HT-Air 1200 Air Supply User Manual Rev J

HT-Air® 2300 User Manual Symbol Reference CE MARKING OF CONFORMITY

OPERATING INSTRUCTIONS

UK MARKING OF CONFORMITY

KEEP DRY

AUTHORIZED REPRESENTATIVE

L ATEX FREE

UK RESPONSIBLE PERSON

LOT NUMBER

SWITZERLAND AUTHORIZED REPRESENTATIVE

MANUFACTURER

ALTERNATING CURRENT

DATE OF MANUFACTURE

TYPE BF APPLIED PART

MEDICAL DEVICE

CAUTION / WARNING

PROTECTIVE EARTH

MANUAL CLEANING

SERIAL NUMBER

DISPOSAL

TEMPERATURE LIMITATION

ELECTRICAL AND ELECTRONIC EQUIPMENT

THIS END UP

HUMIDITY LIMITATION

UNIQUE DEVICE IDENTIFIER

IMPORTER

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HT-Air® 2300 User Manual DECLARATION OF CONFORMITY This product conforms to the requirements of Medical Devices Regulation (2017/745).

PRECAUTIONS

Intended Use and Precautions The HT-Air® 2300 Air Supply provides six airflow options to inflate HoverTech’s air-assisted transfer, lift, and positioning devices.

• Never leave patient unattended on an inflated device.

The Air Supply is used along with HoverTech’s air assisted devices to assist caregivers with patient transfers, positioning, turning and proning.

INTENDED CARE SETTINGS Hospitals, long-term or extended care facilities

INTENDED USERS

• Use this product only for its intended purpose as described in this manual. Only use attachments and/or accessories that are authorized by HoverTech. • Use of this device with products or accessories not authorized by HoverTech could result in injury or equipment malfunction and may void the Manufacturer’s Warranty. HoverTech will not be held responsible for any injuries or damages caused due to the improper use of this device.

• The caregiver/operator is the person handling the equipment.

• When using the air supply in the MRI environment, a 25-ft. specialty MRI hose is required (available for purchase).

• The patient is not the intended operator.

• Avoid electric shock. Do not open air supply. • Reference product specific user manuals for operating instructions. • Warning: To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth. • Warning: The HT-Air is not compatible with DC power supplies. • Warning: The HT-Air is not intended for use with the HoverJack Battery Cart. • Route the power cord in a manner to ensure freedom from hazard. • Avoid blocking the air intakes of the air supply. • Not for use in the presence of flammable anesthetics or in a hyperbaric chamber or oxygen tent. To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.

The HT-Air is not compatible with DC power supplies.

The HT-Air is not intended for use with the HoverJack Battery Cart.

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HT-Air® 2300 User Manual Air Supply Keypad Functions

Part Identification

Adjustable Speed Indication (Green Flashing LED)

Power Cord Strap

Carrying Handle/ Attachment Hook

Standby (Amber LED)

Power Cord

Green LEDs

Adjustable/ Pressure Setting

Hose Release Button

Control Panel Label

Power Indication

Hose Nozzle

Hose

Air Filter Cover

Transfer Speed High Transfer Speed Low

ADJUSTABLE: For use with HoverTech air-assisted positioning devices. There are four different settings. Each press of the button increases the air pressure and rate of inflation. The Green Flashing LED will indicate the inflation speed by the number of flashes (i.e. two flashes equals the second inflation speed). All of the settings in the ADJUSTABLE range are substantially lower than the HoverMatt and HoverJack settings. The ADJUSTABLE function is not to be used for transferring. The ADJUSTABLE setting is a safety feature that can be used to ensure the patient is centered on HoverTech air-assisted devices and to gradually accustom a patient who is timid or in pain to both the sound and functionality of the inflated devices.

CAUTION: NO USER SERVICEABLE PARTS. Only qualified service personnel shall perform repairs on the HoverTech Air Supply.

STANDBY: Used to stop inflation/air flow (Amber LED indicates STANDBY mode).

HOVERMATT 28/34: For use with 28" & 34" HoverMatts and HoverSlings.

HOVERMATT 39/50 & HOVERJACK: For use with 39" & 50" HoverMatts and HoverSlings and 32" & 39" HoverJacks.

