Technical Documentation

Photo-Therapy 4000
Phototherapy Unit

Revision 3.0
6141.420
9036107

Emergency Care Perioperative Care Critical Care Perinatal Care Home Care

Because you care

Contents
General
1

Notes
1.1

Symbols and Definitions ......................................................................................................... 4

Function Description
Photo-Therapy 4000 function description

Schematics and Diagrams

Connecting Diagramm

13

Annex
Parts catalog
Test List

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K6141420IECIVZ.fm 19.12.05

Technical Information

Contents

K6141420IECIVZ.fm 19.12.05

All rights reserved. Copyright reserved.

II

General

Photo Therapy Unit 4000

1

Notes

General
This Technical Documentation conforms to the IEC 60601-1 standard.
Read each step in every procedure thoroughly before beginning any test.
Always use the proper tools and specified test equipment. If you deviate from
the instructions and/or recommendations in this Technical Documentation,
the equipment may operate improperly or unsafely, or the equipment could
be damaged.
Use only original Drger parts and supplies.
The maintenance procedures described in this Technical Documentation may
be performed by qualified service personnel only. These maintenance
procedures do not replace inspections and servicing by the manufacturer.
The information in this manual is confidential and may not be disclosed to
third parties without the prior written consent of the manufacturer.

Strictly follow the Instructions for Use manual / Operating

Instructions! This Technical Documentation does not replace the
Instructions for Use manual / Operating Instructions. Any use of the
product requires full understanding and strict observation of the
product-specific Instructions for Use manual/ Operating Instructions.

Reference is hereby made to the observance of the relevant safety

provisions, for example in Germany, the Medical Product Law (MPG), the
Medical Device Operator Ordinance (MPBetreibV), the Pressure Container
Ordinance (Druckbehlterverordnung), the Technical Rules for Pressurized
Gases (Technische Regeln Druckgase), or the Occupational Health and
Safety Provisions (Unfallverhtungsvorschriften).
Unless otherwise stated, reference is made to laws, regulations or
standards (as amended) applicable in the Federal Republic of Germany.

Observe protection mark DIN 34. Copyright reserved.

Version 2.0_ Released_Printed on_19.12.05_K6142420_General.fm

Follow the laws and regulations applicable in your country.

6141.420

General
1.1

Photo Therapy Unit 4000

Symbols and
Definitions
This symbol indicates a warning.

This symbol indicates tips and useful information.

This symbol is used to alert against unsafe practices when handling

electrostatic sensitive devices (ESD).

= examination of actual condition

Maintenance

= measures to maintain specified condition

Repair

= measures to restore specified condition

Servicing

= inspection, maintenance, and repair

Observe protection mark DIN 34. Copyright reserved.

Inspection

6141.420

Version 2.0_ Released_Printed on_19.12.05_K6142420_General.fm

Definitions according to German standard DIN 31051:

Function Description

Photo-Therapy 4000
Photo-Therapy 4000
function description

Function description
The light of the Photo-Therapy 4000 is helpful for malfunctions of bilirubin
metabolism. If a newborn baby develops icterus because detoxification in the
liver has been inadequate, therapy to lower bilirubin concentration may be
required as early as the first day.
The light converts bilirubin into a water-soluble form by photochemical
reaction. This enables natural excretion via bile and urine.
The blue portion of the light spectrum (wavelength: 460 nm) is most effective
in decomposing bilirubin.

Fig.

1: Light spectrum diagram

Distance (cm)
(4 blue light lamps)

30

40

50

Ebi mW/cm2

2.4 +0.4

1.6 +0.3

1.2 +0.2

Observe protection mark DIN 34. Copyright reserved.

Revision 2.0_ Released_Printed on_19.12.05_F6141420T01.fm

Effective light intensity for bilirubin dissociation Ebi depends on how far away
the lamp housing (lower edge) is at mains voltage:

6141.420

Function description

Photo-Therapy 4000
If a higher bilirubin-effective intensity of light is required, the white light lamps
may be replaced with blue phototherapy lamps. Six blue light phototherapy
lamps will result in the following values for the bilirubin dissociation Ebi:

Distance (cm)
(6 blue light lamps)

30

40

50

Ebi mW/cm2

3.4 +0.6

2.3 +0.4

1.6 +0.3

The Photo-Therapy 4000 consists of the following assemblies:

Plastic-coated aluminum housing

Electronic switching units

Light sources for phototherapy and lighting

Control elements

Fuses

Operating hours counter

4
3

Fig.

