Newport HT50, HT50-H, HT50-H1, HT50-H1-B Service Manual

Newport Medical Instruments, Inc.
NEWPORT HT50 VENTILATOR
Service Manual
SERHT50NA Rev. A
September 2008
(P/N HT50-H, HT50-H1, HT50-H1-B)
www.Ventilators.com email: Info@Ventilators.com
MANUAL REVISION HISTORY
HT50 Service Manual SERHT50NA DATE REVISION PAGES EFFECTED
August 2008 A New release for dual
nal battery update
inter
SERHT50NA A0808
TABLE OF CONTENTS
Section 1 . . . . . . . . . . OPERATOR’S RESPONSIBILITY
• Operator’s Responsibility for Patient Safety
• Limitation of Liability
• Warranty
• Definitions
• Typing Conventions
• Warnings and Cautions
• Factory Maintenance or Repair
• Contact Information
Section 2 . . . . . . . . . . SPECIFICATIONS
Intended Use
• Symbols / Labeling Table
• Controls / Alarms / Monitors
• Hardware Requirements
• Miscellaneous Specifications
• Humidifier Specifications
• Air / Oxygen Entrainment Mixer Specifications
• Oxygen Blending Bag Kit Specifications
Section 3 . . . . . . . . . . DESCRIPTION OF CONTR
ALARMS & CONNECTORS
• Front Panel Overview
• Front Panel Controls & Indicators
• Front Panel Alarms
• Front Panel Message Display Window
• Left Side Connectors
• Right Side Connectors
• Optional Accessories
• User Set Up
Section 4 . . . . . . . . . . THEORY OF OPERATION
• General System Ov
• A/CMV Mode (Assist/Control Mandatory Ventilation)
• SIMV Mode (Synchronized Intermittent Mandatory Ventilation)
• SPONT Mode (Spontaneous Ventilation)
• P support (Pressure Support)
• Pressure Control Ventilation
• Volume Control Ventilation
• Back-Up Ventilation
erview
OLS, INDICATORS,
SERHT50NA A0808
Section 5 . . . . . . . . . . CALIBRATION AND OPERATION VERIFICATION
• Introduction
• Test Equipment Required
• Pre-Test Inspection
• Front Panel Test / Alarm Check
• System Leak Test
• Pressure Transducer Calibration
• Pressure Meter Calibration
• Volume Factor Calibration
• Pressure Relief Valve Calibration
• Exhalation Valve Calibration
• Operational Set-Up (Standard Test Settings)
• Pressure Verification
• P trig
• PEEP / CPAP
• Pressure Control
• Exhalation Valve Sealing
• Manual Inflation
• High Paw Alarm
• Low Paw Alarm
• Check Prox Line Alarm
• Battery Test
• Humidifier (for HT50-H)
• OVP Test Record
Section 6 . . . . . . . . . . MAINTENANCE PR
• Introduction
• Tools Required
• Parts Required
• Routine Maintenance Procedure
• Annual Maintenance Procedure
• 10,000 Hour Maintenance Procedure
Section 7 . . . . . . . . . . TR
OUBLESHOOTING
• Introduction
• Mechanical and Pneumatic Troubleshooting
• Electronic Troubleshooting
OCEDURES
SERHT50NA A0808
Section 8. . . . . . . . . . ELECTRONIC & PNEUMATIC COMPONENT REMOVAL &
REPLACEMENT PROCEDURES
• Introduction
• Tools Required
• Discharge the HT50 Power Supply
• Disassembly (Lower Case)
• Internal Battery Assembly Replacement
• Pump Assembly Replacement
• Outlet Assembly Replacement
• Humidifier Heater Assembly Replacement
• Front Panel Board Replacement
• Front Panel Bezel Replacement
• Main Board Assembly Replacement
• Power Supply Board Replacement
Section 9 . . . . . . . . . . DIAGRAMS AND PARTS LISTS
• Figure 9-1, Internal View Figure 9-2, Final Assembly, Front View HT50-H
• Figure 9-3, Final Assembly, Front View HT50-H1
• Figure 9-4, Main Board with Mounting Hardware
• Figure 9-5, Main Board Tubing Connection, Left Side
• Figure 9-6, Right Side Case
• Figure 9-7, Front Panel, Side View
• Figure 9-8, Pneumatic Schematic
• Drawing Parts Reference List
Section 10 . . . . . . . . . REPACKAGING AND SHIPPING INSTRUCTIONS
Appendix A . . . . . . . . HT50 PARTS AND ACCESSORIES
SERHT50NA A0808
• Introduction RGA (Return Goods Authorization)
• Packaging: Complete Unit
• Packaging: Parts or Accessories
• HT50
Ventilator Parts and Accessories
• Service Parts List
1. OPERATOR’S RESPONSIBILITY
Operator’s Responsibility for Patient Safety . . . . . 1-1
Limitation of Liability. . . . . . . . . . . . . . . . . . . . . . . . 1-2
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Typing Conventions . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . 1-4
Factory Maintenance or Repair . . . . . . . . . . . . . . 1-7
Contact Information . . . . . . . . . . . . . . . . . . . . . . . . 1-8
SERHT50NA A0808
OPERATOR’S RESPONSIBILITY FOR PATIENT SAFETY
The Operation manual (p/n OPRHT50-NA) contains information intended to ensure safe and effective ventilator use. The label on the inside of the front panel cover door is meant to complement not replace the Operation manual.
