Enraf-Nonius Packheater WB 4-30 User manual

Brand: Enraf-Nonius

Model: Packheater WB 4-30

Type: User manual

Enraf-Nonius Packheater WB 4-30 is a reliable and efficient device designed to heat and maintain the temperature of heat packs. It boasts a range of features that make it an invaluable asset in various healthcare settings. The packheater ensures precise and consistent heating, helping to deliver effective therapy to patients. Its durable construction and safety mechanisms provide peace of mind during use. Additionally, the packheater is easy to operate and maintain, making it a practical choice for healthcare professionals.

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Issue date: 2017-10-24

PACKHEATER

WB 4-30

Content

1 Legal Notes .................................................................................................................................. 2

2 Safety Symbols ............................................................................................................................ 2

3 General Information .................................................................................................................... 2

3.1 Installation of the Packheater ........................................................................................................ 2

3.2 Instruction in the Use of the Packheater ....................................................................................... 2

4 Appropriation ............................................................................................................................... 2

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 .......................................................................................................................... 6

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 ........................................................................................................................................ 10

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

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1 Legal Notes

This Operating Manual has 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 manual

carefully and follow all safety advices that are marked by this sign.

This symbol indicates that hot water and

vapor 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 packheater WB 4-30 may be serviced and opened by trained personnel only.

Before getting mounted or dismounted 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 Instruction in the Use of the Packheater

For the instruction of the use of the packheater the national rules and guidelines

concerning the operation of medical devices in health care facilities have to be

obeyed.

4 Appropriation

The packheater WB 4-30 is intended to heat up heat packs and keep them tempered.

It is not intended to treat patients by dipping their extremities into the device. This

way of treatment is contrary to the appropriation and not permitted.

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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 packheater may be used exclusively under dry conditions. All kinds of moisture

have to be kept away from the device. 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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8 Accessories

Following (optional) accessories are available for the packheater:

Accessory

Material

Colour

Art.Nr.

Mobile rack

Steel construction with castor

rolls and shelf

black

3448.421

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 packheater 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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9 Initial Setup

After shipping/storing, the packheater WB 4-30 has to rest several hours at its final

installation site before it is put into operation.

Before the initial setup, the Packheater WB 4-30 has to be checked for transport

damages and the completeness of the scope of delivery. 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 WB 4-30

- Perforated sheet insert

- Power cable

- Service pack

- Operating manual

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. For reasons of hygiene, the

packheater WB 4-30 has to be cleaned and disinfected completely before the initial

setup (for care and maintaining instructions see chapter 12). The separately provided

power cable has to be plugged into the corresponding socket at the rear side of the

device. Afterwards, the power plug has to be plugged into a power socket.

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 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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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 turning the knob until the chosen temperature

shows to the reference point (picture 3). When the packheater is switched on,

the heating starts 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!

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 an overload the packheater is disconnected from the power

supply by two device fuses. They are located on the rear side of the device in the

socket of the power cable (picture 4). Before replacing a blown fuse, the power plug

Main switch

Control lamp for heating

Reference point for

temperature setting

Picture 3

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of the packheater has to be pulled. Blown fuses may only be replaced by fuses of

exactly the same type (see chapter 17.1 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 of the heat packs may vary from the temperature of the

water. 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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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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At the bottom of the tub of the packheater WB 4-30 there is a welding point visible

(picture 5). This welding point results from the production process of the tub and can’t

be avoided. It is no indication for a defect.

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 packheater 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 setting 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

Picture 5

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bottom of the tub. The use of contact-free measurement devices is not permitted. An

aberration of more than ± 5 °C needs correction and has to be reported to the

manufacturer.

14 Service

Apart from regular cleaning the packheater is 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).

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 packheater WB 4-30 is 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 4-30

Tank capacity

30 liter

Number of bars (insert grid)

Number of packs (25x30 cm)

Gas spring supported lid

Power supply

220-240V / 50/60Hz

Heating capacity

900 W

Temperature range

30 – 85 °C

Accuracy (temp. setting)

5 K

Temperature control

thermostatic

Control accuracy

± 5,0 K

Digital temperature display

Thermal cut-out (safety)

95 °C

External dimensions (lxwxh)

575x365x370 mm

Internal dimensions (lxwxh)

500x300x200 mm

Net weight

12,0 kg

Shipping weight

15 kg

Cross section of the power cable

3 x 1 mm²

Device fuses

IEC/EN 60127-2/1

SP 5x20 5,0 A

fast acting

Medical Device Class

Class I

All dimensions are given in SI-units

Abbreviation on the identification plate: SN: Serial number

17.2 Standards and Directives

The packheater WB 4-30 complies 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 packheater WB 4-30 is 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

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18 Installation Checklist

Product

Serial Number

Date of Installation

Packheater WB 4-30

Date, Signature

of the Technician

Was the packheater placed on a horizontal,

stable surface?

yes

Have precautions been taken against burning

on hot surfaces?

yes

Does the electrical installation have a residual

current protective device?

yes

Does the residual current protective device

work properly?

yes

Is the power supply fused with 16 A

maximum?

yes

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: ______________________________________

Enraf-Nonius Packheater WB 4-30 User manual

Enraf-Nonius Packheater WB 4-30 User manual

Enraf-Nonius Packheater WB 4-30 User manual

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