Clinicare 100HF Instructions for Use and Technical Description V04 April 2020

Manufacturer: LINET spol. s r. o. Želevčice 5, 274 01 Slaný Czech Republic Phone: +420 312 576 111 Fax: +420 312 522 668 E-Mail: [email protected] Web: www.linet.com Service department: [email protected]

CliniCare 100 HF Hybrid Foam Mattress Replacement System Author: LINET, s.r.o. Related links: www.linet.cz D9U003VC0-0101 Version: 04 Publication Date: 2020-04 Copyright © LINET, s.r.o., 2020 Translation © LINET, 2020 All rights reserved. All trademarks and brands are the property of the appropriate owners. The manufacturer reserves the right to changes in the contents of the instructions for use that relate to the product´s technical regulations. It is for this reason that the contents of the instructions for use may indicate differences from the current manufacture of the product. Reproduction, also excerpts, only with prior permission of the publisher. Subject to changes due to technical developments. All technical data are rated data and are subject to construction and manufacturing tolerances.

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Table of Contents 1 Symbols and Definitions...4 1.1 Warning Notices...4 1.1.1 Types of Warning Notices...4 1.1.2 Structure of Warning Notices...4 1.2 Instructions...4 1.3 Lists...4 1.4 Symbols on the Package...5 1.5 Symbols and Labels on the Product... 6 1.6 Serial Labels with UDI...9 1.6.1 Serial Label for CliniCare 100 HF (SCU)... 9 1.6.2 Serial Label for CliniCare 100 HF (mattress)... 10 1.6.3 Wash Label (mattress)...10 1.7 Acoustic signalisation (CliniCare 100 HF)... 10 1.8 Abbreviations...11 1.9 Definitions...11 2 Safety Instructions...12 2.1 Before use...13 2.2 Installation...13 2.3 Usage...13 3 Intended use...14 3.1 User population...14 3.2 Contraindications...14 3.3 Operator...14 4 Product Description...15 4.1 Mattress...15 4.1.1 CliniCare 100 HF...15 4.2 SCU (System Control Unit)...16 5 Technical Specification...17 5.1 Mechanical Specification...17 5.2 Electrical Specifications...17 5.3 Electromagnetic compatibility...18 5.3.1 Manufacturer instructions - electromagnetic emissions ...18 5.3.2 Manufacturer instructions - electromagnetic susceptibility ...19 6 Use and Storage Conditions...20 6.1 Storage...20 7 Scope of Delivery and Bed Variants... 20 7.1 Delivery...20 7.2 Contents...20 8 Putting into Service...21 8.1 Placing CliniCare 100 HF on the Bed... 21 8.1.1 Putting into Service – CliniCare 100 HF Mattress... 21 8.1.2 Putting into Service – SCU (System Control Unit)... 21 8.2 Connecting Mattress with SCU...22 8.3 Connecting Air Pipes with Mattress... 23 8.3.1 Mattress with MCM mode...23 8.3.2 Mattress without MCM mode...24 8.4 Disconnecting Air Pipes from Mattress (aka Switching to reactive mattress)...25 8.4.1 Mattress with MCM mode...25 8.4.2 Mattress without MCM mode...26 8.5 Inflation...27 8.5.1 Switching SCU ON/OFF...27 8.5.2 Inflation...27 9 Manipulation...28 9.1 Use...28 9.1.1 Preparing the Bed for the Patient... 28 9.2 Control panel – CliniCare 100 HF with Micro-Climate Management...29 9.2.1 MCM – Micro-Climate Management... 29 9.2.2 APT+MCM – Alternating pressure therapy + Micro-Climate Management...29 9.3 Control panel – CliniCare 100 HF without Micro-Climate Management...30 9.3.1 APT – Alternating pressure therapy... 30 D9U003VC0-0101_04