The design of the HT50 ventilator, the Operating and Service manuals, and the labeling on the ventilator take into consideration that the purchase and use of the equipment is restricted to trained professionals, and that certain inherent characteristics of the ventilator are known to the operator. Instructions, warnings and caution statements are therefore limited to the specifics of the Newport HT50.
Caution Federal law restricts this device to sale by or on the order of a physician.
SECTION 1
This man
ual excludes references to various hazards which are obvious to medical professionals and operators of this equipment, to the consequences of product misuse, and to potentially adverse effects in patients with abnormal conditions.
When the HT50 is used in home care and sub acute environments it is important that the primary caregiver has received training and has demonstrated competency in all equipment functions. A specific written care plan must be established by the attending physician.
Transport of patients with the HT50 requires that medical staff have a good working knowledge of the ventilator’s use and problem resolution. Proper emergency back-up equipment must be immediately available during transport.
HT50 operators must recognize their responsibility for implementing safety monitoring mechanisms which supply appropriate information on equipment performance and patient condition. Patient safety may be achieved through a wide variety of means such as electronic surveillance of equipment performance and patient condition. However, equipment surveillance should not replace direct observation of clinical signs. The HT50 operator is solely responsible for selecting the appropriate level and method of patient monitoring.
SERHT50NA A0808 1-1
Product modification or misuse can be dangerous. Newport Medical Instruments, Inc. (N
EWPORT) disclaims all liability for the
consequences of product alterations or modifications, as well as for the consequences which might result from the combination of this ventilator with other products, whether supplied by Newport or by other manufacturers, unless such a combination has been specifically endorsed by Newport.
OPERATOR’S RESPONSIBILITY
LIMITATION OF LIABILITY
The liability of Newport Medical Instruments, Inc. (NEWPORT) is subject to and limited to the exclusive terms and conditions as set forth herein. Said liability is limited whether arising out of, or related to, the manufacture and sale of goods, their installation, demonstration, sales representation, use, performance, or otherwise. Any liability based upon product warranty, whether breach of warranty or otherwise, is limited regardless of any fault attributable to N breach of warranty, negligence, and strict liability).
The expressed warranties are in lieu of all other warranties, expressed or implied, including, without limitation, warranties of merchantability, fitness for any purpose, or noninfringement.
EWPORT shall not be liable for any special incidental or
N consequential damages incurred by the buyer to a third party. The buyer shall not be entitled to make liability recoveries from N due to such situations.
EWPORT and the nature of the action (including
EWPORT
WARRANTY
The Newport HT50 Ventilator is guaranteed to be free of defects for a period of two (2) years from date of delivery. The following are exceptions to this warranty:
1. Defects caused by misuse, mishandling, tampering, or by modifications not authorized by Newport Medical Instruments, Inc. (N
EWPORT) or its representatives.
2. Rubber and plastic components and materials are guaranteed to be free of defects at time of delivery.
3. The internal batteries are warranted for six months.
Any product which proves to be defective in workmanship or material will be replaced, credited, or repaired. Newport retains the discretion to select the most suitable of these options. Newport is not responsible for deterioration, wear, or abuse. In all cases, Newport will not be liable beyond the original selling price.
Application of this warranty is subject to the following conditions:
1-2 SERHT50NA A0808
EWPORT or its authorized representatives must be promptly
1. N notified upon detection of the defective material or equipment.
2. Defective material or equipment must be returned to N or its authorized representative.
EWPORT
SECTION 1
DEFINITIONS
3. Examination b confirm that the defect is covered by the terms of this warranty.
To ensure complete protection under this warranty, the Warranty Registration Card must be returned to Newport within ten (10) days of equipment receipt.
The above is the sole warranty provided by N warranty, expressed or implied, is intended. Representatives of Newport are not authorized to modify the terms of this warranty.
WARNING Possibility of personal injury, to patient or others, if disregarded.
Caution Possibility of equipment damage if disregarded.
NOTE: Additional information intended to avoid inconveniences
during operation. followed.
y NEWPORT or its authorized representatives must
EWPORT. No other
Notes also indicate important procedures to be
TYPING CONVENTIONS
Inspection: Examination of actual condition.
Service: Measures required to maintain a specified condition.
Repair: Measures required to restore a specified condition.
Maintenance: Required inspection, service, and repair of the
device.
Preventive Maintenance: Maintenance performed at regular
vals to keep the device in good working condition.
inter
Within the text of this manual, controls, alarms, and indicators are designated by the labeling name as they appear on the ventilator, e.g.: Psupport (pressure support), Ptrig (pressure trigger), and SPONT (spontaneous mode).
Please review all WARNINGS and Cautions outlined in this
ual prior to servicing the HT50 for the first time.
man
SERHT50NA A0808 1-3
OPERATOR’S RESPONSIBILITY
WARNINGS AND CAUTIONS
At all times, strictly follow this Manual.The safe use of the HT50 Ventilator requires a full understanding of its operation and adherence to the manual’s instructions.The equipment is only to be used for the purpose specified under “Intended Use” (see Section
2). Observe all of the WARNINGS and Cautions posted in this man accessories.
