Beruflich Dokumente
Kultur Dokumente
4 09/2009
Service Instructions
Manufacturer:
Page
-2-
Rev. 4 09/2009
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-
1 General
1.1
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:
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
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.
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-
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
Attachment device
Page
-6-
Rev. 4 09/2009
6 Key Temperature up
3 Key START
4 Power LED
2 Key STAND-BY
1 Stand-by
LED
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
Key START
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.
Temperature
up key
Temperature
down key
"SET"
temperature
display
Actual
temperature
display
Alarm LED
Rev. 4 09/2009
Page
-7-
Technical Specifications
ASTOFLO PLUS
Electr. connection
Power consumption
Protection class (IEC 60601)
Protective earth resistance
Equipment leakage current
Applied part (IEC 60601-1)
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
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
33.0C to 43.0C ( 1 C)
can be selected by the user in 0.5C steps
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
Excessive temperature alarms can also be triggered by exterior circumstances (external source of heat
such as sunlight or radiators).
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-
Power PWB
Display PWB
Toroidal core
Test socket
Heating profile
Page
- 10 -
Rev. 4 09/2009
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)
Display PWB
Power PWB
Heating profile
Rev. 4 09/2009
Page
- 11 -
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
Schlke &
Mayr GmbH
Rev. 4 09/2009
Bode Chemie
GmbH
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
20.4
2.1 no reaction
Possible cause(s)
Remedy
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 -
Possible cause(s)
Remedy
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
45.8
Remedy
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 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.
32.8
Rev. 4 09/2009
Page
- 15 -
Device reaction
and the following happens?
Cable break alarm
Possible cause(s)
Remedy
Possible cause(s)
Remedy
44.0
41.5
Page
- 16 -
Rev. 4 09/2009
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".
Remedy
Check the test box and have it
repaired/adjusted if there is a
deviation.
See testing instructions chapter 3.3 9.1 Warmer does not react with an
excessive temperature alarms
alarm or does not display
"E16".
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
Rev. 4 09/2009
Page
- 17 -
Page
- 18 -
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
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
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
Rev. 4 09/2009
Page
- 19 -
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 A
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
Possible cause(s)
Page
- 20 -
Rev. 4 09/2009
Remedy
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).
Only use original spare parts (see the spare parts list in the appendix). Using
other parts invalidates the pattern approval.
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.
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 -
5.1
Necessary tool
0.8 x 4 mm screwdriver
4. lay the front housing half on the left of the rear housing half.
5.2
1. Carefully lift the insulation sheet holding it by its underside near the
distance pins.
Page
- 22 -
Rev. 4 09/2009
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.
Necessary tool:
Tx 10 torx screwdriver
2. hold the PWBs in the housing with one hand and turn the unit
upside down.
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 -
1. Take the display frame out of the housing from the top of the
housing.
5.3
1. Lay the display frame in the housing with the correct side up.
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.
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
3. Carefully lay down the unit and secure the PWBs with the short
screws (3x6).
Necessary tool:
Tx 10 torx screwdriver
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.
Rev. 4 09/2009
Page
- 25 -
5.4
Necessary tool:
0.5 x 3 mm screwdriver
Tx 10 torx screwdriver
3. Straighten the wires and pull the power supply cord out of the
housing/anti-kink sleeve.
Necessary tool:
SW10 open-ended or ring spanner
Page
- 26 -
Rev. 4 09/2009
Necessary tool:
-
Necessary tool:
Tx 20 torx screwdriver
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 -
5.5
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.
Necessary tool:
Tx 20 torx screwdriver
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
Necessary tool:
-
2. Make sure that the fuse values comply with the specifications on
the mains supply PWB.
Necessary tool:
0.5 x 3 mm screwdriver
Tx 10 torx screwdriver
Rev. 4 09/2009
Wire
green/yellow
Connection
blue
brown
N
L
Page
- 29 -
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.
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*
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
5.6
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.
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 -
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.
Page
- 32 -
Rev. 4 09/2009
Appendix
A Spare parts list
B Testing instructions (safety and function checks)
C Test before putting into service
Rev. 4 09/2009
Page
- 33 -
Page
- 34 -
Rev. 4 09/2009
Abbildung
Figure
Bezeichnung
Description
0560.4000.10
Gehuse vorne
Front housing
0560.4200.00
Frontplatte ASTOFLO
PLUS
Frontpanel ASTOFLO
PLUS
0560.4000.20-PA
0560.4000.26
Kappe
fr Ausfhrung JA-NA
Cap
for version JA-NA
0860.4000.26
Kappe
fr Ausfhrung 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 -
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
0660.8301.00
Profilklammer
9850.5100.00
Rndelschraube
Knurled screw
Seite
- A2 -
Rev. 4 09/2009
Bestell-Nr.
