Sizewise NPT4 User manual

MFG -0 021P- 0421
NPT4™
User Manual
Doc. #8123, Rev. 1.0, Rev. Date: 07/22/2021
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NPT4 User Manual (8123)

Table of Contents
Section
Page
Introduction
3
Intended Use Statement
3
Product at a Glance
4
Symbols and Labels
5
Safety Instructions
7
Warning Statements
7
Caution Statements
9
General Notes
10
Seven Zones of Bed Rail Entrapment
11
Specifications
12
EMC Information
14
Unpacking
18
Setup
19
Control Unit
20
Operating Instructions
21
Static Pressure Redistribution
21
Control Unit
21
Indicators
22
CPR Event
22
Cleaning Instructions
23
Mattress Cleaning Instructions
24
Laundry Instructions
25
Control Unit
26
Preventative Maintenance
27
HEPA Filter
28
Troubleshooting
30
Storage and Disposal
31
Product Warranty
32
Manufacturer’s Information
35
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NPT4 User Manual (8123)

Introduction
This user manual includes safety and warning information, setup, operating, cleaning, and preventive maintenance
instructions for the NPT4™. Sizewise recommends reading and fully understanding this manual completely before
operating the product. Failure to use the product properly may cause damage to the product, property, or persons
including illness, injury, or death. Questions may be directed to our 24/7/365 customer service team:
Sizewise Customer Service
800-814-9389
[e-mail]
— The product images contained in this user manual are for reference only. Actual product may vary.
— Information in this user manual is subject to change without notice. Ensure current version of this
manual is obtained prior to use.
Intended Use Statement
NPT4 will provide pressure redistribution for individuals at risk for pressure injury development. The polycarbonate
top cover is designed to reduce shear as the patient is repositioned or transferred with the Mattress Asset
Protection (MAP™) Liner. The copper infused memory foam topper will enhance micro-climate control and patient
comfort. Those patients at higher risk for pressure injury development may be managed by using the control unit
that converts the mattress to an active alternating surface with added head to heal micro-climate control. The
patient support surface is designed to fit any standard hospital medical bed.
General Guidance
— Authorized user is defined as an adult.
— Read and completely understand the manual beforeuse.
— DO NOT modify this equipment without authorization from the manufacturer.
— Only use Sizewise accessories that are specific to theNPT4.
— At certain intervals, maintenance of this product is required and must be performed by authorized
personnel only.
— Retain this manual for future use andmaintenance.
— Patients, or users, should be risk assessed to ensure they are able to understand this manual and operate the
NPT4 safely without risk tothemselves orothers.
Symbols, definitions, and fonts are used throughout this manual to aid user readability and understanding of content.
Standard Text: Used for regular information.
Bold Text: Emphasizes a word or phrase.
NOTE: Sets apart special information or important instruction clarification.
Safe Working Load: The equipment’s maximum external mechanical load permitted in normal use. The sum ofthe
patient’s weight, other equipment/accessories, and load supported bythat equipment/accessories may notexceed
the Safe Working Load.
Maximum Patient Weight:The greatest permissible patient weight in normal use. The maximum patient weight may be
lower than the Safe Working Load ifadditional equipment/accessories are used.
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Product at a Glance
Features
Mattress
For more info, see page 21.
Optional Control Unit
For more info, see page 20.
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Symbols
Symbol
Definition
Certification:
Indicates device has been independently tested and meets
the published safety standard(s).
Conformity:
Indicates conformity with health, safety, and environmental
protection standards for products sold within the European
Economic Area.
Device Type:
Indicates a Type BF device properly protected from electrical
shock.
Double Insulated
Electrical Equipment Designation:
Indicates Class II double insulated.
Follow Instructions for Use:
Indicates mandatory action torefer tothe user manual.
Accompanying Documents:
Indicates the need to refer to the operating instructions.
Electrical Shock Hazard Warning:
Symbol alerts user to the presence of electrical shock hazards.
It is important to follow all instructions and special procedures
to avoid electrical shock to the operator, caregiver, and/or
patient.
Contraindication:
Indicates important information that may be contradictory to
the product instructions, which if not understood, could cause
serious injury.
Warning/Caution:
Symbol alerts user to the presence of important operating,
maintenance, or servicing instructions. Disregarding a warning
could result in patient and/or user injury, as well as damage to
equipment.
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Labels
Label
Description
Manufacturer's Label:
Indicates numerous product details, including safety standard
conformance, manufacture date, and electrical rating.