2: Front view of the Photo-Therapy 4000

Operating hours counter

Handle

Switch (blue light lamps)

Switch (white light lamps)

6141.420

Revision 2.0_ Released_Printed on_19.12.05_F6141420T01.fm

Observe protection mark DIN 34. Copyright reserved.

Legend

Photo-Therapy 4000

Function description

4
3

1
2

Fig.

3: Rear view of the Photo-Therapy 4000

Rating plate

Handle

Mains switch selector (only for units with 110-115 V, 120-127 V)

Inlet connector for non-heating apparatus with fuse carrier

Observe protection mark DIN 34. Copyright reserved.

Revision 2.0_ Released_Printed on_19.12.05_F6141420T01.fm

Legend

6141.420

10

6141.420

Revision 2.0_ Released_Printed on_19.12.05_F6141420T01.fm

Observe protection mark DIN 34. Copyright reserved.

Function description
Photo-Therapy 4000

Schematics and Diagrams

11

12

All rights reserved. Copyright reserved.

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Photo-Therapy 4000

6141.420

Schematics and Diagramms

Connecting Diagramm

Figure 1

13

14

6141.420

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All rights reserved. Copyright reserved.

Schematics and Diagramms

Photo-Therapy 4000

Annex

Parts catalog
Test List
Technical Information

Parts catalog
Phototherapie 4000

Revision: 2005-01-06 10:22:55

6141.420

Emergency Care - Perioperative Care - Critical Care - Perinatal Care - Home Care

Because you care

Parts catalog

Electrical Component

Item
No.

Part No.

Description

Qty.

Qty.u Remark
nit

2M21010

FLUORESCENT LAMP,BLUE

1.000

St

2M21009

FLUORESCENT LAMP,WHITE

1.000

St

2M21383

LAMPHOLDER

1.000

St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
6141.420

Revision: 2005-01-06 10:22:55

Parts catalog

Trolley old

Item
No.

Part No.

Description

Qty.

Qty.u Remark
nit

2M18788

CAP (60X30)

1.000

St

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts
6141.420

Revision: 2005-01-06 10:22:55

Phototherapie 4000
Assembly

Description

Parts catalog
Part No.

Electrical Component 100V

FLUORESCENT LAMP,BLUE

2M21010

FLUORESCENT LAMP,WHITE

2M21009

LAMPHOLDER

2M21383

Electrical Component 127V

FLUORESCENT LAMP,BLUE

2M21010

FLUORESCENT LAMP,WHITE

2M21009

LAMPHOLDER

2M21383

Electrical Component 230V

FLUORESCENT LAMP,BLUE

2M21010

FLUORESCENT LAMP,WHITE

2M21009

LAMPHOLDER

2M21383

SUPPLY MAIN

1807331

Housing 230V/127V/90-100V
DISC (PLEXIGLASS)

2M21335

LAMPHOLDER

2M21383

Manuals/ Techn. Documents

DEVICE RECORD SHEET

9037157

IFU Phototherapie 4000 cs

9037834

IFU Phototherapie 4000 hu

9037835

IFU Phototherapie 4000 me (CE)

9029150

IFU Phototherapie 4000 no

9029343

IFU Phototherapie 4000 pl

9037833

IFU Phototherapy 4000 pt

9029345

Products Concerned
PHOTO THERAPY 4000 90-100V

2M22090

PHOTO-THERAPY 4000/110V/127V

2M21700

PHOTO-THERAPY 4000/230V

2M21000

Trolley old
CAP (60X30)

6141.420

2M18788

Revision: 2005-01

Test List

Copyright reserved. Reproduction permitted for non-commercial purposes only.

K6141420TL1.fm 19.12.05

Photo-Therapy 4000

Serial no.:

Installation site:

File no.:
6141.420
Edition:
01.97

This Test List does not replace inspection and servicing by the manufacturer
6141.420 Photo-Therapy 4000

Page 1

Test equipment required for the Test List

Copyright reserved. Reproduction permitted for non-commercial purposes only.

K6141420TL1.fm 19.12.05

VDE portable test kit

This Test List does not replace inspection and servicing by the manufacturer
6141.420 Photo-Therapy 4000

Page 2

General condition of the Photo-Therapy 4000

Check the general condition of the unit.

