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

%
A1 A2
B1
E1 E2
E3 E4
E5 E6
E7 F
B2
1
2
3
4
5
6
7
8
9
10
11
12
1
11
655
12
10
2
3
7
111
5
7
1
WM 67630h 04/2022
13

D1 D2
D3 D4
D5 D6
D7
G
C3
C2
C1
1
2
3
4
4
1
2
3
65
5
12 10
111
3
11
1
7
7
3
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.

WM 67630h 04/2022
JOYCEeasy EN 9
3. Applying the mask (see "4.1 Applying
the mask", page8).
4. Adjust headgear 1 with the aid of the
hook-and-loop fasteners so that the
mask seals on the face but is not too
tight (figure C2).
5. To adjust the hook-and-loop fastener on
top of the head undo the hook-and-
loop fastener, pull on the ends of the
headgear with both hands and close the
fastener again (figure C3).
4.3 Removing the mask
1. Undo 11 the headgear clips.
2. Slip the headgear 1 over the head and
remove the mask.
4.4 Dismantling the mask
1. Undo the headgear clips 11 (figure D1).
2. Release hook-and-loop fasteners from
headgear clips 11 and forehead
support 3 and remove the headgear 1
(figure D1 + D2).
3. Remove the plug for the pressure
measurement port 7 (figure D3).
4. Remove forehead cushion 2 from
forehead support 3 (figure D4).
5. Take mask cushion 12 off mask body 10
(figure D5).
6. Turn retaining ring 5 counterclockwise
and remove it (figure D6).
7. Remove elbow 6 from retaining ring 5
(figure D7).
8. Take rotating sleeve 9 off elbow 6
(figure D7).
9. For full-face masks only: carefully take
the anti-asphyxia valve off the elbow.
In the process, please note: do not
damage the membrane on the inside of
the anti-asphyxia valve.
4.5 Assembling the mask
1. Push rotating sleeve 9 onto elbow 6
(figure E1).
2. Insert elbow 6 in the retaining ring 5
(figure E1).
3. Insert retaining ring in the mask body
with position 5 at 11 o'clock and turn
clockwise to a 12 o'clock position until it
locks into place (figure E2).
4. Fit mask cushion 12 onto mask body 10
(figure E3).
5. Pull forehead cushion 2 over the
forehead support 3 (figure E4).
6. Fit the plug for the pressure
measurement port 7 (figure E5).
7. Attach the headgear 1 with the
headgear clips using the lower hook-
and-loop fasteners 11 (figure E6).
8. Attach the headgear 1 to the mask
(figure E7).
Remember the most convenient
position. To do this, use the scale
between the forehead support and the
lock (figure C1).

10 EN JOYCEeasy
WM 67630h 04/2022
9. For full-face masks only: carefully push
anti-asphyxia valve onto the elbow until
it audibly engages on both sides of the
elbow (figure F).
In the process, please note: do not
damage or trap the membrane on the
inside of the anti-asphyxia valve.
5 Hygiene preparation
•This product may contain disposable
items. Disposable items are
intended for single use. Therefore,
use these items only once and do not
reprocess them. Reprocessing
disposable items may impair
functionality and safety of the product
and lead to unforeseeable reactions due
to ageing, embrittlement, wear, thermal
stress, the effects of chemical processes
etc.
5.1 Cleaning the mask
1. Wash your hands before cleaning.
2. Dismantle the mask (see "4.4
Dismantling the mask", page9).
3. Clean mask in accordance with the table
below:
You can tell whether the headgear is
correctly attached by the hook-and-loop
tabs. The hook-and-loop tabs on the
forehead have the same color as the
inside of the head bands.
Risk of injury from inadequate cleaning!
Residues may congest the mask, impair the
integrated exhalation system and
jeopardize therapy success.
For patients with a compromised
immune system or particular
background of illness, disinfect mask
components daily following consultation
with the physician.
Thoroughly clean the contact surfaces
between the elbow and the rotating
sleeve.

