BIEGLER Medical Electronics
BW 685 and BW 685 S Service Instructions V7 sw V1.5
Service Instructions
27 Pages
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Page 1
Service Instructions Blood and Infusion Warmer
BW 685 / BW 685 S Print version BW 685 V 7 Software V 1.5 BW 685 Service Instructions
July 2007
Table of contents 1. Technical Data... 3 2. Symbols Used ... 4 3. Safety Instructions ... 5 4. Warranty... 7 5. Safety Shutdown ... 8 6. Setting the temperature ... 10 7. Service Interface... 11 8. Maintenance / Testing Instructions ... 14
_______________________________________________________________________________________ Page 2 BW 685 Service Instructions July 2007
1. Technical Data ____________________________________________________________________________________
Technical data for BW 685 / BW 685 S: Device: Type designation: Voltage: Power consumption: Protection class: Degree of protection: Humidity protection: Fuses: Control temperature: Overtemperature shutdown: Max. system pressure: Classification: Operational mode: Dimensions BW 685: Weight BW 685: Dimensions BW 685 S: Weight BW 685 S:
Blood and Infusion Warmer BW 685 / BW 685 S 230 V / 50 Hz 1.5 A I B IPX4 primary 2 x 1.6 AT secondary 500 mAT 37°C - 41°C adjustable in 0.5°C steps 42°C / 42.5°C / 45°C±3°C 300 mm Hg IIb according to Rule 9 Continuous operation WxHxD 228 x 228 x 132 mm 1.9 kg WxHxD 228 x 278 x 132 mm 2.0 kg
Tube warmer Tubeflow for BW 685 S:
Length 1340 mm
______________________________________________________________________________________ Page 3 BW 685 Service Instructions July 2007
2. Symbols Used ____________________________________________________________________________________
0123
Certifies compliance with the Directive 93/42/EEC Observe the instructions for use
Do not dispose of this product as unsorted municipal waste Control for increasing the temperature setting Control for decreasing the temperature setting IPX 4
Humidity Classes Degree of protection B Control for switching On / Standby
- for optional tube warmer Tubeflow
I
Operation
Malfunction
Do not cover
Do not wrap up
Do not expose to direct sunlight
Do not cut
_______________________________________________________________________________________ Page 4 BW 685 Service Instructions July 2007
3. Safety Instructions __________________________________________________________________________________________
The manufacturer, assembler, installer or importer is considered responsible for the device's effect on safety, reliability and performance only if: • the device is used in compliance with the instructions for use • the electrical installations in the affected rooms comply with the existing special technical regulations • modifications, repairs or new adjustments have been or are only performed by Biegler or authorized personnel • only original replacement parts from Biegler are used for repairs (applies also for the mains power cord).
After the buzzing tone sounds or the red alarm light lights up, the infusion or transfusion tube must be removed immediately from the warming cylinder! The infusion or transfusion solution may no longer be used on the patient! •
In the event of any suspected malfunction while in operation, the device should be immediately removed from service and not used for infusions or transfusions until appropriate investigations have demonstrated that there has been no impairment.
•
If the high temperature alarm is triggered the supply of liquid to the patient must be immediately stopped by disconnecting the connection tube to the patient. The medium being used in the device must no longer be administered to the patient.
•
The device may only be fastened to infusion stands, tripods or equipment rails which are suitable due to their stability and load capacity.
•
Only sterile consumables prescribed by BIEGLER may be used in conjunction with the BW 685 / BW 685 S.
•
The device must only be used in areas in which the electrical installations are in accordance with the standards and regulations in force. Safe disconnection from the mains power supply can only be achieved by unplugging the mains plug.
•
•
The device may not be used in rooms subject to explosion hazard.
•
Repairs and modifications to the device may only be carried out by persons or service centres authorised by BIEGLER.
______________________________________________________________________________________ Page 5 BW 685 Service Instructions July 2007
•
The device must not be immersed in liquids or sterilised with steam or by thermochemical methods.
•
All extraneous influences, such as electromagnetic waves or high temperatures are to be kept to a minimum.
•
The system may malfunction due to the effect of strong electromagnetic fields (e.g. by HF therapy or surgical devices). The warmer works perfectly within the limit values of the Standard EN 60601-1-2. The system can be affected by limit values that do not comply with the Standard EN 60601-1-2.
