Instructions for Use
Index 11-EN
Page 1 of 12
Issue date: 2018-09-17
PACKHEATERS
WB 6-50, WB 8-90, WB 16-130
1 Legal Notes .................................................................................................................................. 2
2 Safety Symbols ............................................................................................................................ 2
3 General Information .................................................................................................................... 2
3.1 Installation of the Packheater ........................................................................................................ 2
3.2 lnstruction in the Use of the Packheater ....................................................................................... 2
4 Intended Use ................................................................................................................................ 3
5 Power Supply ............................................................................................................................... 3
6 Operational Safety ....................................................................................................................... 3
7 Environmental Conditions ......................................................................................................... 3
7.1 Storage .......................................................................................................................................... 3
7.2 Operating Conditions..................................................................................................................... 3
8 Accessories ................................................................................................................................. 4
8.1 Mounting of the Drainage Hose (optional) .................................................................................... 4
8.2 Placing the Packheater on the Rack (optional) ............................................................................. 4
9 Initial Setup .................................................................................................................................. 5
10 Start Up ........................................................................................................................................ 5
10.1 Filling ............................................................................................................................................. 5
10.2 Emptying ....................................................................................................................................... 5
10.3 Starting Up .................................................................................................................................... 6
10.4 Safety Installation .......................................................................................................................... 7
11 Daily use ....................................................................................................................................... 7
12 Care, Maintenance and Disinfection ......................................................................................... 8
12.1 Water Change ............................................................................................................................... 8
12.2 Removal of Deposits ..................................................................................................................... 8
12.3 Cleaning of the External Surfaces ................................................................................................. 8
12.4 Cleaning of the Tub and the Insert Grid ........................................................................................ 8
12.5 Recommended Cleaning Agents .................................................................................................. 9
12.6 Surface Disinfection ...................................................................................................................... 9
13 Regular Tasks .............................................................................................................................. 9
13.1 Regular Safety Checks.................................................................................................................. 9
13.2 Limit Values for the Annual Safety Check ..................................................................................... 9
13.3 Check of the Temperature ............................................................................................................ 9
14 Service .......................................................................................................................................... 9
15 Limited Guarantee ..................................................................................................................... 10
16 Manufacturer .............................................................................................................................. 10
17 Technical Data ........................................................................................................................... 11
17.1 Technical Data ............................................................................................................................ 11
17.2 Standards and Directives ............................................................................................................ 11
17.3 Electrical Safety Classification .................................................................................................... 11
18 Installation Checklist ................................................................................................................ 12
Operating Manual
Index 11-EN
Page 2 of 12
1 Legal Notes
These lnstructions for Use have been created with the utmost care. Errors and
mistakes cannot be ruled out.
2 Safety Symbols
This symbol indicates a possible risk of danger. Read this instructions
for use carefully and follow all safety advices that are marked by this
sign.
This symbol indicates that hot water and
vapour bear a risk of scalding. Therefore it is
essential to take precautions when working
with this device. Ignoring this safety symbol
bears risk for the patient, the operator or
other persons, as well as risks for the real
values surrounding the equipment.
This symbol warns to open the enclosure of this device
while it is connected to the power supply. Ignoring this
safety symbol bears risk for the patient, the operator or
other persons, as well as risks for the real values
surrounding the equipment.
3 General Information
3.1 Installation of the Packheater
The packheaters may be serviced and opened by trained personnel only. Before
mounting or dismounting the packheater has to be emptied completely and cleaned.
The installation has to be documented on the installation checklist enclosed to this
manual. This checklist, signed by both user and mechanic has to be sent to the
manufacturer in original. It is the base for the limited warranty.
Attention: The surfaces of the device will be hot during operation!
3.2 lnstruction in the Use of the Packheater
For the instruction of the use of the water bath the national rules and guidellnes
concerning the operation of medical devices in health care facilities have to be
obeyed.
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Index 11-EN
Page 3 of 12
4 Intended Use
The packheaters WB 6-50, WB 8-90 and WB 16-130 are intended to heat up heat
packs and keep them tempered. They are not intended to treat patients by dipping
their extremities into the device. This way of treatment is contrary to the appropriation
and not permitted.
5 Power Supply
The standard power supply for the packheater is 220-240V / 50/60Hz.
The fuse is 16 A maximum. A residual current protective device has to be installed.
Attention:
• To avoid an electric shock the device may only be connected to a power
supply system that is equipped with a protective earth conductor.
• For a complete disconnection from the power supply the plug has to be pulled
out of the socket. Unobstructed access to the socket has to be ensured, so
that in case of an emergency the plug may be pulled immediately.
• The plug may never be pulled by the cable but only by the grip area. The plug
may never be touched with wet hands.
6 Operational Safety
The operating company is obliged to establish operational safety for the user of this
device. All legal requirements regarding operational safety have to be obeyed.