WM 67630h 04/2022
JOYCEeasy EN 11
4. Rinse all parts with clear water.
5. Allow all parts to air-dry.
6. Perform a visual inspection.
7. Replace damaged parts if necessary.
8. Assembling the mask (see "4.5
Assembling the mask", page9).
5.2 Tips
• You can wash all parts (exception: anti-
asphyxia valve and headgear) in a
dishwasher at 65 °C.
• Do not dry parts in direct sunlight.
• Wash headgear before first use, as the
color may run.
• Do not iron the headgear in order to
keep the hook-and-loop fasteners
intact.
• Do not dry the headgear in a tumble-
dryer.
Action
Daily
Weekly
Wash mask parts by hand in hot water
(approx. 30 °C) and with mild detergent
(1 ml detergent to 1 l water) for
15 minutes.
X
Clean mask parts (exception: mask
cushion, anti-asphyxia valve and
forehead cushion), thoroughly with a
cloth or a soft brush for at least
3 minutes when washing.
Or: Put mask parts in the top basket of
the dishwasher. Select a washing
program with a max. temperature of
70 °C and a max. time of 90 minutes.
Use a mild dishwasher detergent (1 ml
dishwasher detergent to 1 l water).
Only wash mask parts in a dishwasher
separately, do not mix with dirty
crockery.
X
Wash the headgear by hand in hot water
(approx. 30 °C) and with mild detergent
(1 ml detergent to 1 l water) for
15 minutes.
X
Material damage due to abrasion!
Rubbing the mask cushion and forehead
cushion can damage the coating.
Do not rub the mask cushion and
forehead cushion dry.
Material damage due to careless use!
Careless handling can damage the anti-
asphyxia valve.
Always handle the anti-asphyxia valve
with care.
Discolorations of mask components do
not impair the functionality of the mask.

12 EN JOYCEeasy
WM 67630h 04/2022
5.3 Hygiene treatment
(clinical sphere)
On change of patient, inadequate hygiene
treatment may lead to a risk of infection for
the patient. In the event of a change of
patient, subject the mask to a hygiene
treatment in line with the “Information on
hygiene treatment” brochure. The brochure
can be found on the manufacturer’s
website. We will send you this brochure on
request.
6 Disposal
You can dispose of all parts in domestic
waste.
7 Faults
8 Replacement parts
A current list of replacement parts can be
ordered on the internet site of the
manufacturer or through your authorized
specialist dealer.
Fault Cause Remedy
Facial
pressure pain.
Mask fits
too tightly.
Loosen headgear.
Adjust position of
forehead support.
Draft in the
eyes.
Mask fits
too loosely.
Tighten headgear.
Adjust position of
forehead support.
Mask does
not fit.
Use different mask
size. Contact your
specialist retailer.
Therapy
pressure is not
reached.
Mask is not
adjusted
correctly.
Re-adjust mask (see
4.2, p.8).
Mask
cushion is
damaged.
Replace mask
cushion.
Tube system
is leaking.
Check connection
and fit of tubes.
Air is escap-
ing from
pressure
measure-
ment con-
nection.
Close pressure
measurement port
with plug (included in
scope of supply).
Anti-
asphyxia
valve
incorrectly
fitted.
Fit anti-asphyxia
valve correctly (see
4.5, p.9).
Anti-
asphyxia
valve
defective
Replace anti-
asphyxia valve
Fault Cause Remedy

WM 67630h 04/2022
JOYCEeasy EN 13
9 Technical data
1 depending on size and variant.
2 Useful life up to 12 months. The materials of the
mask deteriorate if exposed to e.g. aggressive
detergents. In individual cases, therefore, it may be
necessary to replace mask parts sooner.
9.1 Materials
Nasal mask Full-face
mask
Product class
according to
directive MDR (EU)
2017/745
IIa
Dimensions (W x
H x D)
approx.
80 mm x
130 mm x
90 mm1
approx.
120 mm x
150 mm x
110 mm1
Weight approx.72 g1approx.103 g1
Therapy pressure
range 4 hPa - 30 hPa
Hose connection:
Cone according
to EN ISO 5356-1 Ø 22 mm (male)
Pressure
measurement
port
Ø 4 mm
Wide headgear
clips max. 20 mm
Temperature
range:
Operation
Storage
+5 °C to + 40 °C
-20 °C to +70 °C
Flow resistance
at 50 l/min
at 100 l/min
0.16 hPa
0.64 hPa
0.13 hPa
0.53 hPa
Anti-asphyxia
valve flow
resistance
• Inspiration at
50 l/min:
• Exhalation at
50 l/min:
- 0.5 hPa
0.5 hPa
Switching pres-
sure for anti-
asphyxia valve
• Open:
• Close:
-
≤ 1 hPa
≤ 2 hPa
Quoted two-
figure noise
emission value
according to ISO
4871:
-Sound pressure
level
-Sound power
level,
uncertainty
factor:
18 dB(A)
23 dB(A)
3 dB(A)
Service life 5 years2
Standards
applied EN ISO 17510:2020
Mask part Material
Mask cushion, forehead
cushion Silicone, silicone coating
Plug for pressure
measurement port Silicone
Retaining ring (hard
component) PP (polypropylene)
Nasal mask Full-face
mask