•
Avoid exerting force on the device or its accessories.
•
If the device is dropped, damaged by force or if it shows a function deviating from the instructions for use, stop using the device immediately and return it to the service centre.
•
The periodic technical safety inspections must be carried out (see the section "Periodic inspections")
Supplementary safety instructions for the accessory tube warmer Biegler Tubeflow BW 685 S: •
The Biegler Tubeflow may only be clamped to the Biegler blood warmer BW 685 S with the fixing clamp according to the diagram in the chapter of the instructions for use "Initial operation".
•
Do not kink, cover, warm or cool the Biegler Tubeflow. Do not cover the Tubeflow with cloths or dressing material. Do not lead under blankets, warm air blankets, etc. Do not expose to direct sunlight or heat radiation. Lead the Tubeflow through the air unencumbered. Do not lead into or through incubators. Overwarming of the warmed liquid or burns to the patient cannot to be excluded in the case of noncompliance. •
Do not shorten or damage the Biegler Tubeflow.
The BW 685 / BW 685 S may not be used if: •
the housing is damaged or one of the front film layers becomes detached.
_______________________________________________________________________________________ Page 6 BW 685 Service Instructions July 2007
•
the device has been exposed to a hard physical shock (e.g. dropped, hit or shaken)
•
the device has been immersed in water
•
the device has triggered a high temperature alarm that was not caused by external factors.
•
the mains power cord or plug is damaged
•
the device has given somebody an electric shock
the fixing clamps are damaged and no longer assure safe clamping to the infusion stand.
Should a malfunction be evident, suitable warning signs should be attached to the device to ensure that it cannot be used before necessary service and repair work has been carried out.
4. Warranty _________________________________________________________________________________________________
Biegler Medizinelektronik provides a warranty for this device for a period of two years from the purchase date. This warranty applies for defects in materials and workmanship and includes both replacement parts and labour. The activated warranty requires that an invoice or proper receipt be presented and that the warranty claim be made within the warranty period. The warranty expires if the device has been damaged, not used or maintained properly according to the instructions for use or unauthorized repairs or alterations have been made.
______________________________________________________________________________________ Page 7 BW 685 Service Instructions July 2007
5. Safety Shutdown _________________________________________________________________________________________________
42 °C (software alarm): • • • • • •
Switch device on Preheat the BW to 41°C and wait for the temperature to stabilise Disconnect the mains plug Hold down the control ↑ and reconnect the mains power cable. Press the control Operation/Standby (the device now slowly heats up to a target temperature of 42.5 °C) Observe the temperature display carefully. The high temperature alarm should be triggered at 42°C. (for reasons of safety, short beeping sounds are given at intervals of a second in this operational mode – the LEDs of the STANDBY indicator also flash, alternating with each other)
42.5 °C (hardware alarm): Important: Testing of the hardware alarm can only be conducted with the service cable LZ10B0685! • • • • •
Connect the blood warmer to the computer and start a terminal programme Switch the blood warmer on and preselect 41°C on the device Allow the BW to warm up (about 1 minute) Press the "e" key on the computer The blood warmer is now in set-mode. This is signalled by the blinking of the STANDBY indicator and a beep. With the software alarm deactivated, the device now heats up to a temperature of 45°C. The hardware temperature shutdown must be active at 42.5°C +/0.5°C
45 °C (overtemperature cut-out): • • •
If, for any reason, the first and second electronic safety shutdowns do not activate, then the heat exchanger will be shut off by an automatic, resetable thermal cut-off at a temperature of 45°C. After the heat exchanger cools, the electronic shutdown must be tested. If this test is positive, the device can be put back into operation after cooling. This type of shutdown may also activate if the device is stored in the vicinity of strong heat sources or exposed to direct sunlight.
_______________________________________________________________________________________ Page 8 BW 685 Service Instructions July 2007
5 . Safety Shutdown _________________________________________________________________________________________________
37 °C (low temperature alarm): This alarm cannot active until 60 seconds after switching on the device. If the temperature of the heat exchanger is less than 36.5°C, the user will be notified by the low temperature alarm both optically and acoustically. The alarm is signalled by the blinking of the STANDBY display and an intermittent beep. This alarm resets automatically (if the temperature rises again to 37 °C, the alarm stops).