CPR Label:
CPR event disconnect location.
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Safety Instructions
Only authorized users should operate the NPT4™. A thorough understanding of the NPT4 user manual is required
prior to use. Follow the instructions contained in this manual carefully. Use the NPT4 only if it is in proper working
order. The terms Warning and Caution are used frequently throughout this manual. A clear and concise
understanding is required of these two terms.
CONTRAINDICATION: Indicates a condition or circumstance which makes a particular treatment or
procedure potentially inadvisable, which if not understood, could cause serious injury.
ELECTRICALSHOCKHAZARDWARNING:This symbol is intended toalert the user tothe presence of
electrical shock hazards. Itisimportant tofollow all instructions and special procedures toavoid
electrical shock tothe operator, care provider, and/or patient.
WARNING:Indicates a potentially dangerous situation, which if notavoided, could result in injury
ranging from moderate toserious severity up toand including death.
CAUTION:Indicates a potentially dangerous situation, which if notavoided, could result in injury ranging
from minor to moderate severity.
Contraindications
CONTRAINDICATION:
Use of active therapy surfaces (mattresses) with patients who have an unstabilized
spinal cord injury could cause serious injury to the patient.
CONTRAINDICATION:
Use of active therapy surfaces (mattresses) with patients who have cervical or
skeletal traction could cause serious injury to the patient.
Electrical Shock Hazards
ELECTRICAL SHOCK HAZARD WARNING: Inappropriate handling ofthe power supply cord, (e.g. by
kinking, shearing, other mechanical damages) is hazardous.
ELECTRICAL SHOCK HAZARD WARNING: Before any cleaning and disinfection procedures are
performed, unplug power cord from outlet toeliminate possibility ofelectrical shock.
ELECTRICAL SHOCK HAZARD WARNING: Electrical shock may occur when plugging the NPT4™
optional air pump intothe wall outlet. Use ONLY grounded orhospital-grade outlets.
ELECTRICAL SHOCK HAZARD WARNING: To avoid electrical shock, DONOT open the control unit. Refer
servicing toqualified personnel only.
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Safety Instructions
Warnings
WARNING:
This bed must be assembled, positioned, and used in accordance with these instructions.
WARNING:
NPT4™ is to be used in accordance with each facility’s policies and procedures.
WARNING: Any change tothe specifications can result in malfunction or damage tothe NPT4™.
WARNING: Do notexceed safe working load listed in the specifications. Can lead toinjury ordamage.
WARNING: Care shall be taken when repositioning ortransferring a patient in or out of bed. Body
weight should beevenly distributed over bed deck atall times. DONOT allow the patient tolie,sit, or
lean in such a waythat their entire body weight is placed only on the raised head or foot section of the
bed.
WARNING: Bed rail entrapment can result in serious injury or even death. Sizewise recommends
caregivers bemindful of the FDA guidelines relevant tobed rail entrapment. These guidelines can be
found on the FDA website asreferenced below. When using a replacement support surface, the
caregiver is responsible for ensuring the mattress properly fits thebed frame. It isalso the caregiver’s
decision whether ornottouse bed rails with the patient.
WARNING: During operation, cell phone with a maximum output power of 2 watts shall be kept atleast
3.3m distance from unit.
WARNING: This unit shall not beserviced or maintained while in use with a patient.
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Safety Instructions
Cautions
CAUTION:
If patient is in prone position (face down), take extra care to ensure patient’s airway is not
compromised.
CAUTION:
Be sure the siderails are high enough to properly protect the patient when the mattress is fully
inflated, while continuing to be mindful of the FDA guidelines on bed rail entrapment.
CAUTION:
Do not leave a patient positioned prone on the mattress surface. The decision to position a
patient prone should be at the discretion of the facility's medical staff.
CAUTION:
The operator educational background must at least for 8 years.
CAUTION:
Use of NPT4™ is only one element of care in the prevention and treatment of pressure
injuries. Frequent repositioning, proper care, routine skin assessment, wound treatment and proper
nutrition are but a few of the elements required in the prevention and treatment of pressure injuries.
As there are many factors that may influence the development of a pressure injuries for each individual,
the ultimate responsibility in the prevention and treatment of pressure injuries is with the health care
professional.
CAUTION:
Only one person should occupy the bed at a time.
CAUTION:
Specialty mattresses, including powered air mattress surfaces, may pose a risk of
entrapment. Prior to use, ensure the therapeutic benefits outweigh the risk of entrapment.
