AstoFlo Plus Service Instructions [PDF]

Zitiervorschau

Part- No. 0560.9600.12 Rev. 4 09/2009

Service Instructions

Stihler Electronic GmbH • 70597 Stuttgart • Germany

Service Instructions ASTOFLO PLUS (AFP)

Manufacturer:

Page

-2-

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]

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP)

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

Rev. 4 – 09/2009

Page

-3-

Service Instructions ASTOFLO PLUS (AFP)

1 General 1.1

Technical Service and Ordering Spare Parts STIHLER ELECTRONIC GmbH Julius-Hoelder-Str. 36 70597 Stuttgart Germany

Tel: +49 (0) 711-720670 Fax: +49 (0) 711-7206757 www.stihlerelectronic.de 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.

Page

-4-

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP) 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.

Rev. 4 – 09/2009

Page

-5-

Service Instructions ASTOFLO PLUS (AFP) 2.3

Warmer components

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

Heating profile socket

Plug

Control panel control buttons and LEDs

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

Fig. 2 Warmer components Clip for heating profile

Attachment device

secures the infusion line and the heating profile together

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

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

Page

-6-

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP) 2.4

Control panel components 9 Alarm LED 8 Display actual temperature

6 Key Temperature up

7 Display temperature setting

5 Key Temperature down

3 Key START

4 Power LED

2 Key STAND-BY

1 Stand-by LED

Fig. 3 Control panel components Stand-by LED

lights up orange when the device is in STAND-BY.

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 33°C (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

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.

1

2

Arrow keys to select the required temperature setting. Raise or lower the heating profile temperature (from 33 °C to 43 °C) in 0.5°C 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.

Rev. 4 – 09/2009

Page

-7-

Service Instructions ASTOFLO PLUS (AFP) 2.5

Technical Specifications ASTOFLO PLUS Electr. connection Power consumption Protection class (IEC 60601) Protective earth resistance Equipment leakage current Applied part (IEC 60601-1)

Applied part leakage current BF (mains voltage on the applied part) Applied part leakage current CF (mains voltage on the applied part) Primary fuses (F3, F4) Secondary fuse (F1) IP (IEC 60529) Classification acc. to appendix IX Dimensions Height (without heating profile) Width Depth (with universal attachment) Weight Operating mode Perm. ambient conditions during operation during storage Temperature of the heating profile

AFP EU/CH/CN/DK/TH 230VAC ±10% 50-60Hz

AFP AFP UK/AU NA 240VAC ±10% 115VAC ±10% 50-60Hz 50-60Hz

AFP JA 100VAC ±10% 50-60Hz

max. 90 W I ≤ 0.2 Ω ≤ 0.2 mA 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 < 5 mA < 0.05 mA T1.25H 250 V (5 x 20 mm) T2H 250 V (5 x 20 mm) T4H 250 V (5 x 20 mm) IPX1 IIb (rule 9)

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

280 mm 120 mm 175 mm 3 kg Continuous operation Temperature Air pressure +16 °C to +32 °C 700 hPa to 1060 hPa - 20 °C to +60 °C 500 hPa to 1060 hPa

33.0°C to 43.0°C (± 1 °C) can be selected by the user in 0.5°C steps

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

45.0 °C (± 1 °C) 45.0 °C (± 1 °C) 45.0 °C (± 1 °C) 33.0 °C (± 1 °C) The device is not intended for use in potentially explosive atmospheres.

Page

-8-

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP) 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 33°C ± 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.

Rev. 4 – 09/2009

Page

-9-

Service Instructions ASTOFLO PLUS (AFP) 2.7

Description of electronic components Mains supply PWB

Power PWB

Display PWB

Toroidal core

Test socket

Heating profile

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:     

Page

- 10 -

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)

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP) 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 µController with program Preparation of the analogue temperature measurement signal (NTC temperature sensors)

Display PWB Power PWB

Heating profile

Fig. 5 "Electronic/thermal safety" circuit diagram

Rev. 4 – 09/2009

Page

- 11 -

Service Instructions ASTOFLO PLUS (AFP)

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

ClearSurf

Fresenius Medical Care

Mikrozid AF Liquid

®

B. Braun Melsungen AG

Bacillol plus

®

Desomed Dr. Trippen GmbH

Mikrobac forte

Meliseptol

Biguamed Perfekt N

Page

- 12 -

®

Manufacturer Schülke & Mayr GmbH

®

®

Rev. 4 – 09/2009

Bode Chemie GmbH

Service Instructions ASTOFLO PLUS (AFP)

4 Troubleshooting Part I: When putting the warmer into use Action Correct device reaction Incorrect device reaction Does the following take place? If you … 1 … connect the warmer to the The orange stand-by LED lights up if 1.1 no reaction power outlet and observe the the warmer was disconnected from the mains for 30 seconds or more*. control panel

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

20.4

2.1 no reaction

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

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

1.1.5 Faulty power PWB

Replace the power PWB

2.1.1 Key was pressed too briefly 2.1.2 Electronic defect

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

2.2.1 Temporary display control failure

Switch off the warmer with the standby 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) Rev. 4 – 09/2009

Page

- 13 -

Service Instructions ASTOFLO PLUS (AFP) Action If you … 3 … press the Start key



Correct device reaction Does the following take place?