9.3.2 STATIC – Static inflated mode... 30 9.4 Pressure Control...31 9.4.1 Pressure Settings - Mattress...31 9.4.2 Pressure Settings – Changes in Patient’s Position... 31 9.5 CPR – Cardipulmonary resuscitation... 32 9.6 Power failure...32 9.7 System faults...32 10 Cleaning/Disinfection...34 10.1 General Guidance...34 10.2 Routine Cleaning and Disinfection... 35 10.3 Full Cleaning and Disinfection... 35 10.3.1 Cleaning Top Cover and/or Base Cover... 35 10.3.2 Machine washing of CliniCare 100HF removable top mattress cover...35 10.3.3 Cleaning the air pipe...36 10.3.4 Cleaning the SCU...36 10.4 Removing the Mattress Cover... 36 10.5 Removing the Air Pipe Cover...36 11 Maintenance ...37 11.1 Regular maintenance...37 11.2 Spare Parts...37 11.3 Safety Technical Checks...37 12 Disposal...38 12.1 Environment Protection...38 12.2 Disposal...38 12.2.1 Within Europe...38 12.2.2 Outside Europe...38 13 Warranty...39 14 Standards and Regulations...39

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1 Symbols and Definitions 1.1 Warning Notices 1.1.1 Types of Warning Notices Warning notices are differentiated by the type of danger using the following key words: ► CAUTION warns about the risk of material damage. ► WARNING warns about the risk of physical injury. ► DANGER warns about the risk of fatal injury.

1.1.2 Structure of Warning Notices SIGNAL WORDS! Type and source of danger! ► Measures to avoid the danger.

1.2 Instructions Structure of instructions: ► Perform this step. Results, if necessary.

1.3 Lists Structure of bulleted lists: ■ List level 1 □ List level 2 ● List level 3

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1.4 Symbols on the Package

FRAGILE, HANDLE WITH CARE

THIS WAY UP

KEEP DRY (PROTECT FROM HUMIDITY)

PAPER RECYCLING SYMBOL

DO NOT USE HAND TRUCK HERE

DO NOT STACK DURING STORAGE

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1.5 Symbols and Labels on the Product

READ INSTRUCTIONS FOR USE

COVER MATERIALS ARE FIRE RETARDENT TO BS7175, SOURCES 0, 1 AND 5

DO NOT IRON

DO NOT USE A CLEANER CONTAINING PHENOL

DO NOT WRING

REGULARY INSPECT THE INSIDE OF THE COVER FOR CONTAMINATION

MACHINE WASH AT 71 DEG. CENTIGRADE FOR 3 MINUTES

TUMBLE DRY ON LOW HEAT SETTING

HANDWASH WITH DETERGENT. INITIAL TEMPERATURE OF HOT WATER SHOULD NOT EXCEED 50 DEG. CENTIGRADE

DISINFECT USING SOLUTION CONTAINING <1000 PPM OF CHLORINE (SEE CLEANING/ DISINFECTION)

RINSE WITH WATER

DRY

WARNING

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ONLY SUITABLE FOR INDOOR USE

CE MARK OF CONFORMITY WITH EU REGULATION

2X 1A(T) ANTI-SURGE FUSE

PROTECTION AGAINST ACCIDENTS DUE TO ELECTRICAL CURRENT – TYPE B APPLIED PARTS

DOUBLE INSULATION

POWER SWITCH I : ON O: OFF

ALTERNATING CURRENT

WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE, DO NOT PUT INTO THE HOUSEHOLD WASTE)

MEDICAL DEVICE (COMPATIBLE WITH MEDICAL DEVICE REGULATION)

RECYCLING SYMBOL

DO NOT POLLUTE THE ENVIRONMENT

REFERENCE NUMBER (PRODUCT TYPE DEPENDING ON CONFIGURATION)

SERIAL NUMBER

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THERMAL PROTECTION FOR TRANSFORMER

SAFETY ISOLATING TRANSFORMER (GENERAL)

MANUFACTURER

MANUFACTURING DATE

MATTRESS FOOT PART

SAFE WORKING LOAD SYMBOL

UNIQUE DEVICE IDENTIFICATION (FOR MEDICAL DEVICES)

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1.6 Serial Labels with UDI The serial label is located on the back of the SCU (System Control Unit). The serial number and the model number can be found on the type plate. This information is required when contacting LINET. Pictures of serial labels below serve just for explanation of the signs and fields on the serial labels.

