Lowenstein Medical JOYCEeasy User manual

JOYCEeasy
JOYCEeasy Full Face
JOYCEeasy Full Face NV
Nasal Mask
Full Face Mask
面罩
使用说明书
EN Instructions for Use ZH 面罩

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A1 A2
B1
E1 E2
E3 E4
E5 E6
E7 F
B2
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7
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11
12
1
11
655
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10
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7
111
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7
1
WM 67630h 04/2022
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D1 D2
D3 D4
D5 D6
D7
G
C3
C2
C1
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65
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12 10
111
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WM 67630h 04/2022

English 4
中文 16

4EN JOYCEeasy
WM 67630h 04/2022
English
Table of Contents
1 Introduction . . . . . . . . . . . . 5
1.1 Model. . . . . . . . . . . . . . . . . . . . . .5
1.2 Intended use . . . . . . . . . . . . . . . .5
1.3 Contraindications . . . . . . . . . . . .5
1.4 Side effects . . . . . . . . . . . . . . . . .5
1.5 Structure and components . . . . .5
2 Safety . . . . . . . . . . . . . . . . . 5
2.1 Safety information. . . . . . . . . . . .6
2.2 General information . . . . . . . . . .7
3 Product description . . . . . . 7
3.1 Overview . . . . . . . . . . . . . . . . . . .7
3.2 Compatible devices . . . . . . . . . . .7
3.3 Exhalation system . . . . . . . . . . . .8
3.4 Anti-asphyxia valve . . . . . . . . . . .8
3.5 Pressure measurement port . . . .8
4 Operation . . . . . . . . . . . . . . 8
4.1 Applying the mask. . . . . . . . . . . .8
4.2 Adjusting the mask . . . . . . . . . . .8
4.3 Removing the mask . . . . . . . . . . .9
4.4 Dismantling the mask . . . . . . . . .9
4.5 Assembling the mask. . . . . . . . . .9
5 Hygiene preparation . . . . 10
5.1 Cleaning the mask . . . . . . . . . . .10
5.2 Tips . . . . . . . . . . . . . . . . . . . . . .11
5.3 Hygiene treatment (clinical
sphere). . . . . . . . . . . . . . . . . . . .12
6 Disposal . . . . . . . . . . . . . . 12
7 Faults. . . . . . . . . . . . . . . . . 12
8 Replacement parts. . . . . . 12
9 Technical data . . . . . . . . . 13
9.1 Materials . . . . . . . . . . . . . . . . . .13
9.2 Characteristic pressure/
flow curve . . . . . . . . . . . . . . . . .14
10 Markings and symbols . . 14
11 Warranty. . . . . . . . . . . . . . 15
12 Declaration of conformity 15

WM 67630h 04/2022
JOYCEeasy EN 5
1 Introduction
1.1 Model
JOYCEeasy, JOYCEeasy Full Face
1.2 Intended use
JOYCEeasy nasal masks and JOYCEeasy Full
Face masks are used for treating sleep
apnea and for non-invasive and non-life-
sustaining ventilation of patients with
respiratory insufficiency. It serves as a
connecting element between the patient
and the therapy device.
1.3 Contraindications
The mask may not be used in the following
situations: Immediate intubation required;
loss of consciousness, acute vomiting.
The mask may be used in the following
situations only with particular caution:
Pressure points and acute injuries to the skin
of the face; skin allergies involving the face;
deformities of the face or nasopharynx;
acute pain affecting the face; cough reflex
restricted or absent; claustrophobia; acute
nausea.
If you are not certain whether one of these
situations applies to you, please consult your
attending physician or medical advisor.
Please also observe the contraindications in
the instructions for use of your therapy
device.
1.4 Side effects
The following side effects may occur with
use of the mask: nasal congestion, dry nose,
dry mouth in the morning, feeling of
pressure in the sinuses, irritated conjunctiva,
skin rashes, pressure marks on the face,
irritating noises when breathing.
Should such side effects occur, please
contact your attending physician or medical
advisor.
1.5 Structure and
components
The mask consists of a headgear, forehead
cushion, forehead support, lock, retaining
ring, elbow, plug for pressure measurement
port, pressure measurement port, rotating
sleeve, mask body, headgear clip, mask
cushion and an anti-asphyxia valve (on full
face masks only). The product is non-sterile
and reusable.
2 Safety
Please read these instructions carefully. They
are a constituent part of the mask and must
be available at all times. In accordance with
MDR (EU) 2017/745, observe the points
below.