General Warnings
External power connection: To maintain grounding integrity when using A.C. power, only connect to hospital grade receptacles. Always disconnect the external power supply prior to servicing. Always use the power cord supplied with the HT50. Make certain the power cord ferrite is always attached to the A.C. power cord to ensure that the HT50 meets EMC requirements.
There is a risk of explosion if used in the presence of flammable anesthetics.
ual and on labels found on the HT50 Ventilator and associated
All settings and adjustments in the different ventilation modes must be made in accordance with a physician’s prescribed therapy.
EWPORT cannot warrant or endorse the safe performance of third
N party humidifiers for use with the HT50.
When the HT50 is operating on battery power, the optional built-in humidifier does not function. A heat moisture exchanger, or other humidification device, should be used until the unit is connected to A.C. power at which time the built-in humidifier can be used.
Do not use electrically conductive patient circuits.
Always use a clean patient circuit.
Always use an inline filter (p/n HT6004701 or equivalent) at the Airway Pressure Connector to protect the internal transducers from moisture or other contaminants.
Always use appropriate monitors to ensure sufficient oxygenation and ventilation (such as pulse oximeter and/or capnograph) when the HT50 Ventilator is in use on a patient.
The ventilator is ready for operation only when: a) It is completely assembled, and; b) The Quick Check Procedure, including the Exhalation Valve
Calibration (see Appendix A, Operating Manual) or OVP (Service Manual) has been successfully completed.
1-4 SERHT50NA A0808
Constant attention by qualified medical personnel is recommended whenever a patient is ventilated with the HT50.
SECTION 1
When the HT50 is used in homecare environments
, proper education and training of the appointed caregiver must be provided prior to the patient leaving the health care facility.
If a fault is detected in the ventilator and its life support functions are in doubt, immediately discontinue use; use an alternative method of ventilation until the fault has been corrected. Contact
EWPORT Technical Service Department immediately.
N
Failure to identify and correct alarm violations may result in patient injury.
Continuous oxygen monitoring is required for patient safety. The HT50 does not have a built-in alarm system to notify user of a failure or disconnection of the oxygen source.
Ensure that the oxygen source is not empty before and during the use of the optional Air/Oxygen Entrainment Mixer or Oxygen Blending Bag Kit.
The primary internal battery should be replaced every 12 months or sooner if the use time no longer meets the needs of the user.This will depend on a number of factors including settings and usage patterns. The secondary internal battery should be replaced every 24 months.
Please recognize that any life support equipment should have appropriate alternate power sources and means of ventilation readily available in case of a mechanical or system problem. If you need alternative power sources, contact Newport Medical Instruments Inc.
When the HT50 is used for transport applications, ensure that the internal battery system is fully charged prior to use.
When the Battery Empty audible alarm sounds continuously, only a limited time of internal battery power remains and an alternate power source should be found immediately.
Frequent deep discharge of the internal battery system will decrease the amount of time the HT50 will operate on battery power from a full charge state.
If you use the internal battery system as your primary power source, replace the primary battery as needed to ensure that the battery operation time is sufficient.
SERHT50NA A0808 1-5
OPERATOR’S RESPONSIBILITY
Charge the internal battery system for a minimum of 8 hours before powering the ventilator from the internal batteries. This will provide approximately 80% of the battery charge. If the battery system is completely depleted, it will take approximately 10 hours to fully recharge.
Always ensure that the green Ext. Pow er LED lights after connecting the HT50 to an e take up to two minutes to light). If the LED does not light, check all power connections and resolve any problems.
Always plug the HT50 into an external power supply source when not in use to insure best battery performance. The flow resistance of the air inlet filter, located on the right side of ventilator, is likely to increase with repeated use. Ensure that the filter is changed regularly.
The HT50 Ventilator is guaranteed to perform to specification when the Newport HT50 breathing circuit with exhalation valve is used. See Appendix B for circuit configurations and parts list.
xternal AC or DC power source (it can
Only N
EWPORT approved exhalation valves can be used with
the HT50.
Perform an exhalation valve calibration each time a clean circuit/exhalation valve is installed.
The functioning of this machine may be adversely affected by the operation of equipment, such as high frequency surgical (diathermy) equipment, defibrillators or short-wave therapy equipment in the vicinity.
This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93/42/EEC (EN55011 Class A and EN 60601-1-2). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with these instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference with other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
1-6 SERHT50NA A0808
Reorient or relocate the receiving device
Increase the separation between the equipment
SECTION 1
Cautions
Connect the equipment into an outlet on a circuit diff from that to which the devices(s) is connected
Consult the manufacturer or field service technician for help.
Only use medical grade oxygen with the Air/Oxygen Entrainment Mixer or Oxygen Blending Bag Kit.
Do not place liquid containers in the immediate vicinity or on top of the HT50. Liquids that get into the ventilator can cause equipment malfunction and damage.
After servicing an HT50, it must completely pass an Operational Verification Procedure (see Service Manual) before being returned to patient use.
An authorized Newport Medical Instruments factory-trained technician must do all service or repairs performed on the HT50.
Do not open the ventilator or perform service on an open unit while connected to external power.
erent
Use standard anti-static techniques while working inside the ventilator or handling any electronic parts.
Clean all external parts of the ventilator prior to servicing.
Water in the oxygen supply can cause equipment malfunction and damage.
Always replace a blown fuse with one of proper rating for corresponding voltage range.
NOTE: Review HT50 Oper (Section 4 of this manual) before servicing the ventilator.