Incorrect device reaction

3.1 Warmer stays in the alarm  the automatic relay test generates status (acoustic alarm and red an audible click alarm LED)  green power LED is lit permanently  the acoustic alarm goes off  the red alarm LED shows the "Low temperature alarm" below 33°C and then goes out  temperature display slowly goes up until the "SET" temperature is reached

Possible cause(s)

Remedy

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- Replace the heating profile supply line and-socket connection/supply line to the heating profile 3.1.4 Electronic defect

Page

- 14 -

Rev. 4 – 09/2009

Replace the electronic PWBs

Service Instructions ASTOFLO PLUS (AFP)

Part II: During operation Action Device reaction Possible cause(s) If you … …and the following happens? 4 … use the warmer and the Excessive temperature alarm 4.1 Heating profile too hot due to acoustic alarm suddenly sounds

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

45.8

5 … use the warmer and the

Low temperature alarm

acoustic alarm sounds every  the red alarm LED flashes 3 minutes  the acoustic alarm is sounded for 15 seconds every 3 minutes

external heat source (sun, radiator).

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

4.2 Heating profile too hot because Let the fluid and the heating the temperature of the fluid to profile cool down until the be heated is too high. warmer can be restarted.

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 preheat the fluid in another way

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

Find a suitable environment for the application

32.8

Rev. 4 – 09/2009

Page

- 15 -

Service Instructions ASTOFLO PLUS (AFP) Action If you … 6 … use the warmer and the acoustic alarm suddenly sounds

Device reaction …and the following happens? Cable break alarm

Possible cause(s)

Remedy

6.1 Defective heating profile (NTC or heating broken)

Replace the heating profile

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

Replace the heating profile supply line

6.3 Electronic defect

Replace the electronic PWBs

Correct device reaction Does the following take place?

Incorrect device reaction

Possible cause(s)

Remedy

See testing instructions chapter 3.3 display accuracy

7.1 The temperatures shown are outside the tolerance.

7.1.1 Test box defective

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

7.1.2 Electronic defect

Replace the display PWB or have it repaired

 the red alarm LED flashes  the green power LED flashes  the display shows an "L"

L

Part III: During the safety and operation check Action If you … 7 … check the accuracy of the temperature display

44.0 41.5

Page

- 16 -

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP) Action If you … 8 … check the temperature control

Correct device reaction Does the following take place?

Incorrect device reaction

Possible cause(s)

See testing instructions chapter 3.3 8.1 The warmer cannot be started 8.1.1 Test box defective temperature control or fails to react with an alarm or fails to show "E26".

T

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

8.1.2 Electronic defect

Replace the display PWB/power PWB or have it repaired

9.1.1 Test box defective

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

9.1.2 Electronic defect

Replace the display PWB/power PWB or have it repaired

t

9 … check the excessive temperature alarms

See testing instructions chapter 3.3 9.1 Warmer does not react with an excessive temperature alarms alarm or does not display "E16".

T

t

10 … check the NTC cable break See testing instructions chapter 3.3 10.1 Warmer does not react with an 10.1.1 Electronic defect alarms

NTC cable break alarms

alarm or does not display "E16".

Rev. 4 – 09/2009

Replace the display PWB/power PWB or have it repaired

Page

- 17 -

Service Instructions ASTOFLO PLUS (AFP) Action If you … 11 … test the excessive temperature cut-offs

  

12 … test the auto restart after power supply interruption

Page

- 18 -

Correct device reaction Does the following take place?

Incorrect device reaction

See testing instructions chapter 5.1 11.1 The warmer does not react as described on the left operation of the excessive temperature cut-off 1 (H1)

Possible cause(s)

Remedy

11.1.1 Electronic defect

Replace the display PWB/power PWB or have it repaired

12.1.1 Electronic defect

Replace the display PWB/power PWB or have it repaired

See testing instructions chapter 5.1 operation of the excessive temperature cut-off 2 (H2)

See testing instructions chapter 5.1 operation of the excessive temperature cut-off 3 (H3)

See testing instructions chapter 5.2 12.1 The warmer switches to the function of auto restart after power stand-by status: supply interruption

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP) Action If you … 13 … check the temperature sensors of the heating profile

14 … measure the resistance of the protective earthed conductor RSL

Correct device reaction Does the following take place?

Incorrect device reaction

Possible cause(s)

Remedy

See testing instructions chapter 4.2 13.1 The difference between the 13.1.1 Measurement not Provide better measuring conditions measuring the temperature sensors sufficiently accurate highest and the lowest and repeat the measurement due to varying resistance values is more than environmental 200 Ohm conditions or an inaccurate room thermometer. 13.1.2 Temperature sensor(s) Replace the heating profile faulty See testing instructions chapter 3.2.1 protective earth resistance

14.1 The measured value is higher 14.1.1 There is an interruption than the indicated limit value in the power supply or fluctuates when the power cord or in the warmer supply cord is moved interior 14.1.2 The protective earthed contactor contacts in the mains plug are dirty/corroded 14.1.3 The test socket on the warmer is dirty

Rev. 4 – 09/2009

Find the interruption and replace the faulty part

Clean the contacts or replace the power supply cord Clean or replace the test socket

Page

- 19 -

Service Instructions ASTOFLO PLUS (AFP) Action If you … 15 … measure the equipment leakage current

Correct device reaction Does the following take place?

