CH00EN Desciption

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Definitions, general warnings & cautions

Is used to alert the user/operator not to take a


certain action, which if taken can cause a potential
hazard and result in a serious adverse reaction,
Warning injury or death. A warning may also be used to alert
the user/operator to take a certain action to avoid
the potential hazard as above.

Is used to alert the user/operator to take a certain


action to protect against a potential hazard which, if
ignored, could have an adverse effect on the patient
Caution or the device. A caution may also be used to alert the
user/operator not to take a certain action to avoid
the potential hazard as above.

A reminder to the user/operator on normal treatment


activity and on what is a suitable action in a
Note particular situation.

HCEN9151 Rev. 06. 02 0:1


Unauthorized modifications, alterations or repair of the
CWP100, model WRO H, may result in malfunctioning or
Warning have other serious consequences for the safe operation of
the equipment.

1. The CWP 100, model WRO H, may only be operated by


persons trained in this equipment and who have studied
Caution the instructions in this manual. If the CWP100 does not
perform as described in this manual, it should not be used
until the condition is rectified.

2. When unpacking, check the equipment for any signs of


damage. If the equipment is in any way damaged, proper
operation can not be assured.

3. The installation and start up of CWP 100, model WRO H,


must be made by authorized personnel.

4. At delivery the system is filled with a combined


preservation and anti-freeze solution, containing 1%
formaldehyde and 20% glycerine. This solution must be
thoroughly rinsed out before the system is put into
normal operation. Verify that no residual formaldehyde
can be detected before connecting patients.

5. The use of mobile telephones or communication


equipment in the vicinity of the CWP100, model WRO H
could adversely influence the performance of the machine.

6. The CWP100, model WRO H, will perform as designed


only if it is used and maintained in accordance with
Gambro’s instructions. Any warranties made by Gambro
with respect to the CWP100, model WRO H, are void if
the equipment is not used in accordance with the
instructions provided. Gambro will not accept
responsibility for any damage or injury resulting from
improper use or maintenance or unauthorized repair.

7. The user must verify the quality of the protective earth


in the installation.

8. When used as a medical device, Federal law restricts


this device to sale by or on the order of a physician.

0:2 HCEN9151 Rev 06. 02


CE-marking
This product is CE marked in accordance with the re-
quirements in EC Council Directive 93/42/EEC of 14
June 1993 concerning medical devices.

Notified body is: British Standards Institution (BSI) with


the notified body number 0086.

The symbol means: Year of manufacturing.

The CE-marking of this manual is only valid if the device


which it describes is CE-marked.

Manufacturer:
Gambro Lundia AB, Monitor Division,
Box 10101, SE-220 10 LUND, Sweden.
Phone +46 46 16 90 00.

HCEN9151 Rev. 06. 02 0:3


Symbol description
Note: All symbols in this list may not be represented on this product.

Symbol Description

∼ Alternating current

Protective earth (ground)

Attention, consult ACCOMPANYING DOCUMENTS

Off (power, disconnection from the mains)

On (power, connection to the mains)

TYPE B APPLIED PART

Handle with care

This way up

Keep dry

Input / Output

Year of manufacturing

Heater power supply outlet

0:4 HCEN9151 Rev 06. 02


Symbol Description

Conforms to requirements in EC Council Directive


93/42/EEC concerning medical devices.
0086 identifies BSI, British Standards Institution,
as Notified Body

CSA approved for Canada

CSA approved for Canada and USA

CSA-listed Manufacturer

HCEN9151 Rev. 06. 02 0:5


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0:6 HCEN9151 Rev 06. 02

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