housing.

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3. Carefully lay down the unit and secure the PWBs with the short screws (3x6).

c) Installing the connecting cable Necessary tool: Tx 10 torx screwdriver

1. Plug in the NTC connector such that the marking on the

connector housing is pointing to the power PWB. Bend the wire strands down.

2. Plug in the flat connectors of the heating and check that they are tight. Then feed the cable past the outside of the distance pin and install the plastic block in the hole in the housing. Pay attention to the proper orientation: the locking lug on the cable connector must, as a rule, point to the rear of the device.

3. Secure the connecting cable with the cable clip and the long screw (3x10) to the remaining hole in the PWB.

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5.4 Disassembling the rear housing section a) Removing the insulation sheet Necessary tool: SW10 open-ended or ring spanner

1. Loosen the plastic nut and 2. remove the insulation sheet by pulling it upwards and rotating it in a clockwise direction.

b) Removing the power supply cord Necessary tool:

0.5 x 3 mm screwdriver Tx 10 torx screwdriver

1. Loosen the screws of the power supply terminal. 2. Loosen the draw relief screws.

3. Straighten the wires and pull the power supply cord out of the housing/anti-kink sleeve.

c) Removing the toroidal core transformer Necessary tool: SW10 open-ended or ring spanner

1. Loosen the hexagonal nut. 2. Disconnect the flat connectors from the mains supply PWB.

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3. Remove the toroidal core transformer.

d) Removing the mains supply PWB Necessary tool: -

1. Disconnect the connection to the test socket (or alternatively to the connector for potential equalization). 2. Remove the mains supply PWB.

e) Removing the attachment device Necessary tool: Tx 20 torx screwdriver

1. Loosen the screws. 2. Lift the housing away from the attachment device. f) Removing the clip for the heating profile Necessary tool: Flat pliers

1. Pull the clip for the heating profile outwards and hold the metal pin

with flat pliers. Unscrew the clip for the heating profile from the pin by turning it in an anti-clockwise direction.

Note: the clip for the heating profile can also be removed from the complete device.

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5.5 Assembling the rear housing section a) Installing the clips for the heating profile Necessary tool: Flat pliers

1. Pull the metal pin out, hold it with flat pliers and screw the clip for

the heating profile onto the screw thread in a clockwise direction. Caution: plastic thread! Tighten with care.

Note: the clip for the heating profile can also be removed from the complete device.

b) Installing the attachment device Necessary tool: Tx 20 torx screwdriver

1. Lay the insulation sheet in the housing. 2. Insert the countersunk head screw through the "Inner plate" from the

bottom and

3. align the plate and the attachment holes inside the housing. 4. Secure the inner plate, the housing and the attachment device with 4 Torx screws.

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c) Installing the mains supply PWB Necessary tool: -

1. Make sure that the insulation sheet is in the housing. 2. Make sure that the fuse values comply with the specifications on the mains supply PWB.

3. Insert the mains supply PWB.

4. Make the protective earthed conductor connection between the test socket (or alternatively between the connector for potential equalization) and flat plug "X8".

d) Assembling the power supply cord Necessary tool:

0.5 x 3 mm screwdriver Tx 10 torx screwdriver

1. Straighten any wire strands as required and thread the power

supply cord with the strands forwards through the anti-kink sleeve and the housing.

2. Make the electrical connections: Wire Connection

green/yellow blue N

brown L

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3. Attach the strain relief with 2 Torx screw (3 x 10).

d) Installing the toroidal core transformer Necessary tool:

SW10 open-ended or ring spanner poss. flat pliers

1. Thread the central hole of the transformer assembly disk onto the

screws and place it on the inner plate. 2. Make sure that the transformer assembly disk is located securely in

the circular recess of the inner plate.

Connection Rated voltage X2 X3 X4* X5* X6*

100 V [JA] blue brown grey violet yellow 115 V [NA] blue grey brown violet yellow

230 V [EU,DK,CN,CH,TH] blue violet brown grey yellow 240 V [UK, AU] blue yellow brown grey violet

3. Plug in the flat connectors of the toroidal core transformer on the power PWB in accordance with the rated voltage (see the adjacent table).

*These connections have no function and only serve to hold the connection cable which is not necessary.

4. Plug the flat connectors of the transformer screen winding on the

flat plugs marked "X1". 5. Install the washer and the hexagonal nut and tighten the nut with

care. If necessary, hold the countersunk head screw with flat pliers.

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e) Installing the insulation sheet Necessary tool: -

1. Install the insulation sheet with the correct side up. 2. Press the insulation sheet on the toroidal core transformer and

install and finger-tighten the plastic cap nut.

5.6 Assembling the control unit Necessary tool: 0.8 x 4 mm screwdriver

1. Lay the pre-assembled front housing section to the left of the pre-

assembled rear housing section. 2. Connect the two free connecting cables of the toroidal core

transformer with the flat connectors marked "TR" on the power PWB.

3. Check that the connecting cable is tight and insert the insulation

sheet in the housing. Lightly push the insulation sheet onto the distance pins.

4. Take one housing half in each hand and hold them together by their long sides.

Page - 32 - Rev. 4 09/2009


5. Before finally assembling the housing check:

the location of the black plastic block in the hole in the housing the cable run the flush alignment of the distance pin to the sleeve opposite it

6. Fold both housing halves together* and check that the seam is tight all around. *If the housing halves are new you may have to press them into each other with force.