NOTE: Use the tools and equipment specified in this manual to perf
Batteries contain materials that can harm the environment. Do not discard them in an incinerator or force them open. Batteries cannot be disposed of with normal waste.
Factory Maintenance or Repair
ating Manual and Theory of Operation
orm specific procedures.
SERHT50NA A0808 1-7
Scheduled maintenance or repair services are available from the Newport Technical Service Department. To send your ventilator in for service, see HT50 Service Manual for repackaging and shipping instructions.
OPERATOR’S RESPONSIBILITY
Current pricing for scheduled maintenance and labor rates can be found in Newport Medical Instruments Annual Price List. To obtain a copy, please contact your local Newport Sales Representative or contact our Customer Service Department using information below.
Contact Information
Address: Newport Medical Instruments, Inc.
Phone numbers: Toll-free within the United States:
Fax numbers: Main fax: 1.714.427.0489
1620 Sunflower Ave Costa Mesa, California, USA 92626
800.451.3111 Worldwide: 1.714.427.5811
Technical Ser
Website: www.NewportNMI.com /
www
.ventilators.com
Email: Info@NewportNMI.com Department
extensions: Customer Service: 282
T
echnical Service: 500 (24-hour pager activated
after Technical Service department hours) Clinical Support: 123 (24-hour pager)
Corporate Office Monday through Frida hours: (USA Pacific Time)
Technical Service Monday through Friday, 7:00 am to 4:00 pm hours: (USA Pacific Time)
HT50s distributed internationally have CE authorization (HT50-H, HT50­H1) and are represented by: Obelis, s.a. , 34 Ave de Tervuren, bte 44, B­1040 Brussels, Belgium. Tel: +32.2.732.59.54 Fax:+32.2.732.60.03 email:mail@obelis.net
vice fax: 1.714.427.0572
y, 8:00 am to 5:00 pm
1-8 SERHT50NA A0808
2. SPECIFICATIONS
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Symbols / Labeling Table . . . . . . . . . . . . . . . . . . . . 2-1
Controls / Alarms / Monitors . . . . . . . . . . . . . . . . . 2-2
Hardware Requirements . . . . . . . . . . . . . . . . . . . . 2-5
Miscellaneous Specifications . . . . . . . . . . . . . . . . . 2-5
Humidifier Specifications . . . . . . . . . . . . . . . . . . . . 2-7
Air / Oxygen Entrainment Mixer Specifications . . . 2-8
Oxygen Blending Bag Kit Specification . . . . . . . . . 2-8
SERHT50NA A0808
INTENDED USE
SECTION 2
SECTION 2
This device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg or 22 lbs., who require the following general types of ventilatory support, as prescribed by an attending physician: positive pressure ventilation with assist/control, SIMV and SPONT modes of ventilation. The HT50 is suitable for use in hospital, sub-acute, emergency room, home care environments as well as for transport and emergency response applications.
Front panel controls allow trained operators to select between a number of operational modes, pressure support and volume or pressure control. A comprehensive alarm system is built-in to alert the user to violations of set safety limits. When new and fully charged, the internal battery system provides up to 10 hours of power. With its patented, self-contained gas supply source, the HT50 requires no external air compressor.
|
Main Power On
Main Power Standby
Equipotentiality
Refer to Operating Manual
Alarm Setting
Audible Alarm Silence/Reset
High Alarm Set High Alarm
Low Alarm Set Low Alarm
Applied Parts Type BF
SERHT50NA A0808 2-1
SPECIFICATIONS
SPECIFICATIONS
SYMBOLS/LABELING TABLE
Controls/Alarms/Monitors Range/Selection
1. MODE (Pressure or A/CMV Volume Control) SIMV
SPONT
2. Volum e C ont rol (Tidal Volume) 100 to 2,200 mL, ATPS, ± 10%
3. Pressure Control PEEP + 5 to 60 cmH (Target Pressure)
4.
V
(Flow) 6 to 100 L/min
5. t
(Inspiratory Time) 0.1 to 3.0 sec
I
6. ƒ (Frequency) 1 to 99 b/min
7. P trig (Sensitivity) –9.9 to 0 cmH
O / mbar, pressure triggering
2
(Patient Effort Indicator LED blinks once each time the airway pressure reaches the Ptrig setting.)
8. PEEP/CPAP 0 to 30 cmH
9. P support (Pressure Support) 0 to 60 cmH
O / mbar
2
O / mbar above baseline pressure,
2
limited to PEEP + Psupport <
10. I:E Ratio 1:99 to 3:1
11. Maximum Limited Airway 100 cmH
O (98 mbar)
2
Pressure (Safety Valve)
12.
Manual Inflation 3 sec maximum
(While b
utton is pushed, the ventilator closes the exhalation
valve and delivers a operator controlled breath to the patient.)
O / mbar
2
60 cmH2O / mbar
13. Humidifier (Optional) 19ºC to 39ºC
14. Airway Pressure Meter –10 to 100 cmH
15. Alarm Silence/Reset Button Pressing button silences an audib
& Indicator seconds and resets a latched alarm indicator. LED lights to
16. ALARMS Indicators Indicators for violated alarms blink red. When the alar
17. Int. Battery Button & Indicator Pressing button displays the internal battery charge level in the
2-2 SERHT50NA A0808
O / –10 to 98 mbar
2
le alarm violation for 60
indicate that Silence is activ
e
m is no longer violated, the indicator latches (stays lit). Cancel a latched indicator by pressing the Silence/Reset button.
airw
ay pressure meter (Paw) window when operating on the internal battery system for accurate reading. LED lights to indicate internal battery system operation and alarms.