According to legal standards an annual safety check of the packheater has to be
performed and documented.
7 Environmental Conditions
7.1 Storage
This device has to be stored under the following conditions:
Storage temperature: -20 °C - +70 °C
Maximum relative humidity: 75 %, no condensation
Barometric pressure: 500-1060 hPa
7.2 Operating Conditions
Storage temperature: 0 °C - +40 °C
Maximum relative humidity: 75 %, no condensation
Barometric pressure: 500-1060 hPa
The packheaters may be used exclusively under dry conditions. All kinds of moisture
have to be kept away from the devices. Cleaning with damp or wet media is not
permitted. The use in explosive surroundings is not permitted. There has to be a free
space of at least 8 cm to all other surfaces around the device. Operation without
supervision, e.g. by using a time switch, is not permitted!
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Index 11-EN
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8 Accessories
Following (optional) accessories are available for all packheaters:
Accessory
Material
Colour
Art.Nr.
Mobile rack
Steel construction with
castor rolls and shelf
black
3448.422 (for WB 6-50)
3448.423 (for WB 8-90)
3448.424 (for WB 16-130)
Drainage hose
Temperature- and
pressure-tested PVC
hose with adapter
transparent
on request
The use of other accessories is not permitted. Operation with non-approved
accessory will lead to the loss of warranty claim.
8.1 Mounting of the Drainage Hose (optional)
The optional drainage hose will be delivered in the required length. With the hose
comes a fitting that is equipped with a sealing tape to be screwed into the outlet valve
of the packheater. The fitting remains on the device while the hose can be clipped on
or removed when not in use (picture 1).
8.2 Placing the Packheater on the Rack (optional)
The optional mobile rack for the packheaters consists of a welded steel construction
with four castor rolls. The two front castor rolls are equipped with brakes. Before
placing the packheater on the rack the brakes have to be locked. The packheater has
to be placed in the four rings on the rack’s upside (picture 2). If the packheater shall
be moved to another place, the brakes have to be released. By pushing the rack the
packheater can be rolled to the new position. Afterwards the brakes have to be
locked again.
Attention: When moving the packheater, there is a risk of spilling
water.
Picture 1 Picture 2
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Index 11-EN
Page 5 of 12
9 Initial Setup
After shipping/storing, the packheater has to rest several hours at its final installation
site before it is put into operation.
Before the initial setup, the packheater has to be checked fqr transport damages and
the completeness of the scope of delivòry. Transport damages and incomplete scope
of delivery have to be reported immediately to the dealer.
The following parts belong to the scope of delivery:
- Packheater
- Perforated sheet insert with register bars
- Service pack
- lnstructions for Use
Before operating the packheater, the user has to make sure that the device is placed
on a horizontal, stable surface and that there is a distance of at least 8 cm to all
surrounding surfaces. All wrapping has to be removed. It is not permitted to deposit
any items on the device. This manual has to be kept nearby the device.
Attention: The device’s surface will be hot during operation!
10 Start Up
10.1 Filling
After closing the outlet valve the packheater can be filled with tap water (no distilled
water, see chapter 12: Care, Maintenance and Disinfection). The minimal water-level
is 10 cm. The maximal level with heat packs may not exceed 3 cm under the upper
edge of the tub. Heating up the heat packs is not permitted without using the insert
grid. Heat packs that touch the bottom of the tub may burn and stick to the stainless
steel surface. The water-level has to be controlled regularly.
10.2 Emptying
The packheater may be emptied through the outlet valve on the device’s front. Before
emptying, all heat packs have to be taken out. The water may be drained into a
bucket or, using the optional rubber hose, into a floor gully. Out of hygienic reasons a
fix connection to the sewage system is not permitted!
Attention: The water is hot! It bears the risk of scalding!
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Index 11-EN
Page 6 of 12
10.3 Starting Up
Attention: Before operating the packheater all legal safety instructions
according the valid accident prevention regulations have to be
respected.
1. The power supply has to fulfill all requirements on the identification plate.
2. The power supply cable may not be sharply bent or pinched. It may not touch
the surfaces of the packheater. During operation, the power supply cable may
not get moist or wet.
3. When all wrapping is removed, the packheater may be filled with water as
described above. The water-level has to be controlled regularly.
4. Switch on the main switch (picture 3).
5. The temperature is selected by pushing simultaneously the button SET and
or . The selected temperature remains stored when the packheater is
switched off. When it is switched on again, the heating will start immediately.
Attention: if the device is operated without water, there will be danger
to both user and device! Damages caused by dry running will lead to
the loss of guarantee.
Attention: Before a heat pack is applied to a patient, the temperature
has to be controlled with an adequate thermometer!