7. Screw the two housing halves together with 4 slotted-head screws. Tighten the screws with care!

8. Carry out the safety and function checks described in appendix B and record the test results.

Rev. 4 09/2009 Page - 33 -


Appendix A Spare parts list B Testing instructions (safety and function checks) C Test before putting into service

Page - 34 - Rev. 4 09/2009


Ersatzteilliste / Spare parts list ASTOFLO PLUS (AFP)

A Ersatzteilliste/Spare parts list Bestell-Nr. Order no

Abbildung Figure

Bezeichnung Description

0560.4000.10

Gehuse vorne Front housing

0560.4200.00

Frontplatte ASTOFLO PLUS

Frontpanel ASTOFLO PLUS

0560.4000.20-PA

Gehuse hinten mit Potentialausgleichs-anschluss

Rear housing with equipotential terminal

0560.4000.26

Kappe fr Ausfhrung JA-NA

Cap for version JA-NA

0860.4000.26

Kappe fr Ausfhrung AU-CH-DK-EU-TH-UK

Cap for version AU-CH-DK-EU-TH-UK

0560.3120.01

Platte innen Inner plate

Rev. 4 09/2009 Seite - A1 -


Seite - A2 - Rev. 4 09/2009

Bestell-Nr. Order no

Abbildung Figure Bezeichnung Description

0560.2000.01

Leistungsplatine Power PWB

0560.2000.02

Displayplatine Display PWB

0760.4000.03

Displayrahmen Display frame

0760.5101.00

Befestigungsvorrichtung komplett mit Profilklammer

Attachment device complete with Clip for Heating Profile

0660.8301.00

Profilklammer Clip for Heating Profile

9850.5100.00

Rndelschraube Knurled screw




0860.2050.00

Ringkerntransformator 100-115-230-240 VAC inkl. Netzanschlussplatine & Isolationsplatte 2

Toroidal core transformer 100-115-230-240 VAC including Mains Supply PWB & Insulation sheet #2

0860.2100.11

Netzanschlussplatine inkl. Isolationsplatte 2 & Set Sicherungen

Mains Supply PWB including Insulation sheet #2 & Set Fuses

0860.2107.00

Set Sicherungen fr Ausfhrung AU-CH-DK-EU-TH-UK (230/240 VAC) & JA-NA (100/115 VAC)

Set Fuses for version AU-CH-DK-EU-TH-UK (230/240 VAC) & JA-NA (100/115 VAC)

0560.4100.01

Isolationsplatte 1 Insulation sheet #1

0560.2100.02


0560.4100.03


230/240 VAC

100/115 VAC

Rev. 4 09/2009 Seite - A3 -


Seite - A4 - Rev. 4 09/2009



0560.2110.00

Testbuchse Test socket

0560.2111.00

Kabel fr Testbuchse Cable for test socket

0560.4184.00

PA-Anschluss Equipotential terminal

9750.4100.10

Netzanschlussleitung EU (SCHUKO-Stecker CEE 7/7)

Power Supply Cord EU

0350.4100.23

Netzanschlussleitung DK (Afsnit 107-2-D1-Schraubstecker)

Power Supply Cord DK

0760.4210.02

Netzanschlussleitung TH (6-15P) Power Supply Cord TH




9750.4100.16

Netzanschlussleitung CH (Schweizer Stecker) Power Supply Cord CH

9750.4100.12

Netzanschlussleitung UK (BS-Stecker)

Power Supply Cord UK

0760.4210.01

Netzanschlussleitung AU (AS3112-Schraubstecker)

Power Supply Cord AU

9750.4100.17

Netzanschlussleitung JA/NA Power Supply Cord JA/NA

0850.4100.40

Netzanschlussleitung CN Power Supply Cord CN

0560.8220.00

Zuleitung Wrmeprofil Cable for Heating Profile

Rev. 4 09/2009 Seite - A5 -


Seite - A6 - Rev. 4 09/2009



WP2418

Wrmeprofil 2418 Heating Profile 2418

WP2424


WP2618


WP2624


0560.6001.01

Verpackung AFP komplett Packaging AFP complete

0560.9600.11

Service-Anleitung

0560.9600.12

Service Instructions

0860.9500.00

ASTOFLO PLUS System Testbox inkl. Prfanweisung

ASTOFLO PLUS System Testbox including Testing Instructions

Testing Instructions

Par

t No.

056

0.96

10.1

2 R

ev.4

09/

2009

Stihler Electronic 70597 Stuttgart Germany

Page - B2 - Rev. 2 04/2009

Testing Instructions PRISMAFLO II (PF2)

Manufacturer: STIHLER ELECTRONIC GmbH Julius-Hoelder-Strasse 36 70597 Stuttgart Germany Tel. +49 (0) 711-720670 Fax +49 (0) 711-7206757 www.stihlerelectronic.de E-Mail: [email protected]

- 3 -

Testing Instructions ASTOFLO PLUS

List of contents Chapter 1: Preface ...............................................................................................................................4

1. Differences of the safety check with and without System Testbox................. 4 2. Preparation for testing the heating profile ...................................................... 4

