Appendix "A" - RFSO 10733 - 980nm Surgical Laser and Accessories
Technical Specifications Worksheet
Overall Comments: N.B. Please do not adjust column widths in order to facilitate transference to the
comparison matrix for quick and easy selection.
N.B. Please complete one technical specifications worksheet per device being offered.
Copying and pasting is suggested for common responses, but it is key to have a separate
worksheet for distinct products and models in order to facilitate quick and easy selection.
N.B. Proffered systems shall exhibit the factors detailed in the specification below, else
Vendors shall supply justification for consideration as to why their solutions meet/exceed
the clinical application requirements.
Proffered Item(s) Data: Trade Name (M/N)
=>SECTION A: TECHNOLOGY REQUIREMENTS - PRODUCT
A.1. Overall System Components & Requirements:
a) Systems must be proven safe & suitable to intended clinical applications
without excessive changes to clinical processes or excessive physical effort
from staff. Systems shall have quiet operation. Systems must be proven to
have adequately robust construction to withstand the rigours of the intense, Pass/Fail
tertiary/quaternary care hospital environment. Systems shall be proven
acceptable per all requirements of this specification document via in-house
b) Systems must be proven capable of safely and effectively performing at
least all Thoracic Surgery procedures associated with resection / dissection /
transplantation of airway and lung tissues, both open and endoscopic (e.g. Pass/Fail
via bronchoscope). Bidders are invited to detail additional procedures for
which use of their systems is indicated.
Page 1 of 7
c) Controls must be proven to be clear, intuitive, & easy to use.
Minimization of daughter screens and keystrokes is critical in order to
support quality control. CDHA reserves the right to select first from devices
that are compliant with CAN/CSA 60601-1-6 "Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability".
d) Delicate tissue resection / dissection is the sine qua non of these systems.
Hence, systems must be proven to provide adequate controllabilty and
power capability for the given procedures without having to sacrifice
inordinately vis-à-vis delicacy of or rate of tissue resection / dissection.
A.2. Specific Performance Requirements:
Proffered solutions must meet the following specifications or be
proven to provide equivalent function:
> Mandatory requirements (min):
a) The laser must be proven to be as simple as possible to set up and also
to be as robust and easy to use as possible.
b) Must have the following power capacity/controllability, else Vendors to
supply justification for consideration as to why their solutions meet/exceed Pass/Fail
the clinical application requirements:
.1 Wavelength: 980nm Pass/Fail
.2 Power output @ tissue: ~5W to 120W+ Pass/Fail
.3 Power & Operation Monitor & Annunciation Pass/Fail
.4 Continuous mode (CM) and pulsed mode (PM) selections Pass/Fail
.5 Pulse length control: Selection of adjustable ranges from (a) ~5ms to 10s,
or better (PM) and (b) continuous (CM)
.6 Footswitch activation control Pass/Fail
.7 Keyed safety interlock Pass/Fail
c) Aiming laser must be >~1mW, preferrably with variable intensity Pass/Fail
d) Must have integrated internal cooling (i.e. no requirement for external
water connection, drainage, etc). Forced air is preferred.
d) An adequate range of fibers, handpieces, tips, consumables, and
accessories shall be included as separately priced options and proven to Pass/Fail
meet clinical needs for the intended procedures detailed above.
e) Optimization of weight, balance, and surgical drag is key. Handpieces
shall be proven to possess clinically acceptable balance whilst suffering Pass/Fail
minimal surgical drag.
e) Systems shall be mobile, fitted with integrated wheels or supplied with
appropriately designed carts or other mobility solution, which must be proven Pass/Fail
to meet clinical needs via in-house evaluation.
Page 2 of 7
f) Appropriate eye protection and safety filters must be provided. At least six
(6) pairs of safety glasses and two (2) pairs of safety goggles are required;
unit costs are to be included in the cost proposal when quoting for this
fundamental need to afford future ordering of additional safety eyewear.
> Optional requirements (min):
a) Vendors should include smoke evacuation solutions as separately priced
options, if available. Smoke evacuation solutions should be fully Smoke Evacuation Interfaced & Incorporated? Yes / No
incorporated with the remainder of the laser system, complete with smoke Smoke Evacuation Functionality & Control via: laser footpedal? laser console?
evacuation activation synchronized with laser activation. The CDHA Yes / No handpiece?
reserves the right to select first from bids incorporating smoke Smoke Evacuation Make / Model Incorporated: _________________________
evacuation, providing the overall solution meets the clinical needs and Smoke Evacuator Flow rate: ______ Lpm (min); ______ Lpm (max)
is deemed feasible.
o) Detail any additional features, options, &/or value adds that will aid in
Yes / No
meeting the CDHA’s current & future needs better.
A.3. - Engineering & Safety Requirements:
Note that any and all costs to adapt building systems to accommodate the
proferred products will be factored into the comparative cost analysis and will
affect product selection and award. Like costs for like factors will be applied to
a) Detail any & all engineering & safety requirements. Include at least: proffered solutions in order to derive a fair and comparative total cost of
ownership for all proffered solutions. (For instance, 115V power is basic
supply; solutions requiring 220V power will have conversion costs added to
give full cost of ownership.)
.1) Power / electrical requirements, typical consumption, & isolation; Pass/Fail N.B. Include any requirements for UPS, power conditioner, etc.
.2) EMI / EMC specifications; Pass/Fail
.3) Safety requirements & concerns; & Pass/Fail
.4) Other special system & process facility feeds. Pass/Fail
b) All equipment must be proven as adequately robust to withstand the
rigours of Tertiary care surgical environments.
c) Proposed system must withstand typical hospital reprocessing techniques.
Written, validated cleaning/sterilization instructions shall be provided with
the tender response. Adequate sterilization procedures &/or alternative Pass/Fail
measures (e.g. drapes, etc) are to be provided in order to conserve the
d) Report the following for battery power: type; capacity (mAh); recharge time
(from fully drained state); typical lifespac (in charge cycles). Not Applicable Not Applicable Not Applicable
=> Minimum charge life: 2.5 hrs @ 10 ml/hr.
Page 3 of 7
.1) N.B. Equipment will be used with a combination of ac-mains and periodic
ambulation episodes on battery power. Rechargeable batteries shall not
Not Applicable Not Applicable Not Applicable
suffer memory issues due to frequent ac-mains /battery feed switching with
non-depletion of to battery before recharge cycles (e.g. no Ni-cd).
e) Respondents must warrant that the wastewater from their product is
compliant with Halifax Regional Municipality (HRM) bylaw W-101
(“Wastewater discharge by-law”) requirements. Any and all assumptions are
Not Applicable Not Applicable Not Applicable
to be detailed. This warranty of compliance is to consider the detergents
currently in use throughout CDHA and also should include any suggested
detergents. (Details re: current detergents are available upon request.)
f) Vendors shall provide industry standard safety measures, such as but not
limited to: "laser in use" safety signage; two keys for the laser safety Pass/Fail
=>SECTION B: ADMINISTRATION & SUPPORT REQUIREMENTS
B.1 - standards & Device Licensing:
a) All equipment must have Health Canada’s Health Protection Branch
Therapeutic Device (HPB-TPD) Licensing, as required. Bidders shall confirm
their products have such licensing else provide an explanation as to why it is
not required. Pass/Fail
=> Please only supply device license numbers for the tender document
submission phase. Only tentative winning bidders must supply proof of all
applicable HPB-TPD licenses when requested.
b) All equipment must be proven to be certified to all appropriate CSA
standards (e.g. CSA 60601-1 and respecting latest revisions, interpretations,
amendments, supplements, & applicable collaterals) by a recognized Pass/Fail CAN/CSA 60601-1-2 Compliant? Pass / Fail
agency. Must confirm compliance with respect to electromagnetic immunity
and emmissions (cf. CSA 60601-1-2).
=>Only tentative winning bidders will be asked to detail all CSA standards
used to design & test their products, including actual Compliance Test detail
reports. All equipment components require this approval. If
equipment/systems are supplied without such required certification &
labelling, the supplier is responsible for all testing & modification costs to
make the equipment/system acceptable by CSA standards.
c) All power cords (including the plug), power bars, & power outlets must be
hospital grade & CSA approved.
B.2 - Warranty:
Page 4 of 7
Labour coverage duration: ______________ Months
a) One year full warranty (parts plus labour), minimum. Pass/Fail
Parts coverage duration: ______________ Months
b) Quote warranty extensions on a per year basis, as applicable.
(N.B. A 2-year, total warranty for the entire system is preferred. The CDHA
Yes / No
reserves the right to select first from solutions that provide such coverage,
providing all mandatory requirements are met.)
B.3 - Training:
a) On-site in-servicing must be supplied for all affected clinical, Biomedical
Engineering, & SPD staff members. In-servicing shall be scheduled at a
time mutually agreeable to the CDHA & the successful vendor before
commencement of the evaluation period. The CDHA reserves the right to
waive training on equipment with which it is already familiar. Any & all
associated costs are to be detailed in the Cost Proposal.
b) Separate factory-level technical service training for staff members from
Biomedical Engineering should be included as an option, priced per person.
Yes / No
The CDHA's training shall be comparable to the regular technical training
provided to the manufacturer’s own technical support staff.
d) All training is to outline safe practises for handling, cleaning, &
reprocessing of equipment, particularly with a view to potentially
contaminated equipment. Include a copy of the validated reprocessing
instructions with the bid package for confirmation of acceptability by SPD.
e) Training allowances are to be all-inclusive, including tuition, materials,
travel, accommodation, meals, & transportation (i.e. air, ground, etc) for the
instructor &/or students, as applicable. Any costs incurred over-&-above
those included in the Price Proposal are to be borne by the Vendor. Costs Pass/Fail
not included in submission packages (e.g. airfare, etc) will be estimated and
added to the proffered subtotal to facilitate complete cost of ownership
B.4 - Maintenance & Support:
a) Schedules for projected end-of-production (EOP) & end-of-support (EOS)
life are to be provided for all quoted equipment. EOS life is to be greater
than or equal to seven (7) years from date of purchase. Projected EOP: ____________________
=> N.B. Equipment purchased that has an EOS date within less than seven Projected EOS: ____________________
(7) years will be subject to remedial action if this EOS date is excluded or
incorrect in the response to this tender.
Page 5 of 7
b) Vendors are to provide ready access to knowledgeable staff for problem
solving support during CDHA's normal business hours. Vendors are to detail
any & all charges associated with service support consultation, including
both service representative visits & phone consultations for in-house staff.
c) Vendors are to include upon product shipment two (2) user’s manuals plus
one (1) service manual or like documentation per installation site. The Pass/Fail
manuals collectively should contain at least the following:
.1) Safe usage procedures & practise guidelines; Yes / No
.2) Validated cleaning & sterilization instructions; Yes / No
.3) Technical specifications; Yes / No
.4) Circuit documentation & theory of operation; Yes / No
.5) Calibration & preventive maintenance procedures; Yes / No
.6) Trouble-shooting guides; Yes / No
.7) Special maintenance equipment requirements; & Yes / No
.8) Any other information that will facilitate adequate maintenance & support
Yes / No
for the particular power systems safe & effective use.
d) Bidders are to specify where sales & service support originate. Bidders
are to have readily accessible sales & technical support. Bidders are to
describe their various sales & service mechanisms, including but not limited
.1) Current contact names together with role definition, phone / e-mail, etc.
(organization charts would be helpful, in addition);
.2) Maximum & typical response & delivery time periods, else negotiated
penalty; Pass/Fail Actual phone response time:
=> Minimum phone response within 60 minutes
.3) Typical parts & labour sources (e.g. parts & service depots). Pass/Fail
e) Indicate who will be responsible for shipping costs for repairs. Clarify if
specialized shipping containers are required.
f) Detail any & all specialized maintenance equipment required to fully
maintain the equipment throughout its estimated life cycle. This same detail
(along with the associated pricing) is also to be included in the Price
B.5 - Supply, Delivery, & Installation:
a) Vendors must describe the various initial supply schedule data, including
expected date of delivery & any terms of the quote. Free on board (F.O.B.)
location shall be Biomedical Engineering Department, Dickson Building, rm
1025, 1276 South Park Street, Halifax, NS B3H 2Y9).
Page 6 of 7
b) This is a “supply & install” acquisition. Bidders must furnish the
equipment & associated consumables, etc. Bidders are also required to
perform all installation, set-up, calibration, & testing required for the Pass/Fail
equipment to be used, except where indicated. Major job requirements &
.1) Installation must be coordinated with the assigned CDHA project
.2) The successful Bidder must install & configure all system equipment &
.3) All building system requirements are to be relayed in the Technical
Proposal for consideration. Unless otherwise specified &/or negotiated,
Capital Health or its agents will perform all building systems renovations &
B.6 - History & Upgrades:
a) Vendors must supply product history for CDHA’s assessment, including a
detail of all recalls over the previous five (5) years as well as any & all
litigation associated with the proffered products(s) – both completed &
b) Vendors must provide references & current install-base details for
proffered products for CDHA’s assessment. Please include both clinical &
technical references. Vendors are requested to comment on this listing to
show how their products have proven their worth prior to this current
application. (Vendors are to include past or present CDHA users of their
products on their reference lists.)
c) Future development upgrade paths for obsolescence protection for the
various system components are to be detailed, if known.
B.7 - Technology Upgrades:
a) If the vendor introduces a new (and/or replacement)model that would
meet the clinical requirements described in this RFP after a purchase order
has been placed but before installation, the vendor will offer CDHA the option
of supplying the newer model at no additional cost. Pass/Fail
Page 7 of 7