1.6.1 Serial Label for CliniCare 100 HF (SCU) 1

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UDI

CLINICARE 100 HF 4

REF

1VCKU200000M0

SN

20200107934

(01) 8592654093481 (11) 200401 (21) 20200107934

220-240 V~, 50 Hz, 15 VA

5

6

3

2

2020-04-01

7

9

Fig. Serial Label with UDI (CliniCare 100 HF - SCU)

1

Address of Manufacturer

2

Manufacturing Date (Year-Month-Day)

3

DI (Device Identifier) / GTIN (Global Trade Item Number)

4

1D Bar code GS1-128 (Serial Number)

5

Symbols

6

Electrical Specification

7

Serial Number

8

PI (Product Identifier)

9

2D Bar Code (GS1 DataMatrix) DI+PI=UDI

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1.6.2 Serial Label for CliniCare 100 HF (mattress) 1

2

3

4 Fig. Serial Label (CliniCare 100 HF - mattress)

1

Product name with reference number and dimensions

2

Manufacturing Date (Year-Month-Day)

3

1D Bar code (country of origin, identification code of manufacturer, unique number of item)

4

Order number

1.6.3 Wash Label (mattress)

Fig. Wash label (CliniCare 100 HF - mattress)

1.7 Acoustic signalisation (CliniCare 100 HF) There are no acoustic signals in the case of CliniCare 100 HF.

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1.8 Abbreviations AC ( ~ )

Alternating Current

CE

European Conformity

CPR

Cardiopulmonary Resuscitation

dB

Sound Intensity Unit

DC (

)

Direct Current

CUC

Configuration number

EMC

Electromagnetic Compatibility

FET

Field-effect transistor

HF

High Frequency

HPL

High Pressure Laminate

ICU

Intensive Care Unit

INT.

Duty Cycle

IP

Ingress Protection

IV

Intravenous

LED

Light Emitting Diodes

ME

Medical Electrical (Equipment)

ON

Activation

OFF

Deactivation

ppm

parts per million, millionth (1000 ppm = 0,1%)

REF

Reference Number (product type depending on configuration)

SCU

System Control Unit (integrated mattress)

SN

Serial Number

SW

Software

SWL

Safe Working Load

UDI

Unique Device Identification (for medical devices)

USB

Universal Serial Bus

WEEE

Waste Electrical and Electronic Equipment

1.9 Definitions Duty Cycle

Cycle of operation of the motor: time of activity/time of rest.

Maximum Patient Weight

Maximum Patient Weight depends on the application environment according to IEC 606012-52. For application environment 1 (intensive/critical care) and 2 (acute care) reduce Safe working Load by 65 kg. For application environment 3 (long-term care) and 5 (ambulatory care) reduce Safe working Load by 35 kg.

Safe Working Load

The highest allowable load on the bed (patient, mattress, accessories and the load supported by those accessories).

Adult

Patient having a physical size equal to or more than 146 cm, a mass equal to or more than 40 kg and a body mass index (BMI) equal to or more than 17 (according to IEC 60601-252).

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2 Safety Instructions WARNING! Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established! WARNING! Only authorised and trained person using the tool is allowed to change fuses and power supplies!

WARNING! This medical device is not intended for oxygen enriched environment!

WARNING! This medical device is not intended for use with flammable substances!

WARNING! This medical device is not portable medical electrical equipment!

WARNING! Patient is allowed to use selected control elements only if hospital personnel had assessed that the patient´s physical and psychological state is in accordance with use of them and only if the hospital personnel had trained the patient in accordance with the instructions for use! WARNING! Risk of injury due to incorrect use! ► Before placing a patient on a CliniCare 100 HF mattress, always have a qualified person perform a risk assessment to ensure that the support provided is appropriate and fulfills the applicable local stipulations. ► Do not use APT mode for patients undergoing cervical traction. STATIC mode can be used only under supervision of qualified person. ► When using mattress replacement or overlay systems, make sure to use safe and appropriate siderail positions and bed height settings. Which positions and settings are safe and appropriate may vary with the type of bed frame and siderails. ► CliniCare 100 HF mattress without System Control Unit is not intended for immobile patients.