If a type of shutdown is activated, the device must be tested immediately and repaired, if necessary.
______________________________________________________________________________________ Page 9 BW 685 Service Instructions July 2007
6. Setting the temperature _________________________________________________________________________________________________
•
Start the terminal software
•
Connect the BW 685 with the computer or terminal (RS 232) using the connecting power cable LZ 10B0685 (Biegler ID)
•
The monitor must now display data output as described in section 7, Service Interface
•
Attach a suitable temperature probe ( Ø 0.5 mm) in the middle of the heating ring on the upper side with a piece of infusion tubing in such a way that the temperature can be measured on the groove bed
•
Send the command “ * “ to the BW685 to set the correction factors of both sensors to 0
•
Start the warmer's heater and wait until the temperature has stabilised. This measurement must only be conducted in draft-free rooms to avoid false measurements.
•
Conduct the temperature control. The measured temperature should be the same ( +/- 0.1 °C) as the temperatures displayed on the monitor ( actual-f and actual-r) Deviations up to +/- 0.5 °C can be compensated for with the commands “ ! “, “ „ “, “ ? “ and “ = “.
_______________________________________________________________________________________ Page 10 BW 685 Service Instructions July 2007
7. Service Interface ________________________________________________________________________________________________
The BW 685 is equipped with a service interface. This serial interface provides different measured values that can be very useful during calibration and troubleshooting. The BW 685 can be connected directly to a PC or terminal with an appropriate connecting power cable. The data can be displayed using an available terminal programme (hyperterminal). Data format: 19 200, n, 8, 1 Control codes: code r s 0 1 2 3 4 5 6 7 8 9 ! " ? = * $ b : < > c h l t e n ( ) o
description run stop set temp. 37°C set temp. 37.5°C set temp. 38°C set temp. 38.5°C set temp. 39°C set temp. 39.5°C set temp. 40°C set temp. 40.5°C set temp. 41°C set temp 41.5°C heating correction front - 0.1 heating correction front + 0.1 heating correction rear + 0.1 heating correction rear - 0.1 all heating corrections 0 reset hour meter display hour meter set temp. 42°C dec set temp (step 0.1°C) inc set temp (step 0.1°C) low temperature test overtemperature test LED-test testmode 2 (no alarms) testmode 1 (heater 42.5°C) back to normal operation (after testmodes) TubeFlow on TubeFlow off relais test
usage service/remote service/remote service/remote service/remote service/remote service/remote service/remote service/remote service/remote service/remote service/remote debugging calibration calibration calibration calibration calibration service/info service/info debugging debugging debugging service service service service service service service/remote service/remote service
______________________________________________________________________________________ Page 11 BW 685 Service Instructions July 2007
Output:
headline target ist_v ist_h reg mean S>I I>S P% s err t kor_v kor_h
description
usage
setting temperature meas. temp front meas. temp rear temp. value used for regulation mean temperature used for display diff setting/meas temp diff meas/setting temp heat output temp. slew rate error counter low temp. Inhibit alarm timer correction value front correction value rear
service service service debugging service debugging debugging debugging debugging debugging debugging service service
_______________________________________________________________________________________ Page 12 BW 685 Service Instructions July 2007
example of BW685 ASCII output [38.5
38.5
38.6
38.6
38.5
00.0
00.1
008
000
000
085
+0.0
+0.0
]
[38.5
38.6
38.7
38.7
38.5
00.0
00.2
006
001
000
084
+0.0
+0.0
]
[38.5
38.6
38.8
38.8
38.5
00.0
00.3
004
001
000
083
+0.0
+0.0
]
[38.5
38.6
+0.0
]
38.8
38.8
38.6
00.0
00.3
004
000
000
082
+0.0
