Lowenstein Medical prismaAQUA User manual

prismaAQUA
Humidifier
WM 68250e 06/2017 DE, EN, FR, NL, IT, TR, ES-MX
DE Gebrauchsanweisung EN Instructions for Use FR Mode d‘emploi
NL Gebruiksaanwijzing IT Istruzioni d‘uso TR Kullanma Kılavuzu
ES Manual de instrucciones
Löwenstein Medical
Technology GmbH + Co. KG
Kronsaalsweg 40
?22525 Hamburg, Germany
T: [phone]
F: [phone]
www.loewensteinmedical.de
1
2
3
4
5
6

H2O
H2O
1A
2
3
4
5
6
1B
1
1
1
2
2
2
2
3
3
3
3 4
1
11
2
2
2 2
1
1

The right to make design modifications is reserved
11 Warranty
For information about warranty conditions, see the
Instructions for Use for your therapy device.
12 Declaration of conformity
For information about the declaration of conformity,
see the Instructions for Use for your therapy device.
Power capacity
Max. 30 VA (only in
combination with the
approved device)
Classification to EN 60601-1-11:
type of protection against electric
shock
degree of protection against electric
shock
protection against damaging ingress
of water and solids
Protection class II
Type BF
IP22
Classification to DIN EN 60601-1: op-
erating mode Continuous duty
Electromagnetic compatibility (EMC)
to DIN EN 60601-1-2
radio interference suppression
radio interference immunity
(Test parameters and limit values can
be obtained from the manufacturer on
request)
PEN 55011 B
IEC 61000-4 Parts 2
to 6, Part 11, Part 8
EN 61000-3 Parts 2
and 3
Heating of respiratory air Max. +3 °C
Humidification system output
to ISO 8185 at humidifier stage 7
without heatable tube at 23 °C
- 5 hPa (12.2 l/min)
- 10 hPa (18 l/min)
- 20 hPa (25.9 l/min)
22 mg/l
23 mg/l
20 mg/l
Humidification system output
to ISO 8185 at humidifier stage 7 with
heatable tube at 23 °C
- 5 hPa (12.2 l/min)
- 10 hPa (18 l/min)
- 20 hPa (25.9 l/min)
27 mg/l
28 mg/l
21 mg/l
Max. filling volume 400 ml
Pressure drop
Pressure drop does not
increase as a result of
combining therapy de-
vice WM 100 TD with
humidifier
WM 100 TH.
Maximum flow 248 l/min
Max. permissible operating pressure 50 hPa
Gas leak at max. operating pressure 0.0 l/min
WM 100 TH can be combined with
WM 090 TD
WM 100 TD
WM 110 TD
WM 120 TD
1 Operation/key
See the figures for how to fill, connect and remove
the humidifier:
Filling the humidifier
Filling the humidifier (alternative to )
Connecting the humidifier
Removing the humidifier
Dismantling the humidifier
Assembling the humidifier
Replacing the heater rod seal
Making humidifier settings on the therapy
device: operation differs depending on the therapy
device used. Follow the Instructions for Use for your
therapy device.
2 Introduction
2.1 Intended use
Humidifier WM 100 TH warms and humidifies respi-
ratory air and so prevents the mucous membranes in
the respiratory tract from drying out. It can be used in
clinical facilities and in the domestic sphere.
2.2 Description of function
The heatable humidifier operates in accordance with
the "pass-over" principle. The air supplied is passed
over the surface of warm water. This increases the rel-
ative humidity and the temperature of the air flow.
Heating capacity can be set on the therapy device in
stages.
2.3 Indications
Dry upper airways and respiratory air perceived to be
too cold. prismaAQUA may only be used in accor-
dance with a physician's recommendation.
2.4 Contraindications
The humidifier may not be used on patients whose
upper airways have been bypassed.
2.5 Side effects
No side effects are known.
3 Safety
Please read these Instructions for Use carefully. They
are a constituent part of the humidifier and must be
available at all times. In accordance with Directive 93/
42/EEC, observe the points below.
Risk of infection from germs in stale water!
Germs and bacteria can easily colonize and multiply
in stale water.
⇒Clean the humidifier regularly.
⇒Only use the humidifier with fresh water.
Risk of harm from operating the device outside
the specified ambient conditions
Using the device outside the specified ambient
conditions may lead to tolerances being exceeded
and to device failure and harm the patient.
⇒Only operate the device within the specified am-
bient conditions (see "10 Technical data").
Material damage from overfilling!
Escaping water may run into the device and damage
it.
⇒Take the humidifier off the device before filling it.
⇒Only fill the humidifier up to the “max.” mark.
Material damage from hot water and aromatic
additives!
Hot water or aromatic additives (such as eucalyptus
oil) may damage the housing of the humidifier and
the heater rod.
⇒Do not fill with hot water.
⇒Do not use any aromatic additives.
3.1 General information
• In the domestic sphere, sterile or boiled water
need only be used in exceptional medical cases.
Do not use distilled water intended for technical
purposes as it may be microbiologically
contaminated.
• To prevent infection, bacterial contamination or
functional impairments, follow the instructions in
the section entitled “Hygiene treatment” (see "5
Hygiene treatment").
• If third-party items are used, functional failures
and restricted fitness for use may result.
Biocompatibility requirements may also not be
met. In such cases, please be aware that any
claim under warranty and liability will be void if
neither the accessories nor the genuine
replacement parts recommended in the
Instructions for Use are used.
WM 68250e 06/2017 EN
EN EN