Controls/Alarms/Monitors Range/Selection
SECTION 2
18. FIO
19.
2
(with optional accessories)
On / Standby Button Press once to put in Setting condition. (On-Setting/LED off)
0.21 to 1.00
Press again to begin v
entilating (On-Ventilating/LED on). When the HT50 is ventilating, press two times to put ventilator into Standby/Off condition (LED off).
20. Push To Unlock Buttons & Pressing button unlocks front panel buttons if locked by Indicator automatic panel lockfeature. Auto lock is enabled/disabled in User
Set Up
. LED lights to indicate panel is locked.
21. Alarms
Paw (High Pressure) 4 to 99 cmHPaw (Low Pressure) 3 to 98 cmH
O / 4 to 99 mbar, must be 1< Low Paw
2
O / 3 to 98 mbar, limited by > PEEP + 3 and High
2
Paw -1 Low Baseline Pressure Paw < High Baseline Pressure Paw >
PEEP - 3 cmH2O/mbar for 3 sec during exhalation PEEP + 8 cmH
O/mbar at onset of a breath or 3 sec
2
after the start of exhalation Occlusion Paw >
PEEP + 15 cmH2O/mbar at onset of a breath or 3 sec
after start of expiration Apnea 30 sec ± 3 sec PCV Not Reached Paw P < 50% of PCV setting
Insp. Min. Volume 1.1 to 50.0 L/min
V
I
Insp. Min. Volume 0.1 to 49.0 L/min
V
I
Check Prox Line Prox Paw does not match machine Paw during inspiration Humidifier (5 messages) Humidifier malfunction/disconnection Power Switchover External power to internal battery switchover alert Battery Low Minimum of 30 minutes battery time remains until shutdown Battery Empty Minimum of 15 minutes battery time remains until shutdown
NOTE: The time between the Battery Low Alarm violation and the Battery Empty Alarm violation will vary depending on the v Alarm will occur much sooner after the Battery Low Alarm, than it will at lower volumes and pressures. In all cases, the stated minimum times for each alarm will be met, even if the two alarms occur almost simultaneously.
Device Alert (5 messages) Ventilator malfunction: FAULT BAT SYS, OCCLUSION, 10V
Shut Down Alert On to Standby/Off Shut Down Alert
SERHT50NA A0808 2-3
entilator load. At high volumes and pressures, the Battery Empty
SHUTDOWN, SYSTEM ERROR or MOTOR FAULT
SPECIFICATIONS
22. Message Display Window
Up to 16 characters, LED alpha numeric display
yed monitored parameters:
Displa
VT(Actual delivered tidal volume)
V
(Inspiratory minute volume)
I
ƒ (Total breath frequency)
Paw P (Peak airway pressure) Paw M (Mean airway pressure) Paw B (Baseline airway pressure) H (Hours of operation) S (Software version) L (or Q) (Buzzer volume (Loud or Quiet) for audible alarm)
Other displayed parameters (In USER SET UP):
Power Save (On / Off) Airway Pressure Units (cmH Set Up (User / Default) Auto Panel Lock (Enabled / Disabled) Tech. Setup (Technical set up, refer to Service Manual)
23. Front Panel Indicators
Modes
A/CMV Green LED indicates that A/CMV mode is active. SIMV Green LED indicates that SIMV mode is active. SPONT Green LED indicates that SPONT mode is active.
O / mbar)
2
Contr
ols
Volume Control Green LED indicates Volume Control ventilation. Pressure Control Green LED indicates Pressure Control ventilation.
Alarms
Paw (High Pressure) Red LED indicates high peak airway pressure, high baseline
pressure, or occlusion alarm violation.
Paw (Low Pressure) / Apnea Red LED indicates low peak airway pressure, low baseline
pressure
, apnea, or PCV (50% of PCV setting not achieved)
alarm violation.
Device Alert Red LED indicates ventilator malfunction alert.
V
(High Insp. Min. Volume) Red LED indicates high inspiratory minute volume alarm limit is
I
V
(Low Insp. Min. Volume) Red LED indicates low inspiratory minute volume alarm limit
I
(Back-Up Vent) is violated.
Misc.
Indicators
violated.
Silence / Reset Yellow LED indicates that the audible alarm is silenced for 60
seconds. Auto Lock On Green LED indicates that the panel is currently locked. On / Standby Green LED indicates that the HT50 is ventilating. Ptrig Green LED blinks on to indicate patient breathing effort.
V
(Flow) Green LED indicates that Flow is displayed in the V•/ I:E Ratio
numeric window display. I:E Green LED indicates that the I:E Ratio is displayed in the V
/ I:E Ratio numeric window display. Blinking LED indicates a breath with an inverse I:E Ratio.
2-4 SERHT50NA A0808
SECTION 2
Ext. P
ower / Green LED indicates external power is on and the internal
Charging Int. Battery battery is being charged. Red LED indicates power switchover
to internal battery.
