Enraf-Nonius Packheater WB 6-50/8-90/16-130 User manual
- Type
- User manual
Instructions for Use
Index 12-EN
Page 1 of 14
Issue date: 2020-08-26
Packheaters
WB 6-50, WB 8-90, WB 16-130
1 Legal Note ................................................................................................................ 2
2 Safety Symbols ........................................................................................................ 2
3 General Information ................................................................................................. 2
3.1 Installation of the Packheaters WB ............................................................................. 2
3.2 Instruction for Use of the Packheaters WB ................................................................. 2
4 Intended Use ............................................................................................................ 3
5 Mains Supply ............................................................................................................ 3
6 Operational Safety ................................................................................................... 3
7 Environmental Conditions ....................................................................................... 3
7.1 Storage Conditions .................................................................................................... 3
7.2 Operating Conditions ................................................................................................. 3
8 Scope of Delivery and Optional Accessories ......................................................... 4
8.1 Using the Optional Drainage Hose ............................................................................. 4
8.2 Placing the Packheater WB on the Optional Rack ...................................................... 4
9 Initial Setup .............................................................................................................. 5
10 Start Up ..................................................................................................................... 6
10.1 Filling ......................................................................................................................... 7
10.2 Switching on the Packheaters WB ............................................................................. 7
10.3 Emptying .................................................................................................................... 8
10.4 Safety Installations ..................................................................................................... 8
10.4.1 Safety Temperature Limiter ........................................................................................ 8
10.4.2 Device Fuses ............................................................................................................. 8
11 Daily Use ................................................................................................................... 9
12 Regular Tasks .......................................................................................................... 9
12.1 Limit Values for the Annual Safety Inspection ............................................................ 9
12.2 Check of the Temperature ........................................................................................10
13 Care, Maintenance and Disinfection ......................................................................10
13.1 Water Change ...........................................................................................................10
13.2 Removal of Deposits .................................................................................................10
13.3 Cleaning of the Outer Surfaces .................................................................................10
13.4 Cleaning of the Tub and the Perforated Sheet Insert ................................................10
13.5 Recommended Cleaning Agents ...............................................................................11
13.6 Surface Disinfection ..................................................................................................11
14 Service .....................................................................................................................11
15 Limited Guarantee ..................................................................................................11
16 Manufacturer ...........................................................................................................12
17 Technical Data .........................................................................................................13
17.1 Technical Data ..........................................................................................................13
17.2 Standards and Directives ..........................................................................................13
17.3 Electrical Safety Classification ..................................................................................13
18 Installation Checklist ..............................................................................................14
Instructions for Use
Index 12-EN
Page 2 of 14
Issue date: 2020-08-26
1 Legal Note
These Instructions for Use have been created with the utmost care. Errors and mis-
takes cannot be ruled out.
2 Safety Symbols
This symbol indicates a possible risk of danger. Read these Instruc-
tions for Use carefully and follow all notes and warnings marked with
this symbol.
This warning indicates that hot water and
vapor bear a risk of scalding. It is therefore
essential to take precautions when working
with this device. Failure to observe this war-
ning bears risk for the patient, the user or
third parties, as well as risks for material as-
sets.
This label warns against opening the enclosure of this
device while it is connected to the mains supply. Failure
to observe this warning bears risk for the patient, the
user or third parties, as well as risks for material assets.
3 General Information
3.1 Installation of the Packheaters WB
Installation, repair, maintenance and testing of medical devices must be carried out in
accordance with national regulations and guidelines by persons or companies who
have up-to-date knowledge of the activities involved due to appropriate training and
activity, as well as the appropriate tools.
After each repair, an electrical safety test according to DIN EN 62353 (VDE751-1)
must be carried out and documented.
See: 1400772-xx Service Manual
The Packheaters WB must only be installed and serviced by trained personnel. They
must be placed and mounted on a horizontal, stable surface. The Packheaters WB
must only be installed in dry spaces without potential explosive risk. The installation
must be documented with the attached installation checklist
Attention: The surfaces of the Packheaters WB will be hot during oper-
ation!