CAUTION:
Disconnect control unit from electrical supply before cleaning.
CAUTION:
Use only approved replacement parts.
CAUTION:
Do not open assemblies such as the control unit. If unauthorized personnel perform work on
these components, the manufacturer’s warranty becomes void.
CAUTION:
Ensure that maintenance and installation are performed exclusively by qualified personnel.
CAUTION:
Only authorized personnel should engage in the troubleshooting process. Troubleshooting by
unauthorized persons could result in personal injury or equipment damage.
CAUTION:
It is recommended that gloves and protective clothing be worn at all times during cleaning
and disinfecting.
CAUTION:
The mattress requires regular maintenance to ensure performance and avoid premature
wear, damage and injury.
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Safety Instructions
General Notes
NOTE: To ensure that approved chemical agents are being used for the polycarbonate/polyurethane, contact
your Sizewise representative.
NOTE: Do notattempt toclean HEPA filters, as they are to beremoved and replaced only.
NOTE: HEPA filters aid in contamination control for facilities. HEPA filters donot filter out gases and odor
molecules such as chemical vapors and cigarette smoke.
NOTE: HEPA filter must beused in conjunction with the manufacturer supplied filter. DONOT attempt to
install HEPA filter without the original equipment filter.
NOTE: Ensure factory filter iscompletely dry before placing HEPA filter in unit.
NOTE: The HEPA filter is tobe installed in applicable models and pumps in conjunction with the next factory
filter cleaning procedure.
NOTE: Installation and/or handling ofHEPA filter requires PPE. Service personnel should wear a mask, gloves,
and protective clothing toavoid exposure topossible contaminants.
NOTE: Tools are not required for installation of HEPA filter.
NOTE: Ensure unitis off and/or removed from power source prior toservicing orreplacement offilter or
HEPA filter.
NOTE: DO NOT MODIFY HEPA filter for installation. Order filter from Sizewise toreceive filter with correct
dimensions.
NOTE: Only the outer cover of the mattress requires cleaning and maintenance. Disassembly ofthe support
surface for maintenance ofinternal components is notrecommended. Do notuseharsh solvents or
cleaners. Special care should be used tonotpuncture the mattress with needles orsharp instruments. This
mayresult in loss ofintegrity of the mattress cover or internal components.
NOTE: If additional cleaning is necessary, top covers may beremoved and laundered using standard hospital
disinfectant/detergent. DO NOT use temperatures in excess of 120°F (49°C).
NOTE: After washing, the mattress top cover is tobeair dried or dried in a dryer at very low or noheat to
protect itfrom heat-related damage.
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Seven Zones of Bed Rail Entrapment
WARNING:
Bed rail entrapment can result in serious injury or even death. Sizewise
recommends caregivers be mindful of the FDA guidelines relevant to bed rail entrapment.
These guidelines can be found on the FDA website as referenced below. When using a
replacement support surface, the caregiver is responsible for ensuring the mattress properly
fits the bed frame. It is also the caregiver’s decision whether or not to
use bed rails with the patient.
Zone 1:
Within the Rail
Zone 2:
Under the Rail, Between the
Rail Supports, or Next to a
Single Rail Support
Zone 5:
Between Split
Bed Rails
Zone 3:
Between the Rail and the
Mattress
Zone 6:
Between the End of the Rail and
the Side Edge of the Head or
Footboard
Zone 4:
Under the Rail, at the Ends of the
Rail
Zone 7:
Between the Head or Footboard
and the Mattress End
Reference: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. (2006, Mar. 10). U.S. Health and Human Services Food and Drug Administration Center for Devices
and Radiological Health. Retrieved from https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm072729.pdf
ZONE 7
ZONE 6
ZONE 5
ZONE 4
ZONE 3
ZONE 1
ZONE 2
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Specification
Mattress Dimensions
32” Mattress 7”H - 32”W - 80”L (17.5 cm - 81 cm - 203 cm)
35” Mattress
7”H - 35”W - 75”L (17.5 cm - 89 cm - 191 cm)
7”H - 35”W - 80”L (17.5 cm - 89 cm - 203 cm)
7”H - 35”W - 84”L (17.5 cm - 89 cm - 213 cm)