Chapter 2: Safety check without System Testbox................................................................................5 1. Preface........................................................................................................... 5 1.1 Necessary accessories .................................................................................. 5 1.2 Important information ..................................................................................... 5 2. Visual check................................................................................................... 6 3 Inspection of the control unit ASTOFLO PLUS .............................................. 6 3.2 Test of the electrical safety (pursuant IEC 62353) ......................................... 6 4 Inspection of the heating profile of ASTOFLO PLUS ..................................... 7 4.1 Measuring the temperature sensors .............................................................. 7 5 Inspection of the combination control unit/heating profile............................... 8 5.1 Operation of the excessive temperature cut-offs............................................ 8 5.2 Test of the excessive temperature cut-offs .................................................... 9 5.3 Function of Auto restart after power supply interruption............................... 10 A Table Temperature NTC-Resistance ...................................................... 11 B Test protocol (example) - measurements taken without System Testbox.... 12

Chapter 3: Safety check with the System Testbox.............................................................................13 1. The ASTOFLO PLUS System Testbox ........................................................ 13 1.1 Intended use ................................................................................................ 13 1.2 Operating elements...................................................................................... 14 2 Preface for safety and function checks ........................................................ 15 2.1 Necessary accessories ................................................................................ 15 3 Inspection of the control unit ASTOFLO PLUS ............................................ 16 3.1 Visual check................................................................................................. 16 3.2 Test of the electrical safety (pursuant IEC 62353) ....................................... 16 3.2.1 Protective earth resistance........................................................................... 16 3.2.2 Equipment leakage current .......................................................................... 17 3.2.3 Applied part leakage current ........................................................................ 17 3.3 Display accuracy, temperature control, excessive temperature alarms and

NTC cable break alarms............................................................................... 18 4 Inspection of the heating profile of ASTOFLO PLUS ................................... 23 4.1 Visual check................................................................................................. 23 4.2 Measuring the temperature sensors ............................................................ 23 5 Inspection of the combination control unit/heating profile............................. 25 5.1 Operation of the excessive temperature cut-offs.......................................... 25 5.2 Function of Auto restart after power supply interruption............................... 26 6 Verification of the System Testbox............................................................... 27 A Table Temperature NTC-Resistance ...................................................... 29 B Test protocol (example) - measurements taken with System Testbox......... 30 C Verification Protocol for System Testbox ..................................................... 31

- 4 -


Chapter 1: Preface

1. Differences of the safety check with and without System Testbox All required functional and safety checks of the control unit and the heating profile can be carried out with the System Testbox. We recommend the Testbox for users having more units to check and want to check them simple and quickly. In principle it is possible to carry out the biannual safety check without the System Testbox (see chapter 2).

2. Preparation for testing the heating profile The safe operation of the unit depends on the accuracy of the temperature sensors. The 3 sensors can be tested by a comparison of the sensor temperatures with the room temperature. This is possible when the profile is cooled down to room temperature (20 26). All measurements can only be carried out when the room temperature is very constant (a small fan helps to uniform temperature distribution) and when the profile is hanging like described below. Un-uniform temperature distribution because of opened windows or doors, incoming sunrays or other heat sources like heater fans disable this measurement. It is impossible to carry out the measurements with the heating profile lying on the table. Because the sensors are fixed in the groove of the heating profile it should be avoided to touch with the fingers in the groove while measuring.

TIPP

When the heating profile is hanging like described below it is possible to carry out the measurements after a 30 minutes cooling down time. Best is to prepare the profiles in the evening then they can be tested quickly at the next morning.

WARNING

After making repairs all tests must be carried out with the System Testbox.

The heating profile must hang concentric and the thermometer for the room temperature must hang like described in the picture and the table. Only so it is assured that the sensors in the heating profile cool down quickly to room temperature. After that the measurements can be carried out.

Caution: The position of the thermometer for the room temperature is dependent on the type of heating profile.

Profile X WP2418 30 cm WP 2424 50 cm WP 2618 50 cm

WP 2418H 70 cm WP 2618H 70 cm

PF2-WP2418

70 cm

PF2-WP2618

70 cm

X

- 5 -


Chapter 2: Safety check without System Testbox

1. Preface Tests must be carried out within the periodic safety inspection (every 24 months) extend: - visual check control unit and heating profile - test of electrical safety pursuant IEC 62353 - temperature sensors of the heating profile - heating wire resistance value of the heating profile - operation of the safety temperature cut-offs - test of the cut-off temperatures - auto restart after power supply interruption

WARNING

All tests must be passed! If any errors are found, the warmer must be repaired before using it on patients. Errors not being detected or not being remedied can lead to death, serious injury, damage to the device or faulty operation.

You can find instructions on how to perform the various tests below.

1.1 Necessary accessories Table "Temperature-NTC-Resistance" (see attachment A) Test report form to record the results (see attachment B) Protective earthed conductor tester, insulation tester and leakage current measuring

instrument in accordance with IEC 62353 Multimeter with an accuracy of 0.3 % in the measuring range 4 to 6 k

(measuring of temperature sensors) and 0.25 % in the measuring range up to 10 (measuring of heating wire resistance)

Thermometer with an accuracy of 1 C in the range of 20 to 26 C usual hair-dryer

1.2 Important information Since in certain circumstances dangerous conditions may occur for the tester we recommend using special safety testing instruments for medical equipment for the following tests.

TIPP

To avoid unnecessary waiting periods we recommend hanging first the heating profile like described above. The equalisation of the temperatures needs max. 30 to 50 minutes and is dependent on the temperature of the heating profile at the beginning and the environment conditions.