3.2 Instruction for Use of the Packheaters WB
For the instruction for use of the Packheaters WB, the national rules and guidelines
concerning the operation of medical devices in health care facilities must be obeyed.
Instructions for Use
Index 12-EN
Page 3 of 14
Issue date: 2020-08-26
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.
Attention: Any other use of the Packheaters WB, in particular direct ap-
plication to the patient by immersing body parts, is not permitted!
5 Mains Supply
The electrical connection for the Packheaters WB is made by plugging the mains
plug into an earthed socket to the alternating current network 220-240 V / 50/60 Hz
(on-site fuse 16 A). The installation of a residual current protective device is manda-
tory. The absence of a residual current protective device releases the manufacturer
from any liability for accidents caused by electric current.
Attention:
• To avoid the risk of electric shock, the Packheater WB 4-30 must only be con-
nected to a mains supply system that is equipped with a protective earth con-
ductor.
• For a complete disconnection of the Packheaters WB from the mains supply,
the plug must be pulled out of the mains socket. Unhindered access to the
mains socket must always be ensured, so the mains plug can be disconnected
immediately in an emergency situation.
• When pulling the mains plug, never hold the plug by the cable, but only by the
grip surface. The mains plug must not be touched with wet hands.
6 Operational Safety
The operating company is obliged to establish operational safety for the user of the
Packheater WB. All legal requirements regarding operational safety must be obeyed.
According to legal standards, an annual safety inspection of the Packheaters must be
performed and documented.
7 Environmental Conditions
7.1 Storage Conditions
The Packheaters WB must be stored under the following conditions until installation:
Storage temperature: -20 °C - +70 °C
Relative humidity: 10 % - 75 %, no condensation
Barometric pressure: 500-1060 hPa
7.2 Operating Conditions
The Packheaters WB must be operated under the following conditions
Storage temperature: 0 °C - +40 °C
Relative humidity: 10 % - 75 %, no condensation
Barometric pressure: 500-1060 hPa
Instructions for Use
Index 12-EN
Page 4 of 14
Issue date: 2020-08-26
The operation of the Packheaters WB is only permitted in dry spaces free from po-
tentially explosive atmosphere. Any kind of moisture or splash water must be kept
away from it. There must be at least 8 cm of free space on all sides of the device for
heat dissipation.
Attention: The unattended operation of the Packheaters WB, even with
a timer, is not permitted!
8 Scope of Delivery and Optional Accessories
The standard scope of delivery of the Packheaters WB includes a perforated sheet
insert made of stainless-steel with register brackets. The following accessories are
optionally available:
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 pres-
sure-tested PVC hose
with adapter
transparent on request
Attention: Other accessories are not approved for the Packheaters WB.
Operation using non-approved accessories is not permitted and leads
to the loss of any warranty claim.
.
8.1 Using the Optional Drainage Hose
The optional drainage hose is supplied in the length required by the customer. The
hose nozzle included in the delivery is provided with a sealing tape on its thread and
must be screwed into the outlet valve of the Packheater. The nozzle remains on the
valve while the hose can be clipped on for emptying the Packheater or removed
when not in use (Picture 1).
8.2 Placing the Packheater WB on the Optional Rack
The optional mobile rack for the Packheaters WB consists of a welded steel construc-
tion with four castor rolls. The two front castor rolls are equipped with brakes. Before
placing the Packheater WB on the rack, the brakes must be locked. The Packheater
must be placed in the four rings on the rack’s upside (Picture 2). If the Pack-
heater WB shall be moved to another place, the brakes must be released. The Pack-
heater WB is rolled to the new position by pushing the rack. Then, the brakes must
be locked again.
Instructions for Use
Index 12-EN
Page 5 of 14
Issue date: 2020-08-26
Attention: When moving the Packheater WB with the rack, hot water
may spill out of the device.
9 Initial Setup
Attention: No changes shall be made to this medical device!
After transport/storage, the Packheater WB must stand for several hours at its final
installation site before it can be put into operation.
Before the initial setup, the Packheater WB must be checked for transport damage
and completeness of the scope of delivery. Transport damage and incomplete scope
of delivery must be reported to the dealer immediately.