soll ist_v ist_h
reg
mean
S>I
I>S
P%
s
err
t
kor_v kor_h
[38.5
38.6
38.8
38.8
38.6
00.0
00.3
004
000
000
081
+0.0
+0.0
]
[38.5
38.6
38.8
38.8
38.6
00.0
00.3
004
000
000
080
+0.0
+0.0
]
[38.5
38.6
38.8
38.8
38.6
00.0
00.3
004
000
000
079
+0.0
+0.0
]
[38.5
38.6
38.8
38.8
38.7
00.0
00.3
004
000
000
078
+0.0
+0.0
]
[38.5
38.6
38.8
38.8
38.7
00.0
00.3
004
000
000
077
+0.0
+0.0
]
[38.5
38.6
38.8
38.8
38.7
00.0
00.3
004
000
000
076
+0.0
+0.0
]
[38.5
38.6
38.8
38.8
38.7
00.0
00.3
004
000
000
075
+0.0
+0.0
]
[38.5
38.6
38.7
38.7
38.7
00.0
00.3
000
000
000
074
+0.0
+0.0
]
[38.5
38.6
38.8
38.8
38.7
00.0
00.3
000
001
000
073
+0.0
+0.0
]
[38.5
38.6
38.7
38.7
38.7
00.0
00.3
000
000
000
072
+0.0
+0.0
]
[38.5
38.6
38.7
38.7
38.7
00.0
00.3
000
000
000
071
+0.0
+0.0
]
[38.5
38.6
38.7
38.7
38.7
00.0
00.3
000
000
000
070
+0.0
+0.0
]
[38.5
38.5
38.6
38.6
38.7
00.0
00.3
000
000
000
069
+0.0
+0.0
]
[38.5
38.5
38.6
38.6
38.7
00.0
00.3
000
000
000
068
+0.0
+0.0
]
[38.5
38.5
38.6
38.6
38.7
00.0
00.3
000
000
000
067
+0.0
+0.0
]
Standby
Operation
Heating starts with 010
soll ist_v ist_h
reg
mean
S>I
I>S
P%
s
err
t
kor_v kor_h
[38.5
38.5
38.6
38.6
38.6
00.0
00.1
010
000
000
090
+0.0
+0.0
]
[38.5
38.5
38.6
38.6
38.6
00.0
00.1
010
000
000
089
+0.0
+0.0
]
[38.5
38.4
38.6
38.6
38.6
00.0
00.1
010
000
000
088
+0.0
+0.0
]
[38.5
38.4
38.6
38.6
38.6
00.0
00.1
010
000
000
087
+0.0
+0.0
]
[38.5
38.4
38.6
38.6
38.6
00.0
00.1
010
000
000
086
+0.0
+0.0
]
[38.5
38.4
38.6
38.6
38.6
00.0
00.1
010
000
000
085
+0.0
+0.0
]
[38.5
38.4
38.5
38.5
38.5
00.0
00.0
010*
000
000
084
+0.0
+0.0
]
soll ist_v ist_h
reg
mean
S>I
I>S
P%
s
err
t
kor_v kor_h
[38.5
38.4
38.5
38.5
38.5
00.0
00.0
010*
000
000
083
+0.0
+0.0
]
[38.5
38.4
38.5
38.5
38.5
00.0
00.0
010*
000
000
082
+0.0
+0.0
]
[38.5
38.4
38.6
38.6
38.5
00.0
00.1
008
001
000
081
+0.0
+0.0
]
[38.5
38.4
38.6
38.6
38.5
00.0
00.1
008
000
000
080
+0.0
+0.0
]
Description: [
Data start
]
Data Stop
*
Heater on (used with P%)
“Betrieb”
Message: BW685 is in operation mode
“Standby”
Message: BW685 is in standby mode Message: Heater starts with 10% power (for debugging)
“Heizung start mit 010”
______________________________________________________________________________________ Page 13 BW 685 Service Instructions July 2007
8. Maintenance / Testing Instructions _________________________________________________________________________________________________
These instructions serve as a reference. Any changes that occur will be issued by BIEGLER in the form of supplementary sheets and must be added immediately. A maintenance test must be conducted after a repair of the BW 685. This is identical to the PERIODIC INSPECTION. PERIODIC INSPECTION The periodic technical safety inspections (according to the local standards in force e.g. in Austria ÖVE/ÖNORM E 8751-1) must be carried out on the BW 685 / BW 685 S at least every 12 months by persons able to carry out such technical safety inspections based on their training, knowledge and experience gained by practical activities. The results of the periodic inspection are to be documented, together with the date and the inspecting agency, in the inspection protocol provided. Important: Should a malfunction be evident during the periodic inspection, suitable warning signs should be attached to the device to ensure that it cannot be used before necessary service and repair work has been carried out. CHECKING THE WARM-UP PERIOD This is the time taken by the BW 685 / BW 685 S to heat up to 38.5°C from room temperature. The device is malfunctioning if it takes much longer than one minute. CHECKING THE CONTROL TEMPERATURE The control temperature is checked on the groove bed of the heat exchanger. The sensor of a suitable contact thermometer (tolerance +/- 0.15°C) is fixed to this position, e.g. by using a piece of infusion tubing. The examination is performed at a temperature setting of 38.5°C. The measured value is read after it has stabilized. The difference must not exceed +/- 0.5°C. There is a malfunction if a difference from the control temperature of greater than +/- 0.5°C is obtained.