- 6 -


2. Visual check Check that the following parts of the device are in a good and safe condition; replace them if required:

complete and legible labelling housing without damage front panel (since the front panel prevents fluid from entering it is important that the

front panel is in a good condition and that its full surface adheres to the housing) power supply cord and mains connector insulation in a defect-free state, contacts are clean and show no corrosion heating profile without damage or scratches

3 Inspection of the control unit ASTOFLO PLUS 3.2 Test of the electrical safety (pursuant IEC 62353)

WARNING

Since in certain circumstances dangerous conditions may occur for the tester we recommend using special safety testing instruments for medical equipment for the following tests.

Pos Measurement (True RMS) Use connection to electrical safety analyzer

Limit value

1 Protective earth resistance Connection 1 and 3 0.3 2 Equipment leakage current (Alternative method) Connection 1 and 2 1 mA 3 Applied part leakage current (Alternative method) Connection 1 and 2 0.05 mA

Caution

Do not insert anything else in the socket since this might damage the fine contact springs.

Connection 2

Connection 1

OK

Top view: Connector for heating profile

OKOK

OK

OK

Connection 3 Green yellow test socket on backside

The test tip of the measuring lead (Connection 2) must contact carefully one of the 5 sockets of the cable connector. These sockets are marked with OK in the illustration.

- 7 -


4 Inspection of the heating profile of ASTOFLO PLUS 4.1 Measuring the temperature sensors

1. Separate the heating profile from the control unit.

2. The heating profile must hang like described above.

3. Ensure a constant ambient

temperature.

4. Connecting heating profile and multimeter:

Contact consecutively the two pins of each NTC in the socket with the measuring tips of the multimeter and

ACHTUNG

The pins are very delicate. Please contact them carefully.

5. measure and record the resistance values for NTC11, NTC12 and NTC2.

Measure and record the room temperature.

6. Read the resistance value

corresponding to the room temperature from the table in chapter 9.

7. The 3 resistance values measured and the resistance value of the room temperature must be within a 200 Ohm range (= 0.5C).

and

all resistance values (including the value of the room temperature) must be within a range of 400 Ohm (= 1C).

e.g. NTC11 = 5514 NTC12 = 5554 NTC2 = 5570 5570 5514 = 56 (ok, because 200 ) Troom = 22.1C = 5594 5594 5514 = 80 (ok, because 400 )

t

T

t

T

NTC11

NTC2

NTC12

NTC2

NTC12 NTC11

Lowest value

Highest value

21,4C = 5747

- 8 -


5 Inspection of the combination control unit/heating profile 5.1 Operation of the excessive temperature cut-offs

Cut-off 1 (H1)

1. In normal operation (with the heating profile) press and hold the "Temperature up" button for several seconds.

2. The following must take place: the display shows "H1" the power LED blinks the alarm LED blinks the acoustic alarm sounds

3. Press the START key to switch the warmer back to normal operation.

Cut-off 2 (H2)

1. Press and hold both the "Temperature down" and "Temperature up" keys simultaneously for several seconds.

2. The following must take place:

the display shows "H2" the power LED blinks the alarm LED blinks the acoustic alarm sounds


8. Measure the heating wire resistance value at the indicated pins.

9. The resistance value of the heating wire must be within 6.5 +/- 0.5 .

Note: Several multimeters could show measuring variations because of inductance of leads.

H1

H2

- 9 -


Cut-off 3 (H3)

1. In normal operation press and hold the "Temperature down" key for several seconds.



3. Use the key to switch the warmer to Stand-by.

5.2 Test of the excessive temperature cut-offs

1. Connect the heating profile and start the unit. Use the key to select the highest temperature to be set (usually 43C).

2. Press the START key to put the device into use.

3. Determine the locations of the temperature sensors (at two points): the heating profile is rigid where the sensors are located (anti-kink protection). The sensors are located within the last 50 cm of the profile, measured from its end.

4. Both locations have to be warmed up

slowly* with a hair-dryer until the unit reaches excessive temperature alarm condition.

* When warming up from "outside" it takes some time until the heat reaches the sensor. Avoid it to warm up too much because it would create an overshoot and a long waiting time for cooling down.

H3

location of sensors

- 10 -


5. During the cooling down time the

START key must be pressed again and again. The temperature at which it is possible to start the unit * (the alarm condition is cancelled) must be noted.

*Because of the automatic internal start-test it is necessary to press the start key for a moment.

6. Both excessive temperature cut-offs must be in between 45.0 C 1 C.

5.3 Function of Auto restart after power supply interruption

During operation pull the plug from the power outlet (to simulate a power breakdown) and plug it in again within 5 seconds. The warmer must automatically switch on again with the same setting and must start without you having to press any keys.

45.2C 41.0C

- 11 -


A Table Temperature NTC-Resistance Temperature [C] Resistance [] Temperature [C] Resistance []

20 6068 25.1 4981 20.1 6044 25.2 4962 20.2 6021 25.3 4943 20.3 5997 25.4 4925 20.4 5974 25.5 4906 20.5 5951 25.6 4888 20.6 5928 25.7 4869 20.7 5905 25.8 4851 20.8 5882 25.9 4832 20.9 5859 26 4814

21 5838 26.1 4796 21.1 5814 26.2 4778 21.2 5792 26.3 4760 21.3 5769 26.4 4742 21.4 5747 26.5 4724 21.5 5725 26.6 4707 21.6 5703 26.7 4689 21.7 5681 26.8 4671 21.8 5659 26.9 4654 21.9 5637 27 4636