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2.1 Before use „ „ „ „ „ „ „ „

It is necessary to read the instructions for use before operating the mattress system. Follow the instructions carefully. Use the mattress system only as specified in this manual. LINET shall not assume any responsibility for any damage or injury resulting from incorrect use. Position the power cord so that there are no loops or kinks in the cable; protect the cable from mechanical wear and tear. Improper handling of power cord can cause an electric shock hazard, other serious injuries or damage to the mattress system. Position the power cord so there is no risk of injuring the patient (e.g. choking hazard). Regular inspection of the mattress interior to be carried out on a regular basis. In case of any problem please contact manufacturer for help at installation, service or if an unexpected event occurs.

2.2 Installation „ „

Ensure that installation is performed in accordance with the instructions in this manual. Ensure that maintenance is performed only by qualified personnel who have been trained by the manufacturer.

2.3 Usage „ „ „ „ „ „ „ „ „ „ „ „ „ „ „

Ensure that the mattress system is only operated by suitably qualified personnel or after receiving instruction from them. Only use the mattress system if it is in perfect working order. Only use the system in clean environment. Always hold SCU with scoop handle when moving. Only use the mattress system with the correct power supply (see Electromagnetic Compatibility). Replace any damaged parts immediately with original spare parts only. Do not exceed the maximum patient weight (see Mechanical Specifications). Do not use the SCU in near flammable gases. This does not apply to oxygen cylinders. Do not cover SCU while in use. Do not place SCU near extreme heat sources such as radiators. Never handle the power plug with wet hands. Disconnect the product from the outlet only by pulling the power plug. While pulling the power plug, always hold the actual plug, not the cord. Mattress and SCU must be checked at least once a day. Check that: „ the mattress is inflated to the required pressure „ the Low Pressure indicator is not pernamently illuminated in case of error refer to the chapter “System Faults” The handles located on the both sides of the mattress cover are designed only for manipulation with the mattress without load (without patient).

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3 Intended use The intended use is to prevent and support treatment of pressure injuries.

3.1 User population ► Caregivers (nurses, doctors, technical personnel, transport personnel, cleaning personnel) ► Adult patients (weight >= 40 kg, height >= 146 cm, BMI >= 17) at moderate risk levels in the intensive care (Application Environment 1 and 2 as in IEC 60601-2-52); Patients with any stage/category of pressure ulcers

3.2 Contraindications Mattress system is contraindicated for patients: ► with cervical traction ► or unstable spinal fractures, spinal cord injury, fractures at risk of complication by a moving surface, ► or trauma patients where spinal injuries have not been excluded or cleared

3.3 Operator ►

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Caregiver

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4 Product Description 4.1 Mattress The CliniCare 100 HF system is designed for use in all healthcare facilities, hospitals, nursing homes and community care as an aid to the prevention and treatment of skin injuries related to pressure damage.

4.1.1 CliniCare 100 HF CliniCare 100 HF is a hybrid foam including cell system. Cells are connected into two groups for pressure distribution. Air tubes inside the mattress are separate for these two groups. Cells also includes pressure valve to gain pressure from atmosphere when needed. The system can be connected to compressor thanks to outer valves. The system works as a separate mattress or in connection with compressor. Separate mattress redistributes the pressure according to patient’s position and movement. When the compressor is connected the mattress provides alternating therapy. In case of MCM version compressor also delivers air for MCM feature in mattress. Inside the mattress there is foam with different densities. On the top of mattress there is visco foam. Inside the cells there is PU foam. The pressure delivered by compressor can be adjusted by controller.