Int. Battery (Push to Test) Yellow LED indicates internal battery is in use. LED blinks
yellow to indicate Battery Low alarm condition or blinks red to indicate Battery Empty alarm condition.
Humidifier On Green LED indicates humidifier is active. LED blinks yellow to
indicate humidifier alarm condition.
Hardware Requirements
24. Electrical Applied parts type BF
25. External A.C. /D.C. (Battery 100-240 VAC, max. 2 A Input) 50 / 60 / 400 Hz
12-30 VDC, max. 12 A
26. Dual Internal Battery Primary battery: lead acid, 12 VDC, 5 AH
Secondary back up battery: nickel metal hydride,12 VDC, 2.1 AH When new and fully charged, the Dual Pac internal battery supplies power for up to 10 hours of operation at these settings: A/CMV mode, ƒ=15, Volume Control=500 mL, tI=1.0 sec, PEEP=Ø, max. airway pressure 30 cmH Save mode ON.
O/mbar, Power
2
NOTE: The Dual Pac internal battery charges whenever the HT50 is connected to an external power source. Battery charge level is best maintained by keeping the HT50 continuously connected to external power.
NOTE: The primary internal batter
y capacity diminishes with age. As the battery ages the Battery Low alarm will occur sooner. If this begins to infringe on the needed battery time, prior to scheduled replacement, the primary internal battery should be replaced.
27. RS-232C Interface /Remote 8 pin SEMCONN connector. Operates at 19,200 baud. Allows Alarm Output put for interfacing with central alarms systems.
28. Pneumatics Gas delivery system requires no external air compressor.
Miscellaneous Description
29. Operating Temperature –18ºC to 50ºC
NOTE: For proper operation at low range temperatures (-18°C),
the HT50 must be star environment and allowed to run for 30 minutes prior to transfer to colder environment.
NOTE: At temperatures ove disabled and the internal battery does not charge.
ted in a normal room temperature
r 40ºC the charging circuit is
30. Operating Humidity 15 to 95% non-condensing
31. Operating Altitude Sea level to 15,000 ft (0 to 4,572 m)
SERHT50NA A0808 2-5
There is no altitude limitation when HT50 is oper pressurized environment.
ated in a
SPECIFICATIONS
32. Operating Pressure 600 to 1,100 mbar
33. Regulatory and Agency Complies with the following international standards & requirements: Standards/Requirements Testing and evaluation of the NEWPORT HT50
entilator has been conducted in compliance with the following
V voluntary standards:
IEC 60601-1:1988 (+A1:1991 +A2:1995; EN 60601-1:1990 +A1:1993 +A2:1995 +A3:1996) Medical Electr Part 1: General Requirements for Safety CEI/IEC 60529:2001 Degrees of Protection Provided by Enclosures (IP Code) MIL-STD-810E Environmental Test Methods and Engineering Guidelines IEC 601-2-12:1988 Particular Requirements for the Safety of Lung
Ventilators for Medical Use
IEC 60601-1-2:2001 (+A1:2006) Medical Electrical Equipment, Collater Requirements and Tests
IEC 68-2-6 Test Fc Environmental Tests: Vibration (sinusoidal) IEC 68-2-29 Test Eb Environmental Tests: Bump IEC 68-2-32 Test Ed Environmental Tests: Free Fall IEC 68-2-36 Test Fdb Environmental Tests: Random Vibration ISO 8185:1997 Humidifiers for Medical Use: General
Requirements f ASTM F 1100-90:1990 Standard Specifications for V Intended for Critical Care Use ASTM F 1246-91:1991 Standard Specifications for Electrically P
owered Home Care Ventilators - Part 1: Positive-Pressure
Ventilators and Ventilator Circuits DO-160D Environmental Conditions and Test Procedures for Airbor
al Standard: Electromagnetic Compatibility -
or Humidification Systems
ne Equipment
ical Equipment -
entilators
34. Storage Temperature –40ºC to 65ºC
35. Storage Humidity 0 to 95% non-condensing
36. Height (includes handle) 10 inches (26 cm)
37. Width 11 inches (27 cm)
38. Depth 8 inches (20 cm)
39. Weight 16.7 lbs. (7.6 kg) without humidifier
18.0 lbs
40. Patient Range Adult - Pediatric (i.e. infant, child & adolescent) with
body w
. (8.2 kg) with humidifier
eight >
10 kg
2-6 SERHT50NA A0808
41. Factory Default Parameters
P
atient Settings:
MODE A/CMV PEEP/CPAP 0 cmH2O Volume Control 500 mL P support 0 cmH t
I
1.0 sec Humidifier Off
ƒ 15 b/min Buzzer Volume Loud
O Paw
2
2
O
2
O
2
O ▲Paw
I
I
Ptrig –1.0 cmH Paw Alarms 5 cmH
Alarms 3 L/min V
V
I
40 cmH
20 L/min ▲V
User Set Up:
Power Save On Pressure Units cmH Auto Panel Lock Disabled Set Up User
SECTION 2
O
2
42. Patient Circuit Reusable 22 mm I.D. adult/pediatric circuit with 3/16 inch
(4.8
mm) I.D. proximal pressure sensing line, 1/8 inch (3.2 mm)
I.D. exhalation valve control drive line, and exhalation valve.