Picture 3
Increase of preset
temperature
Reduction of preset
temperature
Main Switch
SET button
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Index 11-EN
Page 7 of 12
10.4 Safety Installation
The packheater is protected against overheating by a safety temperature limiter.
When activated, the temperature limiter switches off the device permanently.
Operation will be possible again after the packheater has cooled down to room
temperature and the limiter has been reset manually after consultation with the
manufacturer. If this safety installation was activated, contact the service of your
dealer or the manufacturer before you operate the water bath again!
In case of a short cut or on overload the packheater is disconnected from the power
supply by two device fuses. They are located on the back side of the device nearby
the power connection (picture 4). Before replacing a blown fuse, the power plug of
the packheater has to be pulled. Blown fuses may only be replaced by fuses of
exactly the same type (see chapter 16.1 Technical Data). If this safety installation
was activated, contact the service of your dealer or the manufacturer before you
operate the packheater again!
11 Daily use
Attention: The packheater has to be supervised, while it is operated.
The use of a time switch or remote control is not permitted!
For a well-organized daily use of the packheater we give the following non-binding
recommendations:
▪ Heat packs are medical products with an own operating instruction. All
declarations of this operating instruction have to be followed when treating a
patient.
▪ At closing time the water-level of the packheater has to be checked and
corrected if necessary. As an unsupervised operating is not permitted, the
packheater has to be switched off overnight and on weekends.
▪ Before the first treatment of a patient on a new day an appropriate time for
heating up has to be taken into account.
▪ The temperature shown in the display of the packheater is the temperature of
the water! The temperature of the heat packs may vary from this temperature.
It has to be controlled with an adequate thermometer before applying a heat
pack to a patient.
Device fuses
Picture 4
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Index 11-EN
Page 8 of 12
12 Care, Maintenance and Disinfection
For care and maintenance of the packheater the national rules and guidelines
concerning the operation of devices in health care facilities have to be obeyed.
12.1 Water Change
For hygienic reasons the water in the packheater has to be exchanged completely at
least once a week by tap water.
Attention: Don’t use distilled water!
Due to its chemical structure distilled water is aggressive against metals and may
cause corrosion at areas where the original surface of the stainless steel has been
modified (e.g. welding seams).
12.2 Removal of Deposits
Stainless steel needs caring if its corrosion resistance shall be preserved.
Prerequisite for corrosion resistance is the access of oxygen from air or water to the
metallic surface. If deposits are forming on the stainless steel (especially lime
deposits), the access of oxygen is inhibited and corrosion may occur. Therefore the
tub and the insert grid of the packheater must be cleaned regularly and treated with a
stainless steel polish. This kind of polish contains ingredients that delay the forming
of new deposits. Avoid scouring sponges (especially metallic sponges and steel
wool), scouring powder or other abrasive agents. They cause scratches in the
surface which induce increased staining.
When water is heated, dissolved lime builds white or brownish (not to be confused
with rust!) deposits. They have a porous surface where bacteria may settle.
Therefore deposits have to be removed regularly.
12.3 Cleaning of the External Surfaces
Cleaning and maintenance of the external surfaces may only be performed with a
moist, lint-free cloth. Liquid remnants (cleaning agents, water) have to be removed
immediately.
12.4 Cleaning of the Tub and the Insert Grid
For hygienic reasons the water in the packheater has to be exchanged completely at
least once a week by tap water (don’t use distilled water!). At this occasion calcium
and dirt deposits have to be removed with standard cleaning agents. Using a
standard stainless steel polish helps protecting the stainless steel surfaces against
new deposits. Avoid scouring sponges (especially metallic sponges and steel wool),
scouring powder or other abrasive agents. They cause scratches in the surface
which induce increased staining.
Attention: Tap water with very high lime content may require shorter cleaning cycles!
At periods of standstill (weekends, holidays) the packheater should be cleaned and
left empty with opened lid. The more contact between oxygen and the stainless steel
surfaces the better is the corrosion resistance.
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Index 11-EN
Page 9 of 12
12.5 Recommended Cleaning Agents
• All-purpose cleaner / vinegar based cleaner / citrus based cleaner
• Stainless steel polish
Attention: Don’t use chlorous agents (i.e. bleaching agents) or silver polish.
12.6 Surface Disinfection
Recommended surface disinfecting agents:
• Biguamed Perfekt N, Hersteller Desomed –Dr. Trippen GmbH
• Cleanisept Wipes , Hersteller Dr. Schumacher GmbH
• Incidin Plus, Hersteller Ecolab Deutschland GmbH
• Mikrozid AF liquid, Hersteller Schülke & Mayr GmbH
• TPH protect, Schülke & Mayr GmbH
13 Regular Tasks
13.1 Regular Safety Checks
For the packheaters an annual safety check has to be performed and documented.