1

2 3

7 8 9

4

10

5

11

6

12 13

Fig. CliniCare 100 HF mattress 1 2 3 4 5 6 7 8 9 10 11 12 13

Top cover Comfort layer Mattress Serial Label Holder Mattress Serial Label Lamination Tubing Harness MCM (only version with MCM) Foam layer Cell Sleeve Reactive Cell Tubing Harness A Check Valve Tubing Harness B Base Cover Air Connection

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Top foam: ■ height: 5 cm ■ material: visco foam Middle section: ■ 10 self-adjusting air cells absorb and displace patient weight ■ when used with SCU, air cells alternate in pressure, and micro climate management is optional ■ height: 11 cm ■ material:PU Cover: ■

Top □ 4 way stretch with 360 degree zip □ waterproof / high Moisture Vapour Permeability

■

Base □ high durability / non stretch / waterproof □ 2 strong mattress Transport Handles on each side of the base

4.2 SCU (System Control Unit) The SCU inflates and deflates the air mattress. It is connected to the air mattress with a custom-designed air connector. The analogue electro-mechanical controlled SCU maintains the set pressure regardless of the patient’s weight distribution or position. The SCU is equipped with visual indicators for power failure or mattress low air pressure that may be caused by air pipe disconnection or other faults (see chapter “System Faults”).

Fig. SCU for CliniCare 100 HF with MCM mode

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Fig. SCU for CliniCare 100 HF without MCM mode

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5 Technical Specification 5.1 Mechanical Specification CAUTION! Height value of the edge of not loaded inflated mattress is 20 cm and height value in the middle of the mattress is 24,5 cm. This fact does not increase the risk of patient´s falling down over the siderails. Decisive value for choice of the safe mattress in relation to the siderails is 20 cm.

Parameter

Value

External dimensions of CliniCare 100 HF mattress (length x width) Version 1 Version 2 Version 3

200 x 86 208 x 86 213 x 86

Mattress height (inflated)

24,5 cm

Mattress height (deflated)

20 cm

External dimensions of SCU (length x width x height)

30 x 12 x 22 cm

Weight ■ CliniCare 100 HF ■ CliniCare 100 HF System Control Unit (SCU)

16 kg 2,5 kg

Cycle ■

2 cells technology, 12 minutes

Mattress (inflated)

Environmental conditions (Use conditions) ■ Ambient Temperature ■ Relative Humidity ■ Atmospheric Pressure

10 °C – 40 °C 30% – 75% 795 – 1060 hPa

Environmental conditions (Storage and Transport Conditions) ■ Ambient Temperature ■ Relative Humidity ■ Atmospheric Pressure

-20 °C – 50 °C 20% – 90% 795 – 1060 hPa

Maximal load (SWL)

230 kg

Sound Pressure Level

35 dBA

5.2 Electrical Specifications Parameter Supply nominal voltage ■ Model 230V ■ Model 127V

Value 220-240 VAC, 50/60 Hz

Maximal power CliniCare 100 HF ■ Model 127V

15VA

Ingress Protection (SCU)

IP3X

Power plug

NEMA Type 1-15P polarized

Fuses (SCU)

2x (T 1A L) anti-surge fuse (250 V, type 5x20mm)

Electrical safety class

Class II with applied parts type B

Electrical safety

In conformity with IEC 60601-1

Electromagnetic compatibility

IEC 60601-1-2

Fire Resistance (mattress cover)

BS 7175 ignition sources 0, 1 and 5

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5.3 Electromagnetic compatibility Air mattress system is intended for hospitals except for near active HF surgical equipment and the RF shielded room of a medical system for magnetic resonance imaging, where the intensity of EM disturbances is high. Air mattress system has defined no essential performance. WARNING! It is recommended to avoid the use of this device next to or in block with other device, because it could lead to improper operation. If such use is needed, this device and the other equipment should be under surveillance to verify proper operation. (Does not apply for compatible medical bed from LINET) List of used cables: 1. Mains cable, maximum length 6 m WARNING! Use of the accessories, converters and other cables, than specified and provided by manufacturer of this air mattress system could lead to increase of electromagnetic emission or lower the electromagnetic immunity of this air mattress system and lead to improper operation. WARNING! Mobile RF communication device (including end use devices like antenna cables and external antenna) should not be used closer than 30 cm (12 inches) from any part of this air mattress system CliniCare 100 HF, including cables specified by manufacturer. Otherwise this could lead to deterioration of functionality of this air mattress system. WARNING! Do not overload the air mattress system (SWL), respect the duty cycle (INT.) and consider chapter 11 Maintenance in order to maintain the basic safety with regard to electromagnetic disturbances for the expected service life.