Order no
Abbildung
Figure
Bezeichnung
Description
0860.2050.00
Ringkerntransformator
100-115-230-240 VAC
inkl. Netzanschlussplatine
& Isolationsplatte 2
0860.2100.11
Netzanschlussplatine
inkl. Isolationsplatte 2 &
Set Sicherungen
Set Sicherungen fr
Ausfhrung AU-CH-DKEU-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 -
Bestell-Nr.
Order no
Abbildung
Figure
Bezeichnung
Description
0560.2110.00
Testbuchse
Test socket
0560.2111.00
Kabel fr Testbuchse
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
Bestell-Nr.
Order no
Abbildung
Figure
Bezeichnung
Description
9750.4100.16
Netzanschlussleitung
CH (Schweizer Stecker)
9750.4100.12
Netzanschlussleitung
UK
(BS-Stecker)
0760.4210.01
Netzanschlussleitung
AU (AS3112Schraubstecker)
9750.4100.17
Netzanschlussleitung
JA/NA
0850.4100.40
Netzanschlussleitung
CN
0560.8220.00
Zuleitung Wrmeprofil
Rev. 4 09/2009
Seite
- A5 -
Abbildung
Figure
Bezeichnung
Description
WP2418
Wrmeprofil 2418
WP2424
Wrmeprofil 2424
WP2618
Wrmeprofil 2618
WP2624
Wrmeprofil 2624
0560.6001.01
Verpackung AFP
komplett
0560.9600.11
Service-Anleitung
0560.9600.12
Service Instructions
0860.9500.00
Seite
- A6 -
Rev. 4 09/2009
Testing Instructions
Manufacturer:
Page
- B2 -
Rev. 2 04/2009
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-
Chapter 1: Preface
1.
2.
-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
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.
-5-
2.
Visual check
Check that the following parts of the device are in a good and safe condition; replace them if
required:
Pos
1
2
3
Use connection
to electrical safety
analyzer
Connection 1 and 3
Connection 1 and 2
Connection 1 and 2
Limit value
0.3
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
Connection 2
Caution
Do not insert anything else in the socket since this
might damage the fine contact springs.
-6-
4.1
2.
3.
4.
NTC2
NTC12
NTC11
ACHTUNG
The pins are very delicate. Please contact them carefully.
5.
6.
7.
21,4C = 5747
e.g.
NTC11 = 5514
NTC12 = 5554
NTC2 = 5570
-7-
Lowest value
Highest value
8.
9.
Note:
Several multimeters could show
measuring variations because of
inductance of leads.
5.1
3.
H1
Cut-off 2 (H2)
1. Press and hold both the "Temperature
down" and "Temperature up" keys
simultaneously for several seconds.
2.
3.
-8-
H2
Cut-off 3 (H3)
1. In normal operation press and hold the
"Temperature down" key for several
seconds.
2.
3.
5.2
H3
to put the
-9-
location of
sensors
45.2C
41.0C
5.3
- 10 -
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 []
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 []
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
Prfprotokoll
Test Protocol
Stammdaten/Master data
SN:
Auftrags-Nr./Repair reference:
Gert/Device:
AFP200
100V
Schutzklasse/Protection class:
115V
230V
240V
Wrmeprofil/Heating profile:
ohne/without
WP2-
424
418
ASTOFLO PLUS
618
I
Anwendungsteil/Applied part:
624
CF
BF
Sichtprfung/Visual inspection
ok
Hersteller/Manufacturer:
STIHLER ELECTRONIC GmbH
Julius-Hoelder-Str. 36
70597 Stuttgart Germany
Prfung vor Inbetriebnahme
(Bezugwert)/
Test before putting into service
(reference value)
Wiederholungsprfung/
Recurrent Test
n.ok
ok n.ok
Aufschriften/Labeling
Frontplatte/Front panel
Gehuse/Housing
Befestigungsvorrichtung/Attachment device
Wrmeprofil/Heating profile
Messwert/
measured value
mA
Min
Max
0,010 mA
0,3
1 mA
mA
0,005 mA
BF
5 mA
ok n.ok
CF
0,050 mA
ok n.ok
NTC2:
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/Date:
- 12 -
Unterschrift/Signature:
- 13 -
S1
S2
S4
S3
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:
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:
F:
socket for the heating profile supply line of the control unit for function
checks
G:
- 14 -
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.
* see also IEC 62353 Medical electrical equipment Recurrent test and test after repair of medical electrical
equipment
- 15 -
3.2
- 16 -
AFP 200
1 mA
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
- 17 -
2.
3.
4.
44C
41.5C
40.5C
S1
S2
S3
5.