The following parts are supplied as standard:
• Packheater WB
• Perforated sheet insert with register brackets
• Service kit
• Instructions for Use
For hygienic reasons, the Packheaters WB must be completely cleaned and disin-
fected before initial operation (for cleaning and care instructions s. Chapter 13).
Picture
1
Picture
2
Instructions for Use
Index 12-EN
Page 6 of 14
Issue date: 2020-08-26
Prior to operation, the operator must
ensure that the Packheater WB is set
up tilt proof on a horizontal surface
and that a distance of 8 cm to other
objects is maintained (Picture 3). The
protective foil must be removed com-
pletely. The ventilation openings on
the housing must not be covered or
blocked. There is a risk of over-heat-
ing if the cooling air supply is insuffi-
cient. There is then danger for per-
sons and material assets. These In-
structions for Use must be kept near
the device.
Attention: Placing any objects on the Packheaters WB is not permitted!
Attention: The warnings on the Packheaters WB must be observed for
each application!
Warning: The surface of the Packheaters WB becomes hot during op-
eration!
10 Start Up
Attention: Before switching on the Packheater WB, accident prevention
in the vicinity of the device must be ensured in accordance with the
valid accident prevention regulations! The Packheaters WB must only
be started by competent, instructed personnel. Incorrect use of the de-
vice can lead to scalds/burns.
1. The mains supply must correspond to the data on the type label.
2. The mains supply cable must be laid in such a way that it is not bent or
clamped. It must not touch the surfaces of the Packheater WB. The mains
supply cable must never become damp or wet during operation.
3. When all packaging parts and protective foils are removed, the Pack-
heater WB can be filled as described in Chapter 10.1
Picture
3
Instructions for Use
Index 12-EN
Page 7 of 14
Issue date: 2020-08-26
10.1 Filling
After closing the outlet valve, the Packheater WB can be filled with tap water. Infor-
mation on the use of demineralized or distilled water can be found in Chapter 13:
Care, Maintenance and Disinfection. The minimal water-level is 10 cm. The maxi-
mum level with heat packs must not exceed 3 cm under the upper edge of the tub.
Attention: Heating up heat packs is only permitted using the supplied
perforated sheet insert.
10.2 Switching on the Packheaters WB
The Packheaters WB are switched on at the green main switch on the front of the
device (Picture 4). The required temperature is set by simultaneously pressing the
SET button and the button or . The selected temperature is maintained even af-
ter switching off the Packheater WB. When switching on again, the heating process
starts immediately, even when the Packheater WB is empty.
Warning: The water level in the Packheaters WB must be checked
regularly. If the devices are operated without contents, there is danger
for the heating element and the user. Damage caused by dry operation
will lead to the loss of all warranty claims.
Warning: Before each application on the patient, the temperature of the
heat pack must be checked with an adequate thermometer. There is
danger of burns!
Picture
4
Increase of preset
temperature
Reduction of preset
temperature
Main Switch
SET
button
Instructions for Use
Index 12-EN
Page 8 of 14
Issue date: 2020-08-26
Attention: Heat packs touching the bottom of the Packheater WB can
burn.
10.3 Emptying
The Packheater WB is emptied through the outlet valve on the device’s front. Before
emptying, all heat packs must be taken out. The water contained in the Packheater
can be drained into a bucket or into a floor drain via the optionally available drainage
hose (s. Chapter 8: Optional accessories). For hygienic reasons, the fixed connection
to a sewage system is not permitted!
Warning: The water is hot! There is danger of burns/scalds
10.4 Safety Installations
10.4.1 Safety Temperature Limiter
The Packheaters WB are protected against overheating by a safety temperature lim-
iter. If the safety temperature limiter is activated, the device is permanently switched
off. Operation is only possible again after the Packheater WB has cooled down and
the limiter has been reset manually. If this safety installation is activated, please con-
tact the service department of your dealer or the manufacturer before putting the de-
vice back into operation!