14 EN JOYCEeasy
WM 67630h 04/2022
All parts of the mask do not contain latex,
PVC (polyvinylchloride) and DEHP
(diethylhexyl phthalate).
9.2 Characteristic
pressure/flow curve
The characteristic pressure/flow curve
shows the outlet flow in dependence with
therapy pressure.
10 Markings and
symbols
The following symbols may be applied to
the device, the device label, accessories or
packaging.
Retaining ring (soft
component)
TPE (thermoplastic
elastomer)
Headgear clip, lock
PA (polyamide),
POM
(polyoxymethylene)
Forehead support,
rotating sleeve, mask
body, elbow
PA (polyamide)
Headgear
Elastane, polyester, PU
(polyurethane), UBL
loop, cotton, PA
(polyamide)
Anti-asphyxia valve TPE, PP (polypropylene)
Quick-release cord POM, polyester, PA
(polyamide)
Mask part Material
Outlet pressure at therapy device (hPa)
Mean leakage flow rate (l/min)
JOYCEeasy JOYCEeasy Full Face
Symbol Description
Unique device identifier
(uniform product code for
medical devices)
Permitted temperature range
for transport and storage
Use by date
Keep out of sunlight
Order number
Indicates the product is a
medical device
Lot number
Manufacturer and, if necessary,
date of manufacture
Follow the instructions for use
CE symbol (confirms that the
product conforms to the
applicable European directives/
regulations)

WM 67630h 04/2022
JOYCEeasy EN 15
11 Warranty
Löwenstein Medical gives the customer a
limited manufacturer warranty on new
original Löwenstein Medical products and
any replacement part fitted by
Löwenstein Medical in accordance with the
warranty conditions applicable to the
product in question and in accordance with
the warranty periods from date of purchase
as listed below. The warranty conditions are
available on the website of the
manufacturer. We will also send you the
warranty conditions on request.
Please bear in mind that any claim to
warranty and liability shall be void if neither
the accessories recommended in the
instructions for use nor genuine
replacement parts are used.
In the event of a claim under warranty,
contact your specialist dealer.
12 Declaration of
conformity
The manufacturer Löwenstein Medical
Technology GmbH + Co. KG (Kronsaalsweg
40, 22525 Hamburg, Germany) hereby
declares that the product complies with the
relevant regulations of of the Medical
Device Regulations (EU) 2017/745. The
unabridged text of the Declaration of
Conformity can be found on the
manufacturer's website.
Product Warranty
periods
Masks including accessories 6 months

16 ZH JOYCEeasy
WM 67630h 04/2022
中文
目录
1引言 . . . . . . . . . . . . . . . . . . 17
1.1 产品型号 . . . . . . . . . . . . . . . . . .17
1.2 适用范围 . . . . . . . . . . . . . . . . . .17
1.3 禁忌症 . . . . . . . . . . . . . . . . . . . .17
1.4 副作用 . . . . . . . . . . . . . . . . . . . .17
1.5 结构及组成 . . . . . . . . . . . . . . . .17
2安全须知 . . . . . . . . . . . . . . 17
2.1 安全须知 . . . . . . . . . . . . . . . . . .17
2.3 一般提示 . . . . . . . . . . . . . . . . . .18
3产品说明 . . . . . . . . . . . . . . 18
3.1 概览 . . . . . . . . . . . . . . . . . . . . . .18
3.2 仪器适配 . . . . . . . . . . . . . . . . . .19
3.3 呼气系统 . . . . . . . . . . . . . . . . . .19
3.4 急救呼气阀 . . . . . . . . . . . . . . . .19
3.5 测压接口 . . . . . . . . . . . . . . . . . .19
4操作 . . . . . . . . . . . . . . . . . . 20
4.1 戴上面罩 . . . . . . . . . . . . . . . . . .20
4.2 调整呼吸面罩 . . . . . . . . . . . . . .20
4.3 取下面罩 . . . . . . . . . . . . . . . . . .20
4.4 拆分面罩 . . . . . . . . . . . . . . . . . .20
4.5 组装面罩 . . . . . . . . . . . . . . . . . .20
5卫生处理 . . . . . . . . . . . . . . 21
5.1 清洁呼吸面罩 . . . . . . . . . . . . . .21
5.2 提示 . . . . . . . . . . . . . . . . . . . . . .22
5.3 卫生处理 （临床领域） . . . . . .22
6废弃物回收处理 . . . . . . . . 22
7故障及排除方法 . . . . . . . . 22
8备件 . . . . . . . . . . . . . . . . . . 22
9技术数据 . . . . . . . . . . . . . . 23
9.1 原材料 . . . . . . . . . . . . . . . . . . . .23
9.2 压力流速特性曲线 . . . . . . . . . .24
10 标识和符号 . . . . . . . . . . . . 24
11 保修期 . . . . . . . . . . . . . . . . 24
12 合格声明 . . . . . . . . . . . . . . 25