Incorrect device reaction

See testing instructions chapter 3.2.2 Equipment leakage current

15.1 The measured value is higher 15.1.1 Faulty insulation of the Replace/renew the fault part than the limit value mains plug or the power supply cord or mains supply PWB or toroidal core transformer 15.2 The measured value is 15.2.1 Faulty electrical approximately 0.0 µA connection between screen and protective earthed conductor or defective power supply cord 16.1 The measured value is higher 16.1.1 Faulty screen in toroidal Replace the toroidal core transformer than the limit value core transformer

IEL

16 … measure the applied part See testing instructions chapter 3.2.3 leakage current IAL

Applied part leakage current

Possible cause(s)

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

Page

- 20 -

Rev. 4 – 09/2009

Remedy

Correct the electrical connection

Service Instructions ASTOFLO PLUS (AFP)

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.

Rev. 4 – 09/2009

Page

- 21 -

Service Instructions ASTOFLO PLUS (AFP)

5.1

Necessary tool  0.8 x 4 mm screwdriver

Opening the control unit

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 Necessary tool: -

a) Removing the insulation sheet

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

Page

- 22 -

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP) 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.

2. Disconnect the transformer connectors from the power PWB

*not fitted on all warmers

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.

Rev. 4 – 09/2009

Page

- 23 -

Service Instructions ASTOFLO PLUS (AFP) Necessary tool: -

d) Removing the display frame

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

5.3

Assembling the front housing section Necessary tool: -

a) Installing the display frame

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

Necessary tool:  Tx 10 torx screwdriver

b) Installing the PWBs

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.

Page

- 24 -

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.

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP)

3. Carefully lay down the unit and secure the PWBs with the short screws (Ø3x6).

Necessary tool:  Tx 10 torx screwdriver

c) Installing the connecting cable

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 (Ø3x10) to the remaining hole in the PWB.

Rev. 4 – 09/2009

Page

- 25 -

Service Instructions ASTOFLO PLUS (AFP)

5.4

Disassembling the rear housing section Necessary tool:  SW10 open-ended or ring spanner

a) Removing the insulation sheet

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.

Page

- 26 -

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP)

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.

Rev. 4 – 09/2009

Page

- 27 -

Service Instructions ASTOFLO PLUS (AFP)

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.

Page

- 28 -

4. Secure the inner plate, the housing and the attachment device with 4 Torx screws.

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP) 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:

Rev. 4 – 09/2009

Wire green/yellow

Connection

blue brown

N L

Page

- 29 -

Service Instructions ASTOFLO PLUS (AFP)

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.

Rated voltage 100 V [JA] 115 V [NA] 230 V [EU,DK,CN,CH,TH] 240 V [UK, AU]

X2

Connection X3 X4* X5*

X6*

blue brown grey violet yellow blue grey brown violet yellow blue violet brown grey yellow 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.

Page

- 30 -

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP) Necessary tool: -

e) Installing the insulation sheet

1. Install the insulation sheet with the correct side up.

5.6

2. Press the insulation sheet on the toroidal core transformer and install and finger-tighten the plastic cap nut.

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 preassembled 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.

Rev. 4 – 09/2009

Page

- 31 -

Service Instructions ASTOFLO PLUS (AFP)

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.

Page

- 32 -

Rev. 4 – 09/2009

Service Instructions ASTOFLO PLUS (AFP)

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

Rev. 4 – 09/2009

Page

- 33 -

Service Instructions ASTOFLO PLUS (AFP)

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

Gehäuse vorne

Front housing

0560.4200.00

Frontplatte ASTOFLO PLUS

Frontpanel ASTOFLO PLUS

0560.4000.20-PA

Gehäuse hinten mit Potentialausgleichsanschluss

Rear housing with equipotential terminal

0560.4000.26

Kappe für Ausführung JA-NA

Cap for version JA-NA

0860.4000.26

Kappe für Ausführung AU-CHDK-EU-TH-UK

Cap for version AU-CH-DK-EUTH-UK

0560.3120.01

Platte innen

Inner plate

Rev. 4 – 09/2009

Seite

- A1 -

Ersatzteilliste / Spare parts list ASTOFLO PLUS (AFP)

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 Attachment device komplett mit complete with Clip for Profilklammer Heating Profile

0660.8301.00

Profilklammer

Clip for Heating Profile

9850.5100.00

Rändelschraube

Knurled screw

Seite

- A2 -

Rev. 4 – 09/2009

Ersatzteilliste / Spare parts list ASTOFLO PLUS (AFP)

Bestell-Nr. Order no

Abbildung Figure

Bezeichnung

Description

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

Set Sicherungen für Ausführung AU-CH-DKEU-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

Isolationsplatte 2

Insulation sheet #2

0560.4100.03

Isolationsplatte 3

Insulation sheet #3

0860.2107.00

230/240 VAC

100/115 VAC

Rev. 4 – 09/2009

Seite

- A3 -

Ersatzteilliste / Spare parts list ASTOFLO PLUS (AFP)

Bestell-Nr. Order no

Abbildung Figure

Bezeichnung

Description

0560.2110.00

Testbuchse

Test socket

0560.2111.00

Kabel für Testbuchse

Cable for test socket

0560.4184.00

PA-Anschluss

Equipotential terminal

9750.4100.10

Netzanschlussleitung EU (SCHUKO-Stecker CEE Power Supply Cord EU 7/7)

0350.4100.23

Netzanschlussleitung DK (Afsnit 107-2-D1Schraubstecker)

0760.4210.02

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

Seite

- A4 -

Rev. 4 – 09/2009

Power Supply Cord DK

Ersatzteilliste / Spare parts list ASTOFLO PLUS (AFP)

Bestell-Nr. Order no

Abbildung Figure

Bezeichnung

Description

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 (AS3112Schraubstecker)