There are no sticky residues or dirt on the unit.
Check the power fuse links.
The values of the power fuse-links match the specifications on the
rating plate.
Check the power cable.
The power cable is in a perfect condition.

Functional test

3.1

Enter operating hours.

3.2

Checking the blue phototherapy lamp.

Copyright reserved. Reproduction permitted for non-commercial purposes only.

K6141420TL1.fm 19.12.05

Plug the power plug of the Photo-Therapy 4000 into the AC power
outlet.
Switch on the Photo-Therapy 4000.
Set the switch (blue light) to the ON position.
Four blue phototherapy lamps come on and the hour meter is running.
Set the switch (blue light) to the OFF position.

3.3

Testing the white light

Set the switch (white light) to the ON position.

Two white lamps or 2 blue lamps come on.
Set the switch (white light) to the OFF position.

This Test List does not replace inspection and servicing by the manufacturer
6141.420 Photo-Therapy 4000

Page 3

Electrical safety test

4.1

Protective earth conductor resistance

Connect the VDE portable test kit to the AC power supply.

Connect the Photo-Therapy 4000 to the VDE portable test kit.
Measure the protective earth conductor resistance according to
VDE 0751.
The protective earth conductor resistance should be less than/equal to
0.2 ohms.

4.2

Equivalent leakage current according to VDE

0751

Set both switches (white light and blue light) to the ON position.
Subsequent measurements may exceed the first-measured value in
the Test List by max. 50 %, but must not exceed the specified test
value.
The equivalent leakage current (IA) is less than/equal to 1.0 mA.

Copyright reserved. Reproduction permitted for non-commercial purposes only.

K6141420TL1.fm 19.12.05

The initial value must be recorded in a new Test List.

Initial value: IA =

mA

Stand

Check the general condition of the following stands:

5.1

Stand 2M 18780 (for PT 800/800)

Height adjustment
Castors 2M 15116 (2x)

This Test List does not replace inspection and servicing by the manufacturer
6141.420 Photo-Therapy 4000

Page 4

Lockable castors 2M 20761 (2x)

5.2

Stand 2M 21190

Height adjustment
Castors 2M 21373 (4x)

Handover

Supply fully functional unit to user/owner.

Copyright reserved. Reproduction permitted for non-commercial purposes only.

K6141420TL1.fm 19.12.05

Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

This Test List does not replace inspection and servicing by the manufacturer
6141.420 Photo-Therapy 4000

Page 5

Copyright reserved. Reproduction permitted for non-commercial purposes only.

K6141420TL1.fm 19.12.05

This Test List does not replace inspection and servicing by the manufacturer
6141.420 Photo-Therapy 4000

Page 6

Technical Information

2005-11-24

Technical Information for Photo-Therapy 4000

according to EMC standard IEC/EN 60601-1-2: 2001
General Information
The Photo-Therapy 4000 should not be used adjacent to or stacked with other equipment; if adjacent or
stacked use is inevitable, the Photo-Therapy 4000 should be observed to verify normal operation in the configuration in which it will be used.

Electromagnetic Emissions
Electromagnetic Emissions
Photo-Therapy 4000 is intended for use in the electromagnetic environment specified below. The user
should assure that is used in such an environment.
Emissions
Compliance
Electromagnetic environment
according to
RF emissions (CISPR 11)
Group 1
Photo-Therapy 4000 uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.

Harmonic emissions
(IEC 61000-3-2)
Voltage fluctuations / flicker
(IEC 61000-3-3)

Class A

Photo-Therapy 4000 is suitable for use in all establishments other than domestic and those directly connected
to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Not applicable

Not applicable because RF emissions are according to

class A.
Not applicable because RF emissions are according to
class A.