5.3.1 Manufacturer instructions - electromagnetic emissions Emission Test

Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

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5.3.2 Manufacturer instructions - electromagnetic susceptibility Immunity Tests

Compliance level

Electrostatic discharge (ESD) IEC 61000-4-2

± 8 kV for contact discharge ± 15 kV for contact discharge

Radiated RF IEC 61000-4-3

3 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz

Proximity fields from RF wireless communications equipment IEC 61000-4-3

See Table 1

Fast electrical transients / burst IEC 61000-4-4

±2 kV for power line repetition frequency 100 kHz

Surge IEC 61000-4-5

± 1 kV Line-to-line ± 2 kV Line-to-ground

Conducted RF IEC 61000-4-6

3 V (0,15 MHz – 80 MHz) 6 V in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m

Voltage dips, short interruptions on power supply input lines IEC 61000-4-11

0 % UT; 0,5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° a 315° 0 % UT; 1 cycle and 70 % UT; 25/30 cycle Single phase: at 0° 0 % UT; 250/300 cycle

Table 1 - IMMUNITY to RF wireless communications equipment Test frequency (MHz)

Band (MHz)

Service

Modulation

Immunity Test Level V/m

385

380 - 390

TETRA 400

Pulse modulation 18 Hz

27

450

430 - 470

GMRS 460, FRS 460

FM ± 5 kHz deviation 1 kHz sine

28

710 745 780

704 - 787

LTE band 13, 17

Pulse modulation 217 Hz

9

810 870 930

800 - 960

GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE band 5

Pulse modulation 18 Hz

28

1 720 1 845 1 970

1 700 - 1 990

GSM 1800; CDMA 1900; GSM 1900; DECT; LTE band 1, 3, 4, 25; UMTS

Pulse modulation 217 Hz

28

2 450

2 400 - 2 570

Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE band 7

Pulse modulation 217 Hz

28

5 240 5 500 5 785

5 100 - 5 800

WLAN 802.11 a/n

Pulse modulation 217 Hz

9

NOTE There are applied no deviations to requirements of IEC 60601-1-2 ed. 4 NOTE There are no known other measures for keeping the basic safety based on EMC phenomena.

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6 Use and Storage Conditions DANGER! Risk of injury due using CliniCare 100 HF system in incorrect environments! ► Never use or store CliniCare 100 HF system in environments which contains flammable gases (except oxygen cylinders).

6.1 Storage CAUTION! Incorrect storage can damage the mattress! ► Do not store mattress in compressed state (e.g. underneath other mattresses) or rolled state for long periods of time as this may affect the performance of the air/foam cells. When SCU is not in use: ► Switch off SCU using power switch on the control panel of SCU. ► Unplug power cord. ► Wrap power cord around SCU. ► Pack in suitable cover. ► Store in a place suitable for electronic medical devices. When mattress is not in use: ► Store flat, unfolded and in dust proof bag. ► Store in a place suitable for medical devices. ► The most convenient storage: vertical

7 Scope of Delivery and Bed Variants 7.1 Delivery ■ ■

Upon receipt, check that the shipment is complete as specified on the delivery note. Notify the carrier and supplier about any deficiencies or damages immediately as well as in writing or enter them on the delivery note.

7.2 Contents There are two versions of CliniCare 100 HF. Check the table below to recognize your version. CliniCare 100 HF with MCM mode: ■ Mattress with cover with MCM layer – CliniCare 100 HF □ 3 air connectors ■ SCU (System Control Unit) with hose – Applied part type B □ STATIC and APT+MCM modes ■ Instructions for use

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CliniCare 100 HF without MCM mode: ■ Mattress with cover – CliniCare 100 HF □ 2 air connectors ■ SCU (System Control Unit) with hose – Applied part type B □ STATIC and APT modes ■ Instructions for use

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