39” Mattress 7”H - 39”W - 80”L (17.5 cm - 99 cm - 203 cm)
42” Mattress 7”H - 42”W - 80”L (17.5 cm - 107 cm - 203 cm)
48” Mattress 7”H - 48”W - 80”L (17.5 cm - 122 cm - 203 cm)
54” Mattress 7”H - 54”W - 80”L (17.5 cm - 137 cm - 203 cm)
60” Mattress 7”H - 60”W - 80”L (17.5 cm - 152 cm - 203 cm)
Mattress Characteristics
Air Cells 70 Denier Nylon / Polyurethane Foam Filled
Foam High-Density Polyurethane Open Cell Foam
Mattress Weight Capacity
32” Mattress 500 lb.(227 kg)
35” Mattress 500 lb.(227 kg)
39” Mattress 750 lb.(340 kg)
42” Mattress 750 lb.(340 kg)
48” Mattress 1,000 lb.(454 kg)
54” Mattress 1,000 lb.(454 kg)
60” Mattress 1,000 lb.(454 kg)
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Specification
Control Unit Specifications
Regulatory Compliance ANSI/AAMI ES60601-1 (2005) + AMD (2012) CAN/CSA C22.2 NO. 60601-1:14
IEC60601-1-11 (Edition 1.0, 2010-04)
Safety Standards UL, c-UL, CE
Electrical Classification Class II
Power Supply 120 V AC, 60Hz, 12W, 1A Or 100 V AC 50/60Hz, 12W, 1A
Or 230 V AC 50Hz, 12W, 1A
Fuse Rating 250 V, T1AL
Dimensions 10.2” x 5.1” x 3.1” (26cm x 13cm x 8cm)
Weight 3.3 lb. (1.5kg)
Environment Requirements
Temperature: Operation 41°F to 104°F (5°C to 40°C)
Storage -13°F to 158°F (-25°C to 70°C)
Shipping -13°F to 158°F (-25°C to 70°C)
Humidity: Operation less than 93% non-condensing
Storage less than 93% non-condensing
Atmospheric pressure: Operation 700-1060 hPa
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EMC Information
NPT4™ has been tested for compliance with EMC requirements. The guidelines in this section will help ensure
the equipment meets the requirements of the standard.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equipment should
be observed to verify that they are operating normally.
WARNING:
Use of accessories, transducers, and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
WARNING:
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 in) to any part of the NPT4™ control unit,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
WARNING:
During operation, cell phone with a maximum output power of 2 watts shall be kept at least 3.3m
distance from unit.
CAUTION:
This device conforms to all requirements specified by the standards for electromagnetic
compatibility (EMC). Problems are not likely to be encountered by the user due to inadequate electromagnetic
immunity. While the standards are based on expected environments of use, electromagnetic immunity is
always relative. If unusual, intermittent device behavior is encountered and can be associated with cell
phones, radio or TV transmitters, or electro-medical equipment, electromagnetic interference could be the
cause. If such interference occurs, the interfering equipment should be moved away from this device.
Guidance and Manufacturer’s Declaration – Emissions
NPT4™ is intended for use in the electromagnetic environment specified below. The customer or user of NPT4™
should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment Guidance
RF Emissions CISPR 11
Group 1 NPT4™ uses RF energy only for its internal functions. Therefore, its RF emissions are very low and not likely to cause any interference in
nearby electronic equipment.
RF Emissions CISPR 11
Class B
NOTE:
The higher IMMUNITY TEST LEVELS specified for the HOME
HEALTH CARE ENVIRONMENT are necessary due to the closer
distances to certain electromagnetic sources than found in the
professional healthcare facility environment. Examples include
PORTABLE RF communications equipment such as mobile phones
and amateur radio equipment.
Harmonic Emissions
IEC 61000-3-2
Class B
Voltage Fluctuations and
Flicker
IEC 61000-3-3
Complies
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EMC Information
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6kV, ±8kV Contact
±2kV, ±4kV, ±8kV, and
±15kV, Air
±6kV, ±8kV Contact
±2kV, ±4kV, ±8kV, and
±15kV, Air
Floors should be wood, concrete, or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical Fast
Transients and
Bursts (EFT) IEC
61000-4-4
±2kV Mains ±2kV Mains Mains power quality should be that of a typical
commercial or hospital environment.
Surges
IEC 61000-4-5
±1kV Differential ±2kV Common ±1kV Differential ±2kV Common Mains power quality should be that of a typical commercial or hospital grade.