Not applicable

Information re electromagnetic emissions (IEC 60101-1-2: 2001, table 201)

page 1 of 3

Electromagnetic Immunity
Electromagnetic Immunity
Photo-Therapy 4000 is intended for use in the electromagnetic environment specified below. The user
should assure that is used in such an environment.
Immunity
IEC 60601-1-2 test level
Compliance
Electromagnetic environment
against
level (of PhotoTherapy 4000)
Floors should be wood, concrete or
electrostatic discontact discharge: 6 kV
6 kV
ceramic tile. If floors are covered
charge, ESD
air discharge: 8 kV
8 kV
with synthetic material, the relative
(IEC 61000-4-2)
humidity should be at least 30%.
Mains power quality should be that
electrical fast tran- power supply lines: 2 kV
2 kV
of a typical commercial or hospital
sients / bursts
longer input / output lines:
environment.
(IEC 61000-4-4)
Not
applicable
1 kV
surges on AC
Mains power quality should be that
common mode: 2 kV
2 kV
mains lines
of a typical commercial or hospital
differential mode: 1 kV
1 kV
(IEC 61000-4-5)
environment.
power frequency
3 A/m
Not applicable
In close vicinity to Photo-Therapy
magnetic field
4000, no equipment with extraordi50/60 Hz
nary power frequency magnetic
(IEC 61000-4-8)
fields (power transformers, etc.)
should be operated.
dip >95%, 0.5 periods
>95%, 0.5 per.
voltage dips and
Mains power should be that of a
60%, 5 per.
dip 60%, 5 periods
short interruptions
typical commercial or hospital envi30%, 25 per.
on AC mains input dip 30%, 25 periods
ronment. If user requires continued
dip >95%, 5 seconds
>95%, 5 sec.
lines
operation during power mains inter(IEC 61000-4-11)
ruptions, it is recommended to
power the Photo-Therapy 4000
from an uninterruptible supply or a
battery.
radiated rf
80 MHz 2.5 GHz: 10 V/m
10 V/m
Recommended separation distance
(IEC 61000-4-3)
from portable and mobile rf transmitters with transmission power
PEIRP to Photo-Therapy 4000 including its lines: 1.84 m * PEIRP X1
rf coupled into
150 kHz 80 MHz: 3 V
3V
Recommended separation distance
lines
within ISM bands,
from portable and mobile rf trans(IEC 61000-4-6)
3 V outside ISM bands X2
3V
mitters with transmission power
PEIRP to Photo-Therapy 4000 including its lines: 1.84 m * PEIRP X1
Information re electromagnetic immunity (IEC 60601-1-2: 2001, tables 202, 203, 204)
X1

: For PEIRP the highest possible "equivalent isotropic radiated power" of the adjacent rf transmitter has

interferto be inserted (value in Watt). Also in the vicinity of equipment marked with the symbol
ence may occur. Field strengths from fixed, portable or mobile rf transmitters at the location of PhotoTherapy 4000 should be less than 3 V/m in the frequency range from 150 kHz to 2.5 GHz and less
than 1 V/m above 2.5 GHz.
X2
: ISM bands in this frequency range are: 6.765 MHz - 6.795 MHz, 13.553 MHz - 13.567 MHz, 26.957
MHz - 27.283 MHz, 40.66 MHz - 40.70 MHz.

page 2 of 3

Recommended separartion distances

Recommended separation distances between portable and mobile
rf telecommunication devices and Photo-Therapy 4000
max.
PEIRP (W)

3 V/m distance* (m)

1 V/m distance* (m)

0.001

0.06

0.17

0.003

0.10

0.30

0.010

0.18

0.55

0.030

0.32

0.95

e.g. WLAN 5250 / 5775 (Europe)

0.100

0.58

1.73

e.g. WLAN 2440 (Europe), Bluetooth

0.200

0.82

2.46

e.g. WLAN 5250 (not in Europe)

0.250

0.91

2.75

e.g. DECT devices

1.000

1.83

5.48

e.g. GSM 1800- / GSM 1900- / UMTS- mobiles,

WLAN 5600 (not in Europe)

2.000

2.60

7.78

e.g. GSM 900 mobiles

3.000

3.16

9.49

Hint

Information re separation distances (IEC 60601-1-2: 2001, tables 205 and 206)
* 3 V/m distance to transmitters with frequencies from 150 kHz to 2.5 GHz, otherwise 1 V/m distance.

page 3 of 3

Manufacturer:
Drger Medical AG & Co. KG
Moislinger Allee 53 55
D-23542 Lbeck
Germany
Phone: (++49) (0) 1805-3723437
Fax: (++49) 451/882 - 3779

Subject to change without notice

Will not be replaced in the event of modifications.

Copyright by Drger Medical AG & Co. KG, Lbeck, Germany.

The warranty and liability conditions of the general terms and conditions for business transactions of
Drger Medical AG & Co. KG are not extended by this Technical Documentation.