43. Exhalation Valve N
EWPORT'S HT50 exhalation valve (P/N HT600039) is
manufactured and designed specifically for the N Ventilator. N
EWPORT MEDICAL does not approve of the use of any
EWPORT HT50
type or brand of exhalation valve that has not been tested and approved by N
EWPORT MEDICAL for use with the HT50.
HT50-H, HT50-HB Humidifier Specifications
(operates on A.C. power only)
Set Target T
Operating Water V
Usable Volume of
ater Bottle: 265 mL
W
Compliance at Minimum
ater Level (Refill Line): 0.5 mL/cmH
W
emperature Range: 19ºC to 39ºC
olume: 300 mL
O / mbar @ 23ºC
2
Compliance at Maximum Water Level (Full Line): 0.33 mL/cmH
Intended Use: Adult and pediatric patients whose supraglottic airway is or is
SERHT50NA A0808 2-7
not b
ypassed.
O / mbar @ 23ºC
2
SPECIFICATIONS
Warm-Up Time: 30 minutes
Gas Leakage: 2 mL/min at airway pressure of 80 cmH
O / mbar
2
Humidifier Output: 33.8 mg/L at a continuous flow of 10 L/min @ 39ºC
Maximum Operating
y Pressure: 100 cmH
Airwa
O / 98 mbar
2
Maximum Temperature at
atient Wye That
the P Triggers an Alarm: 41ºC
(optional) Air / Oxyg
en Entrainment Mixer Specifications
Pneumatic Requirements:
Oxygen 35 to 90 psig (2.4 to 6.2 Bar) full operating range
40 to 70 psig (2.7 to 4.8 Bar) accuracy
} .08
Air Atmospheric pressure
Control: adjusted continuously from 0.21 to 1.00
F
IO2
WARNING Continuous oxygen monitoring is required for patient
safety. The HT50 does not have a built-in alarm system to notify user of a failure or disconnect of the oxygen source.
(optional) Oxygen Blending Bag Kit Specifications
Pneumatic Requirements:
Oxygen 0-10 L/min (calibrated) Air Atmospheric pressure
Control: FIO2, indirectly adjusted from 0.21 up to 1.00
F
IO2
WARNING Continuous oxygen monitoring is required for patient
saf of a failure or disconnect of the oxygen source.
via oxygen flow (L/min)
ety. The HT50 does not have a built-in alarm system to notify user
2-8 SERHT50NA A0808
3. DESCRIPTION OF CONTROLS,
INDICATORS, ALARMS & CONNECTORS
Front Panel Overview. . . . . . . . . . . . . . . . . . . . . . . 3-1
Front Panel Controls and Indicators . . . . . . . . . . . 3-5
Front Panel Alarms. . . . . . . . . . . . . . . . . . . . . . . . 3-14
Front Panel Message Display Window . . . . . . . . 3-23
Left Side Connectors . . . . . . . . . . . . . . . . . . . . . . 3-24
Right Side Connectors . . . . . . . . . . . . . . . . . . . . . 3-25
Optional Accessories . . . . . . . . . . . . . . . . . . . . . . 3-26
User Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
SERHT50NA A0808
FRONT PANEL OVERVIEW
Turning the HT50 On and Off
SECTION 3
The following is an overview of the HT50 front panel button functions. For an indepth description, please review FRONT PANEL CONTROLS AND INDICATORS.
The On/Standby button toggles between the following conditions:
Changing the MODE Control
Setting Condition Press the A/CMV, SIMV or SPONT button.The LED on the
On Condition Press the A/CMV, SIMV or SPONT button.The LED on the
Standby
Press On/Standby button once to go from Standby to Setting. Press again to tur
Standby: HT50 dormant. Setting: Enables setting of control parameters and exhalation
valv
On: Enables ventilation
NOTE: There is approximately a two second delay in going from
Standby to Setting condition. During this time, the HT50 performs a self test and will light all displa
The MODE control buttons ( A/CMV / SIMV / SPONT ) function differently in Setting and On conditions.
selected Mode will light g
selected Mode will b will read “PRESS AGAIN.” Press the button again within 5 seconds to confirm the mode change, or the previously selected mode will continue.
g Setting g On gg
n On. Press twice to go from On to Standby.
e calibration.
ys on the front panel.
reen to confirm the selection.
link green and the Message Display Window
Standby
Changing between Pressure Control and Volume Control
On Condition: A/CMV or SIMV Select—Adjust (Up / Down)—Accept
SERHT50NA A0808 3-1
The Pressure Control and Volume Control buttons function differently when in A/CMV or SIMV in On condition compared to when in SPONT mode in On condition or Settings condition.
Select the Pressure Control or Volume Control button. Both the LED indicator and the target value will blink.
Adjust the blinking target value for the selected control with the Up / Down buttons.
To Accept the new control and target v desired control button (Volume or Pressure) a second time.
alue you must press the
DESCRIPTION OF CONTROLS, INDICATORS, ALARMS & CONNECTIONS
On Condition: SPONT or Setting Condition: A/CMV, SIMV, or SPONT
Select—Adjust (Up / Down)—Accept
Select the Pressure Control or Volume Control button. Both the
LED indicator and target v
Adjust the blinking target value for the selected control with the Up / Down buttons.
Accept the new control and target value by either pressing the selected b new parameter for adjustment, or by waiting 5 seconds without making a change.
Note: The transition to a new pressure or volume target may require se
utton again; or by pressing another button to select a
veral breaths.
alue will blink.