4 Product description
4.1 Overview
A diagram of the individual parts can be found on the
fold-out page.
Key
1. Upper part of humidifier
2. Humidifier insert
3. Lower part of humidifier
4. Inlet opening
5. Outlet opening
6. Heater rod
4.2 Marks and symbols
4.3 Symbols on the device ID plate
5 Hygiene treatment
Clean - or in the clinical sphere disinfect - the humid-
ifier weekly. If necessary, descale the humidifier (see
"5.1 Descaling the humidifier"). Replace housing
parts if they are in poor condition (cracked). If the
therapy device or the humidifier have been used with-
out a bacteria filter, the specialist dealer must per-
form a professional hygiene treatment on change of
patient.
1. Dismantling the humidifier (Fig. ).
2. Subject the humidifier to a hygiene treatment in
accordance with the table below. Sterilizing is not
permitted.
3. Rinse off parts with clean water and dry.
4. Perform a visual inspection.
5. If necessary: replace damaged parts.
6. Assembling the humidifier (Fig. ).
Position Symbol Description
4Fill with water.
6Humidifier is heating.Do not touch
heater rod.
Do not dispose of device in domestic waste.
CE symbol (confirms that the product con-
forms to the applicable European direc-
tives).
32 V DC 32 V direct voltage
Application part type BF
IP22
IP protection class Degree of protection
against solid foreign bodies. Device is pro-
tected against drips.
>PC< Material designation: polycarbonate
Date of manufacture (month/year)
Type:
WM100TH
Type designation: Device of the
WM 100 TH type
Follow Instructions for Use.
SN Serial number
Risk of injury from hot heater rod!
During and shortly after operation, the heater rod is
hot and touching it can lead to burns.
⇒Allow the heater rod to cool down completely.
Part Cleaning Disinfecting
Lower part
of
humidifier
With hot water and deter-
gent.
Recommended: wash
weekly in the top basket
of a dishwasher (max.
65 °C).
If necessary: descale (see
5.1)
Disinfect by
immersion
(recommended:
gigasept FF®) /
boil for 5 minutes
Humidifier
insert Boil for 5 minutes
Upper part
of
humidifier
Wipe down: use water or
mild detergent; do not use
microfiber cloth
Disinfect by wiping
(recommended:
terralin®protect /
perform advanced
Alcohol EP)
Heater rod If necessary: descale (see
5.1)
Disinfect by im-
mersion
(recommended:
gigasept FF®)
Disinfect by
spraying
(recommended:
perform advanced)
or boil for
5 minutes
5.1 Descaling the humidifier
1. Remove the humidifier from the therapy device
(Fig. ).
2. Dismantle the humidifier (Fig. ).
3. Pour 300 ml pure household vinegar (5 %
solution without additives) into the lower part of
the humidifier.
4. Put the humidifier insert in bowl of pure
household vinegar (5 % solution without
additives). Humidifier insert must be completely
covered with vinegar.
5. Leave vinegar to take effect for 1 hour.
6. Rinse off the lower part of the humidifier, the
heater rod and the humidifier insert with clean
water.
7. Carefully dry the lower part of the humidifier, the
heater rod and the humidifier insert.
8. Assemble the humidifier (see Fig. ).
5.2 Replacing the heater rod seal
(Fig. )
1. If necessary: allow the heater rod to cool down
completely.
2. Unscrew the heater rod.
3. Replace the sealing ring.
4. Put the heater rod back in.
6Functioncheck
Carry out a function check after every hygiene treat-
ment and repair, but at least every 6 months.
1. Check housing parts for cracks and damage. If
necessary: replace damaged parts.
2. Fill humidifier with water up to the mark (see Fig.
or )
3. Check whether the humidifier has any leaks. If
necessary: replace damaged parts.
4. Fill humidifier with 200 ml water.
5. Connect the humidifier to the therapy device and
switch on.
6. Set heating capacity to the highest stage.
7. Check whether the humidifier is heating up.
8. If the humidifier does not heat up slightly after
10 minutes: contact your specialist dealer.
7 Troubleshooting
8 Servicing
If used in accordance with purpose (see "2.1 Intend-
ed use") the humidifier requires no servicing.
9 Scope of supply
prismaAQUA, black - WM 29680
prismaAQUA, white - WM 29490
9.1 Accessories and replacement
parts
You can order accessories and replacement parts sep-
arately if necessary. You can order a current list on
the Internet or via your specialist dealer.
10 Technical data
Fault Cause Remedy
Humidifier
does not
warm up.
Humidifier stage
switched off. Set humidifier stage.
Humidifier is faulty. Have humidifier
repaired.
Humidifier is
leaking.
Heater rod seal is
faulty. Replace seal (see 5.2).
Humidifier insert is
not inserted
correctly.
Insert humidifier insert
correctly.
Humidifier insert is
faulty.
Replace humidifier
insert.
Cracks in lower part
of humidifier.
Replace lower part of
humidifier.
Humidifier
switches off. Humidifierisempty. Fill humidifier with
water.
Product class to 93/42/EEC IIa
Dimensions
W x H x D in cm 14 x 13.5 x 18
Weight (without water) 0.6 kg
Temperature range
operation
storage
+5 °C to +37 °C
-25 °C to +70 °C
Permitted humidity for operation and
storage
15 % to 93 %, no
condensation
Air pressure range
600 hPa - 1100 hPa,
corresponds to an alti-
tude of 4000 m above
MSL
EN EN