WM 67630h 04/2022
JOYCEeasy ZH 17
1 引言
1.1产品型号
JOYCEeasy，JOYCEeasy Full Face
1.2适用范围
产品与治疗仪连接，用于对有睡眠呼吸暂
停和呼吸功能不全的患者进行无创、非维
持生命的通气治疗。
1.3禁忌症
以下情形不得使用面罩：需要立即插管；
失去知觉、剧烈呕吐。
以下情形应慎用面罩：面部皮肤瘀伤和严
重损伤；面部皮肤过敏；面部或鼻咽腔变
形；面部剧烈疼痛；咳嗽反射受限或无咳
嗽反射；幽闭恐惧症；严重恶心。
如果您不确定这些情形中是否有符合自己
的情况，请咨询您的主治医师或医护人
员。请认真阅读治疗仪使用说明书中禁忌
症的相关说明。
1.4副作用
使用面罩可能产生以下副作用：鼻塞、鼻
干，清晨口干舌燥、鼻窦有压迫感、眼结
膜刺激发炎，皮肤红斑、面部留有压痕、
呼吸时有干扰杂音。
如果出现这些副作用，请咨询您的主治医
师或医护人员。
1.5结构及组成
产品由头带、额垫、额部支架、额部支架
的锁紧装置、固定环、弯头、测压接口堵
头、测压接口、旋转套筒、面罩壳、带
夹、呼吸面罩凸缘、急救呼吸阀 ( 仅用于
口鼻罩 ), 拉绳 ( 选配 )。产品为非灭菌非
一 次性使用产品。
2 安全须知
请仔细阅读本使用说明书，本使用说明属
本鼻罩的重要组成部分，必须随时可供查
阅。按照医疗产品条例 (EU) 2017/745 的
要求，请注意以下事项。
2.1 安全须知
2.2 安全提示
因面罩部件断裂造成受伤危险！
老化或过度使用的面罩部件可能会脱落，
进而危及患者安全。
请注意使用时长。
定期检查面罩部件，如有必要及早更
换。
因泄漏量太大而导致的受伤危险！
泄漏量太大可能导致患者供气不足。
激活治疗仪上的低压 / 泄漏报警装置。
使用正确的面罩尺寸并检查位置是否固
定。
因输氧而构成的人员受伤危险！
氧气会沉积在衣服、床上用品以及头发
上。遇有吸烟、明火和使用电气设备等因
素会引起火灾和爆炸。
禁止吸烟。
切忌使用明火。
请勿使用导电软管 （例外：可电加热
的呼吸软管）。

18 ZH JOYCEeasy
WM 67630h 04/2022
因氧气疗法而构成的人员受伤危险！
如果出现使用 / 计量错误，那么氧气疗法
会产生副作用。
只能遵医嘱施用氧气。
请认真阅读氧气输入装置和治疗仪使用
说明书。
因 CO2反复呼吸而构成的人员受伤危险！
呼吸面罩处置不当时，CO2会被反复呼
吸。
请堵住呼吸面罩上的开口。
只有当治疗仪运行较长时间时，方可佩
戴上呼吸面罩。
仅限于在规定的治疗气压范围内使用呼
吸面罩。
切勿给不能自己摘下呼吸面罩的患者佩
戴呼吸面罩。
在使用 JOYCEeasy 鼻罩的过程中，对
患有阻塞性和限制性肺疾病的患者单独
检查。
因呼吸面罩滑脱而构成的人员受伤危险！
如果呼吸面罩滑脱或脱落，治疗无效。
对患有限制性自发呼吸困难的患者要进
行监测。
激活治疗仪上的负压 / 泄漏报警装置。
对患有阻塞性和限制性肺疾病的患者单
独监测。
在麻醉状态下使用呼吸面罩对患者有危
害！
如果在麻醉状态下使用鼻罩，导入的麻醉
气体会通过口腔泄漏，对患者构成危险。
切忌在麻醉状态下使用鼻罩。
因缺少清洁而导致的受伤危险！
面罩可能带有污染物，这些可能会危及患
者安全。
首次使用面罩前请进行清洁 （参见清
洁与消毒一章的内容）。
定期清洁面罩。
2.3 一般提示
•使用其它厂商的产品可能导致器件功能
障碍以及适用性受到限制。另外，还会
导致设备不能符合生物相容性的要求。
请注意：如果既没有使用说明书中所推
荐的配件也没有使用原装备件，有此类
情况发生时，本公司对产品出现的任何
问题恕不承担产品保修和责任。
•为了防止感染、细菌感染或功能受损，
请参阅 “ 卫生处理 ” （参见 “5 卫生
处理 ”，第 21 页）一章。
•在欧盟：所有用户和 / 或患者必须在产
品发生严重意外时通知制造商和主管部
门。
3 产品说明
3.1 概览
零部件图示，请参见随产品附上的折页说
明书 （插图 A1）。
图例说明
1头带
2额垫
3额部支架
4额部支架的锁紧装置
5固定环
6弯头
7测压接口堵头
8测压接口
9旋转套筒
10 面罩壳
11 带夹
12 呼吸面罩凸缘
13 急救呼气阀 （仅用于口鼻罩，参见插图 F）