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 Wärmeprofil

Cable for Heating Profile

Rev. 4 – 09/2009

Seite

- A5 -

Ersatzteilliste / Spare parts list ASTOFLO PLUS (AFP) Bestell-Nr. Order no

Abbildung Figure

Bezeichnung

Description

WP2418

Wärmeprofil 2418

Heating Profile 2418

WP2424

Wärmeprofil 2424

Heating Profile 2424

WP2618

Wärmeprofil 2618

Heating Profile 2618

WP2624

Wärmeprofil 2624

Heating Profile 2624

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. Prüfanweisung

Seite

- A6 -

Rev. 4 – 09/2009

ASTOFLO PLUS System Testbox including Testing Instructions

Part No. 0560.9610.12 Rev.4 09/2009

Testing Instructions

Stihler Electronic • 70597 Stuttgart • Germany

Testing Instructions PRISMAFLO II (PF2)

Manufacturer:

Page

- B2 -

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]

Rev. 2 – 04/2009

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

-3-

Testing Instructions ASTOFLO PLUS

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

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.

-4-

X Profile WP2418 WP 2424 WP 2618 WP 2418H WP 2618H PF2WP2418 PF2WP2618

X 30 cm 50 cm 50 cm 70 cm 70 cm 70 cm 70 cm

Testing Instructions ASTOFLO PLUS

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 kΩ (measuring of temperature sensors) and ± 0.25 % in the measuring range up to 10 Ω (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.

-5-

Testing Instructions ASTOFLO PLUS

2.

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

3

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

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)

1 2 3

Protective earth resistance Equipment leakage current (Alternative method) Applied part leakage current (Alternative method)

Use connection to electrical safety analyzer Connection 1 and 3 Connection 1 and 2 Connection 1 and 2

Limit value ≤ 0.3 Ω ≤ 1 mA ≤ 0.05 mA Top view: Connector for heating profile

Connection 1 Connection 3 Green yellow test socket on backside

OK

OK OK

OK OK

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.

Connection 2

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

-6-

Testing Instructions ASTOFLO PLUS

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.

T

T

 t

4.

Connecting heating profile and multimeter:

t

NTC2

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

NTC12

NTC11

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 (= ± 0.5°C). and

21,4°C = 5747 Ω

e.g.

NTC11 = 5514 Ω NTC12 = 5554 Ω NTC2 = 5570 Ω

5570 – 5514 = 56 Ω (ok, because ≤ 200 Ω) Troom = 22.1°C = 5594 Ω

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

-7-

Lowest value

Highest value

5594 – 5514 = 80 Ω (ok, because ≤ 400 Ω)

Testing Instructions ASTOFLO PLUS

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.

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.

 H1



Cut-off 2 (H2) 1. Press and hold both the "Temperature down" and "Temperature up" keys simultaneously for several seconds. 2.

3.

 

The following must take place:  the display shows "H2"  the power LED blinks  the alarm LED blinks  the acoustic alarm sounds Press the START key to switch the warmer back to normal operation.

-8-

H2



Testing Instructions ASTOFLO PLUS

Cut-off 3 (H3) 1. In normal operation press and hold the "Temperature down" key for several seconds.

2.

3.

5.2



The following must take place:  the display shows "H3"  the power LED blinks  the alarm LED blinks  the acoustic alarm sounds Use the key to switch the warmer to Stand-by.

H3



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 43°C).

2. Press the START key device into use.

to put the



 

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.

-9-

location of sensors

Testing Instructions ASTOFLO PLUS 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.



45.2°C 41.0°C

*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.

- 10 -

Testing Instructions ASTOFLO PLUS

A

Table „Temperature – NTC-Resistance“

Temperature [°C] 20 20.1 20.2 20.3 20.4 20.5 20.6 20.7 20.8 20.9 21 21.1 21.2 21.3 21.4 21.5 21.6 21.7 21.8 21.9 22 22.1 22.2 22.3 22.4 22.5 22.6 22.7 22.8 22.9 23 23.1 23.2 23.3 23.4 23.5 23.6 23.7 23.8 23.9 24 24.1 24.2 24.3 24.4 24.5 24.6 24.7 24.8 24.9 25

Resistance [Ω] 6068 6044 6021 5997 5974 5951 5928 5905 5882 5859 5838 5814 5792 5769 5747 5725 5703 5681 5659 5637 5616 5594 5573 5551 5530 5509 5488 5467 5446 5425 5404 5384 5363 5343 5323 5302 5282 5262 5242 5222 5202 5183 5163 5144 5124 5105 5086 5066 5047 5028 5000

Temperature [°C] 25.1 25.2 25.3 25.4 25.5 25.6 25.7 25.8 25.9 26 26.1 26.2 26.3 26.4 26.5 26.6 26.7 26.8 26.9 27 27.1 27.2 27.3 27.4 27.5 27.6 27.7 27.8 27.9 28 28.1 28.2 28.3 28.4 28.5 28.6 28.7 28.8 28.9 29 29.1 29.2 29.3 29.4 29.5 29.6 29.7 29.8 29.9 30

- 11 -

Resistance [Ω] 4981 4962 4943 4925 4906 4888 4869 4851 4832 4814 4796 4778 4760 4742 4724 4707 4689 4671 4654 4636 4619 4602 4585 4568 4550 4533 4517 4500 4483 4466 4450 4433 4417 4400 4384 4368 4352 4336 4320 4304 4288 4272 4256 4240 4225 4209 4194 4178 4163 4142