10.4.2 Device Fuses
In case of a short circuit or overload, the Packheaters WB are disconnected from the
mains supply by two device fuses. These are located on the back of the device next
to the mains cable entry (Picture 5). If this safety installation is activated, please con-
tact the service department of your dealer or the manufacturer before putting the de-
vice back into operation!
Device fuses
Picture
5
Instructions for Use
Index 12-EN
Page 9 of 14
Issue date: 2020-08-26
Warning: Before replacing the fuses, the mains plug must be discon-
nected!
Attention: Defective fuses must only be replaced by original fuses
(Chapter 17.1 Technical Data)!
11 Daily Use
Attention: The Packheaters WB must be supervised during operation.
The use of a timer for operating the Packheaters WB without supervi-
sion is not permitted!
For the daily operation of the Packheaters WB, we give the following non-binding rec-
ommendations:
• The heat packs to be heated in the Packheaters WB are medical devices with
their own treatment instructions. For the treatment of the patient, the infor-
mation on the package insert of the heat pack is binding.
• At closing time, fill the Packheater WB with water and check the water level.
The Packheater must be switched off overnight and on weekends.
• Before the treatment of the first patient of the day, an appropriate heating time
should be planned.
• The temperature of the heat packs differs from the temperature of the water.
Before each application on the patient, the temperature of the heat pack must
be checked with an adequate thermometer!
12 Regular Tasks
For the Packheaters WB, an annual safety inspection must be carried out and rec-
orded. The devices must be checked for functionality, maintenance condition and
compliance with the electrical limit values using the Protocol for the Safety Inspec-
tion. See: 1400772-xx Service Manual
12.1 Limit Values for the Annual Safety Inspection
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 the limit values are not observed, the device must be shut down!
Instructions for Use
Index 12-EN
Page 10 of 14
Issue date: 2020-08-26
12.2 Check of the Temperature
As part of the safety inspection, the temperature of the water must be checked with a
suitable thermometer and compared with the temperature setting. Duration of meas-
urement with closed lid: 10 minutes. The temperature sensor must not touch the bot-
tom of the Packheater. The use of non-contact measuring equipment is not permit-
ted. A deviation of more than ± 2.0 °C requires correction and must be reported to
the manufacturer.
13 Care, Maintenance and Disinfection
For care and maintenance of the Packheaters WB, the national rules and guidelines
concerning the operation of devices in health care facilities have to be obeyed.
13.1 Water Change
For hygienic reasons, the water contained in the Packheaters WB must be com-
pletely replaced by fresh tap water at least once a week.
Attention: Don’t use demineralized or distilled water! Due to its chemi-
cal structure, demineralized or distilled water is aggressive to metals
and can cause corrosion (e.g. at welding seams).
13.2 Removal of Deposits
Stainless steel requires a minimum of care if its resistance to corrosion is to be main-
tained. Prerequisite for this corrosion resistance is that oxygen from water or air has
access to the metallic surface. If precipitation forms on the stainless-steel, especially
in the form of lime scale or other stains, this access is inhibited and corrosion may
occur. Tub and perforated sheet insert must therefore be cleaned regularly and
treated with a stainless-steel polish. This usually contains a care component which
delays new deposits. Avoid scouring sponges (especially metallic sponges and steel
wool), scouring powders and other abrasive cleaning agents. They cause scratches
in the surface, which lead to increased staining.
When water is heated, dissolved lime in the form of white to brownish (not to be con-
fused with rust!) precipitation settles on the stainless-steel surfaces. These deposits
have a porous surface on which bacteria can settle. They must therefore be re-
moved regularly
.
13.3 Cleaning of the Outer Surfaces
The outer surfaces of the Packheaters WB are cleaned and maintained exclusively
with a damp, lint-free cloth. Liquid residues (cleaning agents, water) on the surfaces
must be removed immediately.
13.4 Cleaning of the Tub and the Perforated Sheet Insert
During the weekly water change, lime and dirt deposits on the tub and the perforated
sheet insert must be removed with customary cleaning agents and the tub surface
must be protected from new deposits using a stainless-steel polish. The use of scour-
ing sponges, scouring milk or other abrasive cleaning agents should be avoided, as
they damage the surface and lead to staining and scratching.