_______________________________________________________________________________________ Page 14 BW 685 Service Instructions July 2007
8. Maintenance / Testing Instructions _________________________________________________________________________________________________
LONG-TERM TEST: • • •
Start-up at 38.5 °C Measure the temperature on the heat exchanger after about 15 min. Measure the temperature again after 24 hours
The initial value (after 15 minutes) and the end value (after 24 hours) must not lie outside of tolerance range; the measurements must always be made under the same environmental conditions. The end value may deviate from the initial value by ± 0.5°C.
Contact thermometer
Fig.1 - Measurement Set-up •
Attach a suitable temperature probe ( Ø 0.5 mm) in the middle of the heating ring on the upper side with a piece of infusion tubing in such a way that the temperature can be measured on the groove bed
Measuring device used: Type K
TESTO Contact Thermometer 935 Precision: ± 1 digit ±0.7 °C ±0.5 % from the measured value
______________________________________________________________________________________ Page 15 BW 685 Service Instructions July 2007
INSPECTION OF THE OVERTEMPERATURE ALARM (Software) Preheat the device to 41°C and wait for the temperature to stabilise, then disconnect the mains plug. Hold down the control and reconnect the mains power plug. After the beep has ceased, release the control . Press the switch . The device now slowly heats up to a target temperature of 42.5°C. Observe the temperature display carefully. The high temperature alarm should be triggered at a temperature of 42°C. For reasons of safety, short beeping sounds are given at intervals of a second in this operational mode and the STANDBY indicator (Diag.1/4) flashes. There is a malfunction if the high temperature alarm is not triggered. To reset the alarm, either disconnect the mains plug and allow the device to cool and then start up again, or reset the alarm using the service interface.
VISUAL CHECK OF GENERAL CONDITION The device should be checked for mechanical damage (general mechanical condition) and for the completeness of the front film layer, sticker information, particularly the device label on the reverse. There is a malfunction if mechanical damage to the device is evident which could be harmful or impair the functional operation of the device. Also, the device must not have any dirt on it that might impair safety.
ELECTRICAL SAFETY All relevant electrical safety data should be checked, particularly the earth conductor resistance (Target: < 0.3 Ohm) and leakage current (Target: < 0.75 mA). There is a malfunction if there is a measured value outside the tolerances. These tests must be conducted at the operating temperature.
_______________________________________________________________________________________ Page 16 BW 685 Service Instructions July 2007
8. Maintenance / Testing Instructions
( IMPORTANT: Voltage ! ) They are performed using the safety tester GERB - GM- 100 and the test programme BLUTW. 1. The protocol is stored in the PC.
INSPECTION OF THE FUSES IN PLACE Necessary only after repair carried out. The fuse inserts must be especially tested during maintenance work. For this device, either of the following may be used. primary:
BW685
secondary all
BW 685:
230V
1.6 AT 500 m AT
.
______________________________________________________________________________________ Page 17 BW 685 Service Instructions July 2007
MAINTENANCE AND INSPECTION PROTOCOL FOR BW 685 Device no.: 230V
... Date: ... Print number:...