Testing Instructions ASTOFLO PLUS B

Test protocol (example) - measurements taken without System Testbox

Ausführende Stelle/Carried out by:

Prüfprotokoll Test Protocol

Stammdaten/Master data SN:

Auftrags-Nr./Repair reference:

Gerät/Device: AFP200

100V □

Schutzklasse/Protection class: 115V □

230V □

240V □

Wärmeprofil/Heating profile:

ohne/without □

WP2-

424 □

418 □

ASTOFLO PLUS

618 □

I Anwendungsteil/Applied part:

624 □

CF □

BF □ Sichtprüfung/Visual inspection

ok

Hersteller/Manufacturer: STIHLER ELECTRONIC GmbH Julius-Hoelder-Str. 36 70597 Stuttgart – Germany □ Prüfung vor Inbetriebnahme (Bezugwert)/ Test before putting into service (reference value) □ Wiederholungsprüfung/ Recurrent Test

n.ok

ok n.ok

Aufschriften/Labeling

Frontplatte/Front panel

Gehäuse/Housing

Befestigungsvorrichtung/Attachment device

Netzanschlussleitung/Power supply cord

Wärmeprofil/Heating profile

Prüfung Elektrische Sicherheit/Test data electrical safety Prüfgerät/Test equipment: Messungen/Measurements: Schutzleiterwiderstand/Protective earth resistance: Geräteableitstrom/Equipment leakage current Ableitstrom vom Anwendungsteil/ Applied part leakage Funktionstest/Functional Test

Messwert/ measured value Ω mA

Min

Max

0,010 mA

0,3 Ω 1 mA

mA

0,005 mA

BF 5 mA

ok n.ok

CF 0,050 mA ok n.ok

Temperatursensoren des Wärmeprofils/ TR: NTC11: NTC12: Temperature Sensors of the Heating Profile °C Ω B, C, D innerhalb 200 Ohm/ B C B, C, D within 200 Ohms = A Ω A, B, C, D innerhalb 400 Ohm/ A, B, C, D within 400 Ohms Heizwiderstand/Heating wire resistance 6.5 Ohm ± 0.5 Ohm Übertemperaturabschaltungen H1-H2-H3/ Excessive temperature cut-offs H1-H2-H3

NTC2: Ω

Abschalttemperaturen/Cut off temperatures 1. 2. innerhalb/within 45,0 °C ± 1 °C °C Netzausfallüberbrückung 5 sek./Auto restart after power supply interruption 5 sec.

Ω D

Ω

°C

Gesamtbeurteilung/Overall assessment: □ Sicherheits- und Funktionsmängel wurden nicht festgestellt!/ No safety or functional deficiencies were detected! □ Kein direktes Risiko, die entdeckten Mängel können kurzfristig behoben werden!/ No direct risk, deficiencies detected may be corrected on short term! □ Gerät muss bis zur Behebung der Mängel aus dem Verkehr gezogen werden!/ Equipment shall be taken out of operation until deficiencies are corrected! □ Gerät entspricht nicht den Anforderungen – Modifikation/Austausch von Komponenten/Außerbetriebnahme wird empfohlen!/ Equipment does not comply - Modification / Exchange of components / Taking out of service - is recommended! Bemerkungen/Comments:

Datum der nächsten Wiederholungsprüfung/Date of next recurrent test: Prüfer/Tester:

Datum/Date:

- 12 -

Unterschrift/Signature:

Testing Instructions ASTOFLO PLUS

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).  Don’t use the System Testbox, if it is damaged. Check the housing and the insulation of every used measuring line.  Don’t 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  Don’t connect the control unit and the heating profile simultaneously to the System Testbox, the measured resistance values could be falsified.

- 13 -

Testing Instructions ASTOFLO PLUS 1.2 Operating elements G

S1 S2

S4 S3

E

D

C

A

F B

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

S2:

rotary switch for simulating the temperature of the heating profile NTC12

S3:

rotary switch for simulating the temperature of the heating profile NTC2

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

- 14 -

Testing Instructions ASTOFLO PLUS

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 kΩ (measuring of temperature sensors) and ± 0.25 % in the measuring range up to 10 Ω (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

- 15 -

Testing Instructions ASTOFLO PLUS

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: ● ● ● ●

3.2

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

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. AFP 200 ≤ 0.3 Ω

Protective earth resistance Limit value

- 16 -

Testing Instructions ASTOFLO PLUS 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

AFP 200 ≤ 1 mA

Equipment leakage current Limit value

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

AFP 200 ≤ 5 mA ≤ 0.05 mA

Applied part leakage current Limit value BF Limit value CF

- 17 -

Testing Instructions ASTOFLO PLUS 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 44°C, S2 to 41.5°C and S3 to 40.5°C.

4.

44°C

41.5°C

40.5°C

S1

S2

S3



5.

Press the START key device into use.



6.

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

7.

to put the

Check the temperatures displayed: Upper target indication: 43.7°C to 44.3°C

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

- 18 -

SET:

44.0°C 41.5°C



44.0°C Set:

43.0°C

44.0°C X 43.0



Lower target indication: 41.2°C to 41.8°C 8.





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

°C

Testing Instructions ASTOFLO PLUS

Temperature Control 1.

2.

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

Switch on the warmer and select 41°C as Set temperature

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 40.5°C and then set the switch S2 to 40.5°C.

41.5°C

41.5°C

40.5°C

S1

S2

S3





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

7.

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

40.5°C

40.5°C

S1

S2

9.

Reset the switches S1 and S2 to 41.5°C.