Voltage Dips and
Short Interruptions
IEC 61000-4-11
0% UT: 0.5 cycle
At 0˚, 45˚, 90˚, 135˚,
180˚, 225˚,
270˚, and 315˚
0% UT: 1
cycle At 0˚ and180˚
70% UT: 25 cycles
(50Hz) At 0˚ and 180˚
0% UT: 250 cycles
(50Hz) At 0˚ and 180˚
0% UT: 0.5 cycle
At 0˚, 45˚, 90˚, 135˚,
180˚, 225˚,
270˚, and 315˚
0% UT: 1
cycle At 0˚ and180˚
70% UT: 25 cycles
(50Hz) At 0˚ and 180˚
0% UT: 250 cycles
(50Hz) At 0˚ and 180˚
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of NPT4™ requires continued operation during
power mains interruptions, it is recommended
that the control unit be powered from an
uninterruptable power supply or battery.
Power Frequency
Magnetic Fields
IEC 61000-4-8
30A/m (50/60Hz) 30A/m (50/60Hz) Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE
: U
T
is the AC mains voltage prior to application of the test level.
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EMC Information
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment
Guidance
Conducted RF IEC
61000-4-6
3V RMS
0.15MHz – 80MHz
6V RMS
ISM and Amateur Radio
bands between 0.15MHz
– 80MHz
80% AM at 1KHz
3V RMS
0.15MHz – 80MHz
6V RMS
ISM and Amateur Radio
bands between 0.15MHz
– 80MHz
80% AM at 1KHz
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya, should be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with this symbol.
Radiated RF IEC
61000-4-3
10V/m
80MHz – 2.7GHz
80% AM at 1KHz
10V/m
80MHz – 2.7GHz
80% AM at 1KHz
NOTE:
Theseguidelines maynotapplyin allsituations.Electromagneticpropagationis affectedbyabsorptionand
reflection from structures, objects, andpeople.
a Field 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 NPT4™ is used exceeds the applicable RF
compliance level above, the control unit should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the control unit.
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EMC Information
Immunity to Proximity Fields from Radio Frequency Wireless Communications Equipment
In addition to the Radiated RF IEC 61000-4-
3 as shown in the table above, NPT4™ has been tested as specified in the table
below.
Test
Frequenc
y (MHz)
Band (MHz)
Service
Modulation
Maximu
m Power
(W)
Distance (m)
Immunity
Test Level
(V/m)
385 380-390 Tetra 400
Pulse
Modulation
18Hz 1.8 0.3 27
450 430-470 GMRS 460,
FRS 460
Pulse
Modulatio n 18
Hz
2 0.3 28
710
704-787 LTE Band 13,
17
Pulse
Modulation 217
Hz 0.2 0.3
9
745
780
810
800-960
GSM 800/900
2 0.3 28
TETRA 800, Pulse
870 iDEN 820, modulation
930
CDMA 850,
18 Hz
LTE Band 5
1720
1700-1990
GSM 1800;
Pulse
Modulation 217
Hz
2 0.3 28
CDMA 1900;
GSM 1900;
DECT; LTE
Band1,3,4, 25;
UMTS
1845
1970
2450 2400-2570
Bluetooth WLAN,
802.11 b/g/n,
RFID
Pulse
Modulation 217
Hz
2 0.3 28
5240 5100-5800 WLAN
802.11 a/n
Pulse
Modulation 217
Hz 0.2 0.3
9
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Unpacking
Instructions
1. Remove products from packing materials and examine for shipping damage. Notify Sizewise
immediately upon discover of damage.
a. Ifdelivered byafreightcompany: note a description of the damage on the carrier's bill of lading
and take photos for your records. Depending on the shipping arrangement, the obligation to
prepare, file, and pursue any claim for any damage or loss may be on the shipping recipient
(or buyer).
b. If delivered by a Sizewise employee: please reach out to your local contact to initiate the process.
2. If replacement parts are needed, contact Sizewise Customer Service: 800-814-9389.
3. Place product box on flat, level surface to avoid unintended movement during setup.
4. Remove packaging surrounding product.
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Setup
Instructions
1. Verify mattress is the correct size for the bed frame top deck. Refer to Siderail Entrapment Guidelines. (See
Table of Contents).
2. Place bed frame in flat position.
3. Install the mattress with the sloped heel section toward the foot of the bed.
4. Optional connect control unit and perform safety checklist in maintenance section. (See Table of Contents).
5. Disinfect mattress prior to patient use. Refer to Mattress Cleaning Instructions (See Table of Contents).
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Control Unit
Power Button
Soft/Firm Dial
Digital Resources QR Code
Controls Layout
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