6EN JOYCEeasy
WM 67630h 04/2022
2.1 Safety information
2.1.1Safety information
Risk of injury from mask parts breaking
off!
Deteriorated mask parts or those under
severe strain may come off and put the
patient at risk.
Note useful life.
Check mask parts regularly and replace
prematurely if necessary.
Risk of injury from excessive leaking!
Excessive leaking may lead to under-supply
to the patient.
Activate low pressure/leak alarms on the
therapy device.
Use the correct mask size and check that
it is securely in position.
Risk of injury from the supply of
oxygen!
Oxygen can deposit on clothing, bed linen
and hair. In conjunction with smoking,
naked flames or electrical equipment, it can
cause fires and explosions.
Do not smoke.
Avoid naked flames.
Do not use electrically conductive tubes
(exception: breathing tubes which can
be heated electrically).
Risk of injury from oxygen therapy!
Oxygen therapies can lead to side effects in
case of incorrect use or dosage.
Only administer oxygen as prescribed by
a physician.
Follow the instructions for use of the
oxygen system and therapy device.
Risk of injury from re-inhaling CO2!
If the mask is used incorrectly, CO2 may be
re-inhaled.
Do not close the openings of the mask.
Only apply the mask for a prolonged
period if the therapy device is running.
Only use the mask within the quoted
therapy pressure range.
Do not use the mask on patients who
cannot take it off themselves.
Monitor patients with obstructive and
restrictive lung diseases individually
when using JOYCEeasy masks.
Risk of injury from slipping of the
mask!
If the mask slips or falls off, the therapy is
ineffective.
Monitor patients with restricted
spontaneous respiration.
Activate low pressure/leakage alarms on
the therapy device.
Monitor patients with obstructive and
restrictive lung diseases individually.
Patient endangerment through
application of mask during anesthesia!
When the nasal mask is used during
anesthesia, the anesthetic gas supplied can
escape through the mouth and endanger
the patient.
Do not use nasal mask during
anesthesia.
Risk of injury from lack of cleaning!
The mask may show contamination which
may put the patient at risk.
Clean the mask before using for the first
time (see section entitled "Cleaning and
hygiene treatment").
Clean mask regularly.

WM 67630h 04/2022
JOYCEeasy EN 7
2.2 General information
• Use of third-party products may lead to
functional failures and restricted fitness
for purpose. Biocompatibility may also
be compromised. Please note that in
these cases, any claim under warranty
and liability will be void if neither the
accessories nor original replacement
parts recommended in the instructions
are used.
• To prevent infection, bacterial
contamination or functional
impairments, follow the instructions in
the section “Hygiene preparation” (see
"5 Hygiene preparation", page10).
• In the EU: As a user and/or patient, you
must report any serious incidents
occurring in conjunction with the
product to the manufacturer and to the
responsible authority.
3 Product description
3.1 Overview
Illustrations of the individual components
can be found on the enclosed folding sheet
(figure A1).
Key
1Headgear
2Forehead cushion
3Forehead support
4Lock
5Retaining ring
6Elbow
7Plug for pressure measurement port
8Pressure measurement port
9Rotating sleeve
10 Mask body
11 Headgear clip
12 Mask cushion
13 Anti-asphyxia valve (on full-face masks only,
see figure F)
3.2 Compatible devices
The mask can be used with all therapy
devices which are not for life-sustaining
treatment of patients with sleep apnea or
ventilatory insufficiency.
With many combinations of device, the
actual pressure in the mask will not
correspond to the prescribed therapy
pressure, even if the therapy device is
displaying the correct pressure. Have the
combination of devices adjusted by a
physician or specialist dealer so that the
actual pressure in the mask corresponds to
therapy pressure. The therapy pressure
required may vary between different mask
types, so prescription of a suitable therapy
pressure should in each case involve
adjusting/adapting therapy to suit the mask
type which is also going to be used during
therapy itself.
Quick-release cord (optional)
You can use a quick-release cord (accessory)
to open the headgear in emergency
situations (e.g. vomiting).
The quick-release cord consists of a special
clip with a cord which you can fit to the
mask instead of one of the bottom
headgear clips.

8EN JOYCEeasy
WM 67630h 04/2022
In an emergency, simply pull the quick-
release cord. The special clip will detach
itself from the mask. The headgear is now
open and the mask can be removed
(figure G).
3.3 Exhalation system
The mask has an integrated exhalation
system. The retaining ring and mask body
are shaped in such a way that a gap forms
between these parts. The exhaled air can
escape through this gap (figure A2).
3.4 Anti-asphyxia valve
Safety function of the anti-asphyxia
valve
The anti-asphyxia valve has an opening to
the atmosphere through which the patient
can inhale ambient air if the therapy device
fails. This significantly reduces the risk of
breathing CO2 back in and thus also the risk
of asphyxia. Inside the anti-asphyxia valve is
a membrane which can adopt one of two
positions:
• as long as the therapy device is in
operation, the air flow forces the
membrane against the opening to the
atmosphere and seals it completely. The
patient breathes through the therapy
device.
• if the therapy device fails or if the device
is not connected, the membrane is in the
rest position, in other words the
opening to the atmosphere is free. The
patient breathes ambient air through
this opening.
3.5 Pressure measurement
port
The mask has a connection 8 which can be
used for measuring pressure or supplying
oxygen. If you are not using the pressure
measurement port, close it with the plug 7
to reach therapy pressure.
4 Operation
4.1 Applying the mask
1. Pull the headgear 1 over the head and
place the mask on the face (figure B1).
2. Insert headgear clips 11 (figure B2).
4.2 Adjusting the mask
1. Undo lock 4 (figure C1).
2. Pull the forehead support 3 in or out of
the lock 4 bit by bit as necessary (figure
C1).
Risk of asphyxia if anti-asphyxia valve
not working properly!
Residues may block the mask and
jeopardize the success of therapy.
Check before each use that the anti-
asphyxia valve is working properly.
Clean contact surfaces between the
elbow and the rotating sleeve
thoroughly.