Changing a Parameter (or Multiple Parameters)
Select—Adjust (Up / Down)—Accept
Select the parameter by pressing the labeled button (i.e. ƒ, Ptrig,
The parameter’s numeric display will blink.
etc).
Adjust the numeric value with the Up / Down buttons.
Accept the value by either pressing the selected button again; or
by pressing another b adjustment, or by waiting 5 seconds without making a change.
Enabling/Disabling Auto Panel Lock
Auto Panel Lock can be enabled or disabled via User Set Up (see pg 3-27). When the Auto Panel Lock is enabled, the Panel will lock 30 seconds after the last button is pushed and the LED lights green. All touch buttons (except Silence/Reset and Internal Battery Test) are locked, preventing accidental parameter changes.
utton to select a new parameter for
3-2 SERHT50NA A0808
NOTE: Auto P
To temporarily unlock parameters when Auto Panel Lock is active, push the Push To unlock button for at least one second. The Panel will relock 30 seconds after the last button is pushed.
anel Lock is factory preset to “Disabled” (off).
SECTION 3
SERHT50NA A0808 3-3
Figure 3-1
HT50 Ventilator Front Panel
(model HT50-H1, HT50-H1B)
DESCRIPTION OF CONTROLS, INDICATORS, ALARMS & CONNECTIONS
Newport HT50-H, HT50-HB (with built-in humidifier)
3-4 SERHT50NA A0808
Figure 3-2
FRONT PANEL CONTROLS & INDICATORS
Front panel controls that have corresponding LED indicators are included with the description of the control.
The HT50 front panel is shown in Figure 3-1 on pg 3-3.
On / Standby
This button toggles between the following conditions:
Standby (if attached to external power, the battery is being charged)
g Setting (allows setting of control parameters) g On (enables
ventilation)
Standby: The HT50 is dormant and ventilation is not enabled. If attached to e LED is lit green, indicating that the internal battery is being charged. The On/Standby indicator is not lit.
Setting: Pressing the On/Standby button once changes the
entilator from Standby to Setting condition.
v
gg
Standby
xternal power, the Ext. Power/ Charging Int. Battery
SECTION 3
MODE Control
NOTE: There is approximately a two second delay in going from
Standb self test and will light all displays on the front panel.
During Setting condition, all adjustable LEDs are lit. This allows the operator to preset and adjust controls prior to ventilation. The On/Standby indicator is not lit. The Message Display Window shows “Press ON to Vent,” suggesting that the On/Standby button needs to be pressed if you want the HT50 to start ventilation.
On: Pressing the On/Standby b ventilator from Setting to On. In the On condition, the HT50 is ventilating and the On/Standby indicator is lit green.
Pressing the On/Standby button twice while in On condition turns the ventilator from On to Standby.
The MODE control buttons enable the user to switch between the following operational modes:
• A/CMV
• SIMV
• SPONT
y to Setting condition. During this time, the HT50 performs a
utton once more changes the
SERHT50NA A0808 3-5
In A/CMV and SIMV, mandatory breaths can be pressure controlled or volume controlled. A green LED indicates which operational mode is active.
DESCRIPTION OF CONTROLS, INDICATORS, ALARMS & CONNECTIONS
If the HT50 is in Setting condition, changes are made by pressing the requested MODE button once. If in ON condition, changes are made by pressing the requested MODE button twice. After the first press, the Message Display Window reads “PRESS AGAIN” and the requested MODE’s indicator starts to blink. If the requested MODE button is not pressed within 5 seconds, the change is cancelled.
A/CMV (Assist / Control Mandatory Ventilation)
In A/CMV, the user may choose to pressure or volume control mandatory breaths. In either case, all breaths delivered to the patient, whether time (ventilator initiated) or patient-triggered, are the same.
The ƒ (frequency) setting determines the minimum number of time-triggered mandatory breaths delivered each minute. The Ptrig setting determines the airway pressure threshold that patient effort must reach to trigger additional mandatory breaths. If patient effort doesn’t cause airway pressure to drop enough to meet the Ptrig threshold, or if the patient doesn’t breathe, the HT50 will deliver the set ƒ (frequency) of mandatory breaths.
NOTE: If the Ptrig setting is not adjusted to a level that allows the patient’s inspir as CMV (control) mode.
atory effort to be detected, A/CMV mode performs
SIMV (Synchronized Intermittent Mandatory Ventilation)
In SIMV, the user may choose to pressure or volume control mandatory breaths. In either case, all mandatory breaths delivered to the patient, whether time (ventilator initiated) or patient-triggered, are the same. In addition, the user may choose to pressure support the spontaneous breaths in between mandatory breaths.
Unlike A/CMV, the ƒ (frequency) setting in this mode determines the total rather than the minimum number of time (ventilator) or patient triggered mandatory breaths delivered each minute.
The ƒ (frequency) setting also establishes a timing window which determines whether a patient trigger results in a mandatory breath or a spontaneous breath.
The Ptrig setting determines the airway pressure threshold that patient effort must reach to trigger mandatory breaths and also to trigger spontaneous breaths in between mandatory breaths.
3-6 SERHT50NA A0808
If patient effort doesn’t cause airway pressure to drop enough to meet the Ptrig threshold or if the patient doesn’t breathe, the HT50 will deliver the set ƒ (frequency) of mandatory breaths each minute.
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