Select 41°C as set temperature and restart the warmer.

41.0°C

2.

40.5°C E26





8.

41.5°C Set:



1. 6.



41.5°C

41.5°C

S1

S2





Set:

41.5°C Set:

41.0°C

41.0°C



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 40.5°C and then set the switch S1 to 40.5°C.

40.5°C

40.5°C

S1

S2

1.

2.

12. Check: The warmer must change over to the alarm status. 3.

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

- 19 -





40.5°C E26 Set:

41.0°C

Testing Instructions ASTOFLO PLUS 14. Use the key to switch the warmer to Stand-by.



Excessive temperature alarms 1.

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

44°C S1

2.

Switch on the warmer and select 41°C as Set temperature.

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.

Set the switch S1 to 45.7°C.



41.5°C S2

40.5°C S3

 

44.0°C Set:

41.0°C

 45.7°C S1

6.

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

7.

After pressing the key, the display must show E16 alternately.

Set the switch S1 back to 44°C.

44°C S1

9.

Restart the warmer.



10. Check: The warmer must be able to be started and it must not change over to the alarm status. 11. Set the switch S2 to 45.7°C.

45.7°C S2

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

- 20 -

45.7°C E16



8.



Set:

41.0°C

Testing Instructions ASTOFLO PLUS 13. After pressing the key, the display must show E16 alternately.

45.7°C E16



14. Set the switch S2 back to 41.5°C.



Set:

41.0°C

41.5°C S2

15. Restart the warmer.



16. Check: The warmer must be able to be started and it must not change over to the alarm status. 17. Set the switch S3 to 45.7°C.

45.7°C S3

18. Check: The warmer must change over to the alarm status. 19. After pressing the key, the display must show E16 alternately.

41.5°C E16



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



Set:

41.0°C



NTC cable break alarms 1.

2.

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

Switch on the warmer and select 40°C as Set temperature.

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.

Set the switch S1 to

40.5°C

40.5°C

S1

S2







. S1

- 21 -

40.5°C S3



40.5°C Set:

40.0°C

Testing Instructions ASTOFLO PLUS 6.

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

7.

After pressing the key, the display must show E16 alternately.





40.5°C E16 Set:

8.

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

40.5°C S1

9.

40.0°C



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

10. Set the switch S2 to

. S2

11. Check: The warmer must change over to the alarm status. 12. After pressing the key, the display must show E16 alternately.





40.5°C E16 Set:

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

40.5°C S2

40.0°C



14. Check: The warmer must be able to be started and it must not change over to the alarm status. 15. Set the switch S3 to

. S3

16. Check: The warmer must change over to the alarm status. 17. After pressing the key, the display must show E16 alternately.





40.5°C E16 Set:

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

- 22 -



40.0°C

Testing Instructions ASTOFLO PLUS

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.

T

T

 t

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.

- 23 -

t

Testing Instructions ASTOFLO PLUS 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 (= ± 0.5°C). and

21,4°C = 5747 Ω

e.g.

NTC11 = 5514 Ω NTC12 = 5554 Ω NTC2 = 5570 Ω

5570 – 5514 = 56 Ω (ok, because ≤ 200 Ω) Troom = 22.1°C = 5594 Ω

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

- 24 -

Lowest value

Highest value

5594 – 5514 = 80 Ω (ok, because ≤ 400 Ω)

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

Testing Instructions ASTOFLO PLUS

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.

 H1



Cut-off 2 (H2) 1. Press and hold both the "Temperature down" and "Temperature up" keys simultaneously for several seconds. 2.

3.

 

The following must take place:  the display shows "H2"  the power LED blinks  the alarm LED blinks  the acoustic alarm sounds Press the START key to switch the warmer back to normal operation.

H2



Cut-off 3 (H3) 1. In normal operation press and hold the "Temperature down" key for several seconds.

2.

3.



The following must take place:  the display shows "H3"  the power LED blinks  the alarm LED blinks  the acoustic alarm sounds Use the key to switch the warmer to Stand-by.

- 25 -

H3



Testing Instructions ASTOFLO PLUS 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.

- 26 -

Testing Instructions ASTOFLO PLUS

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 kΩ.

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

S1 S4

3.

Set switch S1 successively , 40.5°C, 41.5°C, 44°C, 45.7°C and …

S1

40.5°C

41.5°C

S1

S1

45.7°C S1

4.

… measure the resistance value in every position with the multimeter

- 27 -

44°C S1

Testing Instructions ASTOFLO PLUS 5.

The resistance value of the according position must be within:

: 13369 +/- 150  40.5°C: 2740 +/- 10  41.5°C: 2647 +/- 10  44°C: 2428 +/- 10  45.7°C: 2292 +/- 10  6. Set the switch S4 to S2

S2 S4

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

40.5°C

41.5°C

45.7°C

S2

S2

S2

8. … measure the resistance value in every position with the multimeter 9. The resistance values of the according position must be within:

: 13369 +/- 150  40.5°C: 2740 +/- 10  41.5°C: 2647 +/- 10  45.7°C: 2292 +/- 10  10. Set the switch S4 to S3

S3 S4

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

12. … measure the resistance value in every position with the multimeter 13. The resistance values of the according position must be within:

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

- 28 -

40.5°C

45.7°C

S3

S3

Testing Instructions ASTOFLO PLUS

A

Table „Temperature – NTC-Resistance“

Temperature [°C] 20 20.1 20.2 20.3 20.4 20.5 20.6 20.7 20.8 20.9 21 21.1 21.2 21.3 21.4 21.5 21.6 21.7 21.8 21.9 22 22.1 22.2 22.3 22.4 22.5 22.6 22.7 22.8 22.9 23 23.1 23.2 23.3 23.4 23.5 23.6 23.7 23.8 23.9 24 24.1 24.2 24.3 24.4 24.5 24.6 24.7 24.8 24.9 25

Resistance [Ω] 6068 6044 6021 5997 5974 5951 5928 5905 5882 5859 5838 5814 5792 5769 5747 5725 5703 5681 5659 5637 5616 5594 5573 5551 5530 5509 5488 5467 5446 5425 5404 5384 5363 5343 5323 5302 5282 5262 5242 5222 5202 5183 5163 5144 5124 5105 5086 5066 5047 5028 5000

Temperature [°C] 25.1 25.2 25.3 25.4 25.5 25.6 25.7 25.8 25.9 26 26.1 26.2 26.3 26.4 26.5 26.6 26.7 26.8 26.9 27 27.1 27.2 27.3 27.4 27.5 27.6 27.7 27.8 27.9 28 28.1 28.2 28.3 28.4 28.5 28.6 28.7 28.8 28.9 29 29.1 29.2 29.3 29.4 29.5 29.6 29.7 29.8 29.9 30

- 29 -

Resistance [Ω] 4981 4962 4943 4925 4906 4888 4869 4851 4832 4814 4796 4778 4760 4742 4724 4707 4689 4671 4654 4636 4619 4602 4585 4568 4550 4533 4517 4500 4483 4466 4450 4433 4417 4400 4384 4368 4352 4336 4320 4304 4288 4272 4256 4240 4225 4209 4194 4178 4163 4142

Testing Instructions ASTOFLO PLUS B

Test protocol (example) - measurements taken with System Testbox

Ausführende Stelle/Carried out by:

Prüfprotokoll Test Protocol

Stammdaten/Master data SN:

Auftrags-Nr./Repair reference:

Gerät/Device: AFP200

100V □

Hersteller/Manufacturer: STIHLER ELECTRONIC GmbH Julius-Hoelder-Str. 36 70597 Stuttgart – Germany

Schutzklasse/Protection class: 115V □

230V □

240V □

Wärmeprofil/Heating profile:

ohne/without □

WP2-

424 □

418 □

ASTOFLO PLUS

618 □

I Anwendungsteil/Applied part:

624 □

CF □

BF □ Sichtprüfung/Visual inspection

ok

n.ok

□ Prüfung vor Inbetriebnahme (Bezugwert)/ Test before putting into service (reference value) □ Wiederholungsprüfung/ Recurrent Test □ Prüfung nach Instandsetzung/ Test after repair ok n.ok

Aufschriften/Labeling

Frontplatte/Front panel

Gehäuse/Housing

Befestigungsvorrichtung/Attachment device

Netzanschlussleitung/Power supply cord

Wärmeprofil/Heating profile

Prüfung Elektrische Sicherheit/Test data electrical safety Prüfgerät/Test equipment: Messungen/Measurements: Schutzleiterwiderstand/Protective earth resistance: Geräteableitstrom/Equipment leakage current Ableitstrom vom Anwendungsteil/ Applied part leakage Funktionstest/Functional Test ok

Messwert/ measured value Ω mA

Min

Max

0,010 mA

0,3 Ω 1 mA

mA

0,005 mA

Übertemperaturalarme/Excessive temp. alarms

n.ok

ok

n.ok

CF 0,050 mA

n.ok

Anzeigegenauigkeit/Display accuracy Temperaturregelung/Temperature control

BF 5 mA

ok

NTC-Kabelbruch/NTC cable break Übertemperaturabschaltungen H1-H2-H3/ Excessive temperature cut-offs H1-H2-H3 Netzausfallüberbrückung 5sek./Auto restart after power supply interruption 5 sec. NTC11: NTC12: NTC2: °C Ω Ω Ω B C D

Temperatursensoren des Wärmeprofils/ TR: Temperature Sensors of the Heating Profile B, C, D innerhalb 200 Ohm/ B, C, D within 200 Ohms = A Ω A, B, C, D innerhalb 400 Ohm/ A, B, C, D within 400 Ohms Ω Heizwiderstand/Heating wire resistance 6.5 Ohm ± 0.5 Ohm Gesamtbeurteilung/Overall assessment: □ Sicherheits- und Funktionsmängel wurden nicht festgestellt!/ No safety or functional deficiencies were detected! □ Kein direktes Risiko, die entdeckten Mängel können kurzfristig behoben werden!/ No direct risk, deficiencies detected may be corrected on short term! □ Gerät muss bis zur Behebung der Mängel aus dem Verkehr gezogen werden!/ Equipment shall be taken out of operation until deficiencies are corrected! □ Gerät entspricht nicht den Anforderungen – Modifikation/Austausch von Komponenten/Außerbetriebnahme wird empfohlen!/ Equipment does not comply - Modification / Exchange of components / Taking out of service - is recommended! Bemerkungen/Comments:

Datum der nächsten Wiederholungsprüfung/Date of next recurrent test: Prüfer/Tester:

Datum/Date:

- 30 -

Unterschrift/Signature:

Testing Instructions ASTOFLO PLUS

C

Verification Protocol for System Testbox

Carried out by/Ausführende Stelle

Verification Protocol Prüfprotokoll ASTOFLO PLUS System Testbox

Master Data/Stammdaten SN

Manufacturer/Hersteller STIHLER ELECTRONIC GmbH Julius-Hoelder-Str. 36 70597 Stuttgart – Germany