6.
7.
to put the
- 18 -
SET:
44.0C
41.5C
44.0C
Set:
43.0C
44.0C
X 43.0
Temperature Control
1.
2.
3.
4.
5.
41.5C
41.5C
40.5C
S1
S2
S3
7.
40.5C
40.5C
S1
S2
9.
41.0C
2.
40.5C
E26
8.
41.5C
Set:
1.
6.
41.5C
41.5C
S1
S2
Set:
41.5C
Set:
41.0C
41.0C
40.5C
40.5C
S1
S2
1.
2.
- 19 -
40.5C
E26
Set:
41.0C
44C
S1
2.
3.
4.
5.
41.5C
S2
40.5C
S3
44.0C
Set:
41.0C
45.7C
S1
6.
7.
44C
S1
9.
45.7C
S2
- 20 -
45.7C
E16
8.
Set:
41.0C
45.7C
E16
Set:
41.0C
41.5C
S2
45.7C
S3
41.5C
E16
Set:
41.0C
2.
3.
4.
5.
40.5C
40.5C
S1
S2
.
S1
- 21 -
40.5C
S3
40.5C
Set:
40.0C
7.
40.5C
E16
Set:
8.
40.5C
S1
9.
40.0C
.
S2
40.5C
E16
Set:
40.5C
S2
40.0C
.
S3
40.5C
E16
Set:
- 22 -
40.0C
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
2.
2.
3.
4.
- 23 -
2.
3.
21,4C = 5747
e.g.
NTC11 = 5514
NTC12 = 5554
NTC2 = 5570
5.
- 24 -
Lowest value
Highest value
Note:
Several multimeters could show
measuring variations because of
inductance of leads.
5.1
3.
H1
Cut-off 2 (H2)
1. Press and hold both the "Temperature
down" and "Temperature up" keys
simultaneously for several seconds.
2.
3.
H2
Cut-off 3 (H3)
1. In normal operation press and hold the
"Temperature down" key for several
seconds.
2.
3.
- 25 -
H3
- 26 -
2.
3.
2.
S1
S4
3.
S1
40.5C
41.5C
S1
S1
45.7C
S1
4.
- 27 -
44C
S1
S2
S4
40.5C
41.5C
45.7C
S2
S2
S2
S3
S4
- 28 -
40.5C
45.7C
S3
S3
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 []
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 []
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
Prfprotokoll
Test Protocol
Stammdaten/Master data
SN:
Auftrags-Nr./Repair reference:
Gert/Device:
AFP200
100V
Hersteller/Manufacturer:
STIHLER ELECTRONIC GmbH
Julius-Hoelder-Str. 36
70597 Stuttgart Germany
Schutzklasse/Protection class:
115V
230V
240V
Wrmeprofil/Heating profile:
ohne/without
WP2-
424
418
ASTOFLO PLUS
618
I
Anwendungsteil/Applied part:
624
CF
BF
Sichtprfung/Visual inspection
ok
n.ok
Aufschriften/Labeling
Frontplatte/Front panel
Gehuse/Housing
Befestigungsvorrichtung/Attachment device
Wrmeprofil/Heating profile
Messwert/
measured value
mA
Min
Max
0,010 mA
0,3
1 mA
mA
0,005 mA
n.ok
ok
n.ok
CF
0,050 mA
n.ok
Anzeigegenauigkeit/Display accuracy
Temperaturregelung/Temperature control
BF
5 mA
ok
B
C
D
Datum/Date:
- 30 -
Unterschrift/Signature:
Verification Protocol
Prfprotokoll
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 nchste berprfung:
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 Referenzwiderstnde fr bertemperatur, 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]
Prfablauf
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
Differenz
[]
Pass
+/-150
+/-10
+/-10
+/-10
+/-10
+/-150
+/-10
+/-10
+/-10
+/-150
+/-10
+/-10
Result
Ergebnis
Pass
Fail
Date
Datum
Date
Datum
Reviewed
Geprft
- 31 -
Created by
Erstellt
Name
Fail
- 32 -
Schutzleiterwiderstand
Gerteableitstrom
(Ersatzmessung)
Ableitstrom vom Anwendungsteil
(Ersatzmessung)
3
2*
3*
Verbindung zum
elektrischen
Sicherheitstester
Verbindung 1 und 3
Grenzwerte
BF
0.3
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
Draufsicht:
Stecker fr
Wrmeprofil
Verbindung 3:
grn/gelbe Buchse oder
alternativer PA Anschluss
auf der Rckseite
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
knnte die filigranen Kontaktfedern beschdigen
PN 0961.7300.11
Rev. 1 09/2009
Page 1/2
Pos
3
2*
3*
Limit value
BF
CF
0.3
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