22 5616 27.1 4619 22.1 5594 27.2 4602 22.2 5573 27.3 4585 22.3 5551 27.4 4568 22.4 5530 27.5 4550 22.5 5509 27.6 4533 22.6 5488 27.7 4517 22.7 5467 27.8 4500 22.8 5446 27.9 4483 22.9 5425 28 4466

23 5404 28.1 4450 23.1 5384 28.2 4433 23.2 5363 28.3 4417 23.3 5343 28.4 4400 23.4 5323 28.5 4384 23.5 5302 28.6 4368 23.6 5282 28.7 4352 23.7 5262 28.8 4336 23.8 5242 28.9 4320 23.9 5222 29 4304

24 5202 29.1 4288 24.1 5183 29.2 4272 24.2 5163 29.3 4256 24.3 5144 29.4 4240 24.4 5124 29.5 4225 24.5 5105 29.6 4209 24.6 5086 29.7 4194 24.7 5066 29.8 4178 24.8 5047 29.9 4163 24.9 5028 30 4142

25 5000

- 12 -


B Test protocol (example) - measurements taken without System Testbox Ausfhrende Stelle/Carried out by:

Prfprotokoll Test Protocol ASTOFLO PLUS

Stammdaten/Master data SN: Auftrags-Nr./Repair reference: Hersteller/Manufacturer:

Gert/Device: Schutzklasse/Protection class:

STIHLER ELECTRONIC GmbH Julius-Hoelder-Str. 36

70597 Stuttgart Germany

AFP200 100V 115V

230V

240V I

Wrmeprofil/Heating profile: ohne/without Anwendungsteil/Applied part:

WP2- 418 618 424 624 BF

CF

Prfung vor Inbetriebnahme (Bezugwert)/ Test before putting into service (reference value) Wiederholungsprfung/ Recurrent Test

Sichtprfung/Visual inspection ok n.ok ok n.okAufschriften/Labeling Frontplatte/Front panel

Gehuse/Housing Befestigungsvorrichtung/Attachment device

Netzanschlussleitung/Power supply cord Wrmeprofil/Heating profile Prfung Elektrische Sicherheit/Test data electrical safety Prfgert/Test equipment:

Messungen/Measurements: Messwert/ measured value Min Max ok n.ok

Schutzleiterwiderstand/Protective earth resistance: - 0,3 Gerteableitstrom/Equipment leakage current mA 0,010 mA 1 mA

BF CF Ableitstrom vom Anwendungsteil/ Applied part leakage mA 0,005 mA 5 mA 0,050 mA

Funktionstest/Functional Test ok n.okTR: NTC11: NTC12: NTC2:

CTemperatursensoren des Wrmeprofils/ Temperature Sensors of the Heating Profile B, C, D innerhalb 200 Ohm/ B, C, D within 200 Ohms A, B, C, D innerhalb 400 Ohm/ A, B, C, D within 400 Ohms

= A

B

C

D

Heizwiderstand/Heating wire resistance 6.5 Ohm 0.5 Ohm

bertemperaturabschaltungen H1-H2-H3/ Excessive temperature cut-offs H1-H2-H3 Abschalttemperaturen/Cut off temperatures innerhalb/within 45,0 C 1 C

1. C

2. C

Netzausfallberbrckung 5 sek./Auto restart after power supply interruption 5 sec. Gesamtbeurteilung/Overall assessment: Sicherheits- und Funktionsmngel wurden nicht festgestellt!/ No safety or functional deficiencies were detected! Kein direktes Risiko, die entdeckten Mngel knnen kurzfristig behoben werden!/ No direct risk, deficiencies detected may be corrected on short term! Gert muss bis zur Behebung der Mngel aus dem Verkehr gezogen werden!/ Equipment shall be taken out of operation until deficiencies are corrected! Gert entspricht nicht den Anforderungen Modifikation/Austausch von Komponenten/Auerbetriebnahme wird empfohlen!/ Equipment does not comply - Modification / Exchange of components / Taking out of service - is recommended! Bemerkungen/Comments: Datum der nchsten Wiederholungsprfung/Date of next recurrent test:

Prfer/Tester: Datum/Date: Unterschrift/Signature:

- 13 -


Chapter 3: Safety check with the System Testbox

1. The ASTOFLO PLUS System Testbox

1.1 Intended use The ASTOFLO PLUS System Testbox shall be used for inspection of the ASTOFLO PLUS warmer exclusively. The inspection shall be conducted after corrective maintenance/reparation or during the periodic safety check of the warmer. All required functional and safety checks of the control unit and the heating profile can be carried out with the ASTOFLO PLUS System Testbox safe and easily. Only properly qualified staff, e.g. staff that have the relevant expert professional training shall use the ASTOFLO PLUS System Testbox.

WARNING

Observe the respective safety and warning instructions of all used measurement and control devices.

The System Testbox is not intended for use in potentially explosive or wet or humid atmospheres. Keep the surfaces of the System Testbox clean and dry.

Before switching-on and before measuring, every electrical connection should be set up always (especially before measuring the electrical safety).

Dont use the System Testbox, if it is damaged. Check the housing and the insulation of every used measuring line.

Dont use the System Testbox, if it has malfunctions. Check the System Testbox regularly (see chapter 6)

You must read the testing instructions carefully and complete. Follow the instructions in all points.

PRECAUTION

Dont connect the control unit and the heating profile simultaneously to the System Testbox, the measured resistance values could be falsified.