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HT-Air® 2300 User Manual Product Specifications Dimensions:

CL ASSIFICATION

31.75 x 17.8 x 17.8 cm (12.5 x 7 x 7 inches)

Weight:

5.67 kg (12.5 lbs)

Enclosure Material:

ABS rated UL94V-0/Stainless Steel

Power Cord Set Length:

VDE Certified 457 cm (15 feet)

Cord Type & Rating:

C13 90° Left, 10A, 250Vac

Service Life:

5 years

Power Input:

230Vac, 50 Hz, 6A (European version)

Type of protection against electric shock:

CLASS I EQUIPMENT

Degree of protection against electric shock:

TYPE BF APPLIED PART

Protection against ingress of water: Mode of operation:

Ordinary (not protected). CONTINUOUS OPERATION

To remove supply mains, unplug equipment from wall.

OPERATING CONDITIONS Use Temperature: Use Humidity:

Model #: HTAIR2300 (European Version) – 230Vac, 50Hz, 6A

10° to 40° C (50° to 104° F) 10% to 70% Non-Condensing

Use Altitude:

2,000m / 6,562ft

Maximum Operation Atmospheric Pressure Range:

700 to 1,060 hPa

STORAGE AND TRANSPORT CONDITIONS Storage/Shipping Temperature:

-40° to 70° C (-40° to 158° F)

Storage/Shipping Humidity:

10% to 70% Non-Condensing

CIRCUIT BREAKER Max Operating Voltage:

32Vdc; 250Vac, 50/60Hz

Current:

6A

Operating speed:

5 to 30 seconds

Size:

1.397 x 1.6129 cm)

Resettable Overload Capacity:

10x6=60(A)

Cleaning Between patient use, clean and disinfect the surface of the air supply by wiping it down with EPA approved hospital-grade disinfectant wipes or disinfectant cleaner sprayed on a cleaning cloth. Follow disinfectant manufacturer’s directions for dwell time and other instructions for use. Using the disinfectant wipes/spray cleaner may degrade the graphics on the control panel over time. Replacement panels can be purchased directly from HoverTech, if necessary.

Remove the filter from the air supply and hold it under warm running water. Allow the air filters to dry prior to placing back in the air supply. The filter should be replaced when it is clogged with debris that does not break free when it is washed. The filter should also be replaced if it begins to lose its shape or deteriorate. NOTE: IF AIR SUPPLY NEEDS TO BE DISPOSED, CHECK YOUR LOCAL / STATE / FEDERAL / INTERNATIONAL GUIDELINES BEFORE DISPOSAL.

NOTE: DO NOT SPRAY CLEANERS/LIQUIDS DIRECTLY ON THE AIR SUPPLY.

PREVENTIVE MAINTENANCE Prior to use, a visual inspection should be performed on the air supply to ensure the power cord is not frayed or nicked and that there is no visual damage that would render the air supply unusable. If any damage is found that would cause the air supply not to function as intended, the air supply should be removed from use and returned to HoverTech for repair. The air supply has air filters on either side of the motor. These filters can be accessed by removing the small screws holding the filter covers in place. It is recommended that the air filter is assessed per your facility’s preventive maintenance schedule or annually. Filter should be cleaned if clogged.

INFECTION CONTROL When a HoverTech air supply is used in a patient room where isolation protocols are being observed, the hospital should employ the same protocols/ procedures it utilizes for other equipment used in that patient room. Between use with an airborne isolation patient, the air supply filters can be removed and disinfected or replaced if hospital protocol requires. If the air filters are disinfected, allow them to dry prior to placing back in the air supply. An air hose cover is available. These covers are disposable and come in a box of 25 (Model #ASHC).