Instructions for Use
Index 12-EN
Page 11 of 14
Issue date: 2020-08-26
Attention: Highly calcareous tap water may require shorter cleaning cy-
cles!
If the Packheaters WB are not used for a longer period (weekend, vacation), they
should be left empty and with open lid after the cleaning process. The more oxygen
has access to the surfaces of the stainless steel, the better its corrosion resistance.
13.5 Recommended Cleaning Agents
• All-purpose cleaner / vinegar based cleaner / citrus based cleaner
• Stainless steel polish
Attention: Don’t use cleaners containing chlorine (i.e. bleach) or silver
cleaning agents.
13.6 Surface Disinfection
The following disinfectants are recommended for surface disinfection:
• Biguamed Perfekt N, Manufacturer Desomed –Dr. Trippen GmbH
• Cleanisept Wipes, Manufacturer Dr. Schumacher GmbH
• Incidin Plus, Manufacturer Ecolab Deutschland GmbH
• Mikrozid AF liquid, Manufacturer Schülke & Mayr GmbH
• TPH protect, Manufacturer Schülke & Mayr GmbH
14 Service
Apart from regular cleaning the Packheaters WB are maintenance-free. In case of a
defect the repairing must be executed by a qualified person. For all repairing con-
cerning the heating element, the Packheater WB must be sent to Enraf-Nonius BV,
The Netherlands (unless otherwise agreed).
15 Limited Guarantee
The function of the Packheaters WB is guaranteed by Enraf-Nonius BV, The Nether-
lands, if they are verifiably mounted and operated according to these Instructions for
Use.
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 pack-
aging. Damages caused by insufficient wrapping will be charged to the dispatcher.
Instructions for Use
Index 12-EN
Page 12 of 14
Issue date: 2020-08-26
Further compensations are not included in this limited guarantee.
All warranty claims expire, if:
• the Packheaters WB are installed and put into operation by unauthorized per-
sons;
• the Packheaters WB are operated by unauthorized and/or untrained persons;
• the Packheaters WB are not used in accordance with the intended use speci-
fied in these Instructions for Use;
• the Packheaters WB are not operated according to the specifications given in
these Instructions for Use;
• repairs to the Packheaters WB are carried out by unauthorized persons;
• no genuine spare parts are used when repairing the Packheaters WB
16 Manufacturer
The Packheaters WB are manufactured for Enraf-Nonius BV by:
Heuser Apparatebau GmbH
Am Schlagbaum 10
42781 Haan
Germany
Instructions for Use
Index 12-EN
Page 13 of 14
Issue date: 2020-08-26
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
F 8A H 500V AC
6,3x32 mm
EN 60127
-
1/2
F 8A H 500V AC
6,3x32 mm
EN 60127
-
1/2
F 8A H 500V AC
6,3x32 mm
EN 60127
-
1/2
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 devices
must only be connected to a power supply system that is equipped with a protective
earth conductor.
Degree of enclosure protection IP 22
Instructions for Use
Index 12-EN
Page 14 of 14
Issue date: 2020-08-26
18 Installation Checklist
Product Serial Number
Packheater WB 6-50
Packheater WB 8-90
Packheater WB 16-130
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 connection correspond to the data on the type label?
yes
no
Is a residual current protective device installed by the customer? yes
no
Is the residual current protective device OK according to the built-in test
function?
yes
no
Is the fuse of the mains supply max. 16 Ampere? yes
no
If one of the questions is answered with “no“, the operation of the Packheater WB is
not permitted! In this case all liability claims are rejected!
Place, date:
__________________________________________________
Signature of Operator: _____________________________________
-
1
-
2
-
3
-
4
-
5
-
6
-
7
-
8
-
9
-
10
-
11
-
12
-
13
-
14
Enraf-Nonius Packheater WB 6-50/8-90/16-130 User manual
- Type
- User manual
Ask a question and I''ll find the answer in the document
Finding information in a document is now easier with AI
Related papers
-
Enraf-Nonius Packheater WB 6-50/8-90/16-130 User manual
-
-
-
-
-
-
-
-
-