- 14 -


1.2 Operating elements

The ASTOFLO PLUS System Testbox is made for function checks of the control unit and the heating profile. In addition you are able to check your used multimeter.

S1: rotary switch for simulating the temperature of the heating profile NTC11



S4: rotary switch for measuring the heating profile (NTC11, NTC12, NTC2, heating wire resistance (HZ), and for checking the System Testbox)

A: socket for the heating profile supply line of the control unit for measuring leakage currents

B: socket for the electrical safety analyzer

C: test socket for connecting the multimeter to test the function of the heating profile

D: common test socket for connecting the multimeter to test the function of the heating profile and the applicability of the used multimeter

E: test socket for testing the applicability of the used multimeter

F: socket for the heating profile supply line of the control unit for function checks

G: supply line for heating profile

A F

B

E DC

G

S1 S2 S3

S4

- 15 -


2 Preface for safety and function checks To ensure trouble-free operation, the required performance and safety of ASTOFLO PLUS, you must carry out an inspection* after every repair action, consisting of the following checks. These tests must also be carried out within the periodic safety inspection (every 24 months). visual check test of the electrical safety display accuracy, temperature control, excessive temperature alarms and NTC cable

break alarms temperature sensors of the heating profile operation of the safety temperature cut-offs auto restart after power supply interruption

WARNING

Always carry out the tests after making repairs and before using the device on patients.

All tests must be passed! If any errors are found, the warmer must be repaired before using it on patients. Errors not being detected or not being remedied can lead to death, serious injury, damage to the device or faulty operation.

You can find instructions on how to perform the various tests below.

TIPP

To avoid unnecessary waiting periods we recommend hanging first the heating profile like described above. The equalisation of the temperatures needs max. 30 to 50 minutes and is dependent on the temperature of the heating profile at the beginning and the environment conditions.

2.1 Necessary accessories Table "Temperature-NTC-Resistance" (see attachment A) Test report form to record the results (see attachment B) Protective earthed conductor tester, insulation tester and leakage current measuring

instrument in accordance with IEC 62353 Multimeter with an accuracy of 0.3 % in the measuring range 4 to 6 k

(measuring of temperature sensors) and 0.25 % in the measuring range up to 10 (measuring of heating wire resistance)

Thermometer with an accuracy of 1 C in the range of 20 to 26 C ASTOFLO PLUS System Testbox (order no. 0860.9500.00) * see also IEC 62353 Medical electrical equipment Recurrent test and test after repair of medical electrical equipment

- 16 -


3 Inspection of the control unit ASTOFLO PLUS 3.1 Visual check

Check that the following parts of the device are in a good and safe condition; replace them if required:

complete and legible labelling housing without damage front panel (since the front panel prevents fluid from entering it is important that the

front panel is in a good condition and that its full surface adheres to the housing) power supply cord and mains connector insulation in a defect-free state, contacts are clean and show no corrosion

3.2 Test of the electrical safety (pursuant IEC 62353) Since in certain circumstances dangerous conditions may occur for the tester we recommend using special safety testing instruments for medical equipment for the following tests.

3.2.1 Protective earth resistance The protective earth resistance is measured between the protective earthed conductor on the mains plug and the test socket (or the alternative PA connection) on the rear of the warmer. To determine that the protective earthed conductor of the power supply cord is intact the entire conductor must be kinked section after section while measuring. If kinking the conductor reveals changes in the resistance, it must be assumed that the protective earthed conductor is damaged or there are no suitable connections anymore. Protective earth resistance AFP 200 Limit value 0.3

- 17 -


3.2.2 Equipment leakage current Leakage current testing can only be carried out after successful protective earthed conductor testing! The current flowing from protective earthed conductor and applied part to the two (shorted) power supply connections is measured (Alternative method). Plug the heating profile supply line of the control unit in the socket A and the insulation tester / leakage current measuring instrument in the socket B

Equipment leakage current AFP 200 Limit value 1 mA

3.2.3 Applied part leakage current The current flowing from the applied part to protective earthed conductor and the two (shorted) power supply connections is measured (Alternative method). Plug the heating profile supply line of the control unit in the socket A and the insulation tester / leakage current measuring instrument in the socket B Applied part leakage current AFP 200 Limit value BF 5 mA Limit value CF 0.05 mA

- 18 -


44.0CSet: 43.0C

3.3 Display accuracy, temperature control, excessive temperature alarms and NTC cable break alarms

INFORMATION During operation, the heating profile temperature is measured via the thermistors (NTCs). The warmer converts the resistance values to temperature values which are used for the temperature control and the temperature display. In the tests described below, high-precision fixed resistors are connected to the warmer instead of the NTCs, to check the correct conversion and the resulting reactions.

Display accuracy

1. Separate the heating profile from the control unit

2. Connect the connecting cable for the heating profile to the ASTOFLO PLUS System Testbox (socket F)

3. Set the test box switches S1 to 44C, S2 to 41.5C and S3 to 40.5C.

4. Connect the warmer to the power

supply, switch it on, and use the key to select the highest temperature to be set (usually 43C).

5. Press the START key to put the device into use.

6. Press the START key again for several seconds until the temperature display shows not the word "SET".

7. Check the temperatures displayed:

Upper target indication: 43.7C to 44.3C

Lower target indication: 41.2C to 41.8C


S3

40.5C

S2

41.5C

S1

44C

44.0C 41.5C

44.0CSET: 43.0C X

- 19 -


Temperature Control 1. Set the test box switches S1, S2 to

41.5C and S3 to 40.5C.