These tests require a precise knowledge of the associated maintenance / testing instructions! TEST
TARGET / FUNCTION
1. Long-term test
Initial value:...°C End value:...°C
2. Operational readiness (at room temp.) 3. Overtemperature cut-off 4. Low temperature Cut-off 5. High voltage 6. Electrical fuse 6.1. Earth conductor resistance 6.2. Replacement device leakage current 6.3 Replacement device leakage current 7. Fuse insert 8. Mechanical condition 9. Dirt 10. Verification of labels
EVALUATION OK / not OK Value
Warm-up period:...s Target: < 42.5 °C Target: < 36.5 °C Target: 1.5 kV / 1 minute
Internal to BIEGLER only Internal to BIEGLER only
< 0.3 Ω < 0.75 mA first measured value Only after repair carried out.
Signature of the inspecting personnel:
_______________________________________________________________________________________ Page 18 BW 685 Service Instructions July 2007
The function controls indicated in the operating instructions must be conducted. The replacement leakage current cannot be greater than 1.5 times the first measured value and, at the same time, not greater than the threshold indicated above. If the devices are not functionally and/or operationally safe, they must be repaired or the operator must be informed of the hazard from the device. The proper conducting of the tasks listed above and the correctness of the information must be confirmed. Comments:
Technician
Operator
__________________
________________
(Date, Signature)
(Date, Signature)
______________________________________________________________________________________ Page 19 BW 685 Service Instructions July 2007
--------------------------------------------------------------------------GERB Elektronik GmbH Page 1 BLUTW1 Test Procedure Electrical Safety --------------------------------------------------------------------------Test point Description --------------------------------------------------------------------------GERB024 Power measurement The effective power use of the device being tested is measured The measurement is limited by time. Any time exceeded is indicated. Maximum power use 3.5 kVA. Care must be taken that the blood warmer is in the warming up phase when this measurement is taken. Measurement unit: Watt Target: 0.00 Threshold: 0.00 Interval tol.: 0.00 Measurement unit: Watt Target: 0.00 Threshold: 0.00 Interval tol.: 0.00
Rel. tol. 0.00 Rel. tol. 0.00
GERB003 Insulation resistance network protective earth conductor Test voltage 500V= over 5 Mohm applied to both phases of the device to be tested. The resistance between the phases and the earth conductor is measured. Mains switch ON! Measurement unit: MOhm Measurement unit: MOhm
Target: 0.00 Target: 0.00
Threshold: > 2.00 Threshold: > 2.00
Interval tol. 0.00 Rel. tol. 0.00 Interval tol. 0.00 Rel. tol. 0.00
GERB005 Earth conductor resistance Test voltage 6V max. 25A at the connection of the testing tip. The testing tip must be held on the warming ring. The test is limited by time. If the time is exceeded, this will be displayed on the monitor. Measurement unit: MOhm Target: 0.00 Threshold: < 0.30 Measurement unit: Ohm Target: 0.00 Threshold: < 0.30
Interval tol.: 0.00 Rel. tol. 0.00 Interval tol.: 0.00 Rel. tol. 0.00
GERB005 Earth conductor resistance Test voltage 6V max. 25A at the connection test peak. The testing tip must be held on the fastening clamp. The test is limited by time. If the time is exceeded, this will be displayed on the monitor. Measurement unit: Ohm Target: 0.00 Threshold: < 0.30 Interval tol.: 0.00 Measurement unit: Ohm Target: 0.00 Threshold: < 0.30 Interval tol.: 0.00
Rel. tol. 0.00 Rel. tol. 0.00
GERB006 Earth leakage current N.C. The earth leakage current is measured under operating conditions. No additional grounding connection is allowed to be established between the safety testing device GM 100 and the device to be tested. No testing tip is necessary. Mains switch ON Measurement unit: µA Target: 0.00 Threshold: < 500 Measurement unit: µA Target: 0.00 Threshold: < 500
Interval tol.: 0.00 Interval tol.: 0.00
Rel. tol. 0.00 Rel. tol. 0.00
GERB009 Housing leakage current S.F.C-PE open The testing tip is held on conductive housing parts of the device to be tested. Do not create any additional bond to the device to be tested No testing tip is necessary. Mains switch ON Measurement unit: µA Target: 0.00 Threshold: < 500 Measurement unit: µA Target: 0.00 Threshold: < 500
Interval tol.: 0.00 Interval tol.: 0.00
Rel. tol. 0.00 Rel. tol. 0.00
_______________________________________________________________________________________ Page 20 BW 685 Service Instructions July 2007