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HT-Air® 2300 User Manual Electromagnetic Compatibility Chart Guidance and manufacturer’s declaration – electromagnetic emissions The HTAIR2300 is intended for use in the electromagnetic environment specified below. The customer or the user of the HTAIR2300 should assure that it is used in such an environment. Emission test

Compliance

Electromagnetic environment-guidance

RF emissions CISPR 11

Group 1

The HTAIR2300 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions

Class A

IEC 61000-3-2 Voltage fluctuations /flicker emissions IEC 61000-3-3

The HTAIR2300 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Compliance

Guidance and manufacturer’s declaration – electromagnetic immunity The HTAIR2300 is intended for use in the electromagnetic environment specified below. The customer or the user of the HTAIR2300 should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electrostatic discharge(ESD) IEC 61000-4-2

± 6 kV contact

± 6 kV contact

± 8 kV air

± 8 kV air

Electrical fast transient/ burst IEC 61000-4-4

± 2kV for power supply lines

± 2kV for power supply lines

± 1kV for input/output lines

Not applicable

± 1kV line(s) to line(s)

± 1kV differential mode

± 2kV line(s) to earth

Not applicable

<5% UT(>95% dip in UT) for 0,5 cycle

<5% UT(>95% dip in UT) for 0,5 cycle

40% UT(60% dip in UT) for 5 cycles

40% UT(60% dip in UT) for 5 cycles

70% UT(30% dip in UT) for 25 cycles

70% UT(30% dip in UT) for 25 cycles

<5% UT(>95% dip in UT) for 5 s

<5% UT(>95% dip in UT) for 5 s

Surge IEC 61000-4-5

Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50, 60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

NOTE: UT is the a.c. mains voltage prior to application of the test level.

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Electromagnetic environment-guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

The HTAIR2300 power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

HT-Air® 2300 User Manual Electromagnetic Compatibility Chart Guidance and manufacturer’s declaration – electromagnetic immunity The HTAIR2300 is intended for use in the electromagnetic environment specified below. The customer or the user of the HTAIR2300 should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment-guidance Portable and mobile RF communications equipment should be used no closer to any part of the HTAIR2300 including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF

3 Vrms

IEC 61000-4-6

150 KHz to 80 MHz

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2,5 GHz

Recommended separation distance: 3 Vrms

d = 1,2 √P d = 1,2 √P 80 MHz to 800 MHz d = 2,3 √P 800 MHz to 2,5 GHz

3 V/m

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a F ield strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HTAIR2300 is used exceeds the applicable RF compliance level above, the HTAIR2300 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the HTAIR2300. b O  ver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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HT-Air® 2300 User Manual Electromagnetic Compatibility Chart Recommended separation distance between portable and mobile RF communications equipment and the HTAIR2300 The HTAIR2300 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the HTAIR2300 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HTAIR2300 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d =1,2√P

80 MHz to 800 MHz d =1,2√P

800 MHz to 2,5 GHz d =2,3√P

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where (p) is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

8 | HoverTech

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HT-Air® 2300 User Manual Returns and Repairs All products being returned to HoverTech must have a Returned Goods Authorization (RGA) number issued by the company. Please call (800) 471-2776 and ask for a member of the RGA Team who will issue you an RGA number. Any product returned without an RGA number will cause a delay in the repair time. For European companies, send returned products to:

Returned products should be sent to:

Attn: RGA #____________ Kista Science Tower SE-164 51 Kista, Sweden

HoverTech Attn: RGA # ___________ 4482 Innovation Way Allentown, PA 18109

For product warranties, visit our website: https://hovermatt.com/standard-product-warranty/

HoverTech 4482 Innovation Way Allentown, PA 18109 www.HoverMatt.com [email protected]

These products comply with the standards applicable for Class 1 products in the Medical Device Regulation (EU) 2017/745 on medical devices.

CEpartner4U, ESDOORNLAAN 13, 3951DB MAARN, THE NETHERLANDS. www.cepartner4u.com

Etac Ltd. Unit 60, Hartlebury Trading Estate, Hartlebury, Kidderminster, Worcestershire, DY10 4JB +44 121 561 2222 www.etac.com/uk

TapMed Swiss AG Gumprechtstrasse 33 CH-6376 Emmetten CHRN-AR-20003070 www.tapmed-swiss.ch

In case an adverse event in relation to the device, incidents should be reported to our authorized representative. Our authorized representative will forward information to the manufacturer.

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4482 Innovation Way Allentown, PA 18109 800.471.2776 Fax 610.694.9601 www.HoverMatt.com [email protected]