2. Switch on the warmer and select 41C as

Set temperature 41.5CSet: 41.0C

3. Press the START key to confirm the

temperature.

4. Check: The warmer must be able to be started and it must not change over to the alarm status.

5. First set the switch S1 to 40.5C and then set the switch S2 to 40.5C.

1. 2. 6. Check: The warmer must change over

to the alarm status.

7. After pressing the key, the display must show E26 alternately.

40.5CSet: 41.0C

E268. Reset the switches S1 and S2 to 41.5C.

9. Select 41C as set temperature and

restart the warmer.

41.5CSet: 41.0C

10. Check: The warmer must be able to be started and it must not change over to the alarm status

11. First set the switch S2 to 40.5C and then set the switch S1 to 40.5C.

1. 2. 12. Check: The warmer must change over


3. After pressing the key, the display must show E26 alternately. 40.5C

Set: 41.0C

E26

S1

40.5C

S2

40.5C

S1

41.5C

S2

41.5C

S2

40.5C

S1

40.5C

S1

41.5C

S3

40.5C

S2

41.5C

- 20 -



Excessive temperature alarms

1. Set the test box switches S1 to 44C, S2 to 41.5C and S3 to 40.5C.


Set temperature.

44.0CSet: 41.0C


temperature.


5. Set the switch S1 to 45.7C.

6. Check: The warmer must change over



45.7CSet: 41.0C

E16

8. Set the switch S1 back to 44C.

9. Restart the warmer.

10. Check: The warmer must be able to be

started and it must not change over to the alarm status.




S2

45.7C

S1

44C

S1

45.7C

S3

40.5C

S2

41.5C

S1

44C

- 21 -



45.7CSet: 41.0C

E16

14. Set the switch S2 back to 41.5C.

15. Restart the warmer.







41.5CSet: 41.0C

E16


NTC cable break alarms

1. Set the test box switches S1, S2 and S3 to 40.5C.


Set temperature. 40.5CSet: 40.0C


temperature.


5. Set the switch S1 to .

S3

40.5C

S2

40.5C

S1

40.5C

S3

45.7C

S2

41.5C

S1

- 22 -


6. Check: The warmer must change over to the alarm status.

7. After pressing the key, the display

must show E16 alternately.

40.5CSet: 40.0C

E16

8. Set the switch S1 back to 40.5C and restart the warmer.







40.5CSet: 40.0C

E16

13. Set the switch S2 back to 40.5C and restart the warmer.







40.5CSet: 40.0C

E16


S3

S2

S2

40.5C

S1

40.5C

- 23 -


4 Inspection of the heating profile of ASTOFLO PLUS

4.1 Visual check Check if connecting socket, connecting housing and the silicone rubber jacket* of the heating profile are in good condition and are not damaged. Replace the complete heating profile if necessary. *small damages of the silicone profile could be repaired by the manufacturer potentially.

4.2 Measuring the temperature sensors

Check the applicability of the used multimeter

1. Connect the used multimeter to the sockets D and E (2000 ). Then measure the resistance.

2. The resistance value must be within

2000 +/- 10 .

Prepare for measuring

1. Separate the heating profile from the control unit.

2. The heating profile must hang like described above.

3. Ensure a constant ambient

temperature.

4. o Connecting heating profile and multimeter: Connect the heating profile to the supply line (connection G) of the ASTOFLO PLUS System Testbox Connect the multimeter to sockets C and D.

t

T

t

T

- 24 -


Carry out the measurement

1. o Measure and record the resistance values for NTC11, NTC12 and NTC2 by turning the rotary switch S4.

o Measure and record the room temperature.

2. Read the resistance value

corresponding to the room temperature from the table in chapter 9.

3. The 3 resistance values measured and the resistance value of the room temperature must be within a 200 Ohm range (= 0.5C).

and

all resistance values (including the value of the room temperature) must be within a range of 400 Ohm (= 1C).

e.g. NTC11 = 5514 NTC12 = 5554 NTC2 = 5570 5570 5514 = 56 (ok, because 200 ) Troom = 22.1C = 5594 5594 5514 = 80 (ok, because 400 )

4. Measure the heating wire resistance value by turning the rotary switch S4 on position HZ.

5. The resistance value of the heating

wire must be within 6.5 +/- 0.5 .

Note: Several multimeters could show measuring variations because of inductance of leads.

21,4C = 5747

Lowest value

Highest value

- 25 -


5 Inspection of the combination control unit/heating profile 5.1 Operation of the excessive temperature cut-offs

Cut-off 1 (H1)

1. In normal operation (with the heating profile) press and hold the "Temperature up" button for several seconds.

2. The following must take place: the display shows "H1" the power LED blinks the alarm LED blinks the acoustic alarm sounds


Cut-off 2 (H2)

1. Press and hold both the "Temperature down" and "Temperature up" keys simultaneously for several seconds.




Cut-off 3 (H3)

1. In normal operation press and hold the "Temperature down" key for several seconds.




H1

H2

H3

- 26 -


5.2 Function of Auto restart after power supply interruption During operation pull the plug from the power outlet (to simulate a power breakdown) and plug it in again within 5 seconds. The warmer must automatically switch on again with the same setting and must start without you having to press any keys.