13.2 Limit Values for the Annual Safety Check
Measurement
Limit Value
Protective earth conductor resistance
< 0,2 Ω
Insulating resistance
> 2,0 MΩ
Enclosure leakage current
< 100 µA
Earth leakage current
< 0,5 mA
If any of the measured values exceeds the limit value, the device has to be put out of
service immediately!
13.3 Check of the Temperature
The accuracy of the temperature display has to be checked once every year by
measuring the water temperature with an adequate thermometer. Duration of the
measuring (with closed lid): 10 minutes. The temperature sensor may not touch the
bottom of the tub. The use of contact-free measurement devices is not permitted. An
aberration of more than ± 2 °C needs correction and has to be reported to the
manufacturer.
14 Service
Apart from regular cleaning the packheaters are maintenance-free. In case of a
defect the repairing has to be executed by a qualified person. For all repairing
concerning the heating element, the packheater has to be sent to Enraf-Nonius BV,
The Netherlands (unless otherwise agreed).
Operating Manual
Index 11-EN
Page 10 of 12
15 Limited Guarantee
The function of the packheater is guaranteed by Enraf-Nonius BV, The Netherlands,
if it is verifiably mounted and operated according to this manual.
The guarantee time is twelve months after the delivery to the dealer.
The guarantee is limited to repairs or exchange to a new device; the decision is up to
Enraf-Nonius BV exclusively. Please keep the original packaging for the time of
guarantee. Guarantee will only be granted, if the device is sent back in original
packaging. Damages caused by insufficient wrapping will be charged to the
dispatcher.
Further compensations are not included in this limited guarantee.
16 Manufacturer
The packheaters WB are manufactured for Enraf-Nonius BV by:
Heuser Apparatebau GmbH
Am Schlagbaum 10
42781 Haan
Germany
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17 Technical Data
17.1 Technical Data
Packheater / model
WB 6-50
WB 8-90
WB 16-130
Tank capacity
47 liter
82 liter
99 liter
Number of bars (insert grid)
3
4
7
Number of packs (25x30 cm)
8
12
18
Gas spring supported lid
Yes
Yes
Yes
Power supply
220-240V / 50-60Hz
220-240V / 50-60Hz
220-240V / 50-60Hz
Heating capacity
1500 W
1500 W
1500 W
Temperature range
30 – 85 °C
30 – 85 °C
30 – 85 °C
Accuracy (temp. setting)
0,1 K
0,1 K
0,1 K
Temperature control
electronic
electronic
electronic
Control accuracy
± 2,0 K
± 2,0 K
± 2,0 K
Digital temperature display
Yes
Yes
Yes
Thermal cut-out (safety)
95 °C
95 °C
95 °C
External dimensions (lxwxh)
675x470x385 mm
725x470x490 mm
775x490x515 mm
Internal dimensions (lxwxh)
590x400x200 mm
645x400x320 mm
695x420x340 mm
Net weight
23,2 kg
28,8 kg
30,3 kg
Shipping weight
25,5 kg
45 kg
50 kg
Cross section of power cable
3 x 1 mm²
3 x 1 mm²
3 x 1 mm²
Device fuses
6,3x32 8,04 F
tqc 60127 -2t4
DIN VDE O82O
6,3x32 8,04 F
t9c 60127-2t4
DIN VDE O82O
6,3x32 8,04 F
t9c 60127-2t4
DIN VDE O82O
Medical Device Class
Class I
Class I
Class I
All dimensions are given in SI-units
Abbreviation on the identification plate: SN: Serial number
17.2 Standards and Directives
The packheaters WB comply with the safety requirements of the following standards,
laws and directives:
• German Medical Devices Act
• MDD 93/42/EWG, 2007 – Medical Device Directive
• DIN EN 60601-1: 2007 – Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
• DIN EN 60601-1-2: 2007 – Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests
Therefore no additional protective action is required.
17.3 Electrical Safety Classification
The packheaters WB are class 1 equipment. To avoid an electric shock the device
may only be connected to a power supply system that is equipped with a protective
earth conductor.
Degree of enclosure protection IP 22
Operating Manual
Index 11-EN
Page 12 of 12
18 Installation Checklist
Product
Serial Number
Date of Installation
Packheater WB 6-50
Packheater WB 8-90
Packheater WB 16-130
Date, Signature
of the Technician
Was the packheater placed on a horizontal,
stable surface?
yes
no
Have precautions been taken against burning
on hot surfaces?
yes
no
Does the electrical installation have a residual
current protective device?
yes
no
Does the residual current protective device
work properly?
yes
no
Is the power supply fused with 16 A
maximum?
yes
no
If any of the questions above is answered with „no“, the operation of the device is not
permitted. In case of defects or harm due to incorrect installation all guarantee will be
declined.
Date, signature of user: ______________________________________
/