HT50 Service Manual SERHT50 Rev C Jan 2005

MANUAL REVISION HISTORY HT50 Service Manual SERHT50 DATE REVISION

PAGES EFFECTED

A

New release

June 2001

B

Misc. pages and drawings updated to current software release

January 2005

C

Update to software release 1.066. Update information regarding internal battery usage data, maintenance procedures and OVP

SERHT50 C0105

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 CONTROLS, INDICATORS, 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 Overview • 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

SERHT50 C0105

Section 5... CALIBRATION AND OPERATION VERIFICATION • Introduction • Test Equipment Required • Pre-Test Inspection • Front Panel Test / Alarm Check • 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 • System Leak Test • Humidifier (for HT50-H) • OVP Test Record

Section 6... MAINTENANCE PROCEDURES • Introduction • Tools • Parts Required • Routine Maintenance Procedure • Annual Maintenance Procedure • 10,000 Hour Maintenance Procedure

Section 7... TROUBLESHOOTING • Introduction • Mechanical and Pneumatic Troubleshooting • Electronic Troubleshooting

SERHT50 C0105

Section 8... ELECTRONIC & PNEUMATIC COMPONENT REMOVAL & REPLACEMENT PROCEDURES • Introduction • Tools Required • Disassembly (Lower Case) • Reassembly (Lower Case) • Internal Battery Assembly Replacement • Pump Assembly Replacement • Outlet Assembly Replacement • Humidifier Heater Assembly Replacement • Front Panel Board Replacement • Front Panel Assembly Replacement • Main Board Assembly Replacement • Power Supply 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 • Figure 9-9, Electrical System Overview • Drawing Reference Parts List

Section 10... REPACKAGING AND SHIPPING INSTRUCTIONS • Introduction • RGA (Return Goods Authorization) • Packaging: Complete Unit • Packaging: Parts or Accessories

Appendix A... HT50 PARTS AND ACCESSORIES • HT50 Ventilator Parts and Accessories • Service Parts List

SERHT50 C0105

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... 1-8 Contact Information... 1-8

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SECTION 1 OPERATOR’S RESPONSIBILITY FOR PATIENT SAFETY The Operation manual (p/n OPRHT50-1) 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. WARNING Federal law restricts this device to sale by or on the order of a physician. This manual 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. NOTE: The HT50-T ventilator is the only version of the HT50 Ventilator that has been tested and approved for use in transport applications. 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. Product modification or misuse can be dangerous. Newport Medical Instruments, Inc. (NEWPORT) disclaims all liability for the consequences of product alterations or modifications, as well as for the consequences which might result from the combination of

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OPERATOR’S RESPONSIBILITY this ventilator with other products, whether supplied by Newport or by other manufacturers, unless such a combination has been specifically endorsed by Newport.

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 NEWPORT and the nature of the action (including 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. NEWPORT shall not be liable for any special incidental or consequential damages incurred by the buyer to a third party. The buyer shall not be entitled to make liability recoveries from NEWPORT due to such situations.

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. (NEWPORT) or its representatives. 2. Rubber and plastic components and materials are guaranteed to be free of defects at time of delivery. 3. The internal battery is 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. NEWPORT or its authorized representatives must be promptly notified upon detection of the defective material or equipment. 1-2

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SECTION 1

2. Defective material or equipment must be returned to NEWPORT or its authorized representative. 3. Examination by NEWPORT or its authorized representatives must 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 NEWPORT. No other warranty, expressed or implied, is intended. Representatives of Newport are not authorized to modify the terms of this warranty. NOTE: The serial number label is located on the rear of the ventilator. If it is a seven digit serial number, the ventilator’s year of manufacture is stated in the third and fourth digits of the number series; the month is indicated by the first and second digits and the last three digits are the consecutive numbers. For example: SN 0499123 – the ventilator was manufactured in April 1999. If it is an eight digit serial number, the manufacturing year is stated in the first and second digit, the month is the third and fourth digits and the last four digits are the consecutive numbers. For example: SN 00020123 – the ventilator was manufactured in February 2000.

DEFINITIONS 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. Notes also indicate important procedures to be followed. 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 intervals to keep the device in good working condition.

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OPERATOR’S RESPONSIBILITY TYPING CONVENTIONS 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), P trig (pressure trigger), and SPONT (spontaneous mode). Please review all WARNINGS and Cautions outlined in this manual prior to servicing the HT50 for the first time.

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 manual and on labels found on the HT50 Ventilator and associated 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. Make certain the power cord ferrite is always attached to the A.C. power cord to ensure that the HT50 meets EMC requirements. When plugging the unit into an external power source, make sure to plug the power cord into the power inlet side of the HT50 before connecting the other end of the power cord to the external power source. WARNING There is a risk of explosion if used in the presence of flammable anesthetics. All settings and adjustments in the different ventilation modes must be made in accordance with a physician’s prescribed therapy. NEWPORT cannot warrant or endorse the safe performance of third 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, sterile 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. 1-4

SERHT50 C0105

SECTION 1 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. Constant attention by qualified medical personnel is recommended whenever a patient is ventilated with the HT50. 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 NEWPORT Technical Service Department immediately. Failure to identify and correct alarm violations may result in patient injury. 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 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. When the HT50 is used for transport applications, ensure that the internal battery 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 will decrease the amount of time the HT50 will operate on battery power from a full charge state. If you use the internal battery as your primary power source, replace the battery as needed to ensure that the battery operation time is sufficient. Charge the battery for a minimum of 5 hours before powering the ventilator from the internal battery. This will provide approximately 80% of the battery charge. If the battery is completely depleted, it will take approximately 7 to 8 hours to fully recharge. SERHT50 C0105

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OPERATOR’S RESPONSIBILITY Always plug the HT50 into a A.C. 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 A for circuit configurations and parts list. Only a N EWPORT approved exhalation valve 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: •

Reorient or relocate the receiving device

•

Increase the separation between the equipment

•

Connect the equipment into an outlet on a circuit different from that to which the devices(s) is connected

•

Consult the manufacturer or field service technician for help.

Cautions 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. 1-6

SERHT50 C0105

SECTION 1 After servicing an HT50, it must completely pass an Operational Verification Procedure (see Section 5) 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. 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 Operating Manual and Theory of Operation (Section 4 of this manual) before servicing the ventilator. NOTE: Use the tools and equipment specified in this manual to perform specific procedures. Batteries contain corrosive acid and lead. Do not discard them in an incinerator or force them open. Batteries cannot be disposed of with normal waste.

Factory Maintenance or Repair Scheduled maintenance or repair services are available from the Newport Technical Service Department. To send your ventilator in for service, see Section 10 for repackaging and shipping instructions. Current pricing for scheduled maintenance and labor rates can be found in Newport Medical Instruments Annual Price List. To obtain a copy of the Price List, please contact your local Newport Sales Representative or call, fax or email our Customer Service Department using contact information that follows.

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OPERATOR’S RESPONSIBILITY Contact Information Address:

Newport Medical Instruments, Inc. 1620 Sunflower Avenue Costa Mesa, California, USA 92626

Phone numbers:

Toll-free within the United States: 800.451.3111 Worldwide: 1.714.427.5811

Fax numbers:

Main fax: 1.714.427.0489 Technical Service fax: 1.714.427.0572

Website:

www.NewportNMI.com / www.ventilators.com

Email:

[email protected]

Department extensions:

Customer Service: 282 Technical Service: 500 (24-hour pager activated after Technical Service department hours) Clinical Support: 123 (24-hour pager)

Corporate Office hours:

Monday through Friday, 8:00 am to 5:00 pm (USA Pacific Time)

Technical Service hours:

Monday through Friday, 7:00 am to 4:00 pm (USA Pacific Time)

European Authorized Flight Medical, Ltd. Representative: c/o OBELIS s.a. 34, Av. de Tervuren, bte 44 B-1040 Brussels, Belgium tel: (32) 2.732.59.54 fax: (32) 2.732.60.03 email: [email protected]

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SERHT50 C0105

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 . . 2-7 Oxygen Blending Bag Kit Specification... 2-8

SERHT50 C0105

SECTION 2 INTENDED USE 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 patients, greater than 10 kg or 22 lbs., who require the following general types of ventilatory support, as prescribed by an attending physician: positive pressure ventilation and assist/control, SIMV, SPONT modes of ventilation. The HT50 is suitable for use in post-acute, emergency room, home care environments (p/n HT50-H, HT50-H1) and for transport applications (p/n HT50-T). Transport application is only applicable to the HT50-T. 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 fully charged, the internal battery provides up to 10 hours of power. With its patented, self-contained gas supply source, the HT50 requires no external air compressor.

SYMBOLS/LABELING TABLE

| Main Power On

Alarm Setting

Main Power Standby

Audible Alarm Silence/Reset

▲ Equipotentiality

High Alarm

▼ Refer to Operating Manual

Low Alarm

▲ Set High Alarm

▼ Set Low Alarm

Applied Parts Type BF

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SPECIFICATIONS Controls/Alarms/Monitors

Range/Selection

1.

MODE (Pressure or Volume Control)

A/CMV SIMV SPONT

2.

Volume Control (Tidal Volume)

100 to 2,200 mL, (0.10 - 2.20 L) ATP, ± 10%

3.

Pressure Control (Target Pressure)

5 to 60 cmH2O / mbar

4.

V (Flow)

•

6 to 100 L/min

5.

tI (Inspiratory Time)

0.1 to 3.0 sec

6.

ƒ (Frequency)

1 to 99 b/min

7.

P trig (Sensitivity)

–9.9 to 0 cmH2O / mbar, pressure triggering (Patient Effort Indicator LED blinks once each time the airway pressure reaches the P trig setting.)

8.

PEEP/CPAP

0 to 30 cmH2O / mbar

9.

P support (Pressure Support)

0 to 60 cmH2O / mbar above baseline pressure, limited to PEEP + Psupport ≤ 60 cmH2O / mbar

10. I:E Ratio

1:99 to 3:1

11. Maximum Limited Airway Pressure (Safety Valve)

100 cmH2O (98 mbar)

12. Manual Inflation

3 sec maximum (While button is pushed, the ventilator closes the exhalation valve and delivers a operator controlled breath to the patient.)

13. Humidifier (Optional)

19ºC to 39ºC

14. Airway Pressure Meter

–10 to 100 cmH2O / –10 to 98 mbar

15. Silence / Reset

Silences an audible alarm violation for 60 seconds and resets a latched alarm indicator. When pressed and held for three seconds, it toggles alarm loudness volume between Loud and Quiet functionality.

16. ALARMS Indicators

Indicators for violated alarms blink red. When the alarm is no longer violated, the indicator latches (stays lit). Cancel a latched indicator by pressing the Silence/Reset button.

17. RS-232C Interface

8 pin SEMCONN connector. Operates at 19,200 baud. Allows for interfacing with central monitoring and computer systems and remote alarm systems.

18. External / Battery Input

12-30 Volt D.C. battery input

19. Int. Battery Button

Press to display the internal battery charge level in the airway pressure meter (Paw) window. See pg 3-12 for details.

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SERHT50 C0105

SECTION 2 Controls/Alarms/Monitors

Range/Selection

20. FIO2 (with optional accessories)

0.21 to 1.00

21. On / Standby Button

Press once to set control parameters (Setting condition). Press again to enable ventilation (On condition). When the HT50 is ventilating, press two times to put ventilator into Standby/Off condition. NOTE: The internal battery charges whenever the HT50 is connected to an external power source. See item 27.

22. Push To Unlock

Unlocks front panel buttons if locked by automatic panel lock feature. Auto lock can be enabled/disabled in User Set Up.

23. Alarms ▲Paw (High Pressure) ▼Paw (Low Pressure) Low Baseline Pressure High Baseline Pressure Occlusion Apnea PCV Not Reached • ▲V• I Insp. Min. Volume ▼VI Insp. Min. Volume Check Prox Line Humidifier (5 messages) Battery Low Battery Empty Power Switchover Device Alert (4 messages) Shut Down Alert Alarm Silence

4 to 99 cmH2O / 4 to 99 mbar 3 to 98 cmH2O / 3 to 98 mbar, limited by ≥ PEEP + 3 Paw > 2 cmH2O/mbar <baseline for 3 sec Paw > ▼Paw at onset of a time-triggered breath Paw > PEEP + 15 cmH2O/mbar 3 sec after start of expiration 30 sec ± 3 sec Paw P < 50% of PCV setting 1.1 to 50.0 L/min 0.1 to 49.0 L/min Prox Paw does not match machine Paw during inspiration Humidifier malfunction/disconnection Less than 20% battery charge remains Less than 5% battery charge remains External power to internal battery switchover alert Ventilator malfunction On to Standby/Off Shut Down Alert Silences audible alarm for 60 sec; resets latched alarm LEDs

24. Message Display Window Up to 16 characters, LED alpha numeric display Displayed monitored parameters: V• T (Actual delivered tidal volume) VI (Inspiratory minute volume) 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 (cmH2O / mbar) Set Up (User / Default) Auto Panel Lock (Enabled / Disabled) Tech. Setup (Technical set up, refer to section 5)

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SPECIFICATIONS 25. Front Panel Indicators Modes A/CMV SIMV SPONT

Green LED indicates that A/CMV mode is active. Green LED indicates that SIMV mode is active. Green LED indicates that SPONT mode is active.

Controls Volume Control Pressure Control

Green LED indicates Volume Control ventilation. Green LED indicates Pressure Control ventilation.

Alarms Paw (High Pressure) ▼Paw (Low Pressure) / Apnea Device Alert • VI (High Insp. Min. Volume) •

▼VI (Low Insp. Min. Volume) (Back-Up Vent)

Red LED indicates high peak airway pressure, high baseline pressure, or occlusion alarm violation. Red LED indicates low peak airway pressure, low baseline pressure, apnea, or PCV (50% of PCV setting not achieved) alarm violation. Red LED indicates ventilator malfunction alert. Red LED indicates high inspiratory minute volume alarm limit is violated. Red LED indicates low inspiratory minute volume alarm limit is violated.

Misc. Indicators Silence / Reset Auto Lock On On / Standby P• trig V (Flow) I:E Ext. Power / Charging Int. Battery Int. Battery (Push to Test) Humidifier On

Yellow LED indicates that the audible alarm is silenced for 60 seconds. Green LED indicates that the panel is currently locked. Green LED indicates that ventilator is powered ON. Green LED blinks on to indicate patient breathing effort. • Green LED indicates that Flow is displayed in the V / I:E Ratio numeric window display. • 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. Green LED indicates external power is on and the internal battery is being charged. Red LED indicates power switchover to internal battery. 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. Green LED indicates humidifier is active. LED blinks yellow to indicate humidifier alarm condition.

Hardware

Requirements

26. Electrical

Applied parts type BF 100-240 VAC, max. 2 A 50 / 60 / 400 Hz 12-30 VDC, max. 12 A

27. Internal Battery

Sealed Lead Acid, 12 VDC, 5 A When new and fully charged, supplies power for up to 10 hours of operation at these settings: A/CMV mode, ƒ=20, Volume Control=500 mL, tI=1.0 sec, PEEP=Ø, max. airway pressure 30 cmH2O/mbar, Power Save mode ON.

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SERHT50 C0105

SECTION 2 NOTE: The 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 internal battery capacity begins to diminish at approximately 200 deep discharge cycles. This means that after 200 deep discharge cycles (battery is used to the “Low Battery” alarm and then recharged), the total battery use time will be significantly less than when new. As the battery ages the Low Battery alarm will occur sooner. When this begins to infringe on the needed battery time, the internal battery should be replaced. 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 started in a normal room temperature environment and allowed to run for 30 minutes prior to transfer to colder environment.

30. Operating Humidity

15 to 95% non-condensing

31. Operating Altitude

Sea level to 15,000 ft (0 to 4,572 m) There is no altitude limitation when HT50 is operated in a pressurized environment.

32. Operating Pressure

600 to 1,100 mbar

33. Regulatory and Agency Standards/Requirements (for p/n HT50-H, HT50-H1 and HT50-T)

Complies with the following international standards and requirements: EC 60601-1 Medical Equipment Standard, 1990 IEC 601-2-12 Lung Ventilators, 1988 EN60601-1-4 Medical Electrical Equipment, Programmable Electrical Medical Systems, 1996 EC 60601-1-2 Medical Electrical Equipment, Collateral Standard & Electromagnetic Compatibility, 1993 EN 794-1 Lung Ventilators – Particular Requirements for Critical Care Ventilators, 1996 EN 794-2 Lung Ventilators – Particular Requirements for Home Care Ventilators, 1996 ISO 10651-1 Lung Ventilators for Medical Use, 1993 ISO 10651-2 Particular Requirements for Home Care Ventilators, 1996 ISO 10651-3 Particular Requirements for Emergency and Transport Ventilators, 1997 (p/n HT50-T only) ISO 8185 Humidifiers for Medical Use, 1997 ASTM F 1100-90 Ventilators for Critical Care, 1990 ASTM F 1246-91 Electrically Powered Homecare Ventilators, Positive-Pressure Ventilators and Circuits, 1991

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