- 27 -


6 Verification of the System Testbox

IMPORTANT For the Verification of the resistor values of the ASTOFLO PLUS System Testbox you need a calibrated multimeter with an accuracy of 0,15 % in the measuring range up to 3 k.

Verify the System Testbox every 24 months.

Measuring the reference resistance value

1. Connect the used multimeter to the sockets D and E (2000 ).

2. Measure the resistance.

3. The resistance value must be within 2000 +/- 5.

Measuring the resistance values of the temperature presets

1. Connect the multimeter to sockets C and D.

2. Set the switch S4 to S1

3. Set switch S1 successively , 40.5C, 41.5C, 44C, 45.7C and

4. measure the resistance value in every position with the multimeter

S1

45.7C

S1

44C

S1

41.5C

S1

40.5C

S1

S4

S1

- 28 -


5. The resistance value of the according position must be within:

: 13369 +/- 150 40.5C: 2740 +/- 10 41.5C: 2647 +/- 10 44C: 2428 +/- 10 45.7C: 2292 +/- 10


7. Set switch S2 successively , 40.5C, 41.5C, 45.7C and


9. The resistance values of the according position must be within:

: 13369 +/- 150 40.5C: 2740 +/- 10 41.5C: 2647 +/- 10 45.7C: 2292 +/- 10


11. Set switch S3 successively , 40.5C, 45.7C and


13. The resistance values of the according position must be within:

: 13369 +/- 150 40.5C: 2740 +/- 10 45.7C: 2292 +/- 10

S3

45.7C

S3

40.5C

S3

S4

S3

S2

45.7C

S2

41.5C

S2

40.5C

S2

S4

S2

- 29 -


A Table Temperature NTC-Resistance Temperature [C] Resistance [] Temperature [C] Resistance []

20 6068 25.1 4981 20.1 6044 25.2 4962 20.2 6021 25.3 4943 20.3 5997 25.4 4925 20.4 5974 25.5 4906 20.5 5951 25.6 4888 20.6 5928 25.7 4869 20.7 5905 25.8 4851 20.8 5882 25.9 4832 20.9 5859 26 4814

21 5838 26.1 4796 21.1 5814 26.2 4778 21.2 5792 26.3 4760 21.3 5769 26.4 4742 21.4 5747 26.5 4724 21.5 5725 26.6 4707 21.6 5703 26.7 4689 21.7 5681 26.8 4671 21.8 5659 26.9 4654 21.9 5637 27 4636

22 5616 27.1 4619 22.1 5594 27.2 4602 22.2 5573 27.3 4585 22.3 5551 27.4 4568 22.4 5530 27.5 4550 22.5 5509 27.6 4533 22.6 5488 27.7 4517 22.7 5467 27.8 4500 22.8 5446 27.9 4483 22.9 5425 28 4466

23 5404 28.1 4450 23.1 5384 28.2 4433 23.2 5363 28.3 4417 23.3 5343 28.4 4400 23.4 5323 28.5 4384 23.5 5302 28.6 4368 23.6 5282 28.7 4352 23.7 5262 28.8 4336 23.8 5242 28.9 4320 23.9 5222 29 4304

24 5202 29.1 4288 24.1 5183 29.2 4272 24.2 5163 29.3 4256 24.3 5144 29.4 4240 24.4 5124 29.5 4225 24.5 5105 29.6 4209 24.6 5086 29.7 4194 24.7 5066 29.8 4178 24.8 5047 29.9 4163 24.9 5028 30 4142

25 5000

- 30 -


B Test protocol (example) - measurements taken with System Testbox Ausfhrende Stelle/Carried out by:

Prfprotokoll Test Protocol ASTOFLO PLUS

Stammdaten/Master data SN: Auftrags-Nr./Repair reference: Hersteller/Manufacturer:

Gert/Device: Schutzklasse/Protection class:

STIHLER ELECTRONIC GmbH Julius-Hoelder-Str. 36

70597 Stuttgart Germany

AFP200 100V 115V

230V

240V I

Wrmeprofil/Heating profile: ohne/without Anwendungsteil/Applied part:

WP2- 418 618 424 624 BF

CF

Prfung vor Inbetriebnahme (Bezugwert)/ Test before putting into service (reference value) Wiederholungsprfung/ Recurrent Test Prfung nach Instandsetzung/ Test after repair

Sichtprfung/Visual inspection ok n.ok ok n.okAufschriften/Labeling Frontplatte/Front panel

Gehuse/Housing Befestigungsvorrichtung/Attachment device

Netzanschlussleitung/Power supply cord Wrmeprofil/Heating profile Prfung Elektrische Sicherheit/Test data electrical safety Prfgert/Test equipment:

Messungen/Measurements: Messwert/ measured value Min Max ok n.ok

Schutzleiterwiderstand/Protective earth resistance: - 0,3 Gerteableitstrom/Equipment leakage current mA 0,010 mA 1 mA

BF CF Ableitstrom vom Anwendungsteil/ Applied part leakage mA 0,005 mA 5 mA 0,050 mA

Funktionstest/Functional Test ok n.ok ok n.okAnzeigegenauigkeit/Display accuracy NTC-Kabelbruch/NTC cable break Temperaturregelung/Temperature control bertemperaturabschaltungen H1-H2-H3/

Excessive temperature cut-offs H1-H2-H3

bertemperaturalarme/Excessive temp. alarms Netzausfallberbrckung 5sek./Auto restart after power supply interruption 5 sec.

TR: NTC11: NTC12: NT

astoflo plus service instructions

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