Multimeter ID-Nr. Date of next verification: Datum nächste Überprüfung:

Measuring the reference value of resistor 2000  between socket D and E Vermessung des Referenzwiderstands 2000  zw. den Messbuchsen D und E Test sequence RTarget value RTolerance RActual value Prüfablauf RSollwert RToleranz RIstwert [] [] []

1.1

2000

RDifference RDifferenz []

Result Ergebnis Pass Fail

+/-5

Measuring the reference value of temperature cut off, temperature control and cable cut between socket C and D Vermessung der Referenzwiderstände für Übertemperatur, Regelung und Kabelbruch zw. den Messbuchsen C und D Result RTarget value RTolerance RActual value RDifference Test sequence Switch Ergebnis R R R R T [°C] Prüfablauf Schalter

1.2

1.3

1.4

S1 S1 S1 S1 S1 S2 S2 S2 S2 S3 S3 S3

0 40.5 41.5 44 45.7 0 40.5 41.5 45.7 0 40.5 45.7

Sollwert

Toleranz

Istwert

[]

[]

[]

13369 2740 2647 2428 2292 13369 2740 2647 2292 13369 2740 2292

Verification of System Testbox Überprüfung der System Testbox

Differenz

[]

Pass

+/-150 +/-10 +/-10 +/-10 +/-10 +/-150 +/-10 +/-10 +/-10 +/-150 +/-10 +/-10

Result Ergebnis Pass Fail

Date Datum

Date Datum Reviewed Geprüft

- 31 -

Created by Erstellt

Name

Fail

Testing Instructions ASTOFLO PLUS

- 32 -

ASTOFLO PLUS (AFP)

Überprüfung vor Inbetriebnahme Vor dem ersten bestimmungsgemäßen Einsatz des Geräts müssen gemäß IEC 62353 die entsprechenden Messungen durchgeführt werden: Pos

Messung (True RMS)

1

Schutzleiterwiderstand

2

Geräteableitstrom (Ersatzmessung) Ableitstrom vom Anwendungsteil (Ersatzmessung)

3 2* 3*

Verbindung zum elektrischen Sicherheitstester Verbindung 1 und 3

Grenzwerte BF ≤ 0.3 Ω

Verbindung 1 und 2 Verbindung 1 und 2

Erdableitstrom N.C. Erdableitstrom S.F.C (L offen) Erdableitstrom S.F.C (N offen) Patientenableitstrom N.C. Patientenableitstrom S.F.C (PE offen)

oder Verbindung 1 Verbindung 1 Verbindung 1 Verbindung 1 und 2 Verbindung 1 und 2

CF

≤ 1 mA ≤ 5 mA

≤ 0.05 mA

≤ 0.5 mA ≤ 1 mA ≤ 1 mA ≤ 0.1 mA ≤ 0.01 mA ≤ 0.5 mA ≤ 0.05 mA

Nur zur "Überprüfung vor Inbetriebnahme" (wenn kein entsprechender Sicherheitstester vorhanden ist) können die Messungen Pos. 2 (Geräteableitstrom) und Pos.3 (Ableitstrom vom Anwendungsteil) ersetzt werden durch die Messungen Pos 2* (Erdableitstrom) und Pos. 3* (Patientenableitstrom). Verbindung 1

Draufsicht: Stecker für Wärmeprofil

Verbindung 3: grün/gelbe Buchse oder alternativer PA – Anschluss auf der Rückseite

OK OK OK OK OK

Verbindung 2

Die Messspitze der Messleitung (Verbindung 2) muss vorsichtig auf eine der 5 Buchsen aufgesetzt werden. Diese Buchsen sind in der Abbildung mit OK markiert.

Achtung Achtung, nichts anderes in die Buchse stecken, dies könnte die filigranen Kontaktfedern beschädigen

PN 0961.7300.11

Rev. 1 – 09/2009

Page 1/2

ASTOFLO PLUS (AFP)

Test before putting into service Before first time operation as intended measurements according to IEC 62353 shall be carried out: Use connection to electrical safety analyzer Connection 1 and 3

Pos

Measurement (True RMS)

1

Protective earth resistance

2

Equipment leakage current (Alternative method) Applied part leakage current (Alternative method) or Earth leakage current N.C. Earth leakage current S.F.C (L open) Earth leakage current S.F.C (N open) Patient leakage current N.C. Patient leakage current S.F.C (PE open)

3 2* 3*

Limit value BF

CF ≤ 0.3 Ω

Connection 1 and 2

≤ 1 mA

Connection 1 and 2

≤ 5 mA

≤ 0.05 mA

Connection 1 Connection 1 Connection 1 Connection 1 and 2 Connection 1 and 2

≤ 0.5 mA ≤ 1 mA ≤ 1 mA ≤ 0.1 mA ≤ 0.01 mA ≤ 0.5 mA ≤ 0.05 mA

Only for the "Test before putting into service" (when there is no adequate safety tester) it is possible to replace the measurements Pos. 2 (equipment leakage current) and the Pos. 3 (applied part leakage current) by performing the measurements Pos. 2* (earth leakage current) and Pos. 3* (patient leakage current). Connection 1

Top view: Connector for heating profile

Connection 3: green yellow test socket or alternatively connector for potential equalization

OK OK OK OK OK Connection 2

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.

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

PN 0961.7300.12

Rev. 1